Risk of Unprotected Sex Debated in Gilead HIV Pill Review

Healthy people can protect themselves from the deadly HIV virus if they take Gilead Sciences Inc. (GILD)’s Truvada every day. Whether patients will is an issue dividing AIDS advocates as U.S. regulators weigh approving the pill as the first preventative measure against the disease.

Truvada is safe and effective enough as a preventative medicine, Food and Drug Administration staff concluded in a report yesterday. An advisory panel recommendation for approval, set for debate tomorrow, hinges on who would get the pill and whether patients can be educated on the importance of following through with a prescription.

Doctors say the idea is to get healthy individuals in certain high-risk groups to take a $14,000-a-year pill every day to reduce the estimated 48,000 new U.S. cases of HIV each year. Some advocates say such a medicine to prevent the virus that can be avoided with condoms may encourage unprotected sex and increase infections.

“That’s an issue many of us have talked about for years,” said Mitchell Warren, executive director of AVAC: Global Advocacy for HIV Prevention. “If you have this new option, would you be riskier? There is no evidence to show that that might be the case, but that doesn’t mean it’s not a concern.”

Truvada can reduce the risk of HIV as much as 94 percent for people who took the pill regularly, according to a study cited by the FDA. In other trials, only 10 percent of participants took the medicine as prescribed, and one study was halted after no benefit was gained.

Taking Their Medicine

“Among our own patients who are HIV positive, we have difficulty getting them to adhere, let alone people who don’t have the disease,” said Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation, which provides medical care for 130,000 people worldwide. “Counting on adherence is not going to work.”

Another concern, Weinstein said, is that having a preventative pill will lead to a reduction in condom use among at-risk people. Resistance to the drug, “already a serious problem,” may increase if the pill is used as a preventative, according to a September editorial in the journal Lancet. A further issue is how the drug would be distributed.

“A shortfall exists in access to antiretroviral drugs for populations in need of treatment to prolong their lives,” according to the Lancet. “In the face of the current global economic situation, how can these drugs be provided as prevention to those high-risk populations, while people with the disease in need of treatment continue to go without?”

High-Risk Groups

The pill would be aimed at an estimated 415,000 Americans who are among those at high risk for contracting HIV, the Human Immunodeficiency Virus that leads to AIDS, from sexual activity, according to the Atlanta-based Centers for Disease Control and Prevention. These include people whose spouses or partners have the disease, as well as gay men who had more than two partners in the past year and didn’t wear condoms during sex. The number of people infected with HIV rose to 34 million worldwide in 2009.

Gilead, based in Foster City, California, will work with health agencies on public demonstration projects to further the drug’s use if approved, Howard Jaffe, president and chairman of the Gilead Foundation, said in an interview.

“If deployed correctly and efficiently, it could make a big dent in the epidemic in the U.S.,” Jaffe said. “Against the backdrop of no vaccine on the horizon, I think that there’s a strong case to be made for it.”

Gilead rose 2.4 percent to $50.64 at the close of New York trading. The stock has gained 23 percent in the past 12 months.

Expand Research

Getting approval as pre-exposure prophylaxis, or PrEP, would allow researchers to expand the number of patients on the medicine and further educate at-risk populations, James Loduca, a spokesman for the San Francisco AIDS Foundation, said in an interview. Part of that process would involve focusing on certain people during particular times in their lives, he said.

“We don’t think PrEP is a lifetime prevention tool,” Loduca said. “It would be used in a targeted way for specific populations and in relatively short periods of time.”

Scott Owens, a hair dresser in Boston, was part of a study testing Truvada as a preventative medicine, and would “absolutely” recommend it to others. Still, he is worried that the medicine will give a false sense of security and increase risky behavior.

“The young people I talk to, they know there are these drugs now that work really good and they act like it is no big deal,” Owens, 47, said in an interview. “I feel like we are all at risk, no one is 100 percent safe.”

To contact the reporters on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net; Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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