The FDA today gave the green light to a new anti-HIV pill that combines four medicines to combat the virus that causes AIDS. The agency approved Gilead Sciences' Stribild as a once-a-day treatment to control HIV in adults who have not previously been treated for infection. The pill contains two already approved antiviral drugs (currently sold as the combination pill Truvada) with two new drugs: elvitegravir and cobicistat. Elvitegravir interferes with one of the enzymes that HIV needs to multiply. Cobicistat helps prolong the effect of elvitegravir.
Company studies showed that 88% to 90% of patients taking Stribild had an undetectable level of HIV in their blood after 48 weeks, compared with 87% for patients taking Atripla, another HIV drug that contains Truvada and one other drug. Like most other HIV drugs, Stribild will carry a boxed warning about potentially dangerous side effects, including severe liver problems and the buildup of lactic acid. More common side effects include nausea and diarrhea. (More Stribild stories.)