tag:theconversation.com,2011:/fr/topics/arvs-23618/articlesARVs – The Conversation2022-11-29T12:29:54Ztag:theconversation.com,2011:article/1952442022-11-29T12:29:54Z2022-11-29T12:29:54ZInjectable HIV prevention drug shows promise: we worked out how much South Africa should pay for it<figure><img src="https://images.theconversation.com/files/497226/original/file-20221124-21-w5xkkf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Remembering to take a pill every day can be a barrier to good adherence.</span> <span class="attribution"><span class="source">Daniel Born/The Times/Gallo Images/Getty Images</span></span></figcaption></figure><p>Pre-exposure prophylaxis (PrEP) is an HIV prevention method. It is taken by people who are HIV negative, so that if they are unknowingly exposed to HIV, the drug will prevent the virus from infecting them. </p>
<p>The development of this method is important for South Africa because the country is the epicentre of the HIV pandemic. Around <a href="https://www.unaids.org/en/regionscountries/countries/southafrica">7.5 million</a> people in South Africa live with HIV – about a fifth of the global population of people living with HIV. </p>
<p>The current standard-of-care PrEP is a combination antiretroviral drug that must be taken orally, called tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). This tablet has be taken daily for it to be effective, as <a href="https://pubmed.ncbi.nlm.nih.gov/27149090/">research</a> has <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5175411/">shown</a>. It has been available in South Africa since 2016 as part of demonstration projects and implementation studies. </p>
<p>Since 2020, the National Department of Health has committed to rolling it out at every primary healthcare clinic for those who want it. The pricing of oral TDF/FTC has never been a problem. It’s part of first line HIV treatment, and given the large volumes required for South Africa’s successful HIV treatment programme and generic availability, South Africa buys it at low prices. </p>
<p>However, the effectiveness of oral PrEP is only as good as the adherence to it. And remembering to take a pill every day can be a barrier to good adherence.</p>
<p>Recently, two large clinical trials (<a href="https://www.nejm.org/doi/10.1056/NEJMoa2101016">HPTN 083</a> and <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00538-4/fulltext">HPTN 084</a>), partly run in South Africa, showed that a two-monthly long-acting injectable antiretroviral, cabotegravir (CAB-LA), was even more effective than TDF/FTC at preventing HIV. </p>
<p>The benefit of an injectable product is that it avoids the problem of having to remember to take a pill daily. Moreover, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6813716/">recent</a> acceptability <a href="https://pubmed.ncbi.nlm.nih.gov/32052214/">studies</a>, including ones <a href="https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-7276-1">conducted in South Africa</a>, have shown that people strongly prefer injectable products over oral pills for HIV prevention. </p>
<p>The big question is: at what price would CAB-LA be affordable and acceptable for the South African government? We sought to answer it in our <a href="https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00251-X/fulltext">recent study</a>. </p>
<h2>Our study</h2>
<p>Currently CAB-LA is only offered in a few high-income countries and at high prices. For example, it costs <a href="https://jamanetwork.com/journals/jama/article-abstract/2789293">$22,200 per person per year in the US</a>. This price is prohibitive in South Africa. </p>
<p>South Africa is one of 90 countries that will be able to get a generic version of CAB-LA <a href="https://www.aidsmap.com/news/jul-2022/viiv-healthcare-allow-90-countries-access-generic-versions-hiv-prevention-shot">brokered through the Medicines Patent Pool</a>. But the price at which this version will be offered has not yet been set.</p>
<p>To find out what the optimal price level would be for South Africa, <a href="https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00251-X/fulltext">we ran</a> an established HIV transmission model used by the South African government for all HIV programme planning and budgeting, called Thembisa. </p>
<p>We compared the impact of CAB-LA over the next 20 years to that of the existing oral PrEP, while testing different price levels for CAB-LA. We assumed that everyone who is eligible for oral PrEP now would be able to have CAB-LA in the future. This included anyone between the ages of 15 and 24, female sex workers, and men who have sex with men. We assumed that more people would choose the injectable, and stay on it for longer than on the current oral preparation. </p>
<h2>What we found</h2>
<p><a href="https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00251-X/fulltext">Our analysis</a> found CAB-LA averted 15%-28% of new HIV infections compared to simply continuing with oral PrEP at the current low uptake levels. This is three times more than what maximising coverage with current oral PrEP would achieve. </p>
<p>Importantly, we found that the cost per CAB-LA injection needed to be less than twice that of a two-month supply of TDF/FTC to be at least as cost-effective. This means the acceptable price level for CAB-LA for South Africa would need to be somewhere between R160 and R260 (US$9 and US$14) per injection. </p>
<p>This range is towards the bottom end of the <a href="https://pubmed.ncbi.nlm.nih.gov/31855323/">minimum price range</a> currently discussed by international organisations and the manufacturer (US$16-US$270). We also found that an acceptable price level is easier to achieve if more people choose to start and continue using injectable PrEP, as higher guaranteed volumes will assist in negotiating lower prices.</p>
<h2>Why this matters</h2>
<p>Our findings come just in time for the decision-making process of the South African government. These findings are also likely relevant to governments in other low- and middle-income countries with a high HIV burden, as well as donor agencies worldwide. All of these players are currently contemplating whether, and how quickly, to replace or augment oral PrEP with CAB-LA. </p>
<p>Injectable PrEP has the potential to substantially change HIV prevention, and bring HIV control within reach, allowing a country like South Africa to spend tax money on other pressing health needs. But for implementation at a large enough scale, it would first need to be affordable, and this will require a multi-partner effort. </p>
<h2>Multi-partner effort needed</h2>
<p>What could this multi-partner effort look like? A successful roll-out would involve:</p>
<ul>
<li><p>lowering the drug’s price to a level possibly below the cost of production, and lowering the cost of production</p></li>
<li><p>harnessing, creating and sustaining demand for the product over the long term, wherever possible, in national programmes rather than single demonstration sites</p></li>
<li><p>establishing and maintaining manufacturing capacity, including local manufacture where possible, and supply chains. </p></li>
</ul>
<p>For this, all parties have to work together – including originator and generic manufacturers, donor organisations and other large funders, and the governments of low- and middle-income countries, in particular those with high HIV prevalence, such as South Africa.</p>
<p>For South Africa, the roll-out can only start in earnest if we have a commitment for injectable PrEP from the government, with or without donor organisation involvement. In turn, that commitment has to start with price negotiations with the current manufacturer. By adding the first precise estimate of the maximum drug price that a country like South Africa should accept, we hope to have set that ball rolling.</p><img src="https://counter.theconversation.com/content/195244/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lise Jamieson receives funding from United States Agency for International Development, and Bill and Melinda Gates Foundation. She is a member of the National Department of Health PrEP Technical Working Group.</span></em></p><p class="fine-print"><em><span>Gesine Meyer-Rath receives research funding from the United States Agency for International Development, FIND, WHO, the National Institutes of Health and the Bill and Melinda Gates Foundation. She is a member of the National Department of Health PrEP Technical Working Group, the National TB Think Tank, and WHO's Cost-Effectiveness of HIV testiNg Services Technical Working Group (CENTS).</span></em></p>The benefit of an injectable product is that it avoids the adherence issues related to taking a pill daily.Lise Jamieson, Senior Researcher, University of the WitwatersrandGesine Meyer-Rath, Research associate professor in Global Health, Boston UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1906842022-09-26T13:27:19Z2022-09-26T13:27:19ZHIV treatment in South Africa: how to help people stay on ARVs when life gets in the way<figure><img src="https://images.theconversation.com/files/484889/original/file-20220915-19-ihxxy3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Poor retention in health services is one of the most important reasons people interrupt HIV treatment. </span> <span class="attribution"><span class="source">Stephane de Sakutin/AFP via Getty Images</span></span></figcaption></figure><p>Antiretroviral therapy (ART) has turned HIV into a manageable chronic condition. When ART is working effectively, HIV cannot be transmitted. This allows people with HIV to live fuller lives without the fear of infecting others. It’s also led global HIV control efforts to focus on increasing ART coverage. The aim is to improve the health of people living with HIV, and to decrease and eventually halt the spread of the virus. </p>
<p>UNAIDS set 90-90-90 targets to measure global progress by 2020: 90% of people with HIV know their status, 90% of those with a known status are on treatment, and 90% of those on treatment are virally suppressed (a blood test result that means ART is working effectively). These targets have now been increased to 95-95-95, to be reached by <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8186775/">2030</a>.</p>
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Read more:
<a href="https://theconversation.com/hiv-aids-and-90-90-90-what-is-it-and-why-does-it-matter-62136">HIV, AIDS and 90-90-90: what is it and why does it matter?</a>
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<p>South Africa has <a href="https://www.spotlightnsp.co.za/2022/07/26/spotlight-on-hiv-six-graphs-that-tell-the-story/">achieved</a> the first 90 target but it <a href="https://www.thembisa.org/content/downloadPage/Thembisa4_5report">falls short</a> on the second 90.
