J A Pineda1, L E Morano-Amado2, R Granados3, J Macías4, F Téllez5, M García-Deltoro6, M J Ríos7, A Collado8, M Delgado-Fernández9, M Suárez-Santamaría10, M Serrano3, C Miralles-Álvarez2, K Neukam11. 1. Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain. 2. Unit of Infectious Pathology, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain. 3. Unit of Infectious Diseases, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain. 4. Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain; Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain. 5. Unit of Infectious Diseases and Microbiology, Hospital La Línea, AGS Campo de Gibraltar, La Linea de la Concepcion, Spain. 6. Unit of Infectious Diseases, Consorcio Hospital General Universitario de Valencia, Valencia, Spain. 7. Unit of Infectious Diseases, Hospital Virgen Macarena, Seville, Spain. 8. Unit of Infectious Diseases, Hospital Universitario Torrecárdenas, Almeria, Spain. 9. Unit of Infectious Diseases, Hospital Regional de Málaga, Malaga, Spain. 10. Fundación Biomédica del Complejo Hospitalario Universitario de Vigo (CHUVI), Vigo, Spain. 11. Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain; Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain. Electronic address: karin.neukam@gmail.com.
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.
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-infectedpatients 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.