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Effectiveness and safety of sofosbuvir‐based regimens plus an NS 5A inhibitor for patients with HCV genotype 3 infection and cirrhosis. Results of a multicenter real‐life cohort
Author(s) -
Alonso S.,
RiveiroBarciela M.,
Fernandez I.,
Rincón D.,
Real Y.,
Llerena S.,
Gea F.,
Olveira A.,
FernandezCarrillo C.,
Polo B.,
Carrión J. A.,
Gómez A.,
Devesa M. J.,
Baliellas C.,
Castro Á.,
Ampuero J.,
Granados R.,
Pascasio J. M.,
Rubín A.,
Salmeron J.,
Badia E.,
Planas J. M. M.,
Lens S.,
Turnes J.,
Montero J. L.,
Buti M.,
Esteban R.,
FernándezRodríguez C. M.
Publication year - 2017
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.12648
Subject(s) - sofosbuvir , cirrhosis , genotype , medicine , cohort , multicenter study , virology , gastroenterology , ribavirin , hepatitis c virus , biology , gene , randomized controlled trial , virus , genetics
Summary Patients with HCV genotype 3 (GT3) infection and cirrhosis are currently the most difficult to cure. We report our experience with sofosbuvir+daclatasvir (SOF+DCV) or sofosbuvir/ledipasvir (SOF/LDV), with or without ribavirin (RBV) in clinical practice in this population. This was a multicenter observational study including cirrhotic patients infected by HCV GT3, treated with sofosbuvir plus an NS5A inhibitor (May 2014‐October 2015). In total, 208 patients were included: 98 (47%) treatment‐experienced, 42 (20%) decompensated and 55 (27%) MELD score >10. In 131 (63%), treatment was SOF+DCV and in 77 (37%), SOF/LDV. Overall, 86% received RBV. RBV addition and extension to 24 weeks was higher in the SOF/LDV group (95% vs 80%, P=.002 and 83% vs 72%, P=.044, respectively). A higher percentage of decompensated patients were treated with DCV than LDV (25% vs 12%, P=.013). Overall, SVR12 was 93.8% (195/208): 94% with SOF+DCV and 93.5% with SOF/LDV. SVR12 was achieved in 90.5% of decompensated patients. Eleven treatment failures: 10 relapses and one breakthrough. RBV addition did not improve SVR (RR: 1.08; P=.919). The single factor associated with failure to achieve SVR was platelet count <75×10E9/mL (RR: 3.50, P=.019). In patients with MELD <10, type of NS5A inhibitor did not impact on SVR12 (94% vs 97%; adjusted RR: 0.49). Thirteen patients (6.3%) had serious adverse events, including three deaths (1.4%) and one therapy discontinuation (0.5%), higher in decompensated patients (16.7% vs 3.6%, P<.006). In patients with GT3 infection and cirrhosis, SVR12 rates were high with both SOF+DCV and SOF/LDV, with few serious adverse events.