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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

AuthorsPineda, Juan A.; Morano-Amado, Luis E.; Granados, Rafael; Macias, Juan; Téllez, Francisco; García-Deltoro, Miguel; Ríos-Villegas, María José; Collado, Antonio; Delgado-Fernández, Marcial; Suárez-Santamaría, M.; Serrano, Manuel; Miralles-Álvarez, C.; Neukam, Karin
Direct-acting antivirals
Hepatitis C virus genotype 3
Interferon-free regimens
Sustained virological response
Viral kinetics
Issue DateJun-2017
CitationClinical Microbiology and Infection 23(6): 409.e5-409.e8 (2017)
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.
DescriptionGrupo 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. CuencaI.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.
Publisher version (URL)http://dx.doi.org/10.1016/j.cmi.2016.12.034
Identifiersdoi: 10.1016/j.cmi.2016.12.034
e-issn: 1469-0691
issn: 1198-743X
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