Despite having more than <a href="https://www.unaids.org/en/regionscountries/countries/southafrica">5.5 million people</a> on treatment, only 75% of those with a known status are on ART. </p>
<p>Poor retention in health services is one of the most important reasons for this. People living with HIV need to be on ART for their whole lives. This is a tough ask, and although the pills are available free of charge in public health institutions, many people <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8186775">interrupt treatment</a>. Modelling and programme <a href="https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00310-2/fulltext">data</a> <a href="https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00327-8/fulltext?dgcid=raven_jbs_etoc_email#articleInformation">suggest</a> that the number of people re-initiating ART is as high as, or higher than, the number of people starting treatment for the first time. </p>
<p>Interrupting treatment is a problem for two reasons. First, people who aren’t on treatment are likely to become sick and die. Second, without consistent treatment HIV can be transmitted, leading to additional infections. </p>
<p>At <a href="https://www.anovahealth.co.za/">Anova Health Institute</a> we support the Department of Health in providing HIV services in five districts of South Africa. In a <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0256540">recent study</a>, we wanted to know more about why people with HIV interrupt and return to treatment, and how we can support them to stay in care. </p>
<h2>Reasons for stopping treatment</h2>
<p>We surveyed 562 and interviewed 30 people returning to care after interrupting ART in three provinces in South Africa. We also explored service provider challenges in providing treatment and care.</p>
<p>Our <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0256540">analysis</a> showed that retention in care is influenced by multiple factors. These include individual, family, societal and healthcare service barriers. </p>
<p>Mobility or relocation was the most common reason for treatment interruption, reported by close to a third of respondents. It was followed by ART-related factors, including side effects, and feeling too sick to continue ART (15% of respondents); and time limitations due to work (10%). Participants who move around a lot said managing their ART was difficult because of administrative hurdles.</p>
<p><a href="https://www.tandfonline.com/doi/full/10.1080/16549716.2021.2012019">Health service barriers</a> included negative service provider attitudes and providers insisting on transfer letters, which led to interruption of treatment and care. Feedback sessions conducted with 99 healthcare providers revealed that people returning to care were sometimes sent to the back of the queue or turned away if they did not have transfer letters. Both these practices are discouraged in national guidelines. Most providers <a href="https://www.tandfonline.com/doi/full/10.1080/16549716.2021.2012019">reported</a> they had seen or heard other providers act poorly towards recipients of care after interrupting ART. The poor behaviours and attitudes of providers were partly attributed to limited resources and work overload.</p>
<p>On the other hand, we <a href="https://www.tandfonline.com/doi/full/10.1080/16549716.2021.2012019">found</a> that clinics which had flexible and extended hours services were better able to keep people in care. This shows that health services need to be more responsive to different life circumstances.</p>
<h2>What must be done</h2>
<p>Health systems should be set up to allow people to change where they pick up their drugs. <a href="https://journals.sagepub.com/doi/full/10.1177/11786329211073386">Movement between provinces</a> is common in South Africa. Health services need to be more responsive to people moving within and between districts and provinces, as well as outside South Africa. A functional health information system is needed to link medical records and allow movement between clinics or drug pick-up points anywhere in the country. Healthcare providers should not insist on transfer letters. <a href="https://www.knowledgehub.org.za/elibrary/adherence-guidelines-hiv-tb-and-ncds-standard-operating-procedures-2020">The official policy</a> requires people to be assisted without a transfer letter, in practice many are turned away. Improved treatment literacy would also empower people to understand their own treatment and demand access to care.</p>
<p>ART and other services relating to HIV and other chronic diseases can be provided in <a href="https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00327-8/fulltext?dgcid=raven_jbs_etoc_email#articleInformation">many ways</a> inside and outside <a href="https://journals.sagepub.com/doi/full/10.1177/11786329211073386">health facilities</a>. In South Africa, ART and chronic medication can be provided through the <a href="https://www.health.gov.za/wp-content/uploads/2021/09/ccmdd-dablab-AnQ.pdf">Dablapmeds programme</a>. This allows people to collect three months’ medication at pick-up points closer to home or work. Models like this should be supported and strengthened.</p>
<p>People with HIV <a href="https://ritshidze.org.za/wp-content/uploads/2022/03/Peoples-COP22-South-Africa.pdf">told the Department of Health</a> they wanted prescriptions for 12 months, and ART refills of three to six months. A 12-month prescription was used during COVID-19 as an emergency measure, and Anova’s programmes reported no decrease in viral suppression. This policy should be expanded. </p>
<p>Healthcare providers need improved working conditions and support to improve their ability to provide empathetic, quality services. Overall, the country needs more patient-centred and responsive health services to improve retention on ART.</p>
<p>People on ART need <a href="https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-022-00722-x">comprehensive support</a> that covers medication-related issues, psychosocial support and socioeconomic support. Proactive strategies could include check-in phone calls or messages, appointment reminders, and pop-up sites to collect treatment in remote communities, and after-hours facilities. Task shifting allows different forms of treatment support to be offered and can promote <a href="https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00327-8/fulltext?dgcid=raven_jbs_etoc_email#articleInformation">ART adherence</a>.</p>
<h2>Why this matters</h2>
<p>Supporting people living with HIV to stay on treatment is the biggest challenge currently facing South African HIV services. </p>
<p>The needs and views of people with HIV must be heard and considered to protect and build on the health gains from the country’s antiretroviral programme. </p>
<p>Services that are flexible and take into account people’s changing life circumstances will improve health and decrease HIV transmission.</p><img src="https://counter.theconversation.com/content/190684/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Melanie Bisnauth is employed at the Anova Health Institute, a South African-based NGO, that receives funding from the President's Emergency Plan for AIDS Relief (PEPFAR) through USAID. Some of the work discussed in this article was funded through this grant.</span></em></p><p class="fine-print"><em><span>Kate Rees is employed at the Anova Health Institute, a South African-based NGO, that receives funding from the President's Emergency Plan for AIDS Relief (PEPFAR) through USAID. Some of the work discussed in this article was funded through this grant.</span></em></p><p class="fine-print"><em><span>Cathrine Chinyandura is employed at the Anova Health Institute, a South African-based NGO, that receives funding from the President's Emergency Plan for AIDS Relief (PEPFAR) through USAID. Some of the work discussed in this article was funded through this grant.</span></em></p>When antiretroviral therapy is working effectively, HIV cannot be transmitted. This allows people with HIV to live fuller lives without the fear of infecting others.Melanie Bisnauth, Public Health Technical Advisor, Anova Health Institute and Doctoral Researcher, School of Public Health, University of the WitwatersrandKate Rees, Public Health Medicine Specialist, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1887642022-09-05T18:36:09Z2022-09-05T18:36:09ZHIV patients in Botswana get adequate treatment but not all of them – one group is slipping through the cracks<figure><img src="https://images.theconversation.com/files/481068/original/file-20220825-14-j8bh53.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Franco Volpato/Shutterstock</span></span></figcaption></figure><p>HIV remains a major public health challenge globally. Around <a href="https://www.unaids.org/en/resources/fact-sheet">38 million</a> people are estimated to be living with the infection. Sub-Saharan Africa bears the brunt of the HIV epidemic. Close to two thirds of the HIV cases are in the region. </p>
<p>But huge strides have been made in curbing the epidemic. One of the keys to this has been the introduction of antiretroviral therapy (ART). It’s resulted in people with HIV living long, productive lives and reducing the risks of HIV transmission. </p>
<p>HIV has a high mutation rate, however. As a result, there is evidence of HIV variants with resistance to almost all available antiretroviral drugs. The development of variants with drug resistant mutations is a major challenge to the success of ART – and therefore to efforts to achieve the UN goal of <a href="https://www.unaids.org/en/resources/campaigns/World-AIDS-Day-Report-2014">ending AIDS by 2030</a>.</p>
<p>In developing countries, screening for HIV drug resistant variants is done only when patients who are on treatment have high viral loads – over 1,000 copies/ml, as per the World Health Organization <a href="https://www.who.int/publications/i/item/9789241507196">guidelines</a>. This means drug resistant HIV variants in patients with low viral loads aren’t detected. This is the case in many countries in sub-Saharan Africa – including Botswana.</p>
<p>We <a href="https://www.researchgate.net/publication/358958674_HIV-1_drug_resistance_mutations_among_individuals_with_low-level_viraemia_while_taking_combination_ART_in_Botswana">set out to establish</a> three things.</p>
<p>Firstly, what percentage of patients on ART had low HIV viral loads. This is data that’s never been collected before. Secondly, we wanted to determine HIV drug resistant mutations in this cohort of patients. The third thing we set to establish is whether there’s a connection between patients with low viral loads and treatment failure. This is known as virologic failure.</p>
<p>Answering these three questions has given us a much deeper understanding of where a country like Botswana stands in its efforts to eliminate HIV. As a result of our research we have a better understanding of how many people with HIV have low viral loads, how serious a threat we face from drug resistant HIV variants and finally how many people with low viral levels are at risk of treatment failure. </p>
<p>We found that people with low viral loads were just as likely to harbour drug resistant HIV variants as people with high viral loads. This matters because it points to the need to change how people with HIV who are on ART are managed in developing countries. </p>
<p>We recommend that patients on ART with detectable viral loads above 50 copies/ml be further investigated to ensure that they don’t harbour drug resistant HIV variants. </p>
<h2>What we found</h2>
<p><strong>Number of HIV patients on ART with low viral load:</strong> Our study looked at a cohort of 6,078 people with HIV from across Botswana who were receiving combination antiretroviral therapy. We narrowed this down to 4,443 people who had been on ART treatment for at least six months. </p>
<p>Only 8% had viral loads of more than 50 copies/ml. Testing for mutations only happens on patients with viral loads of over 1,000 copies/ml, which means that this group isn’t being screened.</p>
<p>The figure of 8% may seem low. But it means that this cohort either has a resistant variant, or their treatment isn’t working.</p>
<p><strong>Prevalence of drug resistant mutations:</strong> We sequenced the HIV in the patients with low viral loads as well as those with viral loads above 1,000 copies/ml. We found no difference in the prevalence of HIV drug resistant mutations between the two patient groups. This indicates that patients with low HIV viral loads are just as likely to harbour HIV variants with drug resistance mutations as those with high viral loads.</p>
<p><strong>Treatment failure:</strong> A select group of the patients with low HIV viral loads were followed up for at least a year. We found that there was a statistically significant association of low level HIV viral load with subsequent virological (or treatment) failure. Our results show that patients with a low HIV viral load are more likely to experience virological failure.</p>
<p>Current treatment guidelines describe virologic failure as viral loads above 1,000 copies/ml. Our results challenge this. </p>
<h2>Going forward</h2>
<p>Our results echo the views expressed by others who have <a href="https://www.frontiersin.org/articles/10.3389/fmed.2022.939261/full">looked at this issue</a>. Like them, we recommend that the HIV treatment guidelines in developing countries be improved to ensure that patients with low HIV viral load while on ART get the necessary attention. </p>
<p>In developed countries, screening for drug resistant HIV variants is done when people start ART. Drug resistance screening is also done whenever a patient on treatment has a detectable viral load. </p>
<p>The same approach should be applied in developing countries. </p>
<p>Patients should also have a follow-up viral load test which – if the virus is still detectable – should lead to sequencing of the HIV variants they harbour. If found to have a drug resistant variant, the patient should be switched to an appropriate ART regimen. </p>
<p>If they are found not to harbour HIV drug resistant variants, the patient should undergo intensive adherence counselling because this could point to treatment failure. </p>
<p>Scientists and funders must invest time and resources to develop more sensitive HIV drug resistant assays that can sequence HIV in samples with low viral loads. This is currently a limiting factor as most of the available assays don’t work well with samples with low viral loads.</p><img src="https://counter.theconversation.com/content/188764/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Simani Gaseitsiwe receives funding from : Wellcome Trust, NIH, EDCTP, Bill and Melinda Gates Foundation.
