[Effectiveness of second-generation direct-acting antivirals in chronic hepatitis C]. / Efectividad de los antivirales de acción directa de segunda generación en el tratamiento de la hepatitis C crónica.

BACKGROUND: Second-generation direct-acting antivirals (DAA) have shown high sustained virologic response (SVR) for the treatment of chronic hepatitis C in clinical trials. The objective of this study is to estimate DAA effectiveness in treatment of this disease. METHODS: Hepatitis C virus (HCV) monoinfected patients and HCV-human immunodeficiency virus (HIV) coinfected pa-tients who started interferon-free DAA based regimens during 2015 were included. The primary effectiveness outcome was SVR, defined as an undetectable viral load 12 weeks after the end of treatment. RESULTS: A total of 293 patients were enrolled, and 52 (17.7%) were HIV coinfected. HCV 1b genotype was the most prevalent in monoinfected patients (41.5%) and 1a in HIV coinfected patients (40.4%). The proportion of cirrhosis was higher among HIV coinfected patients (69.2% vs 41.1%; p<0.0001), mostly Child-Pugh A. SVR was achieved by 96.9% of patients (284/293), in an intention-to-treat analysis (CI 95%: 94.9-98.9), in which just 4 people had virologic failure. Both naïve and pretreated patients had SVR higher than 95%, and in most of subgroups, according to the presence of cirrhosis, HIV coinfection and HVC genotype, effectiveness rates were near or above 90%. CONCLUSIONS: DAA are highly effective, with similar or higher rates of SVR than that found in clinical trials, and even among difficult to treat populations.

Efectividad de los antivirales de acción directa de segunda generación en el tratamiento de la hepatitis C crónica / Effectiveness of second-generation direct-acting antivirals in chronic hepatitis C

Fundamento: Los antivirales de acción directa de segunda generación (AAD) han demostrado porcentajes elevados de respuesta viral sostenida (RVS) en el tratamiento de la hepatitis C crónica en ensayos clínicos. Este estudio tiene como objetivo estimar la efectividad de los AAD en el tratamiento de esta enfermedad. Material y métodos: Se estudiaron pacientes monoinfectados por el virus de la hepatitis C (VHC) y coinfectados por VHC y virus de la inmunodeficiencia humana (VIH) que iniciaron tratamientos libres de interferón con AAD durante 2015. La RVS se definió como una carga viral indetectable a las 12 semanas de finalizar el tratamiento, y fue el indicador principal de efectividad. Resultados: Se incluyeron 293 pacientes, 52 (17,7%) coinfectados por VIH. Los genotipos VHC más prevalentes fueron el 1b en monoinfectados (41,5%) y 1a en coinfectados (40,4%). La proporción de cirróticos fue superior en la población coinfectada (69,2% vs 41,1%; p<0,0001), en su mayoría Child-Pugh A. La cifra global de RVS fue del 96,9% (284/293) en un análisis por intención de tratar (IC 95%: 94,9-98,9%), siendo 4 los pacientes con fracaso virológico. Tanto pacientes naïve como pretratados tuvieron RVS superior al 95%, y en la mayoría de subgrupos establecidos según la presencia o no de cirrosis, la coinfección VIH y el genotipo, la efectividad se situó próxima o por encima del 90%. Conclusiones: Los AAD presentan una efectividad elevada, igual o superior a la descrita en los ensayos clínicos, e incluso en subpoblaciones difíciles de tratar (AU)

Background: Second-generation direct-acting antivirals (DAA) have shown high sustained virologic response (SVR) for the treatment of chronic hepatitis C in clinical trials. The objective of this study is to estimate DAA effectiveness in treatment of this disease. Methods: Hepatitis C virus (HCV) monoinfected patients and HCV-human immunodeficiency virus (HIV) coinfected patients who started interferon-free DAA based regimens during 2015 were included. The primary effectiveness outcome was SVR, defined as an undetectable viral load 12 weeks after the end of treatment. Results: A total of 293 patients were enrolled, and 52 (17.7%) were HIV coinfected. HCV 1b genotype was the most prevalent in monoinfected patients (41.5%) and 1a in HIV coinfected patients (40.4%). The proportion of cirrhosis was higher among HIV coinfected patients (69.2% vs 41.1%; p<0.0001), mostly Child-Pugh A. SVR was achieved by 96.9% of patients (284/293), in an intention-to-treat analysis (CI 95%: 94.9- 98.9), in which just 4 people had virologic failure. Both naïve and pretreated patients had SVR higher than 95%, and in most of subgroups, according to the presence of cirrhosis, HIV coinfection and HVC genotype, effectiveness rates were near or above 90%. Conclusions: DAA are highly effective, with similar or higher rates of SVR than that found in clinical trials, and even among difficult to treat populations (AU)