RT Journal Article
T1 Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis.
A1 Esteban, Rafael
A1 Pineda, Juan A
A1 Calleja, Jose Luis
A1 Casado, Marta
A1 Rodriguez, Manuel
A1 Turnes, Juan
A1 Morano Amado, Luis Enrique
A1 Morillas, Rosa Maria
A1 Forns, Xavier
A1 Pascasio Acevedo, Juan Manuel
A1 Andrade, Raul J
A1 Rivero, Antonio
A1 Carrion, Jose Antonio
A1 Lens, Sabela
A1 Riveiro-Barciela, Mar
A1 McNabb, Brian
A1 Zhang, Gulan
A1 Camus, Gregory
A1 Stamm, Luisa M
A1 Brainard, Diana M
A1 Subramanian, G Mani
A1 Buti, Maria
K1 Direct-acting antiviral agent
K1 Drug resistance
K1 Outcome
AB In phase 3 trials and real-world settings, smaller proportions of patients with genotype 3 hepatitis C virus (HCV) infection and cirrhosis have a sustained virologic response 12 weeks after treatment (SVR12) with the combination of sofosbuvir and velpatasvir than in patients without cirrhosis. It is unclear whether adding ribavirin to this treatment regimen increases SVRs in patients with genotype 3 HCV infection and cirrhosis. We performed a phase 2 trial of 204 patients with genotype 3 HCV infection and compensated cirrhosis (mean age 51 ± 7.4 years) at 29 sites in Spain from August 19, 2016 through April 18, 2017. Patients were assigned to groups given sofosbuvir and velpatasvir for 12 weeks (n = 101) or sofosbuvir and velpatasvir plus ribavirin for 12 weeks (n = 103). The primary efficacy end point was SVR12. The overall rates of SVR12 were 91% (92 of 101; 95% CI 84-96) for the sofosbuvir-velpatasvir group and 96% (99 of 103; 95% CI 90-99) for the sofosbuvir-velpatasvir plus ribavirin group. In the sofosbuvir-velpatasvir group, a smaller proportion of patients with baseline resistance-associated substitutions (RASs) in nonstructural protein 5A (NS5A) achieved an SVR12 (84%) than did patients without (96%). In the sofosbuvir-velpatasvir plus ribavirin group, baseline RASs had less effect on the proportion of patients with an SVR12 (96% for patients with baseline RASs; 99% for patients without). The most common adverse events (which occurred in ≥10% of patients) were asthenia (12%) in the sofosbuvir-velpatasvir group and asthenia (27%), headache (24%), and insomnia (12%) in the sofosbuvir-velpatasvir plus ribavirin group. Consistent with findings from previous studies, a high rate of patients (91% and 96%) with genotype 3 HCV infection and compensated cirrhosis achieved an SVR12 with sofosbuvir and velpatasvir, with or without ribavirin. Of patients treated with sofosbuvir and velpatasvir without ribavirin, fewer patients with baseline NS5A RASs achieved an SVR12 compared with patients without baseline NS5A. 
PB Elsevier
YR 2018
FD 2018-06-21
LK http://hdl.handle.net/10668/12659
UL http://hdl.handle.net/10668/12659
LA en
NO Esteban R, Pineda JA, Calleja JL, Casado M, Rodríguez M, Turnes J, et al. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. Gastroenterology. 2018 Oct;155(4):1120-1127.e4
DS RISalud
RD Apr 17, 2025