</span></em></p>Patients with low HIV viral loads are just as likely to harbour HIV variants with drug resistance mutations as those with high viral loads.Simani Gaseitsiwe, Principal Investigator and Research Associate at Botswana Harvard AIDS Institute Partnership, Sub-Saharan African Network for TB/HIV Research Excellence (SANTHE)Licensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1606152021-05-13T09:37:13Z2021-05-13T09:37:13ZPeople with HIV are still dying from a treatable, but neglected, disease: all it needs is a plan<figure><img src="https://images.theconversation.com/files/400238/original/file-20210512-24-1qps1l5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Political is necessary to lower deaths from cryptococcal meningitis.</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Thembi Ngubane was a young woman who became famous through the American National Public Radio show <a href="https://www.comminit.com/hiv-aids-africa/content/thembi%E2%80%99s-aids-diary-year-life-south-african-teenager"><em>Thembi’s AIDS Diary: A Year in the Life of a South African Teenager.</em></a>. She was vibrant, punchy, full of life. She recorded the consultation when, as a doctor, I started her on antiretroviral therapy in 2005. Jo Menell’s documentary film, <a href="https://www.amazon.com/Thembi-Jo-Menell/dp/B07D5X77MN"><em>Thembi</em></a>, gives a sensitive and nuanced account of her fast rise to fame, culminating in meeting Barack Obama and addressing the US Congress, and then equally rapid fall into oblivion, loss from care, and death.</p>
<p>The disease that killed her was cryptococcal meningitis. It is a killer in the dark, responsible for an <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818156/">estimated</a> 181,000 worldwide in 2014, of which 135,900 were in sub-Saharan Africa. Most were people who had been <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818156/">living with HIV</a>. The cryptococcus fungus is everywhere in the environment and for people with a working immune system it causes no harm. But in people with HIV who have a weak immune system it can invade the lining of the brain and other organs, quickly leading to death unless treated.</p>
<p>Most people who <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818156/">die from cryptococcal meningitis</a> are under the age of 40. Yet, with early diagnosis and the best available treatment, mortality can be reduced to <a href="https://pubmed.ncbi.nlm.nih.gov/29539274/">30%</a> of what it is currently.</p>
<p>Why, then, do people still die? It is not because the lifesaving tools and treatments are unaffordable. The CrAg-LFA, a rapid finger-prick test to detect antibodies to cryptococcus in blood and spinal fluid, costs only US$2. The drug flucytosine, which if widely available would reduce deaths from cryptococcal meningitis by as much as <a href="https://pubmed.ncbi.nlm.nih.gov/29539274/">40%</a>, costs only US$100. The other key drug needed for treatment, amphotericin B, is affordable for health department budgets in its convential formulation, while the less toxic liposomal form of amphotericin B remains too expensive for most. </p>
<p>Saving lives does not require high tech tools, but simple point-of-care tests. The key medicines are decades old, generally simple to produce, and off-patent. The biggest part of the treatment cost is that of basic hospitalisation and medical staff. The real problem lies higher up, with a lack of political will to address this leading cause of HIV-related mortality. </p>
<p>In May 2021, a group of health organisations based in Africa, Europe and the US released the <a href="https://www.gaffi.org/special-webinar-announcement-ending-cryptococcal-meningitis-deaths-by-2030-a-new-global-initiative/">Strategic Framework for Ending Cryptococcal Meningitis Deaths by 2030</a>. It calls on the World Health Organisation, donors, governments, civil society organisations and industry to set clear targets, draw up plans and work together to drastically reduce deaths from cryptococcal meningitis.</p>
<h2>Preventable deaths</h2>
<p>Tens of thousands of people die unnecessarily because cryptococcal meningitis has been neglected. </p>
<p>There is a <a href="https://www.who.int/tb/strategy/end-tb/en/">global strategy</a> to end deaths from tuberculosis, but no strategy to end cryptococcal meningitis. A strategy is crucial for priority setting, resource allocation and planning. It focuses attention on the steps needed to end cryptococcal meningitis deaths and who should be responsible for addressing those steps.</p>
<p>Access to tests and optimal treatment remains extremely limited in clinics in sub-Saharan Africa. Flucytosine, the cornerstone medicine for treatment, isn’t registered in any country in Africa. Pharmaceutical companies rarely apply for registration if the market is not deemed to be profitable. Governments do not include unregistered drugs in national guidelines. In the case of flucytosine this catch-22 situation led to <a href="https://pubmed.ncbi.nlm.nih.gov/32126322/">market failure</a>.</p>
<p>There is reason to hope, however. </p>
<p>A few years ago the South African National Institute for Communicable Diseases, with support from the US Centers for Disease Control, scaled up systematic screening for cryptococcal meningitis of people with HIV with severe immune suppression. This helped to diagnose more people but without flucytosine the treatment was still suboptimal. A number of public sector doctors started treating patients with flucytosine after obtaining exemptions from the South African regulator to use an unregistered drug. </p>
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Read more:
<a href="https://theconversation.com/explainer-how-south-africa-regulates-medicines-and-vaccines-154843">Explainer: how South Africa regulates medicines and vaccines</a>
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<p>This inspired Doctors Without Borders to start a clinical access programme to donate flucytosine to one hospital in every province of South Africa. Early <a href="https://pubmed.ncbi.nlm.nih.gov/32126322/">results</a> already show much lower mortality in patients treated with flucytosine. The clinical access programme was taken over by the Clinton Health Access Initiative and expanded to provide supplies for advanced HIV disease to nine countries. </p>
<p>Spurred by the prospect of increasing demand, a large Indian manufacturer of generic medicines took over the production of flucytosine and applied for registration in a number of African countries, including South Africa. An increasing number of <a href="https://sahivsoc.org/Files/crypto%20guidelines.pdf">national guidelines</a> now include the treatment recommended by the World Health Organisation.</p>
<p>Yet, despite this progress, most people with cryptococcal meningitis remain without a diagnosis and without optimal treatment. This is why a global strategy is needed. The strategy must have clear targets and a roadmap to scale up access to tests and medicines. Transforming cryptococcal disease from a silent killer into a disease that is mostly cured is achievable at a modest cost.</p>
<h2>Call for action</h2>
<p>The last time I saw Thembi was in consultation days before she died in 2009. She was a shadow of the person I had started on antiretroviral treatment a couple of years earlier. </p>
<p>After interrupting treatment, she had gradually lost weight and was increasingly confused. My heart sank when I read the referral letter: cryptococcal meningitis. With late diagnosis and optimal treatment out of reach, I knew the prognosis was poor.</p>
<p>The call for attention to cryptococcal meningitis is a plea to bring this neglected cause of death out of the darkness. This can be done by ensuring that testing and treatment becomes available everywhere.</p>
<p><em>Dr Amir Shroufi, Medical Advisor at the CDC Foundation contributed to the article.</em></p><img src="https://counter.theconversation.com/content/160615/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Gilles van Cutsem is affiliated with Doctors Without Borders, a member of the Cryptococcal Meningitis Advocacy Group, and Chair of the Patient Advisory Committee of the slow release flucytosine research project. </span></em></p>Cryptococcal ceningitis is one of the main causes of death of people with HIV. The tests and medicines to diagnose and treat it exist but remain inaccessible to most. A global strategy is needed.Gilles van Cutsem, Honorary Research Associate, Centre for Infectious Disease Epidemiology and Research, University of Cape TownLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1345542020-03-24T14:30:09Z2020-03-24T14:30:09ZTB, HIV and COVID-19: urgent questions as three epidemics collide<figure><img src="https://images.theconversation.com/files/322642/original/file-20200324-115461-mzcsbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Doctors Without Borders supporters march in protest to the American Consulate in Johannesburg in 2012 over lack of funding to fight HIV.</span> <span class="attribution"><span class="source">Photo by Foto24/Gallo Images/Getty Images</span></span></figcaption></figure><p><em>Tuberculosis (TB) and HIV pose a significant burden on South Africa’s health system. There’s a close relationship between the two. About <a href="https://www.avert.org/professionals/hiv-programming/hiv-tb-coinfection">60%</a> of TB patients are also HIV-positive. The novel coronavirus (Sars-CoV-2) is likely to be of particular concern for communities with high rates of TB and HIV. Sars-CoV-2 and its resulting disease (COVID-19) haven’t been fully researched and understood yet. But speculation based on the behaviour of other viruses and chronic illnesses raises concerns that HIV and TB patients may have a higher risk of developing severe disease. Emily Wong answers some questions.</em></p>
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<p><strong>Are people with TB more susceptible to infection with SARS-COV-2?</strong></p>
<p>SARS-COV-2’s primary target is the lungs where it causes inflammation in the delicate tissues that usually allow oxygen to transfer into blood. In mild cases, COVID-19 can just cause a cough, but in severe cases the lungs can fill with inflammation and fluid making it very difficult for them to provide adequate oxygen to the rest of the body. In people who are otherwise healthy, most cases of COVID-19 are mild or moderate.</p>
<p>At this time, I’m not aware of any data that directly address whether TB makes people more susceptible to COVID-19. But from the Chinese experience, we have <a href="https://special.croi.capitalreach.com/">seen</a> that people with chronic lung disease are more likely to have increased severity of COVID-19. On that basis, we are concerned that people with undiagnosed active TB, or people currently undergoing treatment for TB, may have increased risk of developing more severe COVID-19 disease if they become infected with SARS-COV-2.</p>
<p>There is also increasing recognition that post-TB chronic lung disease can be an important long-term <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019552/">consequence of TB</a>. We are concerned that this could also affect COVID-19 severity. After TB, people can get bronchiectasis – chronic damage to the airways of the lung. This can predispose them to other lung infections. Another lung condition – chronic obstructive pulmonary disease – can be caused by tobacco use or by the changes left in the lung after TB. </p>
<p>Even though there’s no data about the effect of post-TB lung disease on COVID-19 at this point, we are concerned that people who have had TB in the past – and have been left with some lung damage – may have a more difficult and severe time with COVID-19.</p>
<p><strong>What about people infected with HIV?</strong> </p>
<p>There is also very little data to guide us here. But we know that in general HIV infection has profound effects on <a href="https://pneumonia.biomedcentral.com/articles/10.1186/s41479-018-0050-9">lung health</a> and <a href="https://erj.ersjournals.com/content/39/3/730">immunity</a>. This is why HIV infection increases susceptibility to both Mycobacterium Tuberculosis (Mtb) – the bacterium that causes TB – infection and TB disease. We are therefore concerned that HIV infection may also affect SARS-COV-2 infection and COVID-19 severity.</p>
<p>But most experts think that people who are on antiretroviral therapy and whose viral loads are suppressed will probably have a better time with COVID-19 than <a href="https://www.bhiva.org/coronavirus-and-HIV-responses-to-common-questions-from-BHIVA">people who aren’t</a>. It is very important that people keep taking their HIV medications throughout any disruptions caused by the current COVID-19 epidemic.</p>
<p><strong>What will the impact of the SARS-COV-2 epidemic be on TB and HIV services in South Africa?</strong></p>
<p>This is a major concern. Even countries with better resourced national health systems have <a href="https://news.sky.com/story/coronavirus-they-call-it-the-apocalypse-inside-italys-hardest-hit-hospital-11960597">rapidly become overwhelmed</a> as the COVID-19 epidemic hits. </p>
<p>South Africa has the world’s largest antiretroviral programme. Huge progress has been made. Even in KwaZulu-Natal, the epicentre of the HIV epidemic in South Africa, new HIV infection rates have been <a href="https://sanac.org.za/sanac-welcomes-the-sahr2019-report/">dropping</a>. This is because of tremendous efforts to test people and to put people on antiretroviral treatment in a sustained way. Other factors have included national programmes like voluntary medical male circumcision. </p>
<p>The country has also started to see a <a href="https://www.aidsmap.com/news/aug-2019/tb-clusters-show-where-hiv-treatment-missing-south-africa">decline</a> in TB rates. We think this is related to improvements in the HIV treatment <a href="https://www.unaids.org/en/regionscountries/countries/southafrica">coverage</a>. This is good news. But it’s the result of massive public health programmes that have taken a huge amount of time and effort to set up and optimise. And they’re still challenged by shortages of human and system resources.</p>
<p>We are very concerned about the impact that COVID-19 epidemic could have on HIV and TB services. </p>
<p>Thought is already going into how to try to maintain these critical HIV and TB services. In light of an impending health crisis, attention is on how to maintain sustained access to HIV and TB care. The President’s Emergency Plan for AIDS Relief (PEPFAR) and the South African HIV Clinicians Society are trying to address this. For example, they are <a href="https://sahivsoc.org/Files/SAHIVSoc_COVID_final2.pdf">urging</a> the health system to make six months of antiretrovirals available to people to save them from having to visit their clinics every month. </p>
<p><strong>Are there extra precautions that individuals with TB and TB/HIV can take?</strong></p>
<p>It’s very important that people ensure a supply of their HIV and TB medications and take them regularly. </p>
<p>At this point all South Africans should be heeding the call made by the <a href="https://www.gov.za/speeches/president-cyril-ramaphosa-escalation-measures-combat-coronavirus-covid-19-pandemic-23-mar">President </a> to focus on the basic hygiene interventions such as frequent hand-washing as well as implementing social distancing to the maximum extent. That means avoiding contact with groups of people outside of households, and staying home strictly. </p>
<p>All of these measures are extremely important, whether someone is personally at higher risk of severe infection, or for people who may not personally be at risk of more severe disease but may have a family member who’s older or HIV-positive or a neighbour who falls into any of those categories. </p>
<p>At this point the national recommendations apply to everyone. All South Africans need to take them very, very seriously because millions of people are immuno-supressed due to HIV or have some lung compromise due to prior TB infection.</p>
<p><strong>Will any of the research on vaccines in South Africa be useful in the search for a COVID-19 vaccine</strong>?</p>
<p>The fact that South Africa has robust vaccine trial infrastructure for both TB and HIV is undoubtedly to its advantage when it comes to thinking about COVID-19 vaccine development. There are already candidate COVID-19 vaccines in human testing. The company Moderna in collaboration with the National Institute of Allergy and Infectious Diseases in the US have started clinical trials of an <a href="https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins">mRNA vaccine candidate</a>. Other candidates are also <a href="https://www.jnj.com/johnson-johnson-announces-collaboration-with-the-beth-israel-deaconess-medical-center-to-accelerate-covid-19-vaccine-development">under development</a>. When these are ready for larger scale human testing, the global scientific community will almost certainly use existing vaccine trial networks to do this testing. Because of both HIV and TB research efforts to date, South Africa is very well represented.</p><img src="https://counter.theconversation.com/content/134554/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Emily Wong is TB and HIV physician-scientist and supervisor in the Sub-Saharan African Network for TB/HIV Research Excellence (SANTHE), based at the Africa Health Research Institute (AHRI) in Durban, South Africa. She receives funding from the National Institutes of Health and the Bill and Melinda Gates Foundation. She also is a member of the Division of Infectious Diseases at Massachusetts General Hospital.
