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

AbstractOBJECTIVE:
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 a nonnucleoside reverse transcriptase inhibitor and other antiretrovirals.
DESIGN:
DUET-1 (NCT00254046) and DUET-2 (NCT00255099) are two identically designed, randomized, double-blind phase III trials.
METHODS:
Patients received twice-daily etravirine 200 mg or placebo, each plus a background regimen of darunavir/ritonavir, investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors and optional enfuvirtide. Eligible patients had documented nonnucleoside reverse transcriptase inhibitor resistance, at least three primary protease inhibitor mutations at screening and were on a stable but virologically failing regimen for at least 8 weeks, with plasma viral load more than 5000 copies/ml. Pooled 48-week data from the two trials are presented.
RESULTS:
Patients (1203) were randomized and treated (n = 599, etravirine; n = 604, placebo). Significantly more patients in the etravirine than in the placebo group achieved viral load less than 50 copies/ml at week 48 (61 vs. 40%, respectively; P < 0.0001). Significantly fewer patients in the etravirine group experienced at least one confirmed or probable AIDS-defining illness/death (6 vs. 10%; P = 0.0408). Safety and tolerability in the etravirine group was comparable to the placebo group. Rash was the only adverse event to occur at a significantly higher incidence in the etravirine group (19 vs. 11%, respectively, P < 0.0001), occurring primarily in the second week of treatment.
CONCLUSION:
At 48 weeks, treatment-experienced patients receiving etravirine plus background regimen had statistically superior and durable virologic responses (viral load less than 50 copies/ml) than those receiving placebo plus background regimen, with comparable tolerability and no new safety signals reported since week 24.
AuthorsChristine 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,
JournalAIDS (London, England) (AIDS) Vol. 23 Issue 17 Pg. 2289-300 (Nov 13 2009) ISSN: 1473-5571 [Electronic] England
PMID19710593 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Pyridazines
  • Reverse Transcriptase Inhibitors
  • etravirine
Topics
  • Adolescent
  • Adult
  • Aged
  • Antiretroviral Therapy, Highly Active
  • Double-Blind Method
  • Drug Resistance, Multiple, Viral
  • Female
  • HIV Infections (drug therapy)
  • HIV-1 (drug effects)
  • Humans
  • Male
  • Middle Aged
  • Pyridazines (pharmacology, therapeutic use)
  • Reverse Transcriptase Inhibitors (pharmacology, therapeutic use)
  • Treatment Outcome
  • Viral Load
  • Young Adult

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