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news.Tibotec Pharmaceuticals, a unit of Janssen Pharmaceutical Companies (Janssen) is all set to present the efficacy and safety results for Edurant (rilpivirine) in HIV treatment, at 13th annual European Aids Conference (EACS).
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Two Phase 3 clinical Echo and Thrive trials evaluated the efficacy and safety of rilpivirine in 1,368 antiretroviral treatment-naïve HIV-1-infected adults.
The 96 week trial demonstrated that rilpivirine showed significantly lower incidences of grade 2-4 overall adverse events (AEs) including better neuropsychiatric (dizziness, abnormal dreams/nightmares) and lipid profiles compared to efavirenz.
Furthermore, a 144 week Monotherapy Resistance Data for Darunavir showed no development of phenotypic resistance to darunavir in patients experiencing virologic failure during the trial.
Darunavir is not currently approved for use as monotherapy in Europe and US Darunavir is currently approved for use in combination with ritonavir and other ARV agents.