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Safety and Efficacy of Raltegravir-Based Versus Efavirenz-Based Combination Therapy in Treatment-Naive HIV-1 Infected Patients
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STARTMRK Protocol 021
Reported by Jules Levin
48th Annual ICAAC/IDSA 46th Annual Meeting, Washington, DC, USA, October 25-28, 2008
Jeffrey Lennox, Edwin DeJesus, Adriano Lazzarin, Richard Pollard, Jose Valdez Ramalho Madruga,
Jing Zhao, Xia Xu, Angela Williams-Diaz,
Anthony Rodgers, Mark DiNubile,
Bach-Yen Nguyen, Randi Leavitt,
and Peter Sklar
For the STARTMRK Investigators
AUTHOR CONCLUSIONS
In treatment-naive patients given 48 weeks of TDF/FTC, the integrase inhibitor raltegravir:
· Had potent, durable antiviral efficacy that was statistically
non-inferior to efavirenz
-- 86% (RAL) versus 82% (EFV) <50 copies/mL at Week 48
-- Achieved faster vRNA suppression <50 copies/mL
_ Had greater immunological effect than efavirenz, measured by increases in CD4 cell counts
-- 189 (RAL) versus 163 (EFV) cells/mm3 at Week 48
_ Was better tolerated than efavirenz
-- Significantly fewer overall and drug-related clinical adverse events
-- Significantly lower percentages of patients with CNS adverse experiences
· Had minimal effects on serum lipids
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