The U.S. Food and Drug Administration has approved Tivicay (dolutegravir), the second antiretroviral (ARV) to hit the market in the integrase strand transfer inhibitor class, after Isentress (raltegravir). Marketed by ViiV Healthcare and manufactured by GlaxoSmithKline, the drug got the green light for use in both treatment-naive and treatment-experienced people with HIV, including those who have taken Isentress. Tivicay was also approved for use in children ages 12 and older who weigh at least88 pounds (40 kilograms) and haven’t taken integrase inhibitors before.
In clinical trials comparing Tivicay to Isentress, the newly approved ARV suppressed HIV as well or better than the older drug. Tivicay is considered a promising alternative because of its once-a-day, 50-milligram dosing, while Isentress requires 400 mg twice a day.
Saying he sees “a lot of very compelling data” for Tivicay’s use, Antonio Urbina, MD, an HIV specialist at the Spencer Cox Center for Health in New York City, praises the drug’s tolerability and its few drug-drug interactions.
“I think there is a lot of excitement about this drug,” he says. “Because, in our field, with the regimens getting simpler and less toxic, the fewer the pills, the better the tolerability, the greater I think their use is going to be.”