New AVAC Report on Pre-Exposure Prophylaxis Calls for Immediate Planning to Anticipate Study Results of Potential New HIV Prevention Option:
Sunday, August 3, 2008
Mexico City, Mexico, August 3, 2008 -- The
AIDS Vaccine Advocacy Coalition (AVAC) today
released a new report, Anticipating the Results
of PrEP Trials, calling for increased action
from governments, global health institutions,
donors, researchers, and advocates to prepare
for initial results -- expected as early as
2009 -- from the first trials of antiretroviral
drugs being tested for HIV prevention, known as
PrEP or pre-exposure prophylaxis. The report
also provides the most up-to-date information
about ongoing and planned PrEP research, and
lays out an agenda for action on key issues
that must be addressed as research on this
promising HIV prevention intervention moves
forward.
The new report is available
online at http://www.avac.org/prep08.pdf.
PrEP clinical trials are currently planned
or underway in countries in Africa, Asia, Latin
America and North America. These studies are
looking at the safety and efficacy of PrEP, an
unproven strategy in which HIV negative people
could take an antiretroviral drug (ARV), or
combination of ARVs, on a regular basis in the
hopes of reducing their risk of acquiring
HIV.
The AVAC report was released today
at a special session of researchers, advocates
and other stakeholders, held at the XVII
International Conference on AIDS in Mexico City
to discuss the challenges of translating PrEP
and other HIV prevention research into
effective policy and practice.
"PrEP
trials are taking place within a changing
landscape of HIV prevention research," said
AVAC Executive Director Mitchell Warren.
"Disappointing results have emerged from recent
studies of vaccine and microbicide candidates,
while male circumcision was found to be
partially effective at preventing HIV
transmission in some populations and is being
rolled out in some African
countries.
"Although still unproven
human clinical research, PrEP is considered one
of the promising clinical interventions against
HIV currently in development," Warren
continued. "By mid-2009, more people will be
enrolling in PrEP studies than in both HIV
vaccine and microbicide efficacy trials
combined. Advocates and communities affected by
HIV need to understand PrEP and its
implications for the AIDS advocacy and global
health agendas, and government and private
funders committed to global health must step
forward now to ensure that PrEP research is
fully funded."
"We cannot wait for the
study results to begin to prepare for the
optimal use and delivery of PrEP," said Pedro
Goicochea, an investigator of the iPrEx PrEP
study currently underway in Peru and Ecuador
"Instead, we should look ahead to consider all
of the possible outcomes of these trials and
make real plans for making PrEP available to
those who can benefit from it, as quickly and
safely as possible if it is proven
effective."
Anticipating the Results of PrEP
Trials provides an up-to-date status report on
current PrEP research; addresses concerns about
PrEP, including the possibilities of drug
resistance, partial efficacy, and the potential
for increased risk behavior and social stigma;
looks at the potential impact of PrEP on future
HIV prevention research; and considers what
questions should we be preparing to ask now
based on possible different research outcomes
as PrEP studies begin reporting data in the
next few years.
"This report provides an
important overview of PrEP research and lays
out the many difficult issues that are critical
for advocates, communities and public health
experts to understand as trials continue and
report results," said Warren. "We cannot shy
away from discussing issues such as potential
drug resistance, the difficulty of adhering to
a once-a-day pill regimen for people who are
not sick, or the cost of providing PrEP. This
report and today's meeting lay the groundwork
for these important discussions."
AVAC's
report identifies five priority issues that
need attention now, including:
1. Ensure
that current clinical trials have the best
chance of providing results: Clinical trials
now underway in Thailand, Africa, Latin
American and the U.S. could establish the
safety and effectiveness of PrEP, but only if
these trials produce clear answers. Trial
sponsors, regulatory agencies and the global
health community must work together to ensure
that these studies are supported to produce the
data needed to determine next steps on the
possible use of PrEP.
2. Identify and
invest in additional research: A plan for
launching additional studies -- including
studies on the safety and efficacy on
intermittent PrEP dosing, bridging studies in
additional populations, and safety and efficacy
of other candidates -- is needed now and will
require additional funding.
3. Plan now
for optimal use of PrEP: A plan of action for
using PrEP to maximum public health impact
should be developed now. This plan should
address the issues set out in a Lancet paper of
July 2007, which called for assessing
appropriate settings and populations for PrEP
use, determining what level of efficacy would
warrant widespread delivery and determining
where targeted vs. more generalized delivery
would be more appropriate.
4. Prepare
for global procurement and delivery of PrEP:
Plans for PrEP delivery must include a
well-planned and resourced campaign to deliver
PrEP, an understanding of which global funders
will pay for PrEP, plans for rollout, and
guidance and support similar to that
implemented for male circumcision.
5.
Provide adequate financing: Underinvestment in
PrEP is hampering progress and must be
corrected. Government and private funders
committed to global health must step forward
now to ensure that PrEP research is fully
funded.
AVAC's Anticipating and
Understanding Results series provides timely
analysis of trials of new HIV prevention
options. For other publications in the series,
visit http://www.avac.org/.
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About AVAC: Founded in 1995, the
AIDS Vaccine Advocacy Coalition (AVAC) is an
international nonprofit, community- and
consumer-based organization that uses public
education, policy analysis, advocacy and
community mobilization to accelerate the
ethical development and global delivery of AIDS
vaccines and other HIV
prevention options.
For more information, visit http://www.avac.org/.