New Prevention Data Leads WHO to Delay Guidelines for Couples

Upbeat new HIV prevention findings presented last week at an international AIDS conference held in Rome have complicated attempts by the World Health Organization (WHO) to draft much-anticipated guidelines for heterosexual couples in which one partner is infected. WHO had planned to release "discordant" couple guidelines, in the works for several months, at the Rome gathering, but pulled the plug at the eleventh hour. "We were a little bit optimistic in really getting it all ready in terms of thinking through the operational implications," says Gottfried Hirnschall, head of the HIV/AIDS department for WHO.

Hirnschall says his group decided not to issue the guidelines because of urgings from "key partners," including the Joint United Nations Programme on HIV/AIDS and the Bill and Melinda Gates Foundation. In particular, the partners had concerns about both the language in the document and its lack of inclusion of surprising news that surfaced shortly before the Rome meeting.

Hirnschall explains that a group of outside experts began a review of the evidence late last year before making five recommendations for discordant couples. In mid-May, the group received its first surprise when an ongoing discordant couple trial went public with results early because of the remarkable power of the intervention: Known as HPTN 052, the study showed that if the infected partner took antiretroviral (ARV) drugs, it reduced the risk of transmission by 96%. Hirnschall said the results made the group think long and hard about how to define a "couple"—be it cohabitation, marriage, or just a long-term relationship—as well as the logistical questions of how to compel partners to come forward for testing and how to calculate how many people in the world would be eligible for this approach, called treatment as prevention.

News from a second study in discordant couples, suddenly announced the week before the Rome meeting began, made the draft guidelines potentially even more confusing. The trial found that treating the uninfected partner with ARVs—so-called pre-exposure prophylaxis (PrEP)—reduced the risk of transmission by 73%. The Partners PrEP study, like HPTN 052, released results early because the intervention worked better than initially expected. "That's when we sat together and talked to our key partners and said, 'What should we do with the guidelines?' " explains Hirnschall. " 'Is this really the best moment to release the guidelines, or should we take a deep breath and sharpen the definition and review the findings that came out of Partners PrEP and probably release the guidelines a few months later?' "

Some attendees at the Rome conference worried that WHO may have withheld the document because of undue pressure from partners over how much to emphasize PrEP versus treating the infected partner—which, in turn, raises issues about how best to invest limited resources. But Hirnschall insists that is not the case: "Our decision was our decision, but it was informed from feedback from a range of partners."

Meanwhile, in keeping with the rush of good news from the Rome meeting, the Foundation for AIDS Research has organized a briefing in Washington, D.C., tomorrow with the bold title "Making AIDS History: Ending the Epidemic." Participants will include Anthony Fauci (director of the National Institute of Allergy and Infectious Diseases), Margaret Hamburg (head of the Food and Drug Administration), and Michel Kazatchkine (executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria). The meeting plans to review Partners PrEP and HPTN 052 data and also present an optimistic road map for bringing the epidemic to a halt over the next few years.