Ninety-six week pooled results from two Phase 3 studies (DUET-1 and DUET-2) showed that significantly more treatment-experienced HIV-1-infected adults with non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI) resistance had an undetectable viral load ( -- The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response.

-- In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.

-- The risks and benefits of INTELENCE have not been established in pediatric patients or in treatment-naive adults.

DUET-1 and -2 Study Design

The DUET-1 and -2 studies, identical in design and conducted across the Americas, Australia, Canada, Europe, Thailand and Europe, assessed the 24-week efficacy and safety of INTELENCE in combination with a BR in treatment-experienced adult HIV-1 patients with documented evidence of NNRTI and PI resistance. They were large randomized, controlled studies and the primary endpoint was the proportion of patients who achieved a confirmed undetectable viral load (less than 50 copies/mL).

Patients with HIV-1 who were eligible 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; after this point, the study was unblinded.

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 (