Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials

• DOI: 10.1097/qad.0b013e3283316a5e
• Publication Date: 2009-10-28T07:22:47Z
• Authors: Christine Katlama; Richard Haubrich; Jacob Lalezari; Adriano Lazzarin; José V Madruga; Jean-Michel Molina; Mauro Schechter; Monika Peeters; Gaston Picchio; Johan Vingerhoets; Brian Woodfall; Goedele De Smedt
• Keywords: Etravirine; Enfuvirtide; Reverse-transcriptase inhibitor; Tolerability; Regimen; Ritonavir

To evaluate the efficacy, safety and virologic resistance profile of etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, over 48 weeks in treatment-experienced adults infected with HIV-1 strains resistant to inhibitor other antiretrovirals.DUET-1 (NCT00254046) DUET-2 (NCT00255099) are two identically designed, randomized, double-blind phase III trials.Patients received twice-daily 200 mg or placebo, each plus background regimen darunavir/ritonavir, investigator-selected nucleoside/nucleotide inhibitors optional enfuvirtide. Eligible patients had documented resistance, at least three primary protease mutations screening were on stable but virologically failing for 8 weeks, plasma viral load more than 5000 copies/ml. Pooled 48-week data from trials presented.Patients (1203) randomized treated (n = 599, etravirine; n 604, placebo). Significantly placebo group achieved less 50 copies/ml week (61 vs. 40%, respectively; P < 0.0001). fewer experienced one confirmed probable AIDS-defining illness/death (6 10%; 0.0408). Safety tolerability was comparable group. Rash only adverse event occur significantly higher incidence (19 11%, respectively, 0.0001), occurring primarily second treatment.At receiving statistically superior durable responses (viral copies/ml) those regimen, no new signals reported since 24.