First HIV prevention drug recommended by FDA panel

 The first proven drug for prevention of HIV infection has been recommended for FDA approval by an expert panel.

Truvada from Gilead Sciences, an oral combination therapy used since 2004 to treat HIV infection, may shortly be available as a preventative therapy.

The panel emphasised that the drug is less effective in women than in men, and must not be used in place of other preventative strategies.

Adherence was also highlighted as an issue, since Truvada is ineffective if not taken every day.

Truvada was recommended for prescription to people at high risk of HIV infection, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

The medication is a combination of two anti-HIV drugs, Emtriva and Viread. Its off-label use to prevent HIV infection is already widespread.

In 2010, a three-year study by the US government found that daily doses of Trevada together with condom use reduced the risk of HIV infection by 42% in gay and bisexual men. In 2011, a similar study found that it reduced infection by 75% in heterosexual couples where one partner was HIV-positive.

The drug’s value is contested among people working to control HIV infection, due to concerns that Trevada will give people who are not compliant with the need for condom use and/or daily dosage a false sense of security.

While the cost of widespread prescription is not a factor in whether the FDA grants marketing approval for Trevada, it will clearly affect its uptake by health workers relative to other strategies.