Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses

• Published in: Journal of acquired immune deficiency syndromes (1999) Vol. 55; no. 1; p. 39
• Main Authors: Lennox, Jeffrey L, Dejesus, Edwin, Berger, Daniel S, Lazzarin, Adriano, Pollard, Richard B, Ramalho Madruga, Jose Valdez, Zhao, Jing, Wan, Hong, Gilbert, Christopher L, Teppler, Hedy, Rodgers, Anthony J, Barnard, Richard J O, Miller, Michael D, Dinubile, Mark J, Nguyen, Bach-Yen, Leavitt, Randi, Sklar, Peter
• Format: Journal Article
• Language: English
• Published: United States 01.09.2010
• Subjects: Adult; Aged; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antiretroviral Therapy, Highly Active - adverse effects; Antiretroviral Therapy, Highly Active - methods; Benzoxazines - adverse effects; Benzoxazines - therapeutic use; CD4 Lymphocyte Count; Female; HIV Infections - drug therapy; HIV-1 - isolation & purification; Humans; Male; Middle Aged; Pyrrolidinones - adverse effects; Pyrrolidinones - therapeutic use; Raltegravir Potassium; RNA, Viral - blood; Treatment Outcome; Viral Load; Young Adult
• ISSN: 1944-7884
• DOI: 10.1097/QAI.0b013e3181da1287

We analyzed the 96-week results in the overall population and in prespecified subgroups from the ongoing STARTMRK study of treatment-naive HIV-infected patients. Eligible patients with HIV-1 RNA (vRNA) levels >5000 copies per milliliter and without baseline resistance to efavirenz, tenofovir, or emtricitabine were randomized in a double-blind noninferiority study to receive raltegravir or efavirenz, each combined with tenofovir/emtricitabine. At week 96 counting noncompleters as failures, 81% versus 79% achieved vRNA levels <50 copies per milliliter in the raltegravir and efavirenz groups, respectively [Delta (95% confidence interval) = 2% (-4 to 9), noninferiority P < 0.001]. Mean change in baseline CD4 count was 240 and 225 cells per cubic millimeter in the raltegravir and efavirenz groups, respectively [Delta (95% confidence interval) = 15 (-13 to 42)]. Treatment effects were consistent across prespecified baseline demographic and prognostic subgroups. Fewer drug-related clinical adverse events (47% versus 78%; P < 0.001) occurred in raltegravir than efavirenz recipients. Both regimens had modest effects on serum lipids and glucose levels and on body fat composition. When combined with tenofovir/emtricitabine in treatment-naive patients, raltegravir exhibited durable antiretroviral activity that was noninferior to the efficacy of efavirenz through 96 weeks of therapy. Subgroup analyses were generally consistent with the overall findings. Both regimens were well tolerated.