</span></em></p>Very little is known about the relationship between COVID-19 and HIV and TB. What is known is that people’s lungs are affected by all three.Emily B. Wong, Faculty Member, Africa Health Research Institute, University of KwaZulu-NatalLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1312422020-02-12T12:41:52Z2020-02-12T12:41:52ZHow nutrition education can make a difference to people with HIV in Nigeria<figure><img src="https://images.theconversation.com/files/313991/original/file-20200206-43123-1loe0jy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>HIV and AIDS are still global health problems and sub-Saharan Africa remains the <a href="https://www.who.int/gho/hiv/en/">most affected</a> region. Globally, around <a href="https://www.unaids.org/en/resources/fact-sheet">770,000</a> people died from AIDS-related conditions in 2018, <a href="https://aidsinfo.unaids.org/">160,000</a> of them in West and Central Africa.</p>
<p>The <a href="https://www.ncbi.nlm.nih.gov/pubmed/29952786">standard treatment</a> for HIV consists of a <a href="https://www.ncbi.nlm.nih.gov/pubmed/29065165">combination</a> of at least three antiretroviral drugs. But <a href="https://www.ncbi.nlm.nih.gov/pubmed/23450554">providing</a> antiretroviral therapy without proper, nutritious diets may compromise the effectiveness of the treatment. </p>
<p>People with HIV have <a href="https://www.ncbi.nlm.nih.gov/pubmed/31108127">higher</a> <a href="https://www.ncbi.nlm.nih.gov/pubmed/16477562">energy needs</a> than those of people without HIV. And the World Health Organisation <a href="https://extranet.who.int/rhl/topics/hiv-aids/food-insecurity-sexual-risk-behavior-and-adherence-antiretroviral-therapy-among-women-living-hiv">recommends</a> that antiretroviral medications be taken with food to avoid possible side effects such as headaches and stomach problems, which can lead to weakness and weight loss.</p>
<p>HIV infection has a <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6522867/">complex relationship</a> <a href="https://www.ncbi.nlm.nih.gov/pubmed/31668643">with nutrition</a>. </p>
<p>Because of the importance of good nutrition in the management of HIV, we <a href="https://www.frontiersin.org/articles/10.3389/fpubh.2019.00030/full">aimed</a> to develop and test a nutrition education programme for adults living with HIV in the Nigerian context. We wanted to evaluate their knowledge of nutrition, their actual diets and the effect on their bodies – in short, the programme’s impact on their health and quality of life.</p>
<p>We <a href="https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0640-4">found</a> that the education programme helped people to choose healthy foods and this improved their physical well-being. This experience could contribute to other education programmes aimed at supporting people with HIV to have a better quality of life.</p>
<p>We started by studying the existing Nigerian nutrition guidelines for adults living with HIV. The nutrition information and recommendations were the same for all adults, whether they had HIV or not. The general premise of the <a href="https://nigeria.savethechildren.net/sites/nigeria.savethechildren.net/files/library/NPFN%20manual%20design%20%20v13.pdf">Nigerian national dietary guidelines</a> is to promote good dietary practices and to avoid alcohol consumption and smoking. </p>
<p>There are no details on key issues relating to HIV and nutrition such as how individuals can improve the variety of foods they eat, how they can get important vitamins and minerals, and how they can access clean drinking water despite limited resources. </p>
<p>In addition, there isn’t much appropriate nutrition information available to public health care staff and patients.</p>
<p>We wanted to design a programme that would plug this gap by teaching adults with HIV how to eat healthy foods with limited resources. </p>
<h2>The intervention</h2>
<p>Our <a href="https://www.frontiersin.org/articles/10.3389/fpubh.2019.00030/full">research</a>, in the form of a nutrition education intervention, focused on outpatients receiving HIV treatment at two selected hospitals in Abeokuta, southwestern Nigeria. </p>
<p>First we conducted a needs assessment in a similar group, which revealed poor <a href="https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0640-4">quality of life</a>, high consumption of unvaried meals, poor nutrition knowledge and unhealthy eating behaviour. We used this information to develop contextualised nutrition education materials. Health care workers could use these materials to provide nutrition education specifically for patients with HIV, such as planning varied meals, the relationship between diet and medication, and dealing with barriers to healthy eating. </p>
<p>The content of the programme also covered the importance of hygiene and exercise, how to deal with problems like diarrhoea and anaemia, and how to shop for healthy food within a limited budget.</p>
<p>We developed a trainer’s manual, brochures, participant’s workbook and flipcharts. We also evaluated the impact of the education materials on the participants before and after the intervention. And we followed up with them for 12 weeks after the intervention.</p>
<h2>Better nutrition choices</h2>
<p>We <a href="https://www.ncbi.nlm.nih.gov/pubmed/31084656">found</a> that using the communication materials we developed could influence the participants’ decisions about healthy food choices and access. The nutrition education programme led to some significant improvements.</p>
<p>Participants were able to function better physically and their activities weren’t as limited by pain or weakness compared with the control group who didn’t receive nutrition education. Participants who received our nutrition education intervention had better nutrition knowledge, quality of life and dietary diversity scores compared to the control groups.</p>
<p>The intervention we designed showed that people don’t need to have more money to make better nutrition choices. They can and do improve their well-being when they have more knowledge. And our programme was effective in imparting this knowledge. We believe that our findings could be useful to improve programmes that help poor people living with HIV to access healthy food.</p><img src="https://counter.theconversation.com/content/131242/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Temitope Kayode Bello does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Providing antiretroviral therapy without incorporating quality diets may not help to reduce illness and death related to HIV.Temitope Kayode Bello, Postdoctoral Fellow, University of JohannesburgLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1277452019-11-27T14:30:50Z2019-11-27T14:30:50ZCommunities can make – or break – strategies to curb HIV<figure><img src="https://images.theconversation.com/files/303481/original/file-20191125-74576-1d7ol9y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The fight against AIDS can't be won without communities.</span> <span class="attribution"><span class="source">Narendra Shrestha/EPA-EFE</span></span></figcaption></figure><p>Communities have long played a critical role in the fight against HIV. Their activism and advocacy have greatly influenced the response to HIV/AIDS over the past four decades. </p>
<p>From the <a href="https://edition.cnn.com/2016/04/14/health/aids-atlanta-emory-university-the-80s/index.html">early 1980s</a>, communities have fought for the rights and needs of those most affected. For example, faced with stigma and discrimination, gay communities in the US provided prevention advice, care and support. They also fought for treatment development and access. </p>
<p>By the <a href="https://www.npr.org/sections/health-shots/2019/02/09/689924838/how-to-demand-a-medical-breakthrough-lessons-from-the-aids-fight">mid-1980s</a> the extent of the pandemic elsewhere in the world was becoming apparent. International, regional and local community activism became instrumental in fighting for access to treatment and stronger policy-level interventions. </p>
<p><a href="https://tac.org.za/category/about/">Communities</a> across Africa, as well as those representing vulnerable groups such as sex workers, began to demand inclusion in the fight against HIV. </p>
<p>Nowhere was this more pronounced than in South Africa, which continues to carry the highest burden of HIV in the world. By the late 1990s community mobilisation and activism were at the heart of much of the debate around HIV/AIDS. </p>
<p>The victories they secured were particularly notable. Fighting against an administration that denied the existence of a link between HIV and AIDS, communities and <a href="https://www.avert.org/professionals/history-hiv-aids/overview">advocacy groups successfully mobilised</a> action on a <a href="https://www.scidev.net/global/disease/news/south-african-activists-win-nevirapine-court-case.html">number of fronts</a>. They fought for – and won – the provision of <a href="https://www.scidev.net/global/disease/news/south-african-activists-win-nevirapine-court-case.html">nevirapine</a> to HIV-positive pregnant women and later fought for the provision of <a href="https://tac.org.za/category/about/">ARV treatment</a> to all HIV positive people.</p>
<p>Communities continue to be vital in efforts to bring the pandemic under control, proving themselves as custodians and keepers of rich knowledge that creates the context in which HIV transmission occurs. They can also be the catalyst for the social change that is needed to reduce future HIV transmission in key populations. One such example is HIV infections among young women, who remain the most vulnerable group in southern Africa.</p>
<h2>Social norms</h2>
<p>Why are communities fundamental to future <a href="https://www.unaids.org/sites/default/files/media_asset/2019-global-AIDS-update_en.pdf">HIV prevention intervention</a> designs? The answer lies in the fact that HIV transmission is profoundly social. </p>
<p>In sub-Saharan Africa, HIV is transmitted primarily in the context of heterosexual sex, which is shaped and controlled by social and cultural norms. Research highlights a host of <a href="https://www.avert.org/professionals/hiv-around-world/sub-saharan-africa/overview">social practices</a> that hinder HIV prevention efforts. These include: </p>
<ul>
<li><p>struggles to negotiate condom use in relationships, </p></li>
<li><p>the use of <a href="https://www.tandfonline.com/doi/abs/10.1080/13691058.2018.1453086">vaginal products</a> to enhance sex, </p></li>
<li><p>issues of stigma, sexual violence and poverty, and </p></li>
<li><p>access to sexual and reproductive health care services. </p></li>
</ul>
<p>Individual models of understanding risk don’t capture the full complexity of HIV transmission. This is because HIV transmission is rooted in social practices, and influenced by the broader context.</p>
<p>A good way to illustrate this is by considering factors that drive HIV transmission among young women. They are the most burdened by HIV in east and southern Africa and accounted for more than a quarter of <a href="https://www.unaids.org/sites/default/files/media_asset/2019-global-AIDS-update_en.pdf">new infections in 2018</a> – and yet they make up only 10% of the population. </p>
<p>Additionally, young women <a href="http://files.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2014/UNAIDS_Gap_report_en.pdf">have higher rates of HIV infection</a> than their male counterparts, acquiring HIV between five to seven years earlier than their male peers.</p>
<p>This gender imbalance in HIV infection is the result of many different factors that cut across the context in which women negotiate their lives. These range from biological vulnerabilities (including genital inflammation and the microbial diversity of the vagina), to relationships, their familial context, school completion rates and the broader socio-political world.</p>
<p>This means that preventing HIV transmission demands a deep engagement with the social, cultural, community and political factors that produce vulnerability and risk. </p>
<p>In HIV prevention this involves designing interventions that tackle the complexity of how young women come to be infected and what potential prevention efforts need to be taken.</p>
<p>But this can only succeed if there’s a deeper effort to include communities in the design of interventions that are responsive to local settings. This could, for example, include tackling harmful social norms, ensuring that women who need them have access to prevention technologies and treatment. They could also include empowering young girls, and tackling negative gender norms and gender based violence.</p>
<h2>The roll-out</h2>
<p>Communities have a critical role to play in ensuring that prevention interventions move from the realm of proven efficacy to real-world effectiveness. </p>
<p>A range of new HIV prevention technologies, such as treatment and prevention, including the oral Pre-exposure Prophylaxis (PrEP) and voluntary medical male circumcision, are now available. Yet global HIV incidence has declined by <a href="https://www.unaids.org/sites/default/files/media_asset/2019-global-AIDS-update_en.pdf">less than 2%</a> per year since 2010. </p>
<p>Research shows that these <a href="https://www.prepwatch.org/">new HIV prevention</a> modalities – such as PrEP – are underutilised. In addition, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4422218/">38.5%</a> of those infected are not receiving treatment. Retention in care remains <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4422218/">suboptimal</a>.</p>
<p>The big question is how to get people to use what is available.</p>
<p>Engagement is an important part of the answer as communities create the social context that not only supports, but facilitates the linkage of those who need HIV prevention and treatment services.</p>
<p>For adolescent girls and young women in particular, communities could support comprehensive sexual health education, leading the way in respecting their rights to independently access sexual and reproductive health services. Communities can help target negative social and gender norms that increase the vulnerability of young women. Examples include ensuring young women who seek prevention or treatment aren’t stigmatised or discriminated against.</p>
<p>Communities can also play a role in holding governments accountable for ensuring that services are accessible to all those who need it.</p>
<h2>Next steps</h2>
<p>UNAIDS affirms the importance of communities in the fight against HIV through <a href="https://www.unaids.org/sites/default/files/media_asset/world-aids-day-2019-communities-make-the-difference_en.pdf">“communities making a difference”</a>. </p>
<p>But communities need more. They need greater <a href="https://www.unaids.org/sites/default/files/media_asset/world-aids-day-2019-communities-make-the-difference_en.pdf">recognition as equal partners</a> in the fight against HIV as well as resources to continue doing the critically important work they are doing.</p><img src="https://counter.theconversation.com/content/127745/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Hilton Humphries does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Communities continue to be vital in efforts to bring the pandemic under control. They are the custodians of rich knowledge that creates the context in which HIV transmission occurs.Hilton Humphries, Behavioural Scientist, Centre for the AIDS Program of Research in South Africa (CAPRISA)Licensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1204642019-07-18T14:38:01Z2019-07-18T14:38:01ZHIV in Kenya: high risk groups aren’t getting the attention they need<figure><img src="https://images.theconversation.com/files/284705/original/file-20190718-116547-1pv9tck.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Women walk past a mural painted to raise awareness on HIV and AIDS in Kibera slum in Nairobi, Kenya.</span> <span class="attribution"><span class="source">EPA/Dai Kurokawa</span></span></figcaption></figure><p>Efforts to manage the HIV epidemic in much of sub-Saharan Africa need to specifically target sections of the population that are most vulnerable to HIV infection. Two such <a href="https://www.unaids.org/en/topic/key-populations">key populations</a> include men who have sex with men and transgender women. But <a href="https://www.news24.com/Africa/News/anti-gay-laws-widespread-in-africa-despite-gains-20190220">in many countries</a> on the continent same sex relationships – and transgender identities – are criminalised. </p>
