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New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FTC Revealed
Date:7/20/2009

CAPE TOWN, South Africa, July 20 /PRNewswire/ -- New data became available today at the 5(th) International AIDS Society Conference from ARTEN (Atazanavir/Ritonavir on a background of Tenofovir and Emtricitabine [Truvada(R)] versus Nevirapine). ARTEN is an open-label, multi-center and international non-inferiority clinical trial. It is the first large study to directly compare the efficacy and safety of nevirapine and ritonavir-boosted atazanavir (ATV/r) when combined with TDF/FTC, a modern backbone therapy commonly used with both nevirapine and ATV/r in clinical practice. All patients enrolled in the study had CD4+ cell counts as recommended in the prescribing information for nevirapine use (men <400 cells/mm3; women <250 cells/mm3). Nevirapine is marketed in the U.S. under the trademark name of Viramune(R) (nevirapine) tablets/oral suspension.

A total of 569 patients were in the study: 188 received once-daily nevirapine (400 mg), 188 received twice-daily nevirapine (200 mg) and 193 received ATV/r (300/100 mg once-daily). Nevirapine is not indicated for once-daily dosing. The safety and efficacy of once-daily dosing have not been established. All study participants also received tenofovir and emtricitabine (Truvada(R)).

The study's primary endpoint was virologic response at 48 weeks of treatment, with response defined as a viral load of <50 copies/mL measured at two consecutive visits prior to week 48 (i.e. suppression at weeks 24 and 36) and without subsequent rebound or change of therapy prior to week 48. In the primary analysis of the primary endpoint, the two nevirapine arms were combined. A non-inferiority endpoint with a two-tailed confidence interval of 5 percent within a 12 percent degree of certainty was applied. ARTEN follow-up is currently planned to continue for a total of 144 weeks.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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