CDC Statement on IPERGAY Trial of Pre-Exposure Prophylaxis (PrEP) for HIV Prevention among Men Who Have Sex with Men
February 24, 2015 - Today at the Conference on Retroviruses and Opportunistic Infections (CROI), the French national HIV
research agency ANRS announced results of the IPERGAY trial, which examined a novel dosing strategy for pre-exposure prophylaxis, or PrEP,
among men who have sex with men (MSM). The study evaluated a three-day PrEP regimen of tenofovir plus emtricitabine (brand name Truvada)
designed to be taken orally before and after sex. The researchers reported that PrEP reduced HIV risk among the MSM who were
prescribed this regimen by an average of 86 percent.
Also today at CROI, researchers from the U.K. Medical Research Council presented the results of the PROUD open-label study, which found
that daily oral PrEP using Truvada reduced risk among MSM in that study by 86 percent. These findings together provide encouraging
additional evidence of the power of PrEP to reduce the risk of HIV infection.
PROUD adds to the substantial evidence regarding the efficacy of daily oral PrEP. The IPERGAY results provide the first evidence that
an event-driven regimen was effective among high-risk MSM with frequent sex (median of ten sex acts per month and eight partners every
two months). CDC cautions, however, that researchers do not yet know if this regimen will work among MSM who have sex less frequently
or among other populations at high risk for HIV infection. In this study overall, available data suggest that men were taking PrEP
an average of three to four days per week.
CDC continues to recommend daily dosing of PrEP and urges people at substantial risk for HIV infection and their health care providers
to continue to follow current CDC guidelines.
IPERGAY Background
IPERGAY was a randomized, placebo-controlled study that began in February 2012 and was stopped by an independent data safety review board
in October 2014 because of high efficacy. At that point, 400 participants had been enrolled. Instead of a daily pill, as in previous
PrEP studies, participants in the IPERGAY study were instructed to take pills three days around the time of sex. This included:
- A dose of two pills between 2-24 hours before having sex (or one pill, if the most recent dose was taken between 1 and 6 days ago)
- Two additional single-pill doses 24 and 48 hours after the last pre-sex dose
- Continue one pill daily if additional sex events took place before the above regimen was completed
Therefore, the number of days PrEP was taken each week would vary depending on the frequency of sex, sometimes resulting in near daily
use. In any week where sex occurred, there could be as few as four PrEP pills used (with a single act of sex) or as many as eight
(with daily sex).
Statement by Dr. Jonathan Mermin, MD, MPH
Director, CDC National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention:
“CDC welcomes the findings presented today by the IPERGAY and PROUD teams, which provide additional evidence of the power of PrEP to
reduce the risk of HIV infection.
The IPERGAY trial provides the first evidence that an event-driven regimen is effective among high-risk MSM with frequent sex.
Since available data suggest that men in this study were taking PrEP an average of three to four days per week, CDC cautions that
researchers do not yet know if this regimen will work among MSM who have sex less frequently and would therefore be taking PrEP less often.
It is not known whether the regimen will work if taken only a few hours or days before sex, without any buildup of the drug from prior
use. Studies suggest that it may take days, depending on the type of sexual exposure, for the active drug in PrEP to build up to an
optimal level for preventing HIV infection.
There are also no data on how effective this regimen would be for heterosexual men and women and injection drug users or on adherence
to this relatively complex PrEP regimen outside a trial setting. CDC continues to recommend only daily use of PrEP, as approved by the
FDA. IPERGAY findings combined with other recent research suggests that even with less than perfect daily adherence, PrEP may still
offer substantial protection if taken consistently.
We applaud ongoing efforts like IPERGAY to identify PrEP dosing strategies that may be more acceptable than oral daily dosing for some
individuals at risk, and could potentially lower costs. In addition, researchers are working to identify alternative delivery vehicles,
including injectable PrEP and insertable products such as a vaginal ring. These are exciting avenues for research.
We encourage people at substantial risk for HIV infection to take steps to reduce their risk, including speaking with their doctor about
PrEP. Daily, oral PrEP is recommended by CDC as an option for men who have sex with men, heterosexual men and women, and injection drug
users.”
CDC Statement on PrEP Findings Among Discordant Heterosexual Couples
Statement by Dr. Jonathan Mermin, MD, MPH
Director, CDC National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention:
“Researchers from the University of Washington also presented results at CROI today from the Partners Demonstration Project being
conducted among discordant couples (in which one partner is infected with HIV and the other is not) in Kenya and Uganda. The project
is evaluating the impact of providing PrEP as a transitional strategy to protect the HIV-negative partner from infection until
their HIV-positive partner can achieve viral suppression through antiretroviral treatment. Preliminary results show that this
dual strategy reduced the risk of HIV infection by 96 percent.
These findings suggest that for heterosexual discordant couples, both PrEP and antiretroviral treatment can play an important role
in HIV prevention – separately and in combination. The two strategies provided together have dramatically reduced HIV transmission in
this population to date. These results underscore the potential impact of combining the increasing number of powerful HIV prevention
options to slow the HIV epidemic.”
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Contact:
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(404) 639-8895
NCHHSTPMediaTeam@cdc.gov
Source: http://www.cdc.gov/nchhstp/newsroom/2015/IPERGAY-2015-Media-Statement.html
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