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. 2017 Jun;23(6):409.e5-409.e8.
doi: 10.1016/j.cmi.2016.12.034. Epub 2017 Jan 28.

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  1 , L E Morano-Amado  2 , R Granados  3 , J Macías  4 , F Téllez  5 , M García-Deltoro  6 , M J Ríos  7 , A Collado  8 , M Delgado-Fernández  9 , M Suárez-Santamaría  10 , M Serrano  3 , C Miralles-Álvarez  2 , K Neukam  11 ; 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)
Collaborators, Affiliations
Free article

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 et al. Clin Microbiol Infect. 2017 Jun.
Free article

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.

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