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96-Week Safety and Efficacy Findings Presented for INTELENCE(TM) (etravirine) As Part of HIV Combination Therapy
Date:7/20/2009

e for the DUET trials had a viral load of greater than 5,000 copies/mL, were on a stable antiretroviral therapy regimen, and had evidence of at least one NNRTI-resistance-associated mutation, either at screening or from historical resistance tests as well as evidence of three or more primary PI mutations (D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, V82A/F/L/S/T, I84V, N88S, or L90M) at screening.

Participants in the DUET studies were randomized to receive INTELENCE 200 mg twice daily (599 patients) or placebo (604 patients), each given in addition to a BR. For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide).

The study was designed to evaluate INTELENCE efficacy and safety over 48 weeks with an optional extension to 96 weeks. The study remained double-blinded until the last study participant reached week 48.

DUET-1 and -2: 96-Week Efficacy Data

The 96-week pooled analysis of the DUET studies showed the following efficacy results:

  • Fifty-seven percent of patients in the INTELENCE arm had an undetectable viral load (<50 copies/mL) compared with 36 percent of patients in the placebo arm (p<0.0001).
  • Sixty percent of patients in the INTELENCE arm achieved an undetectable viral load (<50 copies/mL) at 48 weeks compared to 57 percent at 96 weeks vs. 39 percent of patients in the placebo arm at 48 weeks and 36 percent at 96 weeks.
  • Ninety-one percent of patients in the INTELENCE arm who achieved an undetectable viral load (<50 copies/mL) at week 48 maintained virologic suppression through week 96 vs. 88 percent of patients in the placebo arm.

DUET-1 and -2: 96-Week Safety Data

  • In the DUET studies, the most commonly reported adverse events (greater than or eq
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SOURCE Tibotec Therapeutics
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