FDA Approves INTELENCE(TM) (etravirine) for HIV Combinati... (tially or completely stop the NNRTI from...)

FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy

Date:1/18/2008

tially or completely stop the NNRTI from binding to the reverse transcriptase enzyme, causing the drug to lose effectiveness. As with other HIV medications, patients can develop resistance to INTELENCE; for more information see the resistance section below.

DUET-1 and -2 Study Design

The DUET-1 and -2 studies, identical in design but conducted in different regions, assessed the 24-week efficacy and safety of INTELENCE in combination with a background regimen (BR) in treatment-experienced adult HIV-1 patients with documented evidence of NNRTI and PI resistance. They were large randomized, controlled studies with a primary endpoint of less than 50 copies/mL (known as undetectable viral load). IAS-USA treatment guidelines define less than 50 copies/mL as the goal of therapy for treatment-experienced patients when two or more potent drugs are identified.

Patients with HIV-1 who were eligible for the DUET studies had a viral load of greater than 5,000 copies/mL, while on a stable antiretroviral therapy regimen for at least eight weeks and had evidence of at least one NNRTI resistance-associated mutation, either at screening or from prior 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.

DUET-1 and -2 Efficacy

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 24-week pooled analysis of the DUET studies showed the following results for INTELENCE plus BR vs. placebo plus BR:

-- Significantly more patients in the INTELENCE arm achieved undetectable

viral load (less than 50 copies/mL); 59.8 percent vs. 40.2 percent

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FDA Approves INTELENCE(TM) (etravirine) for HIV Combinati...(tially or completely stop the NNRTI from...)