1 research outputs found
High efficacy of Sofosbuvir plus Simeprevir in a large cohort of Spanish cirrhotic patients infected with genotypes 1 and 4
[Abstract]
Background and Aims. Hepatitis C (HCV) therapy with Sofosbuvir (SOF)/Simeprevir (SMV) in clinical trials and realâworld clinical practice, showed high rates of sustained virological response (SVR) in nonâcirrhotic genotype (GT)â1 and GTâ4 patients. These results were slightly lower in cirrhotic patients. We investigated realâlife effectiveness and safety of SOF/SMV with or without ribavirin (RBV) in a large cohort of cirrhotic patients.
Methods. This collaborative multicentre study included data from 968 patients with cirrhosis infected with HCVâGT1 or 4, treated with SOF/SMV±RBV in 30 centres across Spain between Januaryâ2014 and Decemberâ2015. Demographic, clinical, virological and safety data were analysed.
Results. Overall SVR was 92.3%; the majority of patients were treated with RBV (62%) for 12 weeks (92.4%). No significant differences in SVR were observed between genotypes (GT1a:94.3%; GT1b:91.7%; GT4:91.1%). Those patients with more advanced liver disease (Child B/C, MELDâ„10) or portal hypertension (platelet countâ€100Ă109/L, transient elastographyâ„21 Kpa) showed significantly lower SVR rates (84.4%â91.9%) than patients with less advanced liver disease (93.8%â95.9%, P<.01 in all cases). In the multivariate analysis, the use of RBV, female gender, baseline albuminâ„35 g/L, MELD<10 and lack of exposure to a triple therapy regimen were independent predictors of SVR (P<.05). Serious adverse events (SAEs) and SAEâassociated discontinuation events occurred in 5.9% and 2.6%.
Conclusions. In this large cohort of cirrhotic patients managed in the realâworld setting in Spain, SOF/SMV±RBV yielded to excellent SVR rates, especially in patients with compensated liver cirrhosis. In addition, this combination showed to be safe, with low rates of SAEs and early discontinuations.Instituto de Salud Carlos III; PI15/0015