This year, San Francisco AIDS Foundation’s annual Leadership Recognition Dinner honors two champions in the fight against HIV/AIDS: Anne Donnelly, director of health care policy at Project Inform, and Robert M. Grant, M.D., M.P.H., associate professor of medicine at UCSF and lead investigator of the iPrEx study, which found AIDS medications could be used to prevent infection.
These experts are leading the charge on two important fronts: policy and prevention research. Neither of them is looking backwards. Their eyes are on the horizon, eager to improve the lives of all people living with HIV/AIDS.
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As one of the top HIV/AIDS health care advocates in the state of California, Anne Donnelly knows we are at a critical moment in the 30-year history of the epidemic.
“This is a time of enormous potential and enormous concern,” said Donnelly. “So many positive things are happening, such as health care reform and the National HIV/AIDS Strategy. At the same time, we are facing serious threats like AIDS Drug Assistance Program (ADAP) failures, significant cuts to programs that people with HIV depend on, and debate about dismantling crucial entitlements like Medicaid. The concern is whether we, as a community, will be able to defend hard won gains and take advantages of new opportunities. What we face is enormous and requires new thinking and new ways of operating.”
The scope of Donnelly’s work, addressing myriad policy issues surrounding HIV/AIDS, is immense. At the state level, she works with partners at San Francisco AIDS Foundation and other organizations to ensure federal health care reform is properly implemented here in California so people living with HIV/AIDS get the secure, affordable, and quality care and treatment they need. A big component is the integration of the Ryan White CARE Act into the health care systems that will serve HIV-positive people under the Affordable Care Act.
“Ryan White programs are going to have to integrate into the larger health care system,” said Donnelly. “In preparation for the reauthorization of the bill in 2013, we need to closely examine what Ryan White will need to look like so it works with the new health care system and continues to fill gaps that may impact people living with HIV. It’s a big job. And if anybody said they knew exactly what it would look like, that would be untrue.”
Another major issue is health care for certain immigrant populations, including undocumented people. Health care reform does not provide any coverage or assistance for those who are undocumented, which could jeopardize the health of many people living with HIV. Undocumented people are not eligible for the Medicaid expansion or to receive subsidies for purchasing health care insurance. This makes the Ryan White CARE Act even more essential to ensuring all people with HIV in the United States are able to maintain access to basic care.
Donnelly also works to keep the AIDS Drug Assistance Program (ADAP) strong and efficient in California, collaborates with partners to fend off severe budget cuts so people living with HIV/AIDS do not face terrible health outcomes, and keeps a close eye on the major restructuring of the MediCal program.
This just scratches the surface of the tremendous amount of work that Donnelly, Project Inform, San Francisco AIDS Foundation, and countless other agencies in California and across the nation face right now.
“In the HIV/AIDS community, we’ve always been in a state of change. But in the beginning there was a clear target—to get people adequate health care and treatment,” said Donnelly. “Now, there are so many interrelated issues. We have health care reform, a national strategy, the new world of bio-medical prevention, and serious budget troubles to name a few. We really need all of us, connecting to each other and bringing out our best, to confront the challenges and realize the opportunities that are out there.”
Last November the HIV community received some of the most promising medical news in the history of the epidemic. Researchers found that drugs currently used to treat HIV/AIDS may also help prevent infection when used as part of a comprehensive prevention package including condoms and counseling. The discovery means we may someday have another tool that can play a critical role in reducing the number of new HIV infections in the United States and globally. It means HIV prevention may no longer be one dimensional.
Dr. Robert Grant of UCSF and the Gladstone Institute of Virology and Immunology examined the strategy—called pre-exposure prophylaxis, or PrEP—for HIV prevention as principal investigator in the iPrEx Study. This groundbreaking study, conducted at eleven study sites in six countries (including San Francisco), evaluated the effectiveness of the widely used AIDS drug Truvada to prevent HIV infection in nearly 2,500 gay and bisexual men and transgender females at high risk for acquiring the virus. The results were impressive: study participants who took Truvada almost daily had up to 95% protection against HIV.
“Our job as scientists is to do a study that people are able to interpret, and we did that,” said Grant. “It was the combined effort of a lot of people—687 employees over the years. It took the leadership and effort of every single one of them to get this done.”
The results represent a watershed moment in the fight against HIV/AIDS. But now Grant and other researchers across the globe are looking at the next steps toward full implementation of PrEP as a prevention tool.
“The challenges are clear: Who should take PrEP, and how do you identify candidates in a way that is not ambiguous or stigmatizing?” said Grant. “We often say ‘high-risk people,’ and no one likes to think of themselves as high-risk. There’s quite a lot of work that needs to be done to find helpful ways to identify people who would benefit.”
Looking forward, Grant says medical professionals and government agencies need to figure out how best to promote the consistent use of PrEP, figure out where it should be provided (e.g., sexual health clinics, testing centers, treatment clinics, pharmacies), and determine who is going to pay for it and at what price.
“Many of these questions cannot be fully fleshed out until the product is approved for prevention,” said Grant. “Progress has been good. I think we have to be realistic about how long the FDA takes to review new information. But we’re seeing clear progress on the FDA’s review, and we should know by the end of the year if the agency will approve Truvada for prevention use by men who have sex with men.”
Fortunately, more clinical research is now underway to answer many of the lingering questions surrounding PrEP. The “open-label” phase of the iPrEx study that gets underway next month in San Francisco and Boston will dig deeper into how best to implement PrEP and make it as effective a strategy as it can be—including how to support people in taking the drug every day to get the most protection. For now, Grant says the gay and transgender community is waiting for more results.
“There hasn’t been a lot of demand for this yet. People are being patient. I think they realize there are still a lot of questions that need to be answered. They’re not going to ask for or demand access to something like this when there are still all these programmatic questions, and none of these questions is easy.”
But, Grant says, answers will come soon in large part because of the talent and dedication of researchers and volunteers here in San Francisco and around the world.
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