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Africa: AIDS Research "Game Changer"
AfricaFocus Bulletin
May 16, 2011 (110516)
(Reposted from sources cited below)
Editor's Note
A new randomized study of AIDS treatment as prevention,
beginning early treatment of infected heterosexual people who
are living in partnership with an uninfected person, has shown
a 96% reduction in risk of infection. ... Instead of taking
this as the game changer it is, notes AIDS activist Brook
Baker, U.S. officials are still taking a "We're too broke to
think" response. And the United States and other donor
countries are opposing firm AIDS treatment targets at the UN
meeting on the issue next month.
The result is not unsurprising, as earlier studies have also
indicated the positive effect of AIDS treatment on reducing
the risk of infection. But this study, including 1,763 HIVserodiscordant
couples (couples that have one member who is
HIV-infected and the other who is HIV-uninfected) at 13 sites
across Africa, Asia and the Americas, is by far the most
definitive. The implication is that AIDS treatment, far from
being an alternative to AIDS prevention strategies, is in fact
one of the most effective strategies for prevention.
Meanwhile, only a little more than 5 million of the 15 million
with HIV needing treatment under existing guidelines are
receiving treatment. In total there are 33 million estimated to be
living with HIV, many more of whom might also benefit by
treatment, thus reducing the risks of transmission.
In a May 16 editorial, the San Francisco Chronicle
(http://tinyurl.com/3b73c6s) concluded that failing to fund
early treatment "would be a mistake. Yes, anti-retroviral
medications are pricey - but what are really expensive are new
HIV infections. Early treatment offers enormous returns for
patients' health and productivity, and now, it appears, that
benefit extends to their partners as well. It doesn't come
cheaper than that."
This AfricaFocus Bulletin contains (1) a press release from
FHI (http://www.fhi.org) describing the new study by HIV
Prevention Trials Network (http://www.hptn.org) , (2) a press
release from Médecins Sans Frontières (MSF), presenting their
new report on best practice in AIDS treatment from a 16-
country study, and their call for donor countries to drop
their opposition to treatment targets, and (3) a commentary by
AIDS activist Brooks Baker on the reluctance by U.S.
policymakers to abandon the false opposition between treatment
and prevention.
For previous AfricaFocus Bulletins on health issues, visit
http://www.africafocus.org/healthexp.php
++++++++++++++++++++++end editor's note+++++++++++++++++
Initiation of Antiretroviral Treatment Protects Uninfected
Sexual Partners from HIV Infection (HPTN Study 052)
96% reduction in HIV transmission, according to study
conducted
by HIV Prevention Trials Network
http://www.fhi.org
12 May 2011
Media inquiries:
Matt Matassa
703.647.1909; mmatassa@fhi.org
For more information, visit http://www.hptn.org
Washington, DC - Men and women infected with HIV reduced the
risk of transmitting the virus to their sexual partners
through initiation of oral antiretroviral therapy (ART),
according to findings from a large multinational clinical
study conducted by the HIV Prevention Trials Network (HPTN), a
global partnership dedicated to reducing the transmission of
HIV through cutting-edge biomedical, behavioral, and
structural interventions.
The study, known as HPTN 052, was designed to evaluate whether
immediate versus delayed use of ART by HIV-infected
individuals would reduce transmission of HIV to their HIVuninfected
partners and potentially benefit the HIV-infected
individual as well. Findings from the study were reviewed by
an independent Data and Safety Monitoring Board (DSMB).The
DSMB recommended that the results be released as soon as
possible and that the findings be shared with study
participants and investigators. The DSMB concluded that
initiation of ART by HIV-infected individuals substantially
protected their HIV-uninfected sexual partners from acquiring
HIV infection, with a 96 percent reduction in risk of HIV
transmission. HPTN 052 is the first randomized clinical trial
to show that treating an HIV-infected individual with ART can
reduce the risk of sexual transmission of HIV to an uninfected
partner.
"This is excellent news," said Dr. Myron Cohen, HPTN 052
Principal Investigator and Associate Vice Chancellor for
Global Health and Director of the Institute of Global Health
and Infectious Diseases at the University of North Carolina at
Chapel Hill. "The study was designed to evaluate the benefit
to the sexual partner as well as the benefit to the HIVinfected
person. This is the first randomized clinical trial
to definitively indicate that an HIV-infected individual can
reduce sexual transmission of HIV to an uninfected partner by
beginning antiretroviral therapy sooner. HPTN recognizes the
significant contribution that this study's participants have
made to furthering the progress in HIV treatment and
prevention. We are very grateful for their participation."
