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| |  Etravirine Continues to Be Well Tolerated at 96 Weeks in Treatment-Experienced HIV Patients: Presented at IAS By Charlene Laino CAPE TOWN, South Africa -- July 21, 2009 -- Etravirine, with a safety profile similar to placebo, continues to be well tolerated in treatment-experienced patients with HIV at 96 weeks, according to pooled results from 2 randomised, placebo-controlled phase 3 studies presented here at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. In the pooled analysis of the DUET-1* and DUET-2* studies, no new safety signals were identified between 48 weeks and 96 weeks in either the etravirine or the placebo arm, reported Thomas Campbell, MD, Division of Infectious Diseases, University of Colorado, Denver, Colorado, in a poster presentation on July 20. Previous analyses of 48-week data from the DUET trials showed that except for rash, the incidence and severity of adverse events with etravirine were similar to placebo. "Less than 1% of patients in both treatment groups experienced new onset of rash between 48 and 96 weeks," he said. The most commonly reported adverse events (>=10%) among patients in the etravirine arm versus placebo, regardless of causality, were rash (21% vs 12%), diarrhoea (19% vs 24%), nausea (15% vs 14%), nasopharyngitis (14% vs 12%), headache (12% vs 14%), cough (11% vs 9%), and herpes simplex (10% vs 10%). The incidence of nervous system and psychiatric adverse events was comparable between the etravirine and placebo arms. Nineteen percent of patients in the etravirine arm experienced nervous system disorders and 20% reported psychiatric disorders, compared with 21% of patients in the placebo arm who experienced either adverse event. The randomised, controlled DUET-1 and -2 studies, identical in design and conducted in the United States, Canada, South America, Australia, Thailand, and Europe, assessed the efficacy and safety of etravirine in combination with a background treatment in treatment-experienced adult patients with HIV. To be eligible, patients had to have a viral load >5,000 copies/mL, be on a stable antiretroviral therapy regimen, and have evidence of at least 1 non-nucleoside reverse transcriptase inhibitor-resistance-associated mutation, either at screening or from historical resistance tests as well as evidence of 3 or more primary protease inhibitor mutations at screening. Participants were randomised to receive etravirine 200 mg twice daily (n = 599), or placebo (n = 604), each given in addition to a background regimen. For all patients, the background regimen included darunavir/ritonavir, plus at least 2 investigator-selected antiretroviral drugs. Funding for this study was provided by Tibotec Pharmaceuticals. *Official title of trial: A Phase III Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-Selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options. [Presentation title: Long-Term Safety Profile of Etravirine in Treatment-Experienced, HIV-1-Infected Patients: Pooled 96-Week Results From the Phase III DUET Trials. Abstract MOPEB038]
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