US controversy over Gilead’s plans to market Truvada as a HIV prevention pill

A large debate has sparked among public health advocates in US after the pharmaceutical company Gilead has applied to the FDA to market its HIV treatment medication Truvada as a HIV prevention pill.

Gilead wants to be able to market Truvada (tenofovir+emtricitabine), which is currently used as a HIV treatment, as a preventative pill to uninfected individuals, reports California Watch.

If the product will be approved, it would be the first of its kind.

The move has sparked debate among public health advocates who argue that the wide availability of the drug would discourage safe sex and would, in fact, increase the incidence of HIV.

“I believe that this could be catastrophic in terms of HIV prevention,” said Michael Weinstein, president the AIDS Healthcare Foundation, based in Los Angeles.

There are nearly 42,000 Californians living with HIV as of June 2011.

Michael Weinstein told California Watch that as an HIV treatment, he thinks Truvada is a “fabulous drug – it’s one pill once a day, and it has a low side-effect burden,” which include nausea, vomiting and weight loss.

This new pharmaceutical prevention approach to HIV and AIDS is known in scientific circles as “pre-exposure prophylaxis”, or PrEP, and it involves taking the antiretroviral medications on a daily basis.

Clinical trials supported by the National Institutes of Health have shown that when taken daily, Truvada, a blue oval pill, reduced the risk for contracting HIV by between 44% among gay men in four countries and 73% by heterosexual couples in Uganda and Kenya.

Overall, these studies have generated enthusiasm among many medical researchers, reports California Watch.

Truvada is considered to be “an incredible achievement, a wonderful new tool that could be available to people who need additional protection against the acquisition of HIV”, according to Veronica Miller, executive director of The Forum for Collaborative HIV Research and a visiting professor at the UC Berkeley School of Public Health.

But Michael Weinstein said he’s not yet convinced by the research, and he wouldn’t want to see future mass marketing of the drug discourage gay men – the risk group most seriously affected by HIV, according to the Centers for Disease Control and Prevention – from using condoms based on “the false belief that they are protected by this”, when there’s a possibility that those taking the medication still could contract the disease.

Some HIV and AIDS awareness organizations say that while they wouldn’t want to see Truvada trump other forms of prevention, they are hopeful that the drug will help reach high-risk individuals.

“It comes down to choices,” said David Evans, director of research advocacy at Project Inform, a San Francisco organization focused on improving the health of people with HIV.

“For those who are high at risk, we want them to know that there is something new and a better option available to them.”

Nevertheless, David Evans said he shares some of the drug critics’ concerns. “We don’t want to see people give up safe sex practices,” he said.

The Annals of the Forum for Collaborative HIV Research noted that the drug had performed well in clinical trials; the safety risk is relatively low; and as a result, doctors can currently prescribe the drug for prevention off-label. However, those who use the drug could develop resistance to it, and if they don’t use it daily, the risk for contracting HIV increases, the forum said.

Other drug companies, including ViiV Healthcare, also are planning studies to sell similar prevention drugs, but given the number of clinical trials performed or under way on Truvada, Gilead’s product is likely to be the first to make it to market.

Gilead did not respond to requests for comment from California Watch.