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

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.
DUET-1 (NCT00254046) and DUET-2 (NCT00255099) are two identically designed, randomized, double-blind phase III trials.
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.
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.
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
  • 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

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research network!

Choose Username:
Verify Password: