“How many of you think you will be breaking down the doors?” Oliver Bacon asked the crowd at a San Francisco AIDS Foundation meeting at the Department of Public Health one recent evening. He was asking about their interest in a new AIDS prevention pill — the first to block HIV before it strikes. “Raise your hands.”
About half of the mostly male audience raised hands.
Bacon, who serves as the medical director of the PreP study at San Francisco City Clinic, was seeking volunteers for the first demonstration trial of Truvada, the prevention pill by Gilead Sciences of Foster City. Last Friday doctors opened enrollment to 300 volunteers for the study, which will examine how the drug will be received by the community that is high-risk but so far uninfected.
Among the volunteers recruiters are seeking are men who have sex with men (MSM), and transgender females. The participants will receive 48 weeks of the drug for free, in exchange for regular monitoring of their social habits and tests to assess the pill’s effectiveness in preventing transmission of the virus.
The stakes couldn’t be higher. Every year 400 San Franciscans are infected with HIV, the virus that causes AIDS. That’s down from 500 a year in 2008, according to the San Francisco AIDS Foundation.
The Castro and Mission districts, the Tenderloin and the Western Addition have the highest numbers of people living with HIV/AIDS in San Francisco. Nationwide, 50,000 people become infected every year.
Traditional barriers to HIV/AIDS — safer sex, condom use and monogamy with a partner who is known to be uninfected — have slowed but not stopped the pandemic’s spread. Globally, about 34 million people live with HIV/AIDS, according to the United Nations.
No longer considered an automatic death sentence as it was when it broke out in 1981, HIV/AIDS has become a manageable disease. But it still requires daily treatment with expensive drugs. A daily Truvada pill can cost $14,000 a year.
“We expect that we will reach our target enrollment of 300 in SF, but we don’t know how many people will have to offer it to get there,” said Stephanie Cohen, medical director of the San Francisco City Clinic, a medical facility at Seventh and Harrison streets that sees 70 patients a day.
Despite the lure of free medicine, attracting volunteers may be tough for several reasons. Mistrust of the medical profession is one hurdle; another, Cohen said, is concern over potential side effects from the drug, which include impaired kidney function.
“Do people want to take PrEP [pre-exposure prophylaxis], and why or why not? That is the key question to our study,” she said. (Pre-exposure prophylaxis is the term used for taking a daily pill to reduce the risk of HIV infection.) Cohen is the co-principal investigator of the demonstration trial in San Francisco.
In 2004, Gilead began marketing Truvada as an antiviral treatment to help suppress the virus in people already infected with HIV. In July of this year, the U.S. Food and Drug Administration extended the drug’s approved uses to include not just treatment but prevention after studies showed a daily pill was also effective as a prophylactic.
Company spokeswoman Cara Miller said that with 50,000 new HIV infections annually in the United States and millions more worldwide, new drugs to combat the transmission of HIV are critical.
“Gilead does not view PrEP as a commercial opportunity, but rather as an important public health intervention that may have the potential to reduce the number of new HIV infections,” Miller said in an email.
With no vaccine yet available, Cohen called PrEP “an important milestone in preventing the transmission of HIV.” The next step, she said, is to transfer knowledge from the clinic to use in the real world.
“Now we are just trying to figure out how … to get it effectively to people who need it most, and to get it there safely and equitably,” she said.
About one in five gay San Franciscans are HIV-positive, Cohen said. This means that an individual in the MSM community doesn’t need many social exposures to be considered at high risk for HIV infection.
“If you are gay man living in SF having anal sex a couple of times a year with different partners, you are still high-risk,” said Cohen.
The San Francisco PrEP demonstration trial is working with another demonstration trial in Miami that will recruit 200 volunteers to obtain a well-rounded data set, Cohen said.
In an earlier trial, called the Pre-Exposure Prophylaxis Initiative (iPrEx), that led to FDA approval, researchers found that a daily Truvada pill was over 90 percent effective in preventing HIV transmission.
In addition to concerns about cost, skeptics fear that the drug could subvert safer sex behaviors such as condom use and maintaining a monogamous relationship.
Moreover, a daily pill regimen isn’t something everyone can adhere to, Cohen said.
“For some people the idea of taking a medication every day is the last thing they would want to do.”
Castro resident Derek Brockehurst, 28, is already on PrEP. It calms his anxiety regarding his high-risk lifestyle and maintaining his HIV-negative status, he said.
Brockehurst, who is a nurse, spoke about his risky lifestyle during the information session and urged those in attendance to consider PrEP as just another tool to stay safe and healthy.
“I’d like to think of PrEP as just another prevention strategy, like lube and condoms,” he said. Brockehurst’s insurance covers the pill.
Mission District resident Steve Crow, 52, attended the community forum on PrEP not only to learn more about the demonstration trial for himself, but to pass information about the drug along to patients at the Berkeley Free Clinic, where he regularly volunteers.
Crow participated in an HIV vaccine study seven years ago that failed. Now he’s interested in Truvada as a safety net for occasional high-risk encounters.
But Crow’s ability to take the pill depends on getting into the demonstration trial or convincing his insurer to pay for it. Paying out of pocket isn’t financially feasible, he said.
Gavin Morrow-Hall, 50, recalled friends recently diagnosed with HIV who lacked options such as Truvada.
“I wish this was there for them,” he said.
Chelsi Moy contributed to this article.
Editors Note: In a previous version of this story Oliver Bacon’s first name was reported as Oscar. Also, in an earlier version his title appeared as the lead clinician for the San Francisco Clinic.