FDA Panel Urges Approval of Drug that Prevents HIV Infection

Truvada is a medication that, if taken every day, can prevent a person from contracting HIV. This can be very important for people in high-risk situations, such as gay and bisexual men and heterosexual couples with one HIV-positive partner. The Associated Press reported today that an expert panel appointed by the US Food and Drug Administration has recommended that it be approved for sale. You might assume that this news would be widely welcomed since it would seem to offer a new opportunity to reduce HIV infections and possible death from AIDS. However, there are counter-arguments:

During the meeting's public comment period, FDA panelists heard from more than two dozen doctors, nurses and patients who said patients would not take the drug as recommended — every day, in addition to using condoms.
"Truvada needs to be taken every day, 100 percent of the time, and my experience as a registered nurse tells me that won't happen," Karen Haughey told the panel. "In my eight years, not one patient that I've cared for has been 100 percent adherent."
Other speakers worried that wide scale use of Truvada would divert limited funding from more cost-effective options. Truvada sells for about $900 a month, or just under $11,000 per year. The AIDS Healthcare Foundation, which opposes approval of Truvada, estimates that 20 HIV-positive patients could be treated for the cost of treating one patient with preventive Truvada.
"Truvada for prevention will squeeze already-constrained health care resources that can be better spent on cheaper and more effective prevention therapies," the group states in a petition to the FDA.

If the drug is approved as expected, it may simply become a boutique drug, rather than a real breakthrough. It is the latter, of course, that would be very nice, but every little bit helps. After all, 

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to breakdown, leading to infections which are eventually fatal. Gay and bisexual men account for the majority of cases — nearly two-thirds.
The number of new HIV infections in the U.S. has held steady for 15 years at about 50,000 per year. But with no vaccine in sight and an estimated 240,000 HIV carriers unaware of their status, doctors and patients say new methods are needed to fight the spread of the virus.