| From: |
joya banerjee [ profile ] |
| Subject: |
Fwd: FW: New PrEP data show TDF and TDF/FTC effective in men andwomen; global call July 14
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| Sent: |
Jul 13th, 2011 - 09:55:44 |
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Very exciting breaking news!!!! CDC's comments at the bottom
(including info for those considering PrEP)
-----Original Message-----
From: Advocates' Network [mailto:advocates_network (at) avac.org]
Sent: Wednesday, July 13, 2011 12:57 PM
To: Catey Laube
Subject: New PrEP data show TDF and TDF/FTC effective in men and
women; global call July 14
July 13, 2011
Dear Advocates,
Today, researchers from two different studies of oral pre-exposure
prophylaxis (PrEP) announced evidence that both oral tenofovir (TDF,
marketed as Viread) and oral tenofovir plus emtricitabine (TDF/FTC,
marketed as Truvada) can reduce the risk of HIV transmission among men and
women whose primary route of HIV exposure is penile-vaginal sex. These
landmark findings, which came from the Partners PrEP and CDC TDF2 trials,
extend the benefit previously observed in gay men and transgender women in
the iPrEx trial and have the potential to fundamentally change approaches
to HIV prevention.
On Thursday, July 14 at 7 am EDT / 1 pm South Africa / 2 pm East Africa,
AVAC will host a global teleconference with trial investigators to discuss
these findings. Click here to register:
http://mlist.orchidsuites.net/lists/lt.php?id=NkoDAQZSUAZeAx4NAFNUSgIEBVdTAA%3D%3D
To confirm the time in your area, please visit www.timeanddate.com. This
will be one of several opportunities to discuss these results, and even if
you cant make Thursdays call, we encourage you to send your questions
to avac (at) avac.org. The call will be recorded and made available on our
website.
AVAC will be preparing a document designed to help advocates understand and
analyze these findings in-depth. Some brief, key facts from the findings to
date:
-The two trials, Partners PrEP (funded by the Bill & Melinda Gates
Foundation with study drug donated by Gilead Sciencesand sponsored and
led by the University of Washington in collaboration with sites in Kenya
and Uganda) and TDF2 (sponsored and conducted by the CDC in partnership
with the Botswana Ministry of Health with additional funding from the US
National Institutes of Health and study drug donated by Gilead Science)
looked at the use of either TDF/FTC or TDF in African men and women whose
reported primary HIV risk was through unprotected penile-vaginal sex.
-Both trials found that PrEP using either daily oral TDF/FTC or TDF was
effective at reducing HIV risk in both men and women.
-Both trials also found that the drugs were safe. Although there were no
severe adverse events, there were higher rates of dizziness and nausea
among participants in the active arm of TDF2.
-Both trials reported high rates of adherence based on self-report. TDF2
reported one case of drug resistance in a participant randomized to the
active arm who had acute, undiagnosed HIV at the time of enrollment. This
underscores the need for confirmed HIV-negative diagnosis if PrEP is to be
used safely.
Click here for AVACs PrEP resource page(www.avac.org/prep), which
contains press releases, FAQs and other documents on both TDF2 and Partners
PrEP. More detail is also provided below.
Todays findings make even more critical that stakeholders act on
recommendations put forward in the statement, We CAN End the AIDS
Epidemic, which has been endorsed by more than 30 organizations and
close to 400 individuals around the world to date. (endtheepidemic.org)
In our press release on the new data, we highlight the need for these next
steps:
-Trial teams and Gilead, which donated the study drug, should ensure
continued access to study drug for all participants in the Partners and
TDF2 studies, including those in the placebo arms.
-National governments should work with donors and program implementers to
identify the implementation research needed to address unanswered questions
and evaluate the potential impact of PrEP in key populations and contexts
and to evaluate treatment as prevention, building on the result from HPTN
052.
-At national and international levels, new findings from Partners and TDF2
as well as data from iPrEx and HPTN 052, should be integrated into ongoing
strategic planning, funding proposals for the Global Fund to fight AIDS,
Tuberculosis and Malaria and other processes.
-National AIDS programs along with civil society and other key partners
must swiftly develop clear messages for a range of audiences, including
at-risk individuals and communities, program implementers, policy makers,
regulators and others, about what these data meanand what questions
remain to be answered.
-Funders, trial sponsors and researchers should prioritize additional
research for PrEP and microbicides using different agents and mechanisms of
delivery.
Full press release:
http://mlist.orchidsuites.net/lists/lt.php?id=NkoDAQZSUAZRAh4NAFNUSgIEBVdTAA%3D%3D
The Partners PrEP trial enrolled 4,758 couples in which one partner was
HIV-positive and the other was HIV-negative (a serodiscordant couple).
Partners PrEP was scheduled to run (with its placebo arm) until 2013. At a
meeting on July 10, the trials Data and Safety Monitoring Board (DSMB)
recommended that the trial discontinue its placebo arm and announce its
results to the public due to overwhelming evidence of benefit. Through May
31, 2011, a total of 78 HIV infections occurred in the trial: 18 among
those assigned to the TDF study arm, 13 among those assigned to the TDF/FTC
arm and 47 among those assigned placebo. Thus, those who received TDF had
an average of 62 percent fewer HIV infections (95% CI 34 to 78, p=0.0003)
and those who received TDF/FTC had 73 percent fewer HIV infections (95% CI
49 to 85, p
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