Week 4 response predicts sustained virological response to all-oral direct-acting antiviral-based therapy in cirrhotic patients with hepatitis C virus genotype 3 infection
J A Pineda, L E Morano-Amado, R Granados, J Macías, F Téllez, M García-Deltoro, M J Ríos, A Collado, M Delgado-Fernández, M Suárez-Santamaría, M Serrano, C Miralles-Álvarez, K Neukam, Grupo de Estudio de Hepatitis Vírica, of the Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica: GEHEP-SEIMC, Grupo de Estudio de Hepatitis Vírica, of the Sociedad Andaluza de Enfermedades Infecciosas y Microbiología Clínica: HEPAVIR / Red de Investigación en SIDA (RIS-HEP07), J C Alados-Arboledas, H Albendín, M R Alemán, M Del Mar Alonso, V Asensi, M J Blanco, J Borrallo, R Cabo, Á Camacho, M F Casas, Á Castro, J Cucurull, S Cuéllar, F Cuenca, I de Los Santos-Gil, C Dueñas, E Fernández, C Galera, M C Gálvez, D García, P Geijo-Martínez, A Gómez, J L Gómez, F Gutiérrez, J Hernández, J Hernández, J Llenas-García, M Mancebo, M Márquez, J M Martín, L Martínez, R Martínez-Álvarez, O Martínez Madrid, M Del Mar Masiá, N Merchante, D Merino, P Monje, R Nuñez, M Omar, E Ortega, S Padilla, C Robledano, R Pelazas, E Pérez, I Pérez-Camacho, M Pérez-Pérez, B Pernas, J J Portu, M Raffo, L M Real, G Reina, A Rivero, A Rivero-Juárez, A Romero-Palacios, J Portilla, P Rubio, P Ryan-Murua, P S de la Hoya, J Santos, M Serrano, C Toyas, F Vera-Méndez, A Vergara, M V Hernández, D V García, J A Pineda, L E Morano-Amado, R Granados, J Macías, F Téllez, M García-Deltoro, M J Ríos, A Collado, M Delgado-Fernández, M Suárez-Santamaría, M Serrano, C Miralles-Álvarez, K Neukam, Grupo de Estudio de Hepatitis Vírica, of the Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica: GEHEP-SEIMC, Grupo de Estudio de Hepatitis Vírica, of the Sociedad Andaluza de Enfermedades Infecciosas y Microbiología Clínica: HEPAVIR / Red de Investigación en SIDA (RIS-HEP07), J C Alados-Arboledas, H Albendín, M R Alemán, M Del Mar Alonso, V Asensi, M J Blanco, J Borrallo, R Cabo, Á Camacho, M F Casas, Á Castro, J Cucurull, S Cuéllar, F Cuenca, I de Los Santos-Gil, C Dueñas, E Fernández, C Galera, M C Gálvez, D García, P Geijo-Martínez, A Gómez, J L Gómez, F Gutiérrez, J Hernández, J Hernández, J Llenas-García, M Mancebo, M Márquez, J M Martín, L Martínez, R Martínez-Álvarez, O Martínez Madrid, M Del Mar Masiá, N Merchante, D Merino, P Monje, R Nuñez, M Omar, E Ortega, S Padilla, C Robledano, R Pelazas, E Pérez, I Pérez-Camacho, M Pérez-Pérez, B Pernas, J J Portu, M Raffo, L M Real, G Reina, A Rivero, A Rivero-Juárez, A Romero-Palacios, J Portilla, P Rubio, P Ryan-Murua, P S de la Hoya, J Santos, M Serrano, C Toyas, F Vera-Méndez, A Vergara, M V Hernández, D V García
Abstract
Objective: The aim of this study was to determine the predictive capacity of response at treatment week (TW) 4 for the achievement of sustained virological response 12 weeks after the scheduled end of therapy date (SVR12) to treatment against hepatitis C virus (HCV) genotype 3 (GT3) infection with all-oral direct-acting antiviral (DAA) -based regimens.
Patients and methods: From a prospective multicohort study, HCV GT3-infected patients who completed a course of currently recommended DAA-based therapy at 33 Spanish hospitals and who had reached the SVR12 evaluation time-point were selected. TW4 HCV-RNA levels were categorized as target-not-detected (TND), below the lower limit of quantification (LLOQTD) and ≥LLOQ.
Results: A total of 123 patients were included, 86 (70%) received sofosbuvir/ daclatasvir±ribavirin, 27 (22%) received sofosbuvir/ ledipasvir/ ribavirin and 10 (8.1%) received sofosbuvir/ ribavirin, respectively. In all, 114 (92.7%) of the 123 patients presented SVR12 in an on-treatment approach, but nine (7.3%) patients relapsed, all of them had presented cirrhosis at baseline. In those who achieved TND, LLOQTD and ≥LLOQ, SVR12 was observed in 81/83 (98%; 95% CI 91.5%-99.7%), 24/28 (85.7%; 95% CI 67.3%-96%) and 9/12 (75%; 95% CI 42.8%-94.5%), respectively; p(linear association) 0.001. Corresponding numbers for subjects with cirrhosis were: 52/54 (96.3%; 95% CI 87.3%-95.5%), 14/18 (77.8%; 95% CI 52.4%-93.6%) and 7/10 (70%; 95% CI 34.8%-93.3%); p 0.004.
Conclusions: TW4-response indicates the probability of achieving SVR12 to currently used DAA-based therapy in HCV genotype 3-infected individuals with cirrhosis. This finding may be useful to tailor treatment strategy in this setting.
Keywords: Cirrhosis; Direct-acting antivirals; Hepatitis C virus genotype 3; Interferon-free regimens; Sustained virological response; Viral kinetics.
Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Source: PubMed