Dolutegravir Approved to Treat HIV — Physician’s First Watch
Dolutegravir Approved to Treat HIV
By Kelly Young
The FDA has approved dolutegravir (Tivicay), an integrase strand transfer inhibitor, to treat HIV in both treatment-naive and treatment-experienced patients, the agency announced.
The once-daily pill is approved for use in adults, including those who've taken other integrase strand transfer inhibitors, and children ages 12 and over who've never taken another integrase strand transfer inhibitor.
Roughly 2500 adults with HIV participated in four clinical trials of dolutegravir. Regimens containing dolutegravir reduced viral loads as well as, or better than, regimens containing raltegravir (Isentress) or efavirenz, emtricitabine, and tenofovir (Atripla).
In his HIV and ID Observations blog, Paul Sax called the new drug an "extraordinarily promising antiviral agent." He added that "it's the end of a remarkable stretch of HIV drug development," with six other drugs approved since 2006. The availability of all of these agents, he writes, "means that pretty much anyone who takes their medications will achieve virologic suppression."