HPTN 052 began in April 2005 and enrolled 1,763 HIVserodiscordant
couples (couples that have one member who is
HIV-infected and the other who is HIV-uninfected), the vast
majority of which (97 percent) were heterosexual. The study
was conducted at 13 sites across Africa, Asia and the
Americas. The HIV-infected person was required to have a CD4
cell count between 350-550 per cubic millimeter (cells/mm3) at
enrollment, and therefore did not require HIV treatment for
his or her own health. Couples were randomized to one of two
groups. In one group, the HIV-infected person immediately
began taking ART (immediate ART group). In the other group,
the HIV-infected person began ART when his or her CD4 cell
count fell below 250 cells/mm⢠or if he/she developed an AIDSrelated
illness (the delayed ART group).
Throughout the study, both groups received HIV-related care
that included counseling on safe sex practices, free condoms,
treatment for sexually transmitted infections, regular HIV
testing, and frequent evaluation and treatment for any
complications related to HIV infection. Each group received
the same amount of care and counseling. Any HIV-uninfected
person who became HIV-infected during the course of the study
was referred to local services for appropriate medical care
and treatment.
"This rigorously conducted clinical trial demonstrates that
ART dramatically reduces HIV transmission from an infected
partner to an uninfected spouse or partner," states Sten
Vermund, HPTN Principal Investigator and Amos Christie Chair
of Global Health at the Vanderbilt University School of
Medicine. "Earlier therapy is a superior option that benefits
both an infected individual and his or her uninfected partner
and we support global efforts to offer ART to everyone who
needs it."
Among the 877 couples in the delayed ART group, 27 HIV
transmissions occurred. This was in contrast to only one (1)
transmission that occurred in the immediate ART group. This
difference was highly statistically significant. The viruses
transmitted in these 28 cases were confirmed to be linked by
genetic analysis, confirming that the source of the new
infection was the previously HIV-infected partner.
In the originally HIV-infected individuals themselves, 17
cases of extrapulmonary tuberculosis occurred in the delayed
ART group, compared with three (3) cases in the immediate ART
group, also a statistically significant finding. There were
also 23 deaths during the study. Thirteen (13) occurred in the
delayed ART group and 10 in the immediate ART group. Study
participants and investigators are being informed of the
results, and HIV-infected participants in the delayed ART
group will be offered ART. All study participants will
continue to be followed for at least one more year.
"Previous data about the potential value of antiretrovirals in
making HIV-infected individuals less infectious to their
sexual partners came largely from observational and
epidemiological studies," said NIAID Director Anthony S.
Fauci, M.D. "This new finding convincingly demonstrates that
treating the infected individual â and doing so sooner rather
than later â can have a major impact on reducing HIV
transmission."
"The HPTN 052 study provides compelling evidence for a new HIV
prevention approach that links prevention and care efforts,"
said Quarraisha Abdool Karim, HPTN co-principal investigator
and associate scientific director of CAPRISA. "Strategies for
scaling up knowledge of HIV status and increasing treatment
coverage are critical next steps to realizing the public
health benefits of this finding. This is also very good news
for women who bear a disproportionate burden of HIV infection
acquired from infected male partners but have few options to
reduce their risk especially if their partner refuses to use
condoms
About HIV Prevention Trials Network
The HIV Prevention Trials Network (HPTN) is a partnership
between scientists and communities around the world to
develop, evaluate, and implement cutting-edge biomedical,
behavioral, and structural interventions to reduce the
transmission of HIV. HPTN uses randomized controlled clinical
trials, designed and conducted according to the highest
scientific and ethical standards, to identify the best
combinations of interventions for the populations at highest
risk of HIV infection worldwide. HPTN is largely funded by
NIAID with additional funding from NIDA and NIMH, at the NIH.
About FHI
FHI is a global health and development organization whose
science-based programs bring lasting change to the world's
most vulnerable people. Since 1971, FHI has worked with 1,400
partners in 125 countries, forging strong relationships with
governments, diverse organizations, the private sector and
communities. By applying science to healthcare programs and
clinical research, FHI is helping countries make measurable
progress against disease, poverty, and inequity-improving
lives for millions.
MSF Report: Fragile Progress as Several Countries Upgrade to
Better AIDS Treatment
Top Donor Countries Oppose Crucial Treatment Target Ahead of
UN AIDS Summit
Médecins Sans Frontières (MSF)
MSF began providing antiretroviral therapy (ART) to people
living with HIV/AIDS in 2000 and today provides ART to more
than 170,000 people in 19 countries in Africa and Asia.
To access the report, Getting Ahead of the Wave: Lessons for
the Next Decade of the AIDS Response, visit
http://www.msfaccess.org
New York, 11 May 2011 - A report released today by the
international medical humanitarian organisation Médecins Sans
Frontières (MSF) revealed that several countries hardest hit
by the AIDS epidemic are improving HIV treatment to reduce
deaths and illness - but a lack of support from donors
prevents many from making vital changes. This fragile
progress needs sustained support, but the two biggest AIDS
donors, the US and UK, are opposing a critical HIV treatment
target ahead of next month's AIDS Summit in New York at a time
when mounting evidence shows that HIV treatment can also
prevent HIV infections.
