Sustained Antiretroviral Effect of Raltegravir After 96 Weeks of Combination Therapy in Treatment-Naive Patients With HIV-1 Infection

• DOI: 10.1097/qai.0b013e3181b064b0
• Publication Date: 2009-10-21T07:16:22Z
• Authors: Martin Markowitz; Bach-Yen Nguyen; Eduardo Gotuzzo; Fernando Mendo; Winai Ratanasuwan; Colin Kovacs; Guillermo Prada; Javier O Morales-...; Clyde S Crumpacker; Robin D Isaacs; Havilland Campbell; Kim M Strohmaier; Hong Wan; Robert M Danovich; Hedy Teppler
• Keywords: Raltegravir; Efavirenz; Reverse-transcriptase inhibitor; Liter; Integrase inhibitor; Emtricitabine

The purpose of this study was to evaluate the safety and efficacy raltegravir vs efavirenz-based antiretroviral therapy after 96 weeks in treatment-naive patients with HIV-1 infection.Multicenter, double-blind, randomized (100, 200, 400, or 600 mg twice a day) efavirenz (600 every day), both tenofovir/lamivudine (TDF/3TC), for 48 weeks, which arms were combined all dosed at 400 day. Eligible had RNA > =5000 copies per milliliter CD4 T cells =100 microliter.One hundred ninety-eight treated; 160 received 38 efavirenz. At week 96, 84% groups achieved <400 milliliter; 83% group <50 (noncompleter = failure). Both showed similar increases (221 232 cells/uL, respectively). An additional 2 (1 each group) met protocol definition virologic failure between 96; no known resistance mutations observed recipient; recipient nucleoside reverse transcriptase inhibitor nonnucleoside mutations. Investigator reported drug-related clinical adverse events (AEs) less frequent (51%) than (74%). Drug-related AEs occurring >10% either nausea dizziness headache group. Laboratory remained infrequent. Raltegravir effect on total low-density lipoprotein cholesterol triglycerides. Neuropsychiatric (34%) (58%). There serious receiving raltegravir.In therapy-naive patients, TDF/3TC potent activity, efavirenz/TDF/3TC sustained 96. generally well tolerated; treated compared