Prezcobix, New Once-Daily HIV Drug, Approved by FDA
On Jan. 29, Prezcobix, a once-daily combination drug, was approved by the U.S. Food and Drug Administration (FDA), for the treatment of HIV in adults.
The new drug contains 800 mg of the protease inhibitor darunavir (Prezista) and 150 mg of the pharmacokinetic booster cobicistat (Tybost). Prezcobix is recommended to be taken once a day with food, and in conjunction with other antiretroviral agents.
Prezcobix was the second cobicistat-containing drug approved by the FDA on Jan. 29, shortly after the approval of Evotaz.
Previous studies showed that the safety and efficacy of darunavir boosted with cobicistat were comparable to that of darunavir boosted with ritonavir, according to the FDA press release.
Moreover, a study from ICAAC 2014 found that cobicistat was well-tolerated by HIV-positive patients with mild to moderate renal impairment who made the switch from ritonavir as a booster.
The approval of Prezcobix may help patients reduce the number of pills in their regimen, potentially relieving pill burden and increasing adherence.
Treatment-experienced patients should have resistance testing done before being prescribed Prezcobix, the FDA states.
Prezcobix is manufactured by the pharmaceutical company Janssen Pharmaceuticals.