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 HIV and Coverage of the
17th Conference on Retroviruses and
Infections (CROI 2010)
 February 16 - 19, San Franciso, California
The U.S. HIV Research Agenda and the Future of PEPFAR

SUMMARY: A "seek, test, and treat" approach, viral eradication, and prevention were the 3 key areas of the U.S. HIV/AIDS agenda emphasized by Anthony Fauci of the National Institute of Allergy and Infectious Diseases (NIAID) in a Tuesday plenary at the 17th Conference on Retroviruses & Opportunistic Infections (CROI 2010), taking place this week in San Francisco. In a related session, Ambassador Eric Goosby offered a look at the shifting focus of U.S. global HIV/AIDS efforts.

By Liz Highleyman

Eric Goosby and Anthony Fauci (Photo by Liz Highleyman)

On the opening day of the Retrovirus conference, participants heard 2 overviews of the U.S. HIV/AIDS agenda at home and abroad.

A View from NIAID

NIAID director Anthony Fauci outlined the key points of the federal HIV/AIDS research agenda at a plenary session and an accompanying press conference.

Introducing Fauci, conference Chair John Mellors noted that while "presidents and prime ministers come and go," Fauci has headed NIAID since 1984, and therefore has shepherded the evolution of HIV/AIDS since the beginning of the epidemic.

With an overarching goal of controlling and ultimately ending the HIV epidemic, Fauci picked out 3 key areas of focus, which he characterized as "high risk but high return" if they are succeed:

Aggressively seek, test, and treat to reach more people with HIV.
HIV eradication, or a "cure" for at least a proportion of infected individuals.
Prevention, including new biomedical strategies.

The CDC's current testing strategy has had "overwhelmingly positive results with people we can reach, but treatment in a vacuum will not get our arms around this disease," Fauci said. To do so, it is necessary to either get rid of HIV in currently infected people, or prevent new people from getting infected.

With more than 30 approved antiretroviral agents (ARVs), most people can construct an effective, well-tolerated regimen that suppresses HIV viral load to an undetectable level. "In 1981, we never would have thought we'd have the drugs we do now," said Fauci.

But people with HIV still do not reach a normal lifespan, and there is growing recognition of long-term consequences of HIV infection. This has led researchers to again investigate the possibility of eradication.

Fauci distinguished between sterilizing immunity (complete viral eradication) and permanent viral suppression, which can be considered a "functional cure."

Several strategies -- for example, starting treatment during primary infection and using agents such as interleukin 2 (IL-2) to activate residual HIV in latent cells -- have not shown efficacy.

"Then what has changed?" Fauci asked. "Why do we think we will be successful now?" The answer lies in a variety of new agents and novel strategies that are in the testing pipeline.

With regard to prevention, Fauci addressed recent disappointing results from large-scale human trials of microbicides and HIV vaccines. To date, the microbicides testing in large trials have not contained antiretroviral agents, but several such products are in development.

Microbicides without ARVs "are not dead, but are on a respirator," Fauci said. "I really think experience says we have to go with ARVs."

Many investigators are looking at tenofovir (Viread, also in the Truvada and Atripla pills), with or without emtricitabine. Early studies have demonstrated promising results as a microbicide and as oral or injected pre-exposure prophylaxis (PrEP) in primates and people. Human trials now underway include CAPRISA, studying a tenofovir gel, and VOICE (MTN-003), comparing tenofovir in oral versus gel forms.

While the concept of treatment as prevention is "very, very promising," Fauci said, it faces multiple barriers and challenges.

"Is it feasible to universally voluntarily test everyone infected? We don't know that," he continued. "Is it going to work? Does low viral load produced by treatment equal naturally low viral load? What about weighing benefits to individuals versus society, and cost-effectiveness?"

Turning to vaccines, Fauci noted that researchers have been at HIV vaccine work for 25 years and counting with minimal success. Although several trials have been disappointing -- including STEP, PHAMBILI, and the ALVAC/AIDSVAX combination -- "we learned something from these trials," Fauci said. "ALVAC/AIDSVAX showed the first signal of efficacy, extremely modest though it might be. We need to build on results of Thai trial, but also address fundamental issues in HIV vaccinology."

Asked by Mellors if he could pinpoint an "show-stoppers" in the search for a cure, Fauci replied, "I don't want to seem 'pie in the sky,' but when it comes to science, there really isn't anything you cant do. I'm not going to find the answer in my own lab, but someone's going to do it."

The Future of PEPFAR

At another opening session and in the same press conference, Ambassador Eric Goosby, who heads U.S. global HIV/AIDS efforts, explained the new view of the future of PEPFAR (President's Emergency Plan for AIDS Relief).

"We're looking at a period in PEPFAR's evolution when it has gone through its implementation, and we've reached a level of maturity where its time to look at what do we want to continue, what elements are critical for patients to improve their life, return to work, and support their families, communities, countries. Those types of longer-term needs are a critical part of what PEPFAR needs to do as it moves out of emergency response mode."

Mark Harrington of the Treatment Action Group (TAG) raised the issue of shifting emphasis and resources from a "vertical" approach that focuses on specific diseases such as HIV and tuberculosis to a "horizontal" approach that looks at broader public health issues and health infrastructure. Some activists have criticized the Obama administration for "abandoning" AIDS as it focuses on larger issues such as maternal and child health.

"This is the critical question of our time, how do we allow all boats to rise," Goosby replied. "We want to respond to all the unmet needs of our patient population including HIV...I think we have an opportunity to do this without reducing our HIV commitment."



A Fauci. The HIV/AIDS Research Agenda: A View from NIAID. 17th Conference on Retroviruses & Opportunistic Infections (CROI 2010). San Francisco. February 16-19, 2010. Plenary session 5. February 16, 2010.

E Goosby. The Future of PEPFAR. 17th Conference on Retroviruses & Opportunistic Infections (CROI 2010). San Francisco. February 16-19, 2010. Plenary session 4. February 16, 2010.












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