Africa: AIDS Research "Game Changer"

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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 — and doing so sooner rather than later — 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.

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