FDA to review drug intended for HIV prevention

Preventing HIV/AIDS has been a goal since the disease was recognized in the 1980s.

On Thursday, for the first time, a U.S. Food and Drug Administration advisory committee will review a new drug application for a compound that its manufacturer says will help prevent AIDS.

Gilead Sciences, Inc., produces the drug Truvada (emtricitabine/tenofovir disoproxil fumarate), which is already approved for use in treating some patients that already have AIDS.

Gilead wants the FDA to approve a label that says the drug will help prevent the disease for high-risk patients.

Because of controversy over several aspects of the topic, the FDA said late last week that it was extending the time available for public comment at the FDA hearing. The hearing is scheduled for FDA headquarters in Silver Spring, Md.

As with many new drug applications, there is debate about whether the clinical trials show the drug provides benefits that outweigh the side effects.

In this case, an added element is some concern in the AIDS community that people don't adhere to doctor's prescriptions to letter, which is true of many diseases and patients. They forget to take a pill or decide they really don't need - or can't afford it. This one will cost $14,000 per year. In this segment of health care, is referred to as a pre-exposure prophylaxis (PrEP).

The related concern is that a pill might undermine efforts to promote condom use, which has proven to reduce the spread of the disease.

Those in favor of approval of Truvada include AVAC, which was founded in 1995 as the AIDS Vaccine Advocacy Coalition. AVAC joined other groups in writing a letter of support for approval.

"The U.S. and international AIDS community overwhelmingly supports FDA's priority review of this potentially game-changing new tool to prevent HIV," Mitchell Warren, executive director of AVAC, said in a statement recently. "The evidence is increasingly clear that daily PrEP can help reduce HIV risk in women and men who take it consistently as prescribed. While no single tool will be enough to stop the spread of HIV, PrEP could be a vital part of a comprehensive, global strategy to end the AIDS epidemic."

The state of California recently said it would contribute $11 million to further research on the drug.

The AIDS Healthcare Foundation objected to the California appropriation, arguing that if anyone is funding research, it should be Gilead. Beyond that, the foundation opposes approval of the drug for prevention.

"AHF has long been critical that PrEP will not work on a large-scale basis because, consistent with poor medication adherence rates for most diseases, people will not be able to take Truvada as directed," AHF said in a statement. "Because of this, there will be little or no preventative effect, and drug resistance and drug resistant strains of HIV will develop. In addition, people who falsely believe they are fully protected against HIV very likely may engage in riskier behavior, thereby increasing their risk of HIV infection."

The antiviral drug advisory committee has a couple members with local people.

Susan Ellenberg is a professor of biostatistics at the University of Pennsylvania School of Medicine. Dr. Robin D. Isaacs, vice president of infectious disease clinical research at Merck Research Laboratories, is a non-voting industry representative.

A link to the FDA page with information on the advisory committee meeting is here.