<p>Kenya is one such country where the culture is conservative and homosexuality is generally a taboo subject. Gay people who are open about their sexuality are subjected to significant stigma and discrimination. This <a href="https://theconversation.com/homosexuality-remains-illegal-in-kenya-as-court-rejects-lgbt-petition-112149">legal status</a>, coupled with social stigma, makes it difficult for at-risk populations to seek preventive services in public health care facilities. In Kenya, key populations, including men who have sex with men and transgender women, contribute <a href="https://www.avert.org/professionals/hiv-around-world/sub-saharan-africa/kenya">a third of new HIV infections</a>. </p>
<p>In 2017, the Kenyan ministry of health launched a <a href="https://theconversation.com/kenya-embraces-new-prevention-efforts-to-reduce-hiv-infection-80483">programme</a> to provide Pre-exposure prophylaxis (PrEP) to people at increased risk of HIV infection. PrEP is the use of anti-retroviral medication in HIV negative people as prevention against HIV. The aim of the programme is to make PrEP available at public health facilities. But this model may have shortcomings as men who have sex with men and transgender people <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3852126/">may not feel comfortable</a> in public health settings. Additionally, health care providers may not be prepared to provide services to key populations. </p>
<p>Health care providers refer to the <a href="https://www.nascop.or.ke/?page_id=2744">national guidelines</a> to determine who needs PrEP. But the guidelines don’t address anal sex. This is a major omission given that it carries the highest risk for HIV acquisition. And the guidelines assume that sexual behaviour is the same for all men who have sex with men. But, some may exclusively have sex with men, while others may also have sex with women. This difference in sexual behaviour has been shown to affect <a href="https://insights.ovid.com/pubmed?pmid=23079811">the risk of HIV acquisition</a>. </p>
<p>We conducted a <a href="https://www.ncbi.nlm.nih.gov/pubmed/31194291">study</a> to estimate HIV incidence among men who have sex with men exclusively, men who have sex with men and women as well as transgender women. We also wanted to assess how much interest there was in PrEP and what barriers there were to people accessing them. </p>
<p>Our research adds to existing knowledge about how behavioural differences can affect the risk of HIV acquisition. Our findings support the need to revise guidelines to better target PrEP at those that would most benefit for it. </p>
<h2>The research</h2>
<p>As part of the research we followed a cohort of men who have sex with men between 2016 and 2017 in Malindi on the coast of Kenya. We collected social demographic, sexual orientation and gender identity data that allowed us to classify participants as being either men who have sex with men and women or men who have sex with men exclusively or transgender women. We also explored participants’ knowledge and desire to take up PrEP. </p>
<p>Additionally, we assessed the factors associated with HIV acquisition. Finally, we held focus group discussions with HIV negative participants that were segregated by sexual orientation and gender identity. </p>
<p>Overall, the risk for HIV acquisition in this cohort over a one year period was 5%. But in transgender women this risk was extremely high at 20%. HIV acquisition was associated with a number of factors including exclusive receptive anal intercourse and history of a sexually transmitted infection. </p>
<p>A majority (98.8%) of the participants were interested in initiating PrEP. Transgender women expressed concern that actual PrEP provision may cause them to engage in condomless anal or group sex more frequently.</p>
<p>These results show a number of significant patterns. These include confirmation of a much higher risk of HIV acquisition in transgender women than in men who have sex with men.</p>
<p>Globally, <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(12)70315-8/fulltext">studies</a> have shown that transgender women have the highest risk of HIV acquisition. They also bear a disproportionate burden of HIV prevalence. The existence of transgender women has been generally ignored in most of sub-Saharan Africa. Transgender women are not a recognised key population in Kenya and may have previously been classified incorrectly as men who have sex with men exclusively.</p>
<h2>Way forward</h2>
<p>Our findings confirm that transgender women would benefit most from PrEP. But legal barriers and stigma mean that they are invisible and under-served in Kenya.</p>
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Read more:
<a href="https://theconversation.com/homosexuality-remains-illegal-in-kenya-as-court-rejects-lgbt-petition-112149">Homosexuality remains illegal in Kenya as court rejects LGBT petition</a>
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<p>We believe that our findings could be used to inform policy makers on the need to revise national guidelines to better target the intended recipients of the PrEP programme in Kenya. We hope to raise awareness on the need to recognise the existence of transgender women and the need for their inclusion in HIV prevention activities in Kenya.</p><img src="https://counter.theconversation.com/content/120464/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Makobu Kimani is a SANTHE (Sub-Saharan African Network for TB/HIV Research Excellence) Fellow.</span></em></p>The government needs to revise national guidelines to better target PrEP at those that would most benefit from it.Makobu Kimani, PhD candidate at the University of Amsterdam and researcher , Kenya Medical Research InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1135922019-03-28T13:53:37Z2019-03-28T13:53:37ZWhy ending HIV still rests on a working cure – as well as prevention<figure><img src="https://images.theconversation.com/files/266131/original/file-20190327-139361-yx3de3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">New HIV infections continue to drive the epidemic.</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>The global AIDS response has made significant progress in reducing HIV infections and AIDS-related deaths. New HIV infections dropped by <a href="http://www.unaids.org/en/resources/fact-sheet">16%</a> from 1.9 million 2010 to 1.6 million in 2017. And the number of AIDS-related deaths decreased from 1.4 million to 940 000 in the same period.</p>
<p>But HIV/AIDS has not been brought under control and new infections continue to drive the epidemic. AIDS remains a leading <a href="http://www.aho.afro.who.int/sites/default/files/Atlas%202018-eng_1.pdf">cause of death</a> in Africa.</p>
<p>Even if new infections are prevented, <a href="http://www.unaids.org/en/resources/fact-sheet">36.9 million</a> people with HIV around the world must take antiretroviral treatment to live a healthy life. While treatment is now as simple as taking a single pill a day, there are still many challenges to daily adherence, including ongoing stigma. </p>
<p>An ultimate solution would be a workable cure. At the recent Conference on Retroviruses and Opportunistic Infections researchers <a href="http://www.aidsmap.com/page/3463421/">confirmed</a> the second ever case of HIV remission or “cure”. Known as the “London patient”, the person went into remission after a stem cell transplant as part of his treatment for cancer. He emerged from the procedure free of both his life-threatening Lymphoma and need for anti-HIV therapy.</p>
<p>The <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4287108/">“Berlin patient”</a>, Timothy Brown, made global headlines in 2008 when scientists announced that he had been cured of HIV. It’s been 12 years since Brown was cured, after undergoing chemotherapy, total body irradiation and two stem cell transplants. Brown has been off treatment since the transplant and, after multiple tissue sampling procedures, has no remaining evidence of HIV reservoirs. The London patient is now the longest adult HIV remission after stem cell transplantation since the “Berlin patient”.</p>
<p>This development is a triumph for medical science as well as for the London patient. But, as exciting as it is, stem cell transplant is a gruelling and dangerous procedure and isn’t the magic bullet that will end HIV/AIDS. This is because it’s unfortunately not a scalable, feasible cure for the 39 million people currently living with HIV.</p>
<h2>Stem cell transplants</h2>
<p>The “London patient” was HIV positive, but it was his Hodgkin’s lymphoma that led to the need for a stem cell transplant. </p>
<p>The HI virus must link to a human host T cell in the blood or lymph nodes to replicate and infect the body. The virus attaches itself to a set of special links on the human T cell. If one of those links isn’t available due to genetic mutations, the virus may find it harder to get an infection foothold.</p>
<p>One such genetic mutation occurs in a link called the “CCR5 receptor”. Some people have this mutation naturally. The “London patient”, while on antiretroviral therapy and virally suppressed, had a bone marrow transplant as part of his lymphoma treatment. The bone marrow donor had the genetic mutation and passed it on to the “London patient” through the procedure, making it more difficult for HIV to replicate. </p>
<p>The “London patient” stopped taking antiretroviral therapy 16 months after the transplant. And 18 months later the virus remains undetectable. Usually, when a person with HIV stops treatment, the virus rebounds within the first month. </p>
<p>The achievement of remission in a second patient has provided further critical information to inform our understanding of how HIV infection occurs and the interaction between human cells and the virus. </p>
<p>As important as this work is, there’s no scalable cure yet and it’s also vital that researchers – and countries – keep putting effort into prevention. Important work continues to be done in this area.</p>
<h2>Prevention</h2>
<p>As HIV cure research goes on, so does research into HIV prevention tools, such as <a href="https://www.cdc.gov/hiv/basics/prep.html">Pre-exposure prophylaxis</a> (a daily pill that protects you from HIV infection) and the development of a <a href="http://data.unaids.org/publications/irc-pub01/jc072-ethicalcons_en.pdf">preventative vaccine</a>.</p>
<p>Two late stage vaccine <a href="http://www.mrc.ac.za/media-release/public-private-partnership-begins-hiv-vaccine-clinical-trial-sub-saharan-africa">trials</a> are underway in sub-Saharan Africa. Results will be available in 2022. A preventative vaccine would also greatly enhance efforts to being the HIV epidemic under control. </p>
<p>A working cure, together with a preventative vaccine would be the ingredients for HIV eradication. Until then we need to get effective, accessible treatment for all who need it, while deploying the many prevention tools at our disposal.</p><img src="https://counter.theconversation.com/content/113592/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Linda-Gail Bekker is Professor of Medicine and Deputy Director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine, University of Cape Town</span></em></p>Until then we need to get effective, accessible treatment for all who need it, while deploying the many prevention tools at our disposal.Linda-Gail Bekker, Professor of medicine and deputy director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine, University of Cape TownLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1005092018-11-28T12:57:34Z2018-11-28T12:57:34ZBabies born to mums with HIV face higher risks even though they’re HIV negative<figure><img src="https://images.theconversation.com/files/246685/original/file-20181121-161641-w8psje.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The largest number of HIV-exposed but uninfected children are in South Africa.</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>One of the most remarkable public health successes of the last decade in southern Africa has been the reduction in the number of babies born with HIV. This was achieved through the provision of antiretroviral therapy to pregnant and breastfeeding women living with HIV. For example, the number of new HIV infections in children in South Africa has come down from a peak of 70 000 in 2003 to 13 000 in <a href="http://aidsinfo.unaids.org">2017</a>.</p>
<p>Nevertheless, worldwide there are still an estimated <a href="http://aidsinfo.unaids.org">14.8 million</a> children under the age of 15 who were born HIV uninfected but have been exposed to their mother’s HIV during pregnancy.</p>
<p>The largest number of HIV-exposed but uninfected children – <a href="http://aidsinfo.unaids.org">3.2 million</a> – are in South Africa.</p>
<p>A staggering <a href="http://www.health.gov.za/index.php/shortcodes/2015-03-29-10-42-47/2015-04-30-08-18-10/2015-04-30-08-21-56?download=2584:2015-national-antenatal-hiv-prevalence-survey-final-23oct17">30%</a> of pregnant women in South Africa have HIV. Their infants are exposed to both HIV and antiretroviral drugs during pregnancy and breastfeeding. HIV-exposed but uninfected children don’t have HIV, so what’s the big deal?</p>
<p>It is a big deal because HIV-uninfected children born to mothers with HIV are prone to infections that are more severe, are at almost two times greater risk of dying before their first birthday, and are more likely to be born prematurely than children born to mothers without HIV. </p>
<p>In our <a href="https://www.ncbi.nlm.nih.gov/pubmed/30321432">recent study</a> we set out to try and quantify the contribution of deaths in HIV-exposed but uninfected infants to the overall infant mortality rates in Botswana and South Africa.</p>
<p>What we found was that because children born to mothers with HIV make up almost 1 in every 4 infants in Botswana and South Africa, and because they die more often than children born to mothers without HIV – even when they are HIV-uninfected themselves – this contributed to a higher infant mortality rate in both countries.</p>
<h2>The risks</h2>
<p>Even when they’re not HIV infected, children born to women with HIV experience a complex package of detrimental exposures. </p>
<p>For example, HIV-exposed but uninfected infants are still more often born <a href="https://www.ncbi.nlm.nih.gov/pubmed/29040569">preterm or of low birth weight</a>. This increases their risk for complications and death early in life. </p>
<p>They are also exposed to more infectious pathogens in the home such as <a href="https://www.ncbi.nlm.nih.gov/pubmed/27393540">tuberculosis</a>. </p>
<p>There are other problems too. Breastfeeding has enormous nutritional and immunological benefits, but has often been avoided in infants born to women with HIV. Maternal access to antiretrovirals has made it safer but sustained breastfeeding is still low. One study in South Africa showed that, irrespective of HIV-status, women stopped <a href="https://www.ncbi.nlm.nih.gov/pubmed/29959720">breastfeeding</a> their babies on average when the infants were eight weeks old.</p>
