Long-term efficacy and safety of once-daily nevirapine in combination with tenofovir and emtricitabine in the treatment of HIV-infected patients: a 72-week prospective multicenter study (TENOR-Trial)

BACKGROUND: There is an unmet medical need for simplified antiretroviral therapy regimens to improve patient's compliance and quality of life. The purpose of this study was to evaluate the efficacy and safety of a once-daily regimen with Tenofovir (TDF), Emtricitabine (FTC) and Nevirapine (NVP) for adult patients with HIV-1 infection. METHODS: 70 patients were enrolled in a prospective, multicenter, non-randomized, single arm, open-label cohort study. Patients were either naïve or had problems with their current ART and needed to be changed to another regimen. Daily drug dosage was 300 mg Tenofovir, 200 mg Emtricitabine and 400 mg Nevirapine once daily. Follow-up was performed over 72 weeks. RESULTS: After 72 weeks, the regimen was still continued by 52 patients (74,3%). Of these, 44 patients (84,6%) had a viral load below detection limit. The median viral load had decreased by 2,5 log and the median CD4 cell count had increased by 44,8%. Most side-effects occurred at an early stage during the study. Resistances were rare (only two resistances were considered as newly developed) and occurred rather late during the study. CONCLUSION: A once-daily regimen of Tenofovir, Emtricitabine and Nevirapine is an attractive treatment option since it is safe, effective, and well tolerated.