Safety and Efficacy of Darunavir (TMC114) With Low-Dose Ritonavir in Treatment-Experienced Patients

• DOI: 10.1097/qai.0b013e3181359cfb
• Publication Date: 2007-07-06T08:21:17Z
• Authors: Jean-Michel Molina; Calvin Cohen; Christine Katlama; Beatriz Grinsztejn; Artur Timerman; Rogério de Jesus ...; Tony Vangeneugden; Diego Miralles; Sandra De Meyer; Wim Parys; Eric Lefebvre
• Keywords: Darunavir; Ritonavir; Regimen

Objective: In POWER 1 and 2, darunavir (TMC114) with low-dose ritonavir (darunavir/r) demonstrated greater efficacy versus control protease inhibitors (PIs). To examine the safety of selected darunavir/r dose further, additional patients were analyzed. Methods: Treatment-experienced HIV-1-infected received at a 600/100 mg twice daily plus an optimized background regimen. The primary intent-to-treat analysis was proportion HIV-1 RNA reduction ≥1 log10 week 24. Results: Three hundred twenty-seven treated; baseline mean 4.6 copies/mL, median CD4 count 115 cells/mm3 (median PI mutations = 3, resistance-associated 9). Two forty-six reached 24 by cutoff date included in analysis: 65% 40% achieved reductions <50 respectively, increase 80 cells/mm3. most common adverse events (AEs) diarrhea (14%), nasopharyngitis (11%), nausea (10%). Nine (3%) discontinued treatment because AEs or HIV-1-related events. Six treatment-unrelated deaths (2%) reported. Conclusions: These results corroborate 2. this larger set treatment-experienced patients, provided substantial virologic immunologic responses generally safe well tolerated.