Efficacy, safety and pharmacokinetics of 900/100 mg of darunavir/ritonavir once daily in treatment-experienced patients

Results: One hundred and three patients (47 switch strategies, 56 early salvage therapies) were included. After 6 months, 85/103 (83%; 95% CI: 74%‐89%) and 85/93 (91%; 95% CI: 84%‐97%) patients had ,50 copies/mL HIV-RNA by intention-to-treat and on-treatment analyses, respectively. The respective values were 42/47 (89%; 95% CI: 72%‐96%) and 42/43 (98%; 95% CI: 88%‐100%) in switch therapy, and 43/56 (77%; 95% CI: 64%‐87%) and 43/50 (86%; 95% CI: 73%‐94%) in salvage therapy. There was a significant increase in CD4 cell counts [+73 cells/mm 3 (95% CI: 43%‐102%), P,0.001]. There were no interruptions due to rash or liver toxicity. Significant decreases in cholesterol and triglycerides were seen in patients with abnormal lipids at baseline. Ten patients discontinued antiretrovirals (5 were lost to follow-up and 5 due to side effects). Twenty-five patients were included in the pharmacokinetic study. All patients had trough plasma concentrations .0.05 mg/mL. Conclusions: Darunavir/ritonavir at 900/100 mg once daily is highly effective, safe and well tolerated in treatment-experienced patients with no darunavir resistance, both in early salvage and switch strategies. Adequate drug plasma levels were achieved in all patients.