<p>On top of this, HIV-exposed infants more often have mothers who are unwell or <a href="https://www.ncbi.nlm.nih.gov/pubmed/27091659">who have died</a>. And HIV-affected households experience challenging socioeconomic <a href="https://www.ncbi.nlm.nih.gov/pubmed/27392008">circumstances</a> that can make children more vulnerable. These exposures in the <a href="http://www.who.int/maternal_child_adolescent/child/nurturing-care-framework/en/">first 1000 days of life</a> can be detrimental to early childhood development and have life-long consequences. </p>
<p>In addition, infants born to women with HIV are subject to factors during pregnancy that unexposed infants aren’t. These include exposure to HIV particles, that may make their <a href="https://www.ncbi.nlm.nih.gov/pubmed/27049574">immune systems</a> develop differently. And these infants are exposed to at least three antiretroviral drugs given to the mother during pregnancy. </p>
<h2>What the research found</h2>
<p>To estimate the contribution of deaths in HIV-exposed but uninfected infants to the overall infant mortality rates we used previously published research comparing the mortality risk in HIV-exposed uninfected infants to risk of mortality in <a href="https://www.ncbi.nlm.nih.gov/pubmed/27456985">unexposed infants</a>, as well as United Nations estimates of infant mortality in Botswana and South Africa. </p>
<p>In Botswana, HIV exposed uninfected infants accounted for 26% of the infant population but 42% of all infant deaths. Similarly, in South Africa HIV exposed uninfected infants accounted for 23% of the infant population but 38% of all infant deaths. </p>
<p>Putting this into actual numbers, this extra mortality in HIV exposed uninfected infants increased the overall HIV-uninfected infant mortality rate in both Botswana and South Africa from around 30 deaths per 1000 infants to 35 deaths per 1000 in the year 2013. </p>
<p>Botswana and South Africa have adopted the World Health Organisation’s recommendation to provide lifelong antiretrovirals to all pregnant and breastfeeding women with HIV. But there’s a lack of research comparing the mortality of HIV-exposed to unexposed infants under these new guidelines. Our calculations are therefore based on the year 2013, the most recent year before policy shifts in both countries. There is emerging <a href="https://www.ncbi.nlm.nih.gov/pubmed/29272387">evidence</a> though of a persisting increase in mortality in HIV-exposed infants even with maternal antiretroviral therapy. </p>
<h2>What next</h2>
<p>With 1 in every 4 children in Botswana and South Africa being HIV and ARV-exposed, robust systems need to be put in place to monitor the long-term safety of these exposures during pregnancy. Countries need to invest in research to understand why HIV-exposed children still have an increased risk of dying. And countries need to ensure that routine child health interventions, such as immunisations and promotion of optimal durations of breastfeeding, are uniformly reaching HIV-exposed children.</p>
<p>Most critically, countries like South Africa and Botswana with high HIV infection rates need to find responsible, transparent and accurate ways of sharing what is known and being done about the risks of HIV-exposure with HIV-affected families and involve them in finding solutions.</p><img src="https://counter.theconversation.com/content/100509/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Amy Slogrove receives funding from research funding agencies on a competitive funding basis including the US National Institutes of Health and the International AIDS Society. </span></em></p><p class="fine-print"><em><span>Kathleen M. Powis receives funding from the National Institute of Health and from the Collaborative Initiative for Pediatric HIV Education and Research. </span></em></p><p class="fine-print"><em><span>Mary-Ann Davies receives funding from research funding agencies on a competitive basis including the National Institutes of Health and the International AIDS Society.</span></em></p>HIV negative children born to women with HIV have a greater risk of dying before their first birthday.Amy Slogrove, Senior lecturer in Paediatrics and Child Health, Stellenbosch UniversityKathleen M. Powis, Assistant Professor, Harvard UniversityMary-Ann Davies, Associate Professor and Director of the Centre for Infectious Diseases Epidemiology and Research, University of Cape TownLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1040102018-10-04T11:01:02Z2018-10-04T11:01:02ZLiver transplant from HIV+ living donor to negative recipient: key ethical issues<figure><img src="https://images.theconversation.com/files/238643/original/file-20181001-195266-1xt5yep.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Fundamental questions of ethics are involved in donor transplant decisions. </span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>South Africa has a dire shortage of <a href="http://www.scielo.org.za/pdf/sajcc/v33n2/02.pdf">organ donors</a>. This means that doctors struggle to find suitable donor organs for critically ill patients who would die without receiving a transplant. Sometimes they have to make tough calls such as using a blood group incompatible organ to save a patient’s life – even if this comes with additional risk.</p>
<p>About a year ago we made a tough call of our own: we could save a child’s life by <a href="https://journals.lww.com/aidsonline/Fulltext/2018/10230/Living_donor_liver_transplant_from_an_HIV_positive.1.aspx">giving the child a liver transplant</a> – but risked infecting the child with HIV in the process. The donor was the child’s mother, who is HIV positive and the child was HIV negative. The procedure came with a risk of transmitting HIV to the child.</p>
<p>South Africa’s law does not forbid the transplantation of an organ from a living HIV positive donor to an HIV negative recipient, provided that a robust informed consent process is in place. But this isn’t universally accepted as best clinical practice because of the risk of HIV transmission to the recipient.</p>
<p>The young recipient had been on the organ donor waiting list for 181 days. The average time on the waiting list in our transplant programme is 49 days. The child’s mother had repeatedly asked if she could donate a part of her liver, but we could not consider this because it was against the policy in our unit at the time. Without a transplant, the child would certainly have died. </p>
<p>After much consideration, and with permission from the <a href="https://www.wits.ac.za/research/researcher-support/research-ethics/ethics-committees/">Medical Ethics Committee</a> at Johannesburg’s University of the Witwatersrand, we decided to go ahead with the transplant. With careful planning we were able to give the child <a href="https://www.cdc.gov/hiv/pdf/library/factsheets/prep101-consumer-info.pdf">antiretroviral drugs in advance</a>, with the hope of preventing HIV infection.</p>
<p>The transplant, which happened at the University of the Witwatersrand’s <a href="http://www.dgmc.co.za/">Donald Gordon Medical Centre</a>, was a success. The child is thriving, but at this point we are unable to determine the child’s HIV status. In the first month after the transplant we detected HIV antibodies in the child and it looked like HIV infection might have taken place. But as time went by the antibodies declined and are now almost undetectable. We have not been able to work out for certain whether the child has HIV or not. Even with ultra-sensitive, specialised testing, we have not been able to detect any HIV in the child’s blood or cells.</p>
<p>It will probably still be some time before we can be sure. However, the child is doing very well on antiretroviral treatment. And we know from cases where HIV was transmitted inadvertently that people who get HIV from an organ transplant do as well as those who get an HIV-negative organ.</p>
<p>This operation could be a game changer for South Africa. The country has a large pool of <a href="https://theconversation.com/south-africa-still-has-four-critical-gaps-to-fill-before-it-sees-the-end-of-aids-87640">virally suppressed</a> HIV-positive people who have previously not been considered for living liver donation. <a href="https://www.cdc.gov/hiv/risk/art/index.html">Viral suppression</a> is when a person with HIV takes their antiretroviral medication as prescribed and their viral load – the amount of virus in their blood – is so low that it is undetectable. </p>
<h2>Ethical and legal considerations</h2>
<p>Organ transplant comes with many ethical and legal challenges. In this case, some unique and complex issues were carefully considered.</p>
<p>We took great care to consult widely before doing the transplant. This included speaking to the members of the transplant team, bioethicists, lawyers, experts in the field of HIV medicine and Wits University’s Medical Ethics Committee. The committee’s function is - among other things - to protect patients in medical research, and to make sure doctors are doing procedures for the correct reasons.</p>
<p>It was clear that a transplant was in the child’s best interests. The bigger ethical question was whether it was right to deny the mother the opportunity to save her child’s life. A fundamental principle of ethics is to treat people fairly. People with HIV should have the same health care options as everyone else.</p>
<p>We, along with the Ethics Committee, agreed that as long as the child’s parents understood that there was a risk the child could acquire HIV, it was acceptable to go ahead with the transplant.</p>
<p>Then, to ensure that the child’s parents were properly informed and in the best position to make a decision, we used an <a href="https://onlinelibrary.wiley.com/doi/pdf/10.1111/ajt.13001">independent donor advocate</a>. The advocate was not employed by the hospital and their main role was to support the parents by ensuring that they understood exactly what the risks were for the mother as a donor. The advocate also engaged with the transplant team on the parents’ behalf, if needed.</p>
<p>In this case, the parents were committed to go ahead with the operation, and had already come to terms with the risk of HIV transmission to their child. They were appreciative that the team were willing to carefully consider this option for them, given that there were no alternatives available and their child was critically ill. We asked both parents to consent to the procedure, as both are responsible for taking care of the child going forward.</p>
<h2>Lessons and opportunities</h2>
<p>This operation has shown that doctors can do this type of transplant, and that outcomes for the HIV positive donor and the recipient can be good. It has also created a unique opportunity for scientists at Wits to study HIV transmission under very controlled circumstances.</p>
<p>For now, doctors will not be able to tell parents whether or not their child will get HIV from this type of transplant. This is because this is a single case with many unanswered questions that will hopefully be answered through ongoing research. </p>
<p>Going forward, we will continue to ensure that parents are fully aware of the uncertainty in this situation. All future cases will be part of an ongoing research study that will investigate HIV transmission in children in more detail and the ways in which HIV may or may not be spread through organ transplantation.</p><img src="https://counter.theconversation.com/content/104010/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Doctors in South Africa performed a liver transplant from an HIV-positive donor to a HIV-negative recipient. Major ethical questions came into play.Harriet Etheredge, Bioethicist and Health Communication Specialist, University of the WitwatersrandJean Botha, Head of Transplants at Donald Gordon Medical Centre, University of the WitwatersrandJune Fabian, Research Director at Donald Gordon Medical Centre , University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/875492017-11-22T12:17:48Z2017-11-22T12:17:48ZThree decades on, stigma still stymies HIV prevention and treatment<figure><img src="https://images.theconversation.com/files/195175/original/file-20171117-7545-1xb416z.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>There have been great strides and many important victories in the fight against HIV. <a href="https://theconversation.com/rings-and-things-other-ways-to-prevent-hiv-are-on-the-cards-69192">Scientific innovations</a> and <a href="https://www.gatesfoundation.org/Media-Center/Press-Releases/2002/11/HIVAIDS-Prevention-Effort-in-India">sustained investment</a> have been the most important weapons in this ongoing battle.</p>
<p>Nevertheless the epidemic retains a powerful grip – especially on people in Africa. In sub-Saharan Africa, 19.4 million are living with the virus. In 2016 an estimated 15 000 new infections occurred every week in the region.</p>
<p>Treatment and prevention of HIV are twin endeavours; they rely universally on two elements. The first is the interaction of HIV positive and negative people with HIV services. The second is the willingness of people to modify their risky behaviour and avoid negative health consequences.</p>
<p>Adherence is the cornerstone of these processes: a commitment to taking medication or adopting a risk-reducing behaviour consistently over time. By adhering to their antiretroviral (ARV) regimens those living with the virus are able to lead long, healthy lives. They are able to eliminate the chance of passing on the virus to their partner(s). The concept of an <a href="https://www.preventionaccess.org">undetectable virus is an untransmissable</a> one is now acceptable. </p>
<p>With good adherence to an HIV prevention pill or pre-exposure prophylaxis (PrEP) or consistent use of condoms, HIV negative people can protect themselves from infection.</p>
<p>But real and perceived stigma can undermine all these efforts. This is because stigma stops people from getting tested, stops them discussing their test results with intimate partners when they do test, and then staying on their treatment. Unless stigma is addressed, the aim of ending the AIDs epidemic by 2030 – one of the United Nations’ Sustainable Development Goals – is unlikely to become a reality.</p>
<h2>The logic behind stigma</h2>
<p>Stigma happens when disgrace and shame become associated with an attribute, such as being HIV positive. It results in the person with the attribute being discredited or socially renounced. When stigmatised beliefs are widely held in a community, hostility and discrimination towards stigmatised people becomes common.</p>
<p>A stigmatised person can start to believe these views as well and develop a self-depreciating internal representation of themselves. This is known as internalised stigma. It can lead to diminished mental health and emotional distress. Both general and internalised HIV-related stigma can compromise a person’s ability to seek and stay on treatment. And it can prevent people from taking steps to prevent infection.</p>
<p>For instance, a woman living with HIV could choose not to go back for more medication because she’s scared someone from her community will see her and learn her status.</p>
<p>Conversely, a sexually active teenager might not ask a healthcare professional how she can prevent HIV if she is afraid of being judged for having sex.</p>
<p>There is evidence that these scenarios still play out. The HIV Stigma Index conducted in South Africa in 2014 found that about 45% of the respondents experienced internalised stigma. And 39% lived in fear of potential stigma. Young people between the ages of 15 and 24 were particularly affected by all types of stigma.</p>
<h2>Stigma on top of stigma</h2>
<p>Stigma has the negative psychological consequence of making it more difficult for people to cope and find social support. It also reduces their ability to overcome other barriers to adherence, such as unfriendly healthcare services or side effects from medication.</p>
<p>The research shows that people who do not experience internalised stigma tend to be more successful in adhering to treatment and more capable of overcoming other barriers to access treatment and prevention services.
