The result of the iPrEx study anounced on the 23rd of November 2010 brings lots of new excitement and hope to the field of HIV prevention. The study showed that the use of one antiretroviral pill– Truvada – consistently every day has the potential of
reducing the risk of contracting HIV infection by up to 92-95%.
The study was conducted amongst 2,499 MSM study participants recruited in Brazil, Ecuador, Peru, South Africa, Thailand and USA. The study involved having some of these participants take Truvada every day while other participants took a pill that
looks like Truvada but was not active like Truvada (a placebo). All study participants visted the clinic every month and got tested to check for HIV infection, proper kidney function, and possibility of HIV drug resistance. Study participants were also asked to report on their daily drug use. The pills not used were counted at every study visit. The pills taken by each study participants was calculated by substracting the number of pills left from the number of pills dispensed. Also, in a few participants, blood was taken to examine if there was traces of the drug in their blood as evidence of taking the drug. Analysis of the result showed that:
(i) based on the self report, Truvada is 43.8% effective in prevention new HIV infection among MSMs who engage in sex
(ii) the drug was more protective in study participants who took the drug regularly.For those who took the drug at least 50% of the time based on pill counting, the drug was able to reduce the risk of HIV infection during sex by 50.2%. For those who used the drug at least 90% of the time, the drug was able to reduce the risk of HIV infection during sex by 72.8%.
(iii) having detectable levels of Truvada in the blood was associated with reduced chances of contracting HIV infection when on daily drug regimen. It does not completely eliminate the chances though
(iii) if drug adherence were to be 100%, the drug can possible confera 92-95% protection from HIV infection.
(iv) The drug was found safe with mild side effect. No HIV negative study participant who the trial developed HIV resistance. Neither did any of the study participants who seroconverted. The two study participants who developed resistance appear to have been infected with HIV before their study enrollment.
What does this mean to us as Nigerians?
1. Call to the National Agency for Food and Drug Administration and Control (NAFDAC): Access to ARVs remains extremely difficult in some communities in Nigeria. Currently, access is easier only in the big towns and cities and clustered only in locations that are far difficult to reach for many people living with HIV who need the ARVs. Implementation of PrEP may therefore face its challenges in Nigeria. Unfortunately, wide spread understanding of the potential high benefits of PreP may create a demand for the drug that cannot be met through hospital based services. The thriving black drug market in Nigeria may once again have a potential veritable market for the Truvada as a PreP. NHVMAS calls on NAFDAC to play its critcal role at this time: it need to understand the potential for fake drug sales, and position itself to play a critical important role in preventing fake ARVs sales, especially Truvada, in the market cannot be overemphasised.
2. Call to all International Partners and stakeholders working with MSMs in Nigeria: Even in places where access to ARVs is more stable, PrEP will likely be targeted to groups most at risk for HIV, including MSMs. This would in turn require disclosure of same-sex behaviour, which could prove difficult or even dangerous in a country like Nigeria where violence, stigma and discrimination, and legal restrictions against MSM persists. In a country where MSMs have an HIV incidence that is five times the national average, where MSMS are well know to serve as a bridge for HIV infection to the general population, addressing potential barriers to PreP access needs to be expediated now. NHVMAS calls on all stakeholders working with MSMs should address potential barriers to MSMs’ access to PreP when programmes start to roll out.
3. Call to The National Agency for the Control of HIV/AIDs (NACA) and HIV prevention implementing partners: Truvada is not a magic bullet. Trial participants also had access to suitable HIV prevention tools such as STI management, consistent and regular education on HIV prevention include correct and consistent use of condoms and lubricants, condoms, and monthly HIV testing in addition to the pills. This may have been an important contributing factor underlying these encouraging results. Unfortunately, these additional existing HIV prevention tools ave still out of reach of the general population and less so MSMs. An estimated 90 percent of MSM globally lack access to even the most basic prevention services. To achieve true combination prevention, we must not only significantly expand access to ARVs, but also promote much greater access to condoms, lubricant and other basic sexual health services for all those who need it irrespective of gender, sexual orientation and wealth. NHVMAS therefore calls on NACA, all HIV prevention implementing partners and programmers to intensify efforts at facilitating community access to existing HIV prevention tools even as plans are been made for the roll out of PreP.
4. Call to advocates: One challenge the trial highlighted is that adherence to drug use. Evidence show that the effectiveness of the drug increased with improved adherence. The trial reported that only about half of study participants took the medication consistently. NHVMAS calls on all advocates and HIV community educators to include information on HIV prevention technologies in their HIV prevention messages so as to start discussion the issue of adherence, combination prevention, and the implication of partial efficacy of PreP and other biomedical HIV prevention tools being developed now prior to drug roll out.
5. Call to People Living with HIV: With more and more research evidence showing the efficacy of ARVs as potential HIV prevention tools, the demand for the global limited supply of antirovirals would increase. This will indeed call for concerted efforts between the HIV prevention and treatment field to address the potential challenges this may pose to ARV access for the two fields in the near future. NHVMAS therefore calls on all stakeholders in the field of HIV to work collaboratively as we move the field of HIV prevention into new frontiers. This is a time for joint calls on increased access for HIV treatemtn and prevention within the context of ARV use. The field can no longer be the same again with the announcement of the results of the iPreX trial. We at NHVMAS will continue to use the result of this trial as well as those of existing and forthcoming trials results as an advocacy tool to enhance government, partner and community engagement in HIV prevention research. As the World AIDS day
approaches, the world indeed has a calll to make: a call for universal access to HIV prevention and treatment tools and the respect for the rights and dignity of all men irrespective of their sexual orientation.
