Tuesday, June 21, 2011

ARVs Stop HIV Infection

Harare, Zimbabwe - 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 HIV-uninfected 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). 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.

“The study was designed to evaluate the benefit to the sexual partner as well as the benefit to the HIV-infected 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 HIV-serodiscordant 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 including Zimbabwe, 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/mm³ or if he/she developed an AIDS-related 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.

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.

Recently released data from another study, HPTN 043, demonstrated that community mobilization boosts HIV testing in developing countries and is one option for effectively increasing coverage of HIV testing services. The HPTN is evaluating a test, link to care, plus treat approach for prevention of HIV transmission in HPTN 065, a study currently underway in the USA. This study will demonstrate the population-level impact of increased knowledge of HIV status and linkage to care on HIV transmission.

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 National Institute for Allergy and Infectious Diseases with additional funding from National Institute on Drug Abuse and National Institute for Mental Health, at the US National Institutes of Health.

New Hope for HIV?

Johannesburg, South Africa – Researchers, advocates, funders and pharmaceutical companies’ representatives gathered in Johannesburg, South Africa to prepare and plan for the implementation of 1% Tenofovir Gel. The meeting that ran on 13 and 14 June 2011 is a follow up to a similar meeting, “next steps 1% Tenofovir Gel,” meeting held in South Africa last year. The August 2010 meeting came subsequent to the historic results of the CAPRISA 004 trial released early in July 2010 at the International AIDS Conference at Vienna, Austria. The study results showed that 1% tenofovir gel reduced the risk of HIV infection in women by 39% compared with placebo (control arm), and by 54% in the women who reported more consistent gel use.

The purpose of this high-level indaba was to indentify priority actions to ensure rapid expansion and availability of 1% tenofovir gel following licensure and to inform normative guidance on use of the gel in high HIV incidence countries and settings. The meeting seeks also to identify key contextual issues related to product introduction and implementation that will guide product roll out strategies.
Players in the HIV prevention field are concerned about outlining current plans for market authorization, manufacturing and supply; synthesise and build on existing knowledge on microbicides and other health innovations particularly related to sexual and reproductive health, including family planning.

Follow up studies currently ongoing will provide parallel comparisons of oral and topically applied antiretroviral strategies for prevention of HIV infection in women. One such study, the MTN 003 (Microbicides Trials Network), VOICE (Vaginal & Oral Interventions to Control the Epidemic) is a phase IIb safety and effectiveness study of 1% tenofovir gel, tenofovir tablet, Truvada tablet for prevention of HIV infection in women. This study is being rolled out at sites in South Africa, Uganda and Zimbabwe with a target sample size approximately 5000 women.

The Zimbabwe arm of the study has enrolled 600 women at sites in Chitungwiza's Zengeza Clinic, Seke South and Harare at the Spilhaus Clinic, Harare Central Hospital. The sites under the auspices of the UZ-UCSF are part of the larger effort to bring much needed HIV prevention empowerment hope for many women who make up the majority of people living with HIV.

The WHO/UNAIDS meeting was being attended by close to 60 delegates form USAID, WHO, UNAIDS, and various research institutions,advocacy groups and government representatives. Conspicuous with their absence were Ministry of Health officials from Zimbabwe, where a reasonably sized population is part of the trials. The meeting was fully sponsored by UNAIDS, WHO and USAID.