The Global Forum on MSM & HIV welcomes positive results of PrEP safety trial among MSM

Published: July 24, 2010

The Global Forum on MSM & HIV welcomes positive results of PrEP safety trial among MSM

Study gives hope about an expanded prevention tool kit

Vienna, Austria (July 24, 2010) – The Global Forum on MSM & HIV (MSMGF) welcomes the results from the CDC 4323 trial, released by the Centers for Disease Control and Prevention (CDC) during a late breaker session on the closing day of the 2010 International AIDS Conference in Vienna.  This trial, designed to assess the safety of the oral antiretroviral (ARV) drug tenofovir when used as pre-exposure prophylaxis (PrEP), was conducted among 400 HIV-negative gay men and other men who have sex with men (MSM) in the United States.  Preliminary findings from the trial suggest that the use of PrEP presents no significant safety concerns for MSM. 

It is important to note that CDC 4323 is a safety trial; no conclusions can be drawn about PrEP’s efficacy in preventing HIV among MSM by this study.  Other studies are currently underway around the world to determine if PrEP is effective at reducing HIV infection among individuals at high risk for HIV, including MSM.

In addition to clinical safety, CDC 4323 assessed whether those using PrEP might increase their risk behaviors. While analyses of risk behavior data are not yet complete, early results suggest there was no increase in risk behaviors among MSM taking PrEP during the first nine months of their participation in the study.

PrEP entails the administration of oral ARV agents before exposure to HIV in order to reduce risk of infection if exposure occurs. Although no conclusive evidence currently exists regarding PrEP’s ability to prevent HIV infections, CDC 4323 goes a long way towards lending additional assurance that the strategy may be well tolerated among MSM, should it prove effective. 

Key thought leaders have universally agreed upon the need for multiple, safe and effective HIV prevention approaches. Safety results released today offer hope for an expanded prevention portfolio, one that includes a broad range of peer-led behavioral and community-level approaches that are anchored with concerns for the broader health and human rights of MSM.

MSM continue to shoulder a disproportionate disease burden when it comes to the HIV epidemic in all regions of the world.  Prevalence among MSM is higher than that of the general population in nearly every country that reliably collects and truthfully reports HIV and AIDS surveillance data. On average, MSM are 19 times more likely to be infected with HIV than the general population in low- and middle-income countries. And in resource rich countries, MSM are up to 40 percent more likely to be infected with HIV than the general population, as is the case in the United States. Stigma, violence and discrimination facing MSM worldwide work to aggravate the situation;  homosexuality is criminalized in nearly 80 countries in stigmatized in countless others.

News about the CDC 4323 safety trial follows the positive results of CAPRISA 004, a proof-of-concept study that found a 39 percent lower HIV infection rate in HIV-negative women living in South Africa who used a 1% tenofovir vaginal gel when compared to women who did not. While more exciting progress on ARV-based prevention interventions is anticipated in the near future, we must continue to stress the importance of a comprehensive and balanced approach to the fight against HIV, one that addresses both the unacceptably high HIV sero-prevalence among MSM and the ongoing human rights abuses they endure.

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