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

Abstract

BackgroundGeneric 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.MethodsA 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.ResultsSixty 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 Of the nine patients excluded from the study, only one was withdrawn due to adverse events.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.ConclusionsThe 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 registrationRegistro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202. Registered 19 November 2015.

Lysine and threonine plasma concentrations in Ivorian patients living with human immunodeficiency virus

“…The excess threonine observed in HIV positive patients and the control population was not as a result of the high amount of threonine ingested which could disrupt liver function, causing the formation of excess urea, and consequently the toxicity of ammonia, in actual fact, the biochemical assessment of urea, creatinine and transaminases in this study revealed normal level which is similar to the study of Galindo et al (2016) on the treatment of naive HIV infected patients.…”

“…With regards to the metabolic disorder, no biochemical disruption of blood glucose, creatinine, urea and transaminases were observed in this study. In the study of Galindo et al (2016), this same observation was reported.…”

Efectividad y seguridad del esquema genérico lamivudina/tenofovir y efavirenz en pacientes con VIH/SIDA naïve: estudio fase IV no aleatorizado, Cali-Colombia 2012-2014

“…A pesar de esta limitación, en este grupo de pacientes, con condiciones socio-económicas tan adversas, en los que se logra adherencia al programa de atención integral, incluyendo el TARc, los resultados, en términos de efectividad y seguridad, son similares a los obtenidos en estudios previos con el mismo esquema de TARc con medicamentos innovadores. Además, este estudio, de forma similar a estudios previos 12,13 , provee información relevante de la efectividad y seguridad del esquema 3TC/ TDF/EFV genérico, lo que se asocia a una mayor confianza con la utilización de este tipo de productos. Por tanto, en este grupo pequeño de pacientes, el esquema genérico 3TC/TDF/EFV es efectivo y seguro en el tratamiento de la infección por VIH en pacientes naïve.…”

“…El tamaño de muestra se estimó con las siguientes consideraciones: tasa de abandono y porcentaje de fracaso virológico de 20 y 15%, respectivamente (acorde a estudios institucionales, previos con pacientes similares 5,12 ); potencia de 80% y nivel de confianza de 95%. Para ello, utilizando el software estadístico Epidat 4.0-módulo tamaño de muestra comparación de proporciones emparejadas, se determinó un mínimo de 33 pacientes para encontrar cinco fracasos por tratamiento 12,13 . Sin embargo, anticipando una tasa de retiro de 20%, el tamaño de muestra estimado fue de 40 pacientes.…”

Budget Impact Analysis Highlighting the Cost-Saving Potential of Generic Tenofovir Disoproxil Based Antiretroviral Therapy in Comparison with Tenofovir Alafenamide Based Treatment Regimens in the German Healthcare System

“…However, in the field of ARV therapy, this concept has so far only been tested to a limited extent in clinical trials [55] or cohort studies [51] and therefore a more extensive integration of generic drugs into study concepts is demanded [14,48].…”