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Tibotec Pharmaceuticals announced today that the European Commission approved once-daily dosing of 800 mg Prezista (darunavir), a protease inhibitor, with low-dose ritonavir as part of combination therapy in treatment-naïve adults (those who have never taken HIV medication before).
This approval broadens the previous indication of darunavir for treatment-experienced HIV-1 patients. Darunavir was developed by Tibotec Pharmaceuticals and is marketed in Europe by Tibotec, a division of Janssen-Cilag.
“We welcome Prezista’s availability as an effective, once-daily option for adults who have never taken HIV medication before. It has made a significant contribution in the care of treatment-experienced adults with HIV for the last two years, and this is an important treatment development for patients,” said Mark Nelson, consultant physician and deputy director of HIV Research at Chelsea and Westminster Hospital, London, UK.
The approval is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from Artemis, an open‑label phase III trial in antiretroviral treatment-naïve HIV-1-infected adults.
Artemis studied the efficacy and safety of darunavir/r vs. lopinavir/r in combination with other antiretrovirals. The data showed that darunavir was non-inferior to the comparator, although more patients in the darunavir/r arm achieved undetectable viral load (less than 50 copies/mL) compared to lopinavir/r (84 percent vs. 78 percent).
The common adverse drug reactions (ADRs) reported of at least moderate intensity (≥Grade 2) in the darunavir/r arm were hypertriglyceridaemia, hypercholesterolaemia, headache, diarrhoea, nausea, and increased alanine aminotransferase.
Darunavir was given conditional marketing authorisation by the European Commission in February 2007, and received full marketing authorisation in December 2008.
“We strive to provide innovative treatment options for people living with HIV,” said Roger Pomerantz, M.D., President of Tibotec Research and Development. “We are proud to make darunavir available to those who are just starting HIV treatment for the first time.”