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
| Autor: | 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, 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. 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, C. Toyas, F. Vera-Méndez, A. Vergara, M.V. Hernández, D.V. García |
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| Přispěvatelé: | Instituto de Salud Carlos III, European Commission, Junta de Andalucía, [Pineda, J. A.] Hosp Univ Valme, Unit Infect Dis & Microbiol, Ave Bellavista S-N, Seville 41014, Spain, [Macias, J.] Hosp Univ Valme, Unit Infect Dis & Microbiol, Ave Bellavista S-N, Seville 41014, Spain, [Neukam, K.] Hosp Univ Valme, Unit Infect Dis & Microbiol, Ave Bellavista S-N, Seville 41014, Spain, [Morano-Amado, L. E.] Hosp Univ Alvaro Cunqueiro, Unit Infect Pathol, Vigo, Spain, [Miralles-Alvarez, C.] Hosp Univ Alvaro Cunqueiro, Unit Infect Pathol, Vigo, Spain, [Granados, R.] Hosp Univ Gran Canaria Dr Negrin, Unit Infect Dis, Las Palmas Gran Canaria, Spain, [Serrano, M.] Hosp Univ Gran Canaria Dr Negrin, Unit Infect Dis, Las Palmas Gran Canaria, Spain, [Macias, J.] Inst Biomed Sevilla IBiS, Seville, Spain, [Neukam, K.] Inst Biomed Sevilla IBiS, Seville, Spain, [Tellez, F.] Hosp La Linea, AGS Campo Gibraltar, Unit Infect Dis & Microbiol, La Linea De Concepcion, Spain, [Garcia-Deltoro, M.] Consorcio Hosp Gen Univ Valencia, Unit Infect Dis, Valencia, Spain, [Rios, M. J.] Hosp Virgen Macarena, Unit Infect Dis, Seville, Spain, [Collado, A.] Hosp Univ Torrecardenas, Unit Infect Dis, Almeria, Spain, [Delgado-Fernandez, M.] Hosp Reg Malaga, Unit Infect Dis, Malaga, Spain, [Suarez-Santamaria, M.] Complejo Hosp Univ Vigo CHUVI, Fdn Biomed, Vigo, Spain, Plan Nacional R+D+I, ISCIII-Subdireccion General de Evaluacion, Fondo Europeo de Desarrollo Regional (FEDER), Consejeria de Salud of the Junta de Andalucia, Servicio Andaluz de Salud of the Junta de Andalucia |
| Rok vydání: | 2017 |
| Předmět: |
Liver Cirrhosis
Male Pyrrolidines Cirrhosis Sustained Virologic Response Sofosbuvir Hepacivirus Administration Oral medicine.disease_cause Direct-acting antivirals Gastroenterology chemistry.chemical_compound 0302 clinical medicine Genotype Prospective Studies 030212 general & internal medicine Prospective cohort study Velpatasvir biology Imidazoles virus diseases Valine General Medicine Middle Aged Hepatitis C virus genotype 3 Sustained virological response Treatment Outcome Infectious Diseases Hcv Female 030211 gastroenterology & hepatology medicine.drug Microbiology (medical) Ledipasvir Phase-iii medicine.medical_specialty Hepatitis C virus Antiviral Agents Daclatasvir 03 medical and health sciences Internal medicine Interferon-free regimens Ribavirin medicine Humans Viral kinetics Fluorenes business.industry Hepatitis C Chronic biology.organism_classification medicine.disease digestive system diseases chemistry Immunology Benzimidazoles Carbamates business |
| Zdroj: | Digital.CSIC. Repositorio Institucional del CSIC instname |
| Popis: | 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. 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. [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. This work has been partially funded by the RD12/0017/0012 project as part of the Plan Nacional R+D+I and co-financed by ISCIII-Subdirección General de Evaluación, the Fondo Europeo de Desarrollo Regional (FEDER) and the Consejería de Salud of the Junta de Andalucía (grant number AC-0095-2013 and PI-0492-2012). JAP is the recipient of an intensification grant from the Instituto de Salud Carlos III (grant number Programa-I3SNS). JM is the recipient of a grant from the Servicio Andaluz de Salud of the Junta de Andalucía (grant number B-0037). KN is the recipient of a Miguel Servet research grant from the Instituto de Salud Carlos III (grant number CP13/00187). |
| Databáze: | OpenAIRE |
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