HIV stigma poses additional difficulties for positive people who already belong to stigmatised population groups, such as men who have sex with men transgender people, sex workers, and people who inject drugs.</p>
<p>Stigma against these groups already reduces access to healthcare services and social support. But disclosure of being HIV positive can result in people facing even more stigma, discrimination and hostility.</p>
<p>This is especially the case in African countries where homosexuality and sex work are criminalised.</p>
<p>Moralistic support for criminalisation often interferes with public health initiatives. As a result, stigmatised populations are frequently made more vulnerable to HIV infection due to this discrimination and restricted access to healthcare services.</p>
<h2>Changing the tide</h2>
<p>The good news is that stigma can be reduced if three basic interventions are put in place.</p>
<p>Firstly, through the implementation of effective and sustained mass media campaigns and health promotion aimed at dispelling the common myths. These campaigns should involve HIV positive people as message bearers.</p>
<p>Secondly, normalising and promoting the interaction with HIV prevention services. What is needed here are more people openly engaging about HIV testing and taking PrEP (pre-exposure prophylaxis).</p>
<p>And thirdly laws and policies that protect those living with the virus from discrimination and promote them being able to access healthcare services.
These are especially important for key population groups living in countries where criminalisation disrupts public health strategies.</p><img src="https://counter.theconversation.com/content/87549/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Linda-Gail Bekker receives funding from a number of academic funding agencies including the NIH (USA). She is currently the President of the International AIDS Society.</span></em></p>Stigma stops people from getting tested for HIV, and staying on their treatment. Unless it’s addressed, the AIDS epidemic will persist.Linda-Gail Bekker, Professor of medicine and deputy director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine, University of Cape TownLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/695292017-01-29T16:41:16Z2017-01-29T16:41:16ZHow a gene test can solve side effects linked to ARV drugs in Africa<figure><img src="https://images.theconversation.com/files/154343/original/image-20170126-23845-2w3yp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">People with a certain gene have an adverse reaction to the antiretroviral efavirenz. </span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Antiretrovirals have significantly improved the lives of people living with HIV. Today there are more than <a href="http://www.who.int/hiv/mediacentre/news/global-aids-update-2016-news/en/">17 million people on treatment</a> and the number of deaths from the disease has been <a href="http://www.who.int/bulletin/volumes/87/10/08-058982/en/">drastically reduced</a>. </p>
<p>But many people who take the treatment regimens daily experience <a href="http://i-base.info/ttfa/4-side-effects-of-arvs/">severe side effects</a>. Adverse drug reactions result in people not sticking to the treatment regime. This in turn leads to poor treatment outcomes and the risk of resistance developing.</p>
<p>One particular antiretroviral – efavirenz – presents a challenge. </p>
<p>It is considered one of the most <a href="http://link.springer.com/article/10.1007/s40274-016-3005-5/fulltext.html">cost effective antiretroviral treatments</a> available and is recommended by the World Health Organisation (WHO) as a <a href="http://www.who.int/hiv/pub/guidelines/arv2013/intro/rag/en/index4.html">firstline treatment</a> against HIV. By 2014 just less than half of all the people on antiretrovirals in low and middle income countries – that’s 8 million – were on the drug regime.</p>
<p>But up to 50% of patients taking it have to change treatment within a year. And the World Health Organisation has it on its list of drugs with the harshest side effects. People taking the drug can experience serious neuropsychiatric drug reactions including depression, nightmares, headaches and suicidal tendencies. </p>
<p>But there may be a solution. </p>
<p>Studies have shown that people who react particularly badly to efavirenz have a particular gene variant that messes with an enzyme responsible for processing the drug in their bodies. </p>
<p>We set out to find a way for patients to continue using the drug without the side effects. As part of <a href="http://www.clintonhealthaccess.org/content/uploads/2015/11/CHAI-ARV-Market-Report-2015_FINAL.pdf">our study</a> we developed a mechanism to test whether people have this gene. Those that test positive for the genetic variant can be put on reduced doses of the drug. It remains effective but is less toxic. </p>
<p>This is an important step because it addresses three problems: it makes it possible for people to stick to continuous treatment cycles; this in turn reduces the risk of resistance developing; and it means that a cost effective antiretroviral treatment can be administered better. </p>
<h2>Finding the problematic gene</h2>
<p>At the current dose of 600 mg daily patients who have variations of a specific gene – CYP2B6 – have a higher chance of developing side effects because of toxic blood levels. We did a continent wide population genotyping study with 11 major African populations groups to establish how prevalent this genetic variant was. </p>
<p>The population groups were the Yoruba, Ibo, Hausa tribes in Nigeria, the Kikuyu, Luo, Masaai in Kenya, mixed groups of Tanzania, the Venda in South Africa and the Shona, Ndebele and San in Zimbabwe.</p>
<p>We found there was a <a href="https://www.ncbi.nlm.nih.gov/pubmed/18057928">30% to 60% likelihood</a> of the genetic variant being found in African populations. This is compared to a 15% to 20% likelihood in white and Asian people.</p>
<p>Using this information we were able to derive a <a href="http://bmcpharmacoltoxicol.biomedcentral.com/articles/10.1186/s40360-015-0004-2">dosing algorithm</a> that could be used to tailor drug doses in patients with the gene variant.</p>
<p>The algorithm indicates that patients who have two low activity variants should be given 200 mg of the drug instead of the standard 600 mg. Those who have one normal activity and one low activity variant should be given 400 mg per day.</p>
<p><a href="http://www.clintonhealthaccess.org/content/uploads/2015/11/CHAI-ARV-Market-Report-2015_FINAL.pdf">Our studies</a> were done in our laboratory in Zimbabwe and then replicated in South Africa, Tanzania, Uganda and Ethiopia by independent research groups.</p>
<p>This algorithm is now being developed into a test kit – GeneDose-EFV test kit – which can be used in clinics. </p>
<h2>A quicker and cheaper solution</h2>
<p>It is not the first time that antiretrovirals have caused <a href="http://i-base.info/ttfa/4-side-effects-of-arvs/">serious side effects</a> in patients. But it took up to five years to physically <a href="http://journals.lww.com/aidsonline/Fulltext/2009/08240/Stavudine_in_antiretroviral_therapy__is_this_the.12.aspx">remove the drug</a> with side effects due to the number of places that it had been distributed to across the continent. </p>
<p>The widespread use of efavirenz on the continent, and the fact that it’s inexpensive, means there is an urgent need to address the burden of its adverse effects without dropping it as a treatment option. </p>
<p>There are several benefits from the test. Patients can stay on the drug by being given a dose they can tolerate. This, in turn, will result in increased treatment compliance among patients and therefore less of a risk for HIV drug resistance.</p>
<p>And for governments, it means they will still be able to administer cost effective antiretroviral treatment at a public health level and keep more patients on sustained antiretroviral treatment at a cheaper cost.</p><img src="https://counter.theconversation.com/content/69529/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Collen Masimirembwa works for the African Institute of Biomedical Science and Technology. He receives funding from SANBIO BIOFISAII. </span></em></p>Up to 50% of the people who take the efavirenz antiretroviral react particularly badly to it and need to change drug regimens.Collen Masimirembwa, Honorary Prof. of Clinical Pharmacology,, University of Cape TownLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/623822016-07-19T14:10:07Z2016-07-19T14:10:07ZIt will take more than $36 billion every year to end AIDS<figure><img src="https://images.theconversation.com/files/131093/original/image-20160719-7903-1mu176c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">South African HIV rights group, the Treatment Action Campaign, marching through Durban, calling for antiretroviral access for all. </span> <span class="attribution"><span class="source">International AIDS Society/Rogan Ward</span></span></figcaption></figure><p>In the past 15 years, the global community has provided <a href="http://journals.lww.com/aidsonline/Abstract/2016/06010/Tracking_development_assistance_for_HIV_AIDS___the.18.aspx">US$109.8 billion</a> in development assistance to curb HIV/AIDS. Several international aid organisations created in this period have been instrumental in galvanising the resources needed to combat the epidemic. </p>
<p>But meeting the UNAIDS <a href="https://theconversation.com/hiv-aids-and-90-90-90-what-is-it-and-why-does-it-matter-62136">90-90-90</a> targets – that 90% of HIV positive people will know their status, 90% of those people will be on antiretrovirals and 90% will be virally suppressed by 2020 – will require major changes in how programmes are delivered and financed. </p>
<p>Maintaining and scaling up the <a href="https://secure.jbs.elsevierhealth.com/action/getSharedSiteSession?rc=1&redirect=http%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flancet%2Farticle%2FPIIS0140-6736%2815%2960658-4%2Ffulltext%3Frss%253Dyes&code=lancet-site">funding of AIDS efforts</a> in the next 20 years to end the epidemic is crucial.</p>
<p>The challenge is that since 2010 development assistance for HIV has <a href="http://www.healthdata.org/policy-report/financing-global-health-2015-development-assistance-steady-path-new-global-goals">remained nearly constant</a>. <a href="https://secure.jbs.elsevierhealth.com/action/getSharedSiteSession?rc=1&redirect=http%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flancet%2Farticle%2FPIIS0140-6736%2815%2960658-4%2Ffulltext%3Frss%253Dyes&code=lancet-site">Researchers estimate</a> that $36 billion is needed annually to achieve the United Nations goals. </p>
<p>Current epidemiological and financial trends suggest there’s a major risk of a substantial shortfall in the funds required to sustain life-saving antiretroviral programmes. </p>
<h2>The three phases of the epidemic</h2>
<p>The number of people living with HIV/AIDS steadily increased to 38.8 million in 2015, according to the 2015 <a href="http://www.thelancet.com/pdfs/journals/lanhiv/PIIS2352-3018(16)30087-X.pdf">Global Burden of Disease</a> study.</p>
<p>The unfolding global HIV pandemic has advanced through three phases. In the first phase, 1981 to 1997, HIV moved from being ranked as the 39th leading cause of death worldwide to the 11th. </p>
<p>In the second phase, from 1998 to 2005, incidence declined by 25.4%. But because of the lag between infection and mortality, the number of deaths caused by HIV increased. </p>
<p>In the third phase, from 2005 to 2015, the mass scaling of prevention of mother-to-child transmission and antiretrovirals – particularly in low-income sub-Saharan Africa – led to several developments. These included declining HIV mortality, a stagnation in the decline of global incidence rates and steadily rising prevalence. These global patterns mask well documented but extraordinary heterogeneity across countries. </p>
<p>The need for HIV programmes, particularly antiretroviral ones, keeps growing. This is due to both the sustained high number of infections and the success of antiretrovirals in extending the lifespan of people living with HIV.</p>
<h2>Dealing with the financing gap</h2>
