title: Etravirine in combination with darunavir/ritonavir and optimized background regimen results in suppression of HIV replication in treatment-experienced patients. Evaluation of Katlama C, Haubrich R, Lalezari J, et al. Efficacy and safety of etravirine in treatment-experienced HIV-1 patients: pooled 48-week analysis of two randomized, controlled trials. AIDS 2009; 23: 2289-300.
abstract: Therapeutic options for treatment-experienced HIV-infected patients have been limited. The DUET trial evaluated the use of etravirine, a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), or placebo, in 1203 treatment-experienced, HIV-infected patients. Eligible patients had to have evidence of NNRTI and protease inhibitor resistance-associated mutations, and evidence of virologic failure, as defined as a plasma viral load > 5000 copies/ml on antiretroviral therapy at the time of screening. Patients in both arms received an optimized background regimen including darunavir/ritonavir. DUET demonstrated superior outcomes in virologic suppression (plasma viral load < 50 copies/ml) and clinical end points including new AIDS-defining illnesses and death, in those randomized to receive etravirine. These results were maintained at 48 weeks of follow-up. Furthermore, etravirine was shown to be safe and well-tolerated over this period. In exploratory analyses, patients in the DUET study with greater number of active agents within the background regimen were more likely to have a fully suppressive response. Taken together, the DUET results highlight the high rates of virological success that can be achieved using new active agents, such as ritonavir-boosted darunavir and etravirine, in treatment-experienced patients with underlying drug-resistant HIV infection.
authors.affiliation: Faculty of Medicine, University of British Columbia, 1081 Burrard St., Vancouver, BC, Canada.
authors.forename: Mark W
authors.initials: MW
authors.lastname: Hull
authors.forename: Julio S G
authors.initials: JS
authors.lastname: Montaner
mesh_terms: D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D000069454:Darunavir; D024921:Drug Resistance, Multiple, Viral / Q000187:drug effects; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D009570:Nitriles; D011724:Pyridazines / Q000627:therapeutic use*; D011743:Pyrimidines; D016032:Randomized Controlled Trials as Topic; D019438:Ritonavir / Q000627:therapeutic use*; D013449:Sulfonamides / Q000627:therapeutic use*; D019562:Viral Load / Q000187:drug effects
chemical_list: D017320:HIV Protease Inhibitors; D009570:Nitriles; D011724:Pyridazines; D011743:Pyrimidines; D013449:Sulfonamides; C451734:etravirine; D019438:Ritonavir; D000069454:Darunavir