Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naive HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012
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Galindo, Jaime; Amariles Muñoz, Pedro; Mueses, Héctor F.; Hincapié, Jaime A.; Gonzalez-Avendano, Sebastian; Galindo-Orrego, XimenaEditorial
Biomed Central
Materia
HIV/AIDS Generic drugs Antiretroviral drugs Phase IV study
Date
2016Referencia bibliográfica
Galindo, J.; et al. Effectiveness and safety of generic version of abacavir/lamivudine and efavirenz in treatment naive HIV-infected patients: a nonrandomized, open-label, phase IV study in Cali-Colombia, 2011-2012. BMC Genomics, 17: 735 (2016). [http://hdl.handle.net/10481/49875]
Sponsorship
This research was made possible by contribution from the Corporación de Lucha Contra el SIDA, Cali-Colombia, and Comité para el Desarrollo de la Investigación (CODI), Universidad de Antioquia, Medellín, Colombia. In addition, Humax Pharmaceutical S.A. provided the antiretroviral drugs.Abstract
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-naïve HIV-infected patients.
Methods: A monocentric, nonrandomized, open-label, phase IV study in treatment naïve 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
<40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses
increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal,
skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety
profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were
used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians.
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 <40 copies/mL. There was a significant
increase (172 cells/mm3) 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 naïve
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.