02/18/10

PRN Report from 17th CROI:  Once-daily Darunavir - 48 Week Data

Darunavir (DRV) is currently recommended at a dose of 600mg twice daily, boosted with ritonavir (/r) 100mg twice daily for antiretroviral therapy (ART) experienced patients. Today, at CROI 2010, phase IIIb data was presented evaluating the efficacy of DRV/r dosed at 800mg/100mg once daily for treatment-experienced patients.

Dr. Pedro Cahn presented data on the ODIN trial, which randomized 294 patients to 800/100mg DRV/r once daily, and 296 patients to 600/100mg DRV/r twice daily with a primary endpoint of virologic suppression (<50 copies/mL). Both regimens contained optimized background regimens of nucleoside reverse transcriptase inhibitors (NRTIs). No patients had known DRV resistance mutations at the start of the study and 46% were protease inhibitor (PI) naïve.

At week 48, 72% once-daily versus 71% twice-daily DRV/r had HIV RNA <50 copies/mL, establishing non-inferiority of the once-daily dose. Median CD4 increases were 100 and 94 cells/mm3 with DRV once daily and twice daily respectively. One patient developed a primary PI resistance mutation. Lower rates of increases in triglycerides, cholesterol and liver function test elevations were noted in the once-daily DRV group as were total number or adverse drug events.

48-week data of DRV/r dosed once daily shows non-inferiority in viral load suppression and decreased numbers of unwanted side effects and metabolic complications for ART experienced patients making it a useful, easy regimen.

Reference:
Pedro Cahn et al. Efficacy and safety at 48 weeks of once-daily vs. twice-daily DRV/r in treatment-experienced HIV-1+ patients with no DRV resistance-mutations: The ODIN trial. Presented at 17th Conference on Retroviruses and Opportunistic Infections; San Francisco, CA. Oral Abstract 57.

Source: Reporting from San Francisco for PRN News: A.C. Demidont, DO