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

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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