Open AccessReal‐world experience with daclatasvir plus sofosbuvir ± ribavirin for post‐liver transplant HCV recurrence and severe liver disease
Author(s) -
Herzer Kerstin,
Welzel Tania M.,
Spengler Ulrich,
Hinrichsen Holger,
Klinker Hartwig,
Berg Thomas,
Ferenci Peter,
PeckRadosavljevic Markus,
Inderson Akin,
Zhao Yue,
JimenezExposito Maria Jesus,
Zeuzem Stefan
Publication year - 2017
Publication title -
transplant international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.998
H-Index - 82
eISSN - 1432-2277
pISSN - 0934-0874
DOI - 10.1111/tri.12910
Subject(s) - medicine , daclatasvir , sofosbuvir , ribavirin , gastroenterology , liver disease , hepatitis c , adverse effect , liver transplantation , cirrhosis , hepatitis c virus , transplantation , immunology , virus
Summary Optimizing therapy of post‐transplant HCV recurrence remains important, especially in advanced liver disease. We evaluated daclatasvir ( DCV ) plus sofosbuvir ( SOF ), with or without ribavirin ( RBV ), in patients with post‐liver transplant recurrence in a real‐world European cohort at high risk of decompensation or death within 12 months. Recommended treatment was DCV 60 mg plus SOF 400 mg once daily for 24 weeks; RBV use/shorter treatment duration was at physicians’ discretion. Patients ( N = 87) were 70% male, 93% white, and mostly infected with HCV genotypes 1b (48%), 1a (32%), or 3 (9%); 37 (43%) had cirrhosis (16 decompensated), five had fibrosing cholestatic hepatitis. Sustained virologic response at post‐treatment week 12 ( SVR 12) was 94% (80/85) in a modified intention‐to‐treat analysis: 95% (58/61) without RBV and 92% (22/24) with RBV , with no virologic failures. SVR 12 was 100% (80/80) in an as‐observed analysis excluding five nonvirologic failures. Four patients (5%) discontinued therapy for adverse events ( AE s); 16 (18%) experienced serious AE s. One patient died on treatment and five during follow‐up. Most AE s were associated with advanced liver disease and unrelated to therapy. No clinically significant drug–drug interactions were observed. DCV + SOF ± RBV was well tolerated and achieved high SVR 12 (94%) in patients with post‐transplant HCV recurrence, including patients with severe liver disease.