By Richard Hasunira, Lydia Mulwanyi-Mukombe and Moses Supercharger Nsubuga
The Uganda National Council for Science and Technology (UNCST) must expedite approval of its demonstration protocol
In a recent public statement (see “Gileads phony consensus on PrEP”, The Independent, Aug.18), the American-based AIDS Healthcare Foundation (AHF), which specialises in HIV treatment, expressed fears that “Expanding the use of ARVs to include PrEP will increase the risk of resistance, which is already a serious problem (in HIV treatment.
Furthermore, it said, although some of the trial results have been very impressive, the protection with PrEP is unlikely to be 100%, and making drugs available as prophylaxis could encourage high-risk sexual behaviour among those who believe themselves to be protected.
The AHF statement followed a decision, in mid-July, by the Food and Drug Administration (FDA) of the United States to approve Truvada, an ARV that has been used to treat HIV since 2004, for daily use as pre-exposure prophylaxis (PrEP) by uninfected adults to help prevent the sexual acquisition of HIV. The FDA approval was based on clear evidence from clinical studies conducted in Uganda and other countries showing that Truvada, as well as another ARV known as Tenofovir, can also be used to prevent HIV among men and women at risk of HIV infection.
Following the FDA approval, World Health Organisation (WHO) issued guidelines for use of the drugs in demonstration projects, which will generate information on the safety and effectiveness of PrEP outside a clinical trial setting, as well as its feasibility when used alongside other existing HIV prevention methods.
While these fears by AHF and other interest groups may be genuine, they do not in any way nullify the research evidence upon which the FDA based its approval. AHF itself acknowledges the robustness of the PrEP trial results. And indeed, WHO has stated that “There is a compelling case for the use of TDF/FTC (Truvada) as PrEP for the uninfected partner in heterosexual HIV discordant couples.”
According to a programmatic update published in June, WHO expects all countries to maximise the use of ARVs for HIV prevention, including countries still working on scaling up treatment for treatment’s sake.
In its recommendations, WHO states, “In countries where HIV transmission occurs among serodiscordant couples, where discordant couples can be identified and where additional HIV prevention choices for them are needed, daily oral PrEP (specifically tenofovir or the combination of tenofovir and emtricitabine (Truvada)) may be considered as a possible additional intervention for the uninfected partner.”
Discordance, where one partner is HIV-positive and the other negative, is a major problem in Uganda, and PrEP will be of specific benefit to couples wishing to have children – which they will not get while using condoms – as well as in cases where one partner is unable to negotiate condom use. More than half of the people living with HIV (PLHIV) are thought to have a negative partner, and nearly half of the infections in Uganda are estimated to be occurring among discordants.
Two research sites in Uganda are waiting for regulatory approval of studies to demonstrate the use of antiretroviral drugs (ARVs) in reducing the risk of HIV infection. The launch of the demonstration studies in the coming months will be another milestone in the steady progress toward PrEP as a new HIV prevention strategy.
Over the coming two years, the demonstration projects in Wakiso and Bushenyi districts will provide more answers to key concerns of interest groups that fear that PrEP may pull resources away from HIV treatment and increase risky sex.
Mathematical modelling has already showed that PrEP will be most beneficial when targeted to groups of people that are at highest risk of infection. In Uganda’s context, PrEP will particularly be beneficial to HIV-negative partners in discordant relationships, as well as other high risk groups. The demonstration projects in Uganda are targeting people in discordant relationships.
PrEP is unlikely to become a mass intervention for everyone throughout their lifetime. Due to relatively higher risk awareness, discordant couples are among the few groups with high levels of adherence, which is crucial in minimising risk of resistance and enhancing PrEP efficacy. PrEP will also be most useful to people going through periods of high risk in their lives and who may discontinue it when circumstances change. And the need for additional HIV prevention options has become even more urgent. Findings from the 2011 National HIV Indicator Survey announced recently indicate that HIV prevalence is on the rise. It is estimated at 7.3%, up from 6.4% in 2004/05. This has also reflected in the number of new infections, which increased from about 124,000 in 2009 to 128,000 in 2010, and to 130,000 in 2011. And, according to Uganda AIDS Commission (UAC) Chairman Prof. Vinand Nantulya, “more are expected next year, and the year after!”
There is therefore need to strengthen the prevention effort with new tools, and now is the time for the country to develop a framework for targeted implementation of PrEP. This will ensure a smooth scale up of PrEP to key targeted populations once the demonstration projects deliver the needed additional information.
We call upon Uganda National Council for Science and Technology (UNCST) to expedite the approval of the demonstration protocol. We also call upon the Ministry of Health and UAC to ensure that the results from the demonstration projects feed into planning and action. This calls for exploring innovative fundraising ideas, strengthening the health system, and laying ground for targeted implementation of PrEP.
Richard Hasunira is HIV/AIDS Advisor at HEPS-Uganda and Coordinator of Uganda Civil Society HIV Prevention Working Group; Lydia Mulwanyi-Mukombe is a 2012 AVAC HIV Prevention Research Advocacy Fellow; and Moses Supercharger Nsubuga is an HIV/AIDS Activist and a person living with HIV in a discordant relationship