Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection
Por:
Crespo, J, Calleja, JL, Fernandez, I, Sacristan, B, Ruiz-Antoran, B, Ampuero, J, Hernandez-Conde, M, Garcia-Samaniego, J, Gea, F, Buti, M, Cabezas, J, Lens, S, Morillas, RM, Salcines, JR, Pascasio, JM, Turnes, J, Saez-Royuela, F, Arenas, J, Rincon, D, Prieto, M, Jorquera, F, Ruano, JJS, Navascues, CA, Molina, E, Moya, AG and Moreno-Planas, JM
Publicada:
1 jun 2017
Resumen:
Patients with hepatitis C virus (HCV) genotype 4 infection are poorly represented in clinical trials of second-generation direct-acting antiviral agents (DAAs). More data are needed to help guide treatment decisions. We investigated the effectiveness and safety of DAAs in patients with genotype 4 infection in routine practice. In this cohort study, HCV genotype 4-infected patients treated with ombitasvir/paritaprevir/ritonavir (OMV/PTVr) + ribavirin (RBV) (n=122) or ledipasvir/sofosbuvir (LDV/SOF) +/- RBV (n=130) included in a national database were identified and prospectively followed up. Demographic, clinical and virologic data and serious adverse events (SAEs) were analyzed. Differences between treatment groups mean that data cannot be compared directly. Overall sustained virologic response at Week 12 post treatment (SVR12) was 96.2% with OMV/PTVr+RBV and 95.4% with LDV/SOF +/- RBV. In cirrhotic patients, SVR12 was 91.2% with OMV/PTVr+RBV and 93.2% with LDV/SOF +/- RBV. There was no significant difference in SVR12 according to degree of fibrosis in either treatment group (P = .243 and P = .244, respectively). On multivariate analysis, baseline albumin <3.5 g/dL (OMV/PTVr) and bilirubin >2 mg/dL (both cohorts) were significantly associated with failure to achieve SVR (P < .05). Rates of SAEs and SAE-associated discontinuation were 5.7% and 2.5%, respectively, in the OMV/PTVr subcohort and 4.6% and 0.8%, respectively, in the LDV/SOF subcohort. DAA-based regimens returned high rates of SVR12, comparable to limited data from clinical trials, in cirrhotic and non-cirrhotic HCV genotype 4 patients managed in a realworld setting. Safety profiles of both regimens were good and comparable to those reported for other HCV genotypes.
Filiaciones:
Crespo, J:
Univ Cantabria, IDIVAL, Hosp Univ Marques de Valdecilla, Gastroenterol & Hepatol Unit, Santander, Spain
Calleja, JL:
Univ Autonoma Madrid, Hosp Univ Puerta Hierro, Dept Gastroenterol, Madrid, Spain
CIBEREHD, Madrid, Spain
Fernandez, I:
Hosp Univ 12 Octubre, Dept Gastroenterol, Madrid, Spain
Sacristan, B:
Hosp San Pedro, Dept Gastroenterol, Logrono, Spain
Ruiz-Antoran, B:
Hosp Univ Puerta Hierro, Dept Clin Pharmacol, Madrid, Spain
Ampuero, J:
Hosp Univ Virgen Rocio, IBIS, Dept Gastroenterol, Seville, Spain
CIBEREHD, Seville, Spain
Hernandez-Conde, M:
Univ Autonoma Madrid, Hosp Univ Puerta Hierro, Dept Gastroenterol, Madrid, Spain
Garcia-Samaniego, J:
Hosp Univ La Paz, CIBERehd, IdiPAZ, Liver Unit, Madrid, Spain
Gea, F:
CIBEREHD, Madrid, Spain
Hosp Univ Ramon & Cajal, Dept Gastroenterol, Madrid, Spain
Buti, M:
Hosp Univ Vall Dhebron, Liver Unit, Barcelona, Spain
CIBERehd, Barcelona, Spain
Cabezas, J:
Univ Cantabria, IDIVAL, Hosp Univ Marques de Valdecilla, Gastroenterol & Hepatol Unit, Santander, Spain
Lens, S:
Hosp Clin Barcelona, IDIBAPS, Ciberehd, Liver Unit, Barcelona, Spain
:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
CIBEREHD, Badalona, Spain
Salcines, JR:
Hosp Comarcal Laredo, Dept Gastroenterol, Laredo, Spain
Pascasio, JM:
Hosp Univ Virgen Rocio, Dept Gastroenterol, Seville, Spain
Turnes, J:
Complejo Hosp Univ Pontevedra, Dept Gastroenterol, Pontevedra, Spain
IISGS, Pontevedra, Spain
Saez-Royuela, F:
Hosp Univ Burgos, Dept Gastroenterol, Burgos, Spain
Arenas, J:
Hosp Univ Donostia, Dept Gastroenterol, San Sebastian, Spain
Rincon, D:
CIBEREHD, Madrid, Spain
Hosp Gen Univ Gregorio Maranon, Dept Gastroenterol, Madrid, Spain
Prieto, M:
Hosp Univ & Politecn La Fe, Unidad Hepatol, Serv Med Digest, Valencia, Spain
CIBEREHD, Valencia, Spain
Jorquera, F:
Complejo Asistencial Univ Leon, Dept Gastroenterol, Leon, Spain
Ruano, JJS:
Hosp Univ Toledo, Dept Gastroenterol, Toledo, Spain
Navascues, CA:
Hosp Univ Cent Asturias, Dept Gastroenterol, Oviedo, Spain
Molina, E:
Hosp Clin Univ Santiago, Dept Gastroenterol, Santiago De Compostela, Spain
Moya, AG:
Hosp Santa Creu & Sant Pau, Dept Gastroenterol, Barcelona, Spain
Moreno-Planas, JM:
Complejo Hosp Univ Albacete, Dept Gastroenterol, Albacete, Spain
|