Evidence that daily antiretroviral pill reduces HIV risk in gay men
is a major breakthrough says AVAC
Public health agencies and communities must move quickly to
translate trial results into impact
New York, 23 November 2010 - "This is a great day in the fight against AIDS. The positive
results of the iPrEx oral PrEP study are a major milestone in HIV prevention research and
provide important information about how antiretroviral drugs might be used for prevention by
HIV-negative people at high risk for HIV infection," said AVAC Executive Director Mitchell
Warren.
"It's a result that requires immediate action. Because the pill evaluated in iPrEx is licensed and
available as treatment for HIV-positive people, gay men and others at risk of HIV need
immediate information about what these data tell us and what questions remain. Moreover, gay
men and others at risk of HIV need to give crucial input and have influence on what the next
steps for this new intervention might be," Warren said.
"There is a global imperative to act on the results with ambitious, carefully prioritized research
and implementation agendas, including strategic demonstration projects," Warren continued.
The iPrEx pre-exposure prophylaxis, or PrEP, trial evaluated the safety and effectiveness of a
once-daily dose of the antiretroviral drug TDF/FTC (brand name Truvada) for HIV prevention
among 2,499 HIV-negative gay men and transgender women who have sex with men. At the
end of the three-year trial, there were 36 infections in participants who received TDF/FTC and
64 in placebo recipients. This translates into an average 43.8% reduction in HIV risk overall in
participants who received TDF/FTC compared to those who received the placebo.
"We congratulate the trial sponsors, scientific collaborators and partners who conducted this
landmark global trial. We especially want to thank the nearly 2,500 gay men and transgender
women from four continents whose altruism and commitment as trial volunteers made this effort
possible," Warren added. "The commitment of the iPrEx volunteers is especially important in
light of the current human rights struggles in many countries and communities of gay men and
other men who have sex with men. These volunteers and their communities have made an
inestimable contribution to HIV prevention research and to the eventual development of new
ways for both men and women to protect themselves from HIV. The world owes them and their
communities an enormous debt of gratitude."
"The identification of any new HIV prevention strategy is a landmark moment for the global AIDS
response. iPrEx tells us that we have a new tool for gay men and transgender women. At the
same time, the adherence and resistance data reported in today's New England Journal of
Medicine article tell us that there's a lot of work to be done on identifying the best possible ways
to deliver PrEP to these communities in ways that are safe, effective and grounded in a rightsbased
response. It's also important to remember that even more data will emerge as follow up
and analysis continue over the coming months," Warren said.
One important source of additional information will be a follow-up trial, which will begin in early
2011 and be open to all participants from the original iPrEx trial. All HIV-negative participants
who choose to join this open-label trial will receive the active TDF/FTC pill along with an HIV
prevention package and will be counseled on daily use of the drug. However, monitoring and
HIV testing will be less frequent, with the goal of learning about PrEP safety and effectiveness in
a "real world" context.
"As this information is gathered, public health officials, regulatory bodies and policy makers
must quickly provide clear statements on what we know and what we don't, stressing that PrEP
reduced risk in gay men and transgender women in the context of intensive counseling around
safer sex, condom use and daily pill-taking, as well as regular monitoring including HIV testing."
Warren said.
The trial underscores the importance of providing a comprehensive prevention package. All of
the iPrEx participants received a full prevention package, including condoms, safer sex
counseling and treatment of sexually transmitted infections. At each monthly clinic visit,
participants were tested for HIV and counseled about daily use of the trial drug, a level of
counseling and testing not easily achieved outside of a clinical trial.
The trial also demonstrates that PrEP is only safe in people with confirmed HIV-negative
diagnoses. Two cases of drug resistance documented in iPrEx occurred among two men who
started PrEP while in the earliest phases of HIV infection, and therefore did not test positive for
HIV using the trial's diagnostics.
iPrEx shows that adherence to the drug regimen is essential. Participants who received
TDF/FTC and had detectable levels of drug in their blood were at much lower risk of HIV
compared to participants who received TDF/FTC and had no drug in their blood. The trial also
analyzed risk of infection as it related to reported rates of pill taking. Participants who reported
taking their pills correctly and consistently the majority of the time had significantly lower risk of
HIV infection compared to those who reported taking the pills less frequently.
These data can't be extrapolated to people at risk of HIV via heterosexual sex or injection drug
use. Differences in biology of the vagina and rectum, and between HIV risk in sexual versus
injection exposure make it essential that ongoing trials looking at PrEP in these contexts must
continue.
"iPrEx is the first of several PrEP trials to provide results. There are more than 20,000
participants enrolled in additional PrEP trials worldwide that must continue," said Warren.
The iPrEx findings add to a growing body of evidence confirming the powerful potential of
antiretroviral drugs for HIV prevention. This includes findings from CAPRISA 004, a trial of 1%
tenofovir gel as an HIV prevention tool for heterosexual women, which found that women who
received the gel had an estimated 39 percent lower risk of infection compared to those who
received an inactive placebo gel.
After many years of disappointing results from biomedical prevention trials, iPrEx and CAPRISA
004-along with the RV144 AIDS vaccine trial-mark the beginning of a new era of HIV
prevention.
"New strategies come with new costs. We must ensure that any new strategy is well-validated
before it is widely introduced, and that this introduction comes with new resources and not at the expense of any proven prevention modality,” said Warren.
"As we move towards potential PrEP implementation, it is critical to remember that millions of
HIV-positive people around the world, including thousands in the United States, lack access to
the HIV treatment they need, which is often the same drug used in this trial," Warren said. "We
can and must find a way to ensure that PrEP is a part of comprehensive, well-funded response
to HIV. That means ensuring access for all who need it to existing HIV prevention and treatment
options; ensuring continued research to find and refine effective new options, including PrEP,
microbicides, vaccines and the possibility of treatment as prevention; and planning for
integrating these new interventions into combination programs."
Additional information about the trial is available on the official iPrEx trial website at www.iprexnews.com
More information about key issues around the iPrEx study and the future of PrEP generally is
available in AVAC's PrEP and the iPrEx Trial FAQ that is online at www.avac.org/iprex.
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About AVAC:
Founded in 1995, AVAC is an international non- profit organization that uses
education, policy analysis, advocacy, and community mobilization to accelerate the ethical
development and eventual global delivery of AIDS vaccines and other new HIV prevention
options as part of a comprehensive response to the pandemic.
www.avac.org
CONTACT:
Contacts:
Mitchell Warren, +1-914-661-1536, mitchell@avac.org
Kay Marshall, +1-347-249-6375, kay@avac.org
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