<p>Enormous progress has been made in reducing HIV deaths. This is particularly true in low-income countries. But this is mainly because programmes that prevent mother-to-child transmission and antiretroviral interventions, largely funded through development assistance for HIV, have been expanded. </p>
<p>This scaling up has been fuelled by the increase in development assistance for HIV from <a href="http://www.healthdata.org/policy-report/financing-global-health-2015-development-assistance-steady-path-new-global-goals">$1.3 billion</a> in 2000 to <a href="http://dx.doi.org/10.1016/S0140-6736(16)30168-4">$10.8 billion</a> in 2015. </p>
<p>UNAIDS and other international development agencies hope that the <a href="http://www.unaids.org/en/resources/documents/2014/JC2686_WAD2014report">growing need for funding</a> will be partly solved by <a href="http://www.unaids.org/en/resources/documents/2016/2016HighLe%2030%20velMeeting">expanded health spending</a> in low-income countries.</p>
<p>But the scarcity of adequate funds to provide antiretrovirals to people living with HIV – together with the possibility of rising drug resistance to existing antiretroviral treatments – will make achieving the goal to <a href="http://www.unaids.org/en/resources/documents/2014/JC2686_WAD2014report">end AIDS by 2030</a> extremely difficult.</p>
<p>In middle-income countries, increased commitments to funding health programmes from national budgets could fill the gap. </p>
<p>But domestic resources won’t be sufficient in low-income countries where, as in eastern and some southern sub-Saharan African countries, HIV rates are the highest.</p>
<p>Researchers have projected that <a href="http://www.sciencedirect.com/science/article/pii/S0140673616301672">government health expenditure</a> in southern sub-Saharan Africa is going to increase from $30.8 billion in 2015 to $53.1 billion in 2030.</p>
<p>Meeting the needs of people living with HIV will require a combination of the following evidence-informed strategies:</p>
<ul>
<li><p>concentrating development assistance for HIV in these low-income countries;</p></li>
<li><p>improving the efficiency of HIV programmes; </p></li>
<li><p>increasing domestic financing; </p></li>
<li><p>lowering the cost of treatment (including the prices of antiretrovirals); and </p></li>
<li><p>reducing future incidence through more concerted efforts. </p></li>
</ul>
<p>Development assistance efforts will also need to be scaled up if the free flow of low-cost generic drugs is hampered. </p>
<p>The World Health Organisation now <a href="http://www.who.int/hiv/pub/guidelines/arv2013/en/">recommends</a> universal <a href="http://www.who.int/hiv/pub/arv/policy-brief-arv-2015/en/">antiretroviral treatment for all</a> people with HIV.</p>
<p>In 2015, only <a href="http://www.who.int/gho/hiv/epidemic_response/ART_text/en/">41% of people living with HIV</a> were receiving antiretroviral therapy. But the 90-90-90 goals imply that 81% should be receiving antiretrovirals and 73% will have viral suppression. No country has achieved this yet. To do so, antiretroviral coverage will need to be extended to at least 15.5 million additional people by 2020. This implies an addition of 3.1 million per year between 2015 and 2020, while ensuring complete treatment adherence.</p>
<p>It will require concerted efforts to scale up detection of new infections to meet the target of 90% of people knowing their status. The targeted expansion in antiretroviral therapy coverage would play an important part in reducing the still high number of people dying from HIV.</p>
<p>But such expansion has enormous cost implications in an era when even maintenance of coverage in some low-income settings could be at risk in the presence of declining development assistance for health. </p>
<p>Increased antiretroviral coverage might also play a part in <a href="http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0011068">reducing population transmission</a> of HIV and therefore <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61697-9/abstract">incidence</a>. The quality of antiretroviral therapy embodied in the third 90 target of the UNAIDS strategy remains a major issue, as does the potential role of other care in extending survival.</p><img src="https://counter.theconversation.com/content/62382/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Charles Shey Wiysonge does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Current epidemiological and financial trends suggest there’s a major risk of a substantial shortfall in the funds required to sustain life-saving antiretroviral programmes.Charles Shey Wiysonge, Professor of Clinical Epidemiology at the Faculty of Medicine and Health Sciences, Stellenbosch UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/525392015-12-21T05:12:59Z2015-12-21T05:12:59ZHow a drug can help prevent 5000 girls being infected with HIV every week<figure><img src="https://images.theconversation.com/files/106634/original/image-20151218-27887-fle144.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The WHO has recommended pre-exposure prophylaxis, or PrEP, as an additional HIV prevention choice for people with a high risk of being infected. Truvada has been licensed in South Africa.</span> <span class="attribution"><span class="source"> Epa/Maurizio Gambarini</span></span></figcaption></figure><p>South Africa has became one of the first African countries to <a href="http://www.mccza.com/documents/2e4b3a5310.11_Media_release_ARV_FDC_PrEP_Nov15_v1.pdf">license</a> a fixed-dose combination of anti-retrovirals to be used as an oral pre-exposure prophylaxis.</p>
<p>Pre-exposure prophylaxis, more commonly referred to as PrEP, is the use of anti-retroviral drugs by people who do not have HIV to prevent them from becoming infected. The World Health Organisation recently <a href="http://apps.who.int/iris/bitstream/10665/197906/1/WHO_HIV_2015.48_eng.pdf">recommended</a> it as an additional HIV prevention choice for people with a high risk of being infected. </p>
<p>The recommendations are based on <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1011205">studies</a> showing that daily doses of the drug effectively reduce the HIV risk in men and women. This was irrespective of age, mode of HIV transmission or the drug regimen used. The only common factor in the level of protection was how well people adhered to the drug regimens. </p>
<p>The studies also showed that pre-exposure prophylaxis is safe to use in healthy populations as there was no evidence of increased side effects in trial participants.</p>
<h2>Breaking a new frontier</h2>
<p>South Africa’s Medicines Control Council has <a href="http://www.mccza.com/documents/2e4b3a5310.11_Media_release_ARV_FDC_PrEP_Nov15_v1.pdf">ruled</a> that the drug Tenofovir disoproxil/emtricitabine (TDF/FT3), more commonly referred to as Truvada, is safe and effective for use as pre-exposure prophylaxis in the country. This paves the way for the government to issue a tender to procure the drug.</p>
<p>South Africa’s license is incredibly important for HIV prevention in the country as well as the region. It is a critical step to including pre-exposure prophylaxis in publicly-funded HIV prevention programmes. The licensing also means that other countries in the region are likely to follow. </p>
<p>Several policy, programme and procurement processes need to be followed before the drug can be distributed through the healthcare system.</p>
<p>The government is likely to start with pilot sites as it did with anti-retrovirals given to mothers to prevent mother to child transmission. This will help it learn:</p>
<ul>
<li><p>how to identify populations who need and want to use PrEP, </p></li>
<li><p>what systems are needed for delivery, and </p></li>
<li><p>how best to monitor health so that it doesn’t overburden the health service.</p></li>
</ul>
<h2>A solution for young women</h2>
<p>One of the critical steps in developing programmes is defining who will most likely benefit from them. Mathematical models suggest that it is likely to be cost-effective in settings where there are three new infections in every 100 people each year. </p>
<p>In Africa, the populations that have been prioritised to date are sex workers, men who have sex with men and couples where one partner is HIV infected and the other is not. </p>
<p>But research shows that unless HIV prevention in teenage girls and young women is prioritised, the ambitious <a href="http://www.unaids.org/en/resources/campaigns/World-AIDS-Day-Report-2014">targets</a> set by UNAIDS to end HIV by 2030 will not happen. </p>
<p>Every week more than 5000 adolescent girls and young women acquire <a href="http://www.unaids.org/en/resources/campaigns/2014/2014gapreport/gapreport">HIV</a>. And the vast majority of them live in southern Africa. Young women are up to eight times more likely to be infected than their male peers of the same age in eastern and southern Africa. This is despite the rate of new HIV infections <a href="http://www.unaids.org/en/resources/campaigns/HowAIDSchangedeverything/factsheet">declining or stabilising</a> in many other populations. </p>
<p>And although their HIV risk is driven in part by individual behaviour, other factors also play a role. These include:</p>
<ul>
<li><p>poverty, </p></li>
<li><p>gender inequality and high exposure to violence, </p></li>
<li><p>limited economic options, and </p></li>
<li><p>the low social power of young people. </p></li>
</ul>
<h2>Adherence pitfalls</h2>
<p>For PrEP to be effective, it will need to be integrated into existing HIV prevention services. </p>
<p>People at high risk for infection and who wish to start PrEP will need to be tested for HIV before they start and then every three months while taking the drugs. This will ensure that those with an early HIV infection are detected and don’t develop anti-retroviral drug resistance. They will also have their kidney function tested as Truvada can cause <a href="http://www.aidsmap.com/iTruvadai-PrEP-does-not-harm-the-kidneys-trial-shows/page/2827796/">kidney problems</a> in some people.</p>
<p>But the biggest challenge is ensuring that young people, particularly young women, who start PrEP take the pills daily as required. Those taking PrEP daily cannot miss a single dose. While two trials of pre-exposure prophylaxis in South Africa, Zimbabwe, Tanzania, Kenya and Uganda <a href="https://theconversation.com/what-drove-women-to-lie-in-an-hiv-clinical-trial-in-southern-africa-51143">raised questions</a> about whether young women will adhere to pre-exposure prophylaxis, recent open-label studies have shown that when populations at-risk, including young <a href="http://www.hptn.org/web%20documents/HPTN067/HPTN067_SAresults_Fact%20Sheet_V1.0.pdf">women</a>, recognise their risk and know that pre-exposure prophylaxis is effective in preventing HIV, they are able to use it effectively. </p>
<h2>It’s time to implement</h2>
<p>Several pre-exposure prophylaxis demonstration projects are either underway or are being planned across southern and eastern Africa. These projects will inform the development of national policies and programmes, adding to the evidence base to understand how best to innovate, integrate and implement Truvada within a combination HIV prevention package. </p>
<p>The challenges of delivery will only be truly understood through implementing delivery projects. Once we have gained insights into the challenges, we will be able to refine an HIV combination prevention programme to meet the needs and preferences of teenage and young women.</p><img src="https://counter.theconversation.com/content/52539/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sinead Delany-Moretlwe receives funding from USAID/PEPFAR, DFID, and NIH</span></em></p><p class="fine-print"><em><span>Deborah Baron receives funding from DFID and USAID/PEPFAR. </span></em></p>Young women in southern Africa are most at risk of becoming infected with HIV. If they take a pre-exposure prophylaxis like Truvada it could change their lives.Sinead Delany-Moretlwe, Associate Professor and Director: Research at the Wits Reproductive Health and HIV Institute I, University of the WitwatersrandDeborah Baron, Researcher and Programme Manager: Clinical Research Consortium for Wits Reproductive Health and HIV Institute (RHI), University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.