By: Paul Sixpence
During the course of 2015, two major global HIV and AIDS conferences were convened: the Conference on Retroviruses and Opportunistic Infections (CROI) and the International AIDS Society (IAS) 2015. At both conferences focus was on the presentation of results from efficacy and feasibility studies of Truvada as Pre-Exposure Prophylaxis (PrEP). A common and consistent thread ran through all presentations, they all presented conclusions to the effect that if PrEP is taken correctly by HIV negative at risk populations, it can prevent primary HIV infections by up to 92 percent. Yes, 92 percent. These new science findings present a new revolution in reversing the spectre of HIV and AIDS.
These results were ably complimented by new World Health Organisation (WHO) guidelines released in October 2015 recommending that people who test HIV positive should immediately be put on treatment regardless of their CD4 count. This policy announcement was in line with positive efficacy results from the Strategic Timing of Anti-Retroviral Treatment (START) study which sought to examine the link between early start of anti-retroviral therapy among HIV positive people and reduced chances of transmission to their HIV negative: a concept otherwise known as Treatment as Prevention(TasP). Of significant note in the October 2015 HIV treatment and prevention policy pronouncements by WHO was the recommendation for PrEP to be availed to populations who need it the most.
The subject of this instalment is to advocate for PrEP roll-out for young women, sex workers and sero-discordant couples in Zimbabwe as a matter of urgency. Young women and other key populations have traditionally existed as a subordinate group and thus their ability to negotiate for safe sex is almost diminished. PrEP offers the aforementioned subordinate groups with a real option to take charge of their bodies and lives through prevention of HIV infection.
What the science says!
Pre-exposure prophylaxis is the use of antiretroviral medications (ARVs) to reduce the risk of HIV infection in people who are HIV negative. Truvada is an antiretroviral containing tenofovir (TDF) and emtricitabine (FTC). It is being used in clinical trials and other follow-on actions to test the efficacy and feasibility of Truvada as PrEP in real world settings. Truvada is currently approved in Zimbabwe for treatment purposes. In a nutshell, PrEP is the taking of preventive drugs to prevent primary infection prior to engaging in a potential risky sexual encounter that can possible expose one to HIV infection. In other words, it is akin to taking anti-malaria tablets prior to getting into a malaria zone.
This instalment is informed by results from clinical trials on the efficacy of Truvada as PrEP in preventing primary HIV infections. Clinical case studies presented in this piece have been deliberately chosen because they were conducted in Africa, in resource constrained settings relatively similar to those obtaining in Zimbabwe. There are other clinical trials that have been conducted in France, Britain, Brazil and the United States of America among diverse set of populations and they have all presented positive results on the efficacy of Truvada as PrEP.
In May 2007, the Centres for Disease Control (CDC) in Botswana launched a clinical trial to test the efficacy of Truvada in preventing primary HIV infection among young adult heterosexuals. To ensure objectivity, participants were randomly assigned to either the controlled arm and or the placebo (a sugar pill) arm. Participants in the controlled arm of the study took a single daily pill dose regimen of Truvada, while those on the placebo arm took a sugar pill. In March 2007, after enrolling 1 200 participants, the study reported positive results: an up to 62 percent risk reduction, which went up to 78 percent among participants with high adherence levels.
The follow-on TDF2 open label extension study which was meant to test the feasibility of Truvada as PrEP in real world settings outside the controlled clinical trials presented more good news. The results were presented at IAS 2015 in July 2015. The study was done over a period of 12 months and results highlighted that 87.8 percent of the participants indicated that they took Truvada as PrEP every day for 3 days prior to sex, 5.5 percent indicated that they took it 1 to 2 times and 6.7 percent reported that they did not take it. Non among the 229 participants who adhered to the daily dose regimen contracted HIV.
Further good news on the efficacy of PrEP were recorded in the Partners PrEP study in Kenya and Uganda. The study enrolled 4758 HIV-serodiscordant heterosexual couples from Kenya and Uganda. HIV negative participants received Truvada as PrEP or placebo once daily, with monthly follow ups for a period of between 24-36 months. The results of the clinical trial indicated a 75 percent risk reduction and this reduction correlated with adherence levels.
Taking note of all these positive and inspiring findings in the field of HIV biomedical interventions, the President of the International AIDS Society and Chair of IAS 2015, Chris Beyrer had this to say;
“The science on PrEP is overwhelming and its conclusions are clear: PrEP works when taken. Access to PrEP is now a public health and human rights imperative. The studies presented here [at IAS 2015] provide the most detailed data to date on PrEP implementation successes and challenges, underscoring that the intervention is feasible and effective in the real world. We hope these studies launch the beginning of a new PrEP era.”
Current global trends in adopting PrEP
The most telling and inspiring story of PrEP regulatory approval and roll-out resides with the United States of America. In July 2012, the United States of America (USA) Food and Drug Administration approved PrEP roll-out in the USA.
The Southern Africa HIV Clinicians Society has issued comprehensive guidelines for the use of Truvada as PrEP for both women and men. An application for PrEP licensure has also been filed with the relevant authorities in South Africa.
Is PrEP for Zimbabwe?
PrEP is not for everyone but for specific populations at high risk of infection. Among those who are in need of PrEP in Zimbabwe are key populations, namely, young women, sero-discordant couples and sex workers.
Presenting oral evidence to the Parliament of Zimbabwe Thematic Committee on HIV and AIDS in July 2015, National AIDS Council (NAC) Chief Operations Officer, told the Committee that his organisation was worried with the increasing rates of new infections among young girls and women between the ages of 15 – 24years. He noted that about 80 000 young girls and women were living with HIV as compared to 36 000 of their female counterparts. These statistics speak of the need to urgently find working solutions to stem the tide of new infections.
According to the Centre for Sexual Health and HIV AIDS Research (Ceshhar) out of 52 214 sex workers almost 11 000 (20 percent) are living with HIV. These figures speak of an urgent need to provide sex workers with new and effective solutions in preventing primary HIV infection in addition to messages on correct and consistent use of condoms and behaviour change messages.
The way forward
There is an urgent need for collaborative engagement between policy makers in the Executive, Ministry of Health and Child Care (MoHCC), the Executive, Medicines Control Authority of Zimbabwe (MCAZ), NAC, HIV and AIDS researchers and civil society actors to analyse the science that proves that PrEP works, work on regulatory approval, develop guidelines and roll-out PrEP to those at high risk of HIV infection and who need it.
From 29 November to 04 December 2015, Zimbabwe will host the International Conference on AIDS and STI’s in Africa (ICASA). In light of the encouraging PrEP efficacy and feasibility results, ICASA 2015, should serve as an opportune moment to call upon relevant policymaking institutions in Zimbabwe and other African nation-states to consider PrEP roll out to all those who need it through public health systems. Furthermore, the conference should serve as a marketplace of ideas and exchange of knowledge on how to mobilise resources for PrEP roll-out, enhancing the capacity of public health systems to integrate PrEP into their existing comprehensive HIV treatment and prevention packages and raising awareness among the people of the existence of this new HIV prevention option.
Paul Sixpence is an HIV treatment and prevention advocate and works with Centre Stage Media Arts Foundation Zimbabwe. He can be contacted on: firstname.lastname@example.org