"Our report shows that there is clear engagement from
countries to providing an ambitious response to AIDS, by
changing their guidelines to put people on treatment earlier
and with better drugs," said Dr Tido von Schoen-Angerer,
Executive Director of MSF's Access Campaign. "But because of
funding constraints, some of them are unable to put these
guidelines into practice, which serves as a reminder of how
fragile this progress really is."
MSF's new report, Getting Ahead of the Wave, provides a
snapshot of the response to the epidemic today, by looking at
the policies put in place in 16 countries that together
account for 52% of the global HIV/AIDS burden. Of the 16, 12
have changed their treatment protocols to provide people with
treatment earlier in the course of their disease and 14 have
changed guidelines to move to better-tolerated drugs. Both
policies are part of the latest recommendations from the World
Health Organization. Several countries, such as Malawi and
Zimbabwe, planned to implement improved treatment protocols,
but are unable to because of funding constraints. This means
keeping people on inferior drugs, or treating people only once
their immune systems are weak.
Governments are meeting at the UN in early June to commit to
the blueprint for the next decade of the global AIDS response.
They have been asked by Secretary-General Ban Ki-Moon to
support a treatment target of putting at least 13 million
people on treatment by 2015 - others have called for the
number to be 15 million people. But in closed meetings, the US
and some European governments, such as the UK, have so far
expressed opposition to support such a target. Having all
governments commit to a treatment target is important if a
credible global response is to be mounted to break the back of
the epidemic.
"Today, ten million people are in urgent need of treatment,"
said Dr von Schoen-Angerer. "We know so much more from the
past decade about how to get treatment to as many people as
possible as quickly as possible. With the right policies in
place, we could triple the number of people on treatment
without tripling the costs. But if key donor governments don't
support a treatment target, they are sending a clear message
that they do not intend to ever come to grips with this
pandemic."
Recent scientific evidence also supports scaling up early
treatment, as this helps reduce the spread of the virus, by
lowering the level of virus in people's blood sooner. People
whose 'viral load' has been suppressed to undetectable levels
have a 92% reduced risk of transmitting the virus.
"We know that HIV treatment saves lives, reduces illness and
even dramatically reduces the risk of one person passing the
virus to another," said Dr Marcella Tomassi of MSF in
Swaziland, where MSF provides treatment in clinics throughout
the small country in which 26% of the adult population has
HIV. "Now, more than ever, governments need to renew their
ambition to fighting the epidemic and put people on
treatment".
Mission Crash: The Intolerable Policy Incoherence in US AIDS
Policy, Global and Domestic
Brook Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the
Global Economy
b.baker@neu.edu
http://www.healthgap.org /
https://lists.critpath.org/pipermail/healthgap/
May 14, 2011
For the past three years, US global health pundits in the
White House have been calling for greater efficiencies, for a
renewed focus on prevention rather than treatment to turn the
tide of new infections, and paradoxically for reduced
expectations because fiscal realities and budget reductions
are the order of the day. They have bemoaned the HIV/AIDS
treatment mortgage and espoused unmet needs in other priority
global health arenas, like child and maternal health,
neglected diseases, and even chronic conditions.
Their talking game is strong. When jobs are lost at home,
when formal unemployment hovers near 10%, when an entire
generation of young people look forward to dimming job
prospect, why shouldn't we turn inward, protect our own, and
hunker down into a bunker mentality? When federal deficits
soar, can we continue to spend, individually and collectively,
more than we earn, when our excesses are subsidized from
creditors abroad, some of whom may jump currencies and call in
their loans if our national debt becomes too onerous, why
shouldn't we cut back, deep and hard, anywhere and everywhere
we can?
Even during these atavistic periods of national introspection,
some people, including government-sponsored scientists, just
carry on. They look to the future, they hear the cries of
those without medicines and those most at risk of disease.
They try to discern the razor-edge path to better programming,
more effective treatments, and to health interventions that
will beat back the tide of disease.
Just this week, scientists employed by and supported by US tax
dollars reported a stunning, though not wholly unexpected
finding in a randomized trials of AIDS treatment as HIV
prevention. They had planned a long-term study, extending
until 2015, to study whether starting heterosexual people,
living in partnership with an uninfected person, could reduce
their risk of onward transmission by starting antiretroviral
therapy early, before their CD4 cell counts (a measure of
immune system strength) plummeted to 250 CD4 per mm3.
Alternatively, they explored whether starting early had little
or no discernible effect on infectivity and onward
transmission of HIV, whether early treatment might just
benefit the patient but not the community.
