If the FDA approves Truvada for preventive use, it "would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex," according to a company statement at the time of the filing last month.
Gilead's application, however, 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 [PDF] living with HIV as of June 2011.
Weinstein added 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 percent among gay men in four countries and 73 percent by heterosexual couples in Uganda and Kenya. One trial among women in sub-Saharan Africa was stopped in April 2011.
Overall, these studies have generated enthusiasm among many medical researchers
1 comment:
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