Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment na?ve HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011–2012

摘要

Background Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-na?ve HIV-infected patients. Methods A monocentric, nonrandomized, open-label, phase IV study in treatment na?ve HIV-infected patients 18?years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load Results Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12?months, 31 of 42 patients (73.8?% in intention-to-treat analysis) achieved a viral load of HIV1 RNA 3) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2?% in the median of the percentage of cardiovascular risk. Conclusions The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment na?ve patients showed the expected safety and effectiveness profile of proprietary ARV drugs. Trial registration Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202 . Registered 19 November 2015.