When scientists first unblinded the study (looked at the
interim results on infection of sex partners), they were
stunned. Compared to patients who started treatment at 250
CD4 cell counts, the patients who started early had a 96%
reduction in risk of infection. To put it in clearer
mathematic terms, instead of 27 partners becoming HIV-infected
only one partner became infected in the early treatment arm.
The results were so compelling that the scientists stopped the
study in its tracks. They found it ethically unjustified to
continue to research something that had such strong evidence
of an unequivocal benefit, not only for the patient but for
the health of the patient's lover.
This is a stop-the-presses kind of moment. If you can test
people for HIV and start them early on treatment rather than
when they show up sick, or pregnant, or worse yet in a
wheelbarrow, you might save and extend their lives (because
early treatment has numerous benefits in preserving patient
longevity and well-being) and you might prevent new
infections, even in steady relationships where condom use is
less likely.
In a rational world, US politicians one both sides of the
aisle and White House officials would catch their collective
breathe and say: "Hey, this is important; this is a game
changer; this has promise to help defeat HIV/AIDS both at home
and abroad."
Instead, we get something that feels like a yawn, a cynical
"We're too broke to think" response. So politicians and
bureaucrats will let ADAP wait lists grown (ADAP is a
federal/state program that provides AIDS medicines for people
in the U.S. who are uninsured and too poor to pay for
medicines out of pocket). Likewise, they will flat-fund or
even reduce funding to global AIDS initiatives like the
President's Emergency Plan for AIDS Relief and the Global Fund
to Fight AIDS, Tuberculosis and Malaria, initiatives that
provide AIDS medicines for the vast majority of people living
with HIV who are on treatment. They will turn their backs and
withhold the promise of treatment for those waiting in line.
And waiting in line they are. Ten million people are eligible
for treatment under WHO guidelines based on their well-being
alone. But many people living with HIV would like to save the
lives of their sex partners and loved ones as well. They
might want to start even earlier in order to protect others,
and might be willing to do especially since most of the
evidence to date shows that earlier treatment initiation is
better for them not just their partners.
What is our government saying to these people desperate for
treatment and eager to protect others? They're saying "We
can't commit to achievable expanded ARV coverage because ... "
No real finish to the "because," except perhaps, "We have a
large deficit; come back when we're flush."
These are the same politicians and White House officials who
can give a $700 billion dollar tax break over ten years to the
richest people on earth. These are the same people who can
find trillions of dollars to pay for protracted wars and
armaments under a mantle of deceit. These are the same people
who found hundreds of billions of dollars to bail out banks,
banks that are now reaping their highest ever profits just
three years later.
So, the money excuse - the we're broke excuse - falls flat on
its face.
But stop, US policy incoherence doesn't stop here. At the
same time that the US is signaling that it will regrettably
ignore science, and at the same time that it spend money handover
-fist for to preserve the interests of rich people,
bankers, and military contractors, it is also negotiating
trade agreements that will ultimately raise the costs of
medicines needed in the life-and-death struggle against
HIV/AIDS, TB, malaria, heart disease, diabetes and cancer.
The US insists on protecting the corporate interests of the
hugely profitable pharmaceutical industry by demanding higher
levels of protection for the patent and data monopolies of Big
Pharma and for more stringent enforcement measures to enforce
those enhanced rights. All of these intellectual property and
trade efforts have the predictable impact of raising the
prices of new and improved medicines that fight AIDS and of
delaying the introduction of generic competition that drives
prices down.
This short-sightedness, this callous disregard, this
intolerable policy incoherence must stop - it must be opposed
by all rational people. Forced over time to respond to
demands for AIDS treatment at home and abroad, the US solemnly
promised a mission to halt, reverse, and eventually eliminate
the pandemic - it promised universal access to comprehensive
prevention, treatment, and care. Instead of all speed ahead,
especially in light of new breath-taking research, the US is
engaging in mission crash. The cost of disinvestment is paid
in the lives of our brothers and sisters, fathers and mothers,
and sons and daughters, here and abroad. As the mission
crashes, the lives lost are not those of politicians, who have
plenty of insurance, thank you very much, but of people who
can't afford treatment on their own, and who certainly cannot
afford the even higher costs of patent monopolies.
Expert communities in medicine, law, and development should be
beating down doors to the White House and Congress. People
living with HIV/AIDS and their allies should be taking to the
streets. Proponents of human development, social justice, and
global equity should be shouting "Enough is enough." All of
us live in a world of political choice and political action.
In the promising light of science, the new wages of silence
are even more death.
AfricaFocus Bulletin is an independent electronic publication
providing reposted commentary and analysis on African issues,
with a particular focus on U.S. and international policies.
AfricaFocus Bulletin is edited by William Minter.
AfricaFocus Bulletin can be reached at africafocus@igc.org.
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