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Efficacy of ledipasvir/sofosbuvir plus ribavirin for 12 weeks in patients with chronic hepatitis C genotype 3 and compensated liver disease

Moser, Stephana; Kozbial, Karinb; Laferl, Hermannc; Schütz, Angelikad; Reiberger, Thomasb; Schwabl, Philippb; Gutic, Enisaa; Schwanke, Corneliad; Schubert, Raphaeld; Luhn, Juliand; Lang, Tobiasa; Schleicher, Michaela; Steindl-Munda, Petrab; Haltmayer, Hansd; Ferenci, Peterb; Gschwantler, Michaela,e

European Journal of Gastroenterology & Hepatology: March 2018 - Volume 30 - Issue 3 - p 291–295
doi: 10.1097/MEG.0000000000001027
Original Articles: Hepatitis C
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Introduction In the era of direct-acting antivirals, hepatitis C virus (HCV) genotype (GT) 3 remains as the most difficult-to-treat HCV-GT. Currently, data on the efficacy of ledipasvir/sofosbuvir plus ribavirin (SOF/LDV+RBV) in GT3-infected patients are limited. We investigated the efficacy of this regimen in a real-life cohort from Austria.

Patients and methods A total of 55 patients with HCV-GT3 and compensated liver disease (20% treatment-experienced, 33% with cirrhosis, 7% with HIV coinfection) from four Austrian hepatitis centers received treatment with SOF/LDV+RBV for 12 weeks. The primary endpoint was sustained virological response 12 weeks after end of therapy (SVR12).

Results In the modified intention-to-treat analysis – excluding patients lost to follow-up – the overall SVR12 rate was 94% (95% confidence interval: 84–99%). In treatment-naive and treatment-experienced patients, SVR12 rates were 95 and 89%, respectively. SVR12 rate was 91% in patients without cirrhosis and 100% in patients with cirrhosis. There were no serious adverse events. Viral sequencing did not show the presence of any resistance-associated substitutions in any of the three relapsed patients.

Conclusion Despite a very weak antiviral activity of ledipasvir against HCV-GT3 in vitro, a 12-week course of SOF/LDV+RBV was highly effective, with a 94% SVR12 rate in our cohort of compensated HCV-GT3-infected patients. Thus, if pangenotypic NS5A inhibitors are not available or not reimbursed by insurances, SOF/LDV+RBV seems to be an effective alternative in patients with HCV-GT3 infection.

aDepartment of Internal Medicine IV, Wilhelminenspital

bDepartment of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University

cDepartment of Internal Medicine IV, Kaiser-Franz-Josef-Spital, Vienna

dSuchthilfe Wien gGmbH, Ambulatorium Suchthilfe Wien

eSigmund Freud University Vienna, Vienna, Austria

Correspondence to Michael Gschwantler, MD, Department of Internal Medicine IV, Wilhelminenspital, Montleartstrasse 37, A-1160 Vienna, Austria Tel: +43 1 49150 2401; fax: +43 1 49150 2409; e-mail: michael.gschwantler@wienkav.at

Received August 11, 2017

Accepted September 12, 2017

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