The European Medicines Agency has approved once-daily dosing of the HIV protease inhibitor darunavir (Prezista) for treatment-experienced adults without signs of potential resistance to the drug.
Once-daily dosing of darunavir requires patients to take two 400mg tablets with 100mg of ritonavir (Norvir) as a boosting agent.
The agency’s Committee on Medicinal Products for Human Use (CHMP) has approved Prezista 400mg tablets for use in treatment-experienced adults without daraunavir-associated resistance mutations. Patients should undergo resistance testing before starting treatment with darunavir, the committee recommends.
However the committee has recommended that once-daily dosing should be restricted to those with CD4 counts above 100 cells/mm3 and viral load below 100,000 copies/ml.
Those with a lower CD4 count and/or high viral load should stick with the already-approved 600mg/100mg twice-daily dosing schedule.
Once-daily darunavir for treatment-experienced patients was approved in the United States in December 2010. Prezista is manufactured by Janssen-Cilag International.