Africa: ‘Game Changer’ For Aids Research

16 May 2011

analysis

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 MÃ decins 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

—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

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

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