New PrEP Findings Represent Important Progress, Point to Daunting Challenges in HIV Prevention for Gay Men

Novel technology shows 44% efficacy when used in concert with established prevention strategies among men who have sex with men and transgender women

November 23, 2010 - The Global Forum on MSM & HIV (MSMGF) welcomes the encouraging results from the first-ever clinical trial assessing the safety and efficacy of oral pre-exposure prophylaxis (PrEP) in preventing HIV infection among men who have sex with men (MSM) and transgender women. With a reported efficacy rate of 43.8 percent among these at-risk groups, the trial findings signal important progress toward an expanded repertoire of HIV prevention options.

The Pre-Exposure Prophylaxis Initiative, or iPrEx, involved oral administration of anti-retroviral medications (ARVs) – drugs that are currently used to treat people living with HIV – to persons who are HIV negative in order to help prevent HIV infection.  ARVs were taken once a day in combination with a full range of additional HIV prevention interventions, including HIV testing and counseling, management of STIs and access to free condoms.  More than 2,500 participants took part across 11 sites in Peru, Ecuador, Brazil, South Africa, Thailand and the United States. 

A total of 100 new infections were recorded during the course of the trial – 64 in the placebo group and 36 in the experimental group.  Data from the study also indicated that the PrEP regimen used in the trial does not pose significant safety concerns, reinforcing results from previous PrEP safety trials.

These findings are promising and show that there is a potential role for PrEP to play in HIV prevention for MSM. However, with this new reality comes the fact that we, as a community of advocates, must now confront difficult questions about roll-out, cost, HIV-prevention messaging and the place PrEP takes in a broader continuum of prevention interventions. 

Access to ARVs remains extremely difficult around the world. UNAIDS has estimated that only 36 percent of people living with HIV who need ARVs could access them just one year ago.  Implementation of PrEP is highly unlikely in countries where access to ARVs is already seriously limited.  Even in places where access to ARVs is more stable, PrEP will likely be targeted to groups most at risk for HIV, including MSM. This would in turn require disclosure of same-sex behavior, which could prove difficult or even dangerous in countries where violence, stigma and discrimination against MSM persists. 

The iPrEx team has rightly noted that this is not a study of PrEP in a vacuum, but a study of PrEP when combined with a suite of other proven HIV prevention interventions – a state-of-the-art model of combination prevention, which may have been an important contributing factor underlying these encouraging results.  However, the additional components of this intervention also remain out of reach for the vast majority of MSM; 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. 

Another challenge is adherence.  Although study participants learned about PrEP and the importance of adherence as part of the trial protocol, researchers reported that only about half of study participants took the medication consistently.  Compounding the problem of adherence is the challenge of developing communication strategies about an intervention that is just 44% effective - and only when taken in combination with a full complement of prevention services. 

The MSMGF congratulates the iPrEx team on an important step forward in the fight against HIV among MSM and transgender people.  The study opens the door to new opportunities that were not before possible; it also serves as an important reminder that there is no silver bullet for stopping the spread of HIV.  We must now look ahead and redouble our work to address the stigma, discrimination and criminalization that have been driving the epidemic since the beginning; remove barriers that block access to basic HIV-related care, treatment and support services; and support further research to establish optimal implementation practices for PrEP, while emphasizing the value of existing prevention tools such as condoms, lubricant, behavioral interventions, and community mobilization. 

The Global Forum on MSM & HIV (MSMGF) is an expanding network of AIDS organizations, MSM networks, and advocates committed to ensuring robust coverage of and equitable access to effective HIV prevention, care, treatment, and support services tailored to the needs of gay men and other MSM. Guided by a Steering Committee of 20 members from 17 countries situated mainly in the Global South, and with administrative and fiscal support from AIDS Project Los Angeles (APLA), the MSMGF works to promote MSM health and human rights worldwide through advocacy, information exchange, knowledge production, networking, and capacity building.