FDA Approves Two New Fixed-Dose HIV Combination Therapies

The FDA last week approved two fixed-dose combination therapies aimed at lowering viral loads and reducing treatment failure rates in patients with HIV.

Bristol Myers Squibb’s Evotaz (atazanavir/cobicistat) and Janssen’s Prezcobix (darunavir/cobicistat) are both protease inhibitors that combine a pharmacokinetic booster — Tybost (cobicistat) — made by Gilead Sciences.

Both drugs are indicated alongside other antiretroviral treatments.

The improvement over other protease inhibitors is largely due to the cobicistat booster, according to clinical trial data. In BMS’ head-to-head trials, the experimental and control arms both showed roughly the same decline in HIV RNA levels, but patients treated with Evotaz had lower failure rates at 48 weeks than patients who got ritonavir.

Janssen also elected to use ritonavir as a comparator. Two Phase III studies showed that the newer combination therapy had a similar safety profile to darunavir combined with ritonavir.

Both companies tout the ease of adhering to treatment regimens, saying Evotaz and Prezcobix allow patients to see similar levels of viral suppression with fewer pills per day. — Lena Freund