CHMP recommends Tybost (Gilead) for HIV treatment

On 25 July 2013, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tybost,(cobicistat) from Gilead Sciences, 150 mg, Film-coated tablet intended for use as a pharmacokinetic enhancer of the human immunodeficiency virus-1 (HIV-1) protease inhibitors atazanavir and darunavir in adults. The active substance of Tybost is cobicistat, a PK enhancer (V03AX03) and is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.

The benefits with Tybost are its ability to inhibit CYP3A-mediated metabolism and to enhance the systemic exposure of CYP3A substrates (such as atazanavir or darunavir) that have limited oral bioavailability and a short half-life due to CYP3A-dependent metabolism. The most common side effects with cobicistat-boosted atazanavir are associated with elevated bilirubin levels.