Vaccine Briefs

By Regina McEnery

WHO Updates Guidelines on ARV Treatment

The World Health Organization (WHO) released new treatment guidelines in April for low- and middle-income countries with generalized epidemics. The revised guidelines strongly recommend that HIV-infected individuals in serodiscordant relationships be offered antiretroviral (ARV) treatment when they have more than 350 CD4+ T cells per microliter of blood. The recommendations stem from compelling data obtained from recent studies of treatment as a mode of prevention, notably the HPTN052 trial involving 1,763 serodiscordant couples (see Treament is PreventionIAVI Report, July-Aug. 2011), which demonstrated the pronounced benefits of earlier ARV administration in reducing HIV transmission.

The new guidelines come in the wake of a statement by the WHO on the use of hormonal contraception that has drawn criticism from some public health experts for its vagueness (see VAX March 2012 Spotlight article, A Hot Cup of CROI).

The WHO had previously recommended that HIV-infected serodiscordant partners start treatment when their CD4+ T-cell counts were at or below 350/µl. The organization originally planned to announce the new guidelines for serodiscordant couples at last summer’s International AIDS Society meeting in Rome, but held off to allow the dust to settle from an influx of new data related to pre-exposure prophylaxis (PrEP) and couples counseling of injection drug users and men who have sex with men (MSM). However, the authors of the new guidelines ultimately omitted mention of any review of current data on the preventive benefits of antiretroviral therapy in populations other than heterosexual serodiscordant couples.

The 54-page report, posted on www.who.org, also recommends increased counseling and testing of serodiscordant couples in a manner that encourages mutual disclosure of HIV status in a controlled setting. The aim is to ease the psychological burden and curtail potential risks associated with receiving such information without professional support. Providing counseling and testing in such settings, it is hoped, will encourage joint decision making by the couple on matters related to safer sex practices, childbearing, and infant feeding. These settings include antenatal consultations, where the father and mother can learn together about their HIV status and their unborn child’s risk of infection.

The WHO is currently reviewing and analyzing data from recent PrEP efficacy trials and expects to offer advice later this year to guide PrEP demonstration projects being conducted in MSM communities and among serodiscordant heterosexual couples.

Global HIV Vaccine Enterprise Appoints New Director

The Global HIV Vaccine Enterprise Secretariat, an organization that has, since its launch, struggled to find its niche, has picked a new leader. Bill Snow, who co-founded the HIV prevention advocacy group AVAC and is a respected voice among AIDS vaccine researchers, has been appointed its new director.

Snow takes the helm of a leaner organization, filling a vacancy created in June, when the inaugural director of the Enterprise Alan Bernstein departed after three and half years at the post. The Enterprise’s seven-member board of directors, following an exhaustive review, released in October the details of a re-envisioned Enterprise Secretariat that will focus on three key priorities: coordination, collaboration and resource optimization. The main activities of the Enterprise will now include organizing the AIDS Vaccine Conference, holding an annual funders’ forum later this year to optimize current resources and mobilize new funding, and convening relevant parties to address strategic issues (see The Enterprise Changes Course,IAVI Report, Sep.-Oct. 2011.)

“We have found the perfect person,” says AVAC executive director Mitchell Warren and a member of the Enterprise’s board. “There is no one who could provide better leadership or vision to the Enterprise than Bill.”

Though not a scientist, Snow brings a certain “field cred” to the Enterprise that it has lacked since its inception, says Warren. Besides his longstanding involvement with AVAC, Snow also sits on various advisory committees including the AIDS Vaccine Research Subcommittee of the US National Institute of Allergy and Infectious Diseases, and the US National Institutes of Health’s (NIH) Vaccine Research Center Scientific Advisory Working Group. He has also at one time or another contributed to the leadership of many HIV vaccine clinical trials groups.

Snow also served on the Enterprise’s original council and as treasurer of its board when it received its first round of funding—largely from the Bill & Melinda Gates Foundation. His strong opinions about what the Enterprise could and should bring to the field convinced him to throw his hat in the ring. “I felt I knew the Enterprise as well as anyone except José,” says Snow, referring to José Esparza, the senior advisor on vaccines for the Gates Foundation and the interim president of the Enterprise board. “The job was too tempting to resist.” So tempting, in fact, that he and his longtime partner, interior designer Christian Nielsen, relocated from San Francisco to New York so Snow could take the job.

“We have no doubt that Bill’s leadership, intellect, passion and commitment will enable the Secretariat to help make this vision of the Enterprise a reality,” said Esparza, in a statement announcing Snow’s appointment.

The New York-based Secretariat, which consists of Snow and a staff of five, vacated its Union Square offices in March. It is now at 125 Broad St. in downtown Manhattan, where IAVI, one of its partners, is providing temporary workspace. “We and IAVI are considering it open-ended,” says Snow.

On the heels of the Enterprise’s change of leadership comes news that one of its bread and butter projects—the AIDS Vaccine Conference—will no longer be an annual event. At the International Microbicides Conference in Sydney this April, the two largest funders of HIV prevention research—the Gates Foundation and the NIH—jointly announced that, beginning in 2014, they no longer plan to fund single-themed conferences focused on microbicides, AIDS vaccines, or ARV-based prevention. Instead, they will fund a single biennial conference centered on all aspects of HIV prevention.

“We now know that HIV treatment and primary prevention modalities will have to be used in an integrated manner within the field,” says Gina Brown, a senior staff member at the NIH Office of AIDS Research, at the close of the Sydney conference, according to a news summary by aidsmap, an HIV/AIDS information clearinghouse. “It is becoming clear that there needs to be an end-to-end plan that runs from discovery to delivery of each approach, and that this is unlikely to be achieved by the continued ‘silo-ization’ of the field.”

A program committee is being convened to plan the biennial conference. In the meantime, the 2012 AIDS Vaccine Conference in Boston will be held as planned as will the 2013 AIDS Vaccine Conference in Barcelona. Snow says the idea of a biennial conference that maximizes resources, brings together scientists with similar goals, and inspires cross-fertilization of research and development is welcome. “Recent breakthroughs in vaccines and other HIV prevention technologies have shown that we must consider implications and synergies as we continue to move HIV vaccine research forward,” says Snow.

He says the Enterprise plans to meet with a variety of stakeholders in the coming months to determine how best to achieve the benefits of an integrated meeting while keeping true to the Enterprise’s mission of advancing AIDS vaccine science.