Premium
Open‐label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1‐infected patients who failed placebo plus peginterferon and ribavirin
Author(s) -
Foster G. R.,
Ferenci P.,
Asselah T.,
Mantry P.,
Dufour J.F.,
Bourlière M.,
Forton D.,
Maevskaya M.,
Wright D.,
Yoshida E. M.,
GarcíaSamaniego J.,
Oliveira C.,
Wright M.,
Warner N.,
Sha N.,
Quinson A.M.,
Stern J. O.
Publication year - 2016
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.12485
Subject(s) - ribavirin , medicine , gastroenterology , adverse effect , placebo , hepatitis c virus , hepatitis c , virology , virus , alternative medicine , pathology
Summary Faldaprevir, a hepatitis C virus ( HCV ) NS 3/4A protease inhibitor, was evaluated in HCV genotype 1‐infected patients who failed peginterferon and ribavirin (Peg IFN / RBV ) treatment during one of three prior faldaprevir trials. Patients who received placebo plus Peg IFN / RBV and had virological failure during a prior trial were enrolled and treated in two cohorts: prior relapsers ( n = 43) and prior nonresponders (null responders, partial responders and patients with breakthrough; n = 75). Both cohorts received faldaprevir 240 mg once daily plus Peg IFN / RBV for 24 weeks. Prior relapsers with early treatment success ( ETS ; HCV RNA <25 IU /mL detectable or undetectable at week 4 and <25 IU /mL undetectable at week 8) stopped treatment at week 24. Others received Peg IFN / RBV through week 48. The primary efficacy endpoint was sustained virological response ( HCV RNA <25 IU /mL undetectable) 12 weeks post treatment ( SVR 12). More prior nonresponders than prior relapsers had baseline HCV RNA ≥800 000 IU /mL (80% vs 58%) and a non‐ CC IL 28B genotype (91% vs 70%). Rates of SVR 12 (95% CI ) were 95.3% (89.1, 100.0) among prior relapsers and 54.7% (43.4, 65.9) among prior nonresponders; corresponding ETS rates were 97.7% and 65.3%. Adverse events led to faldaprevir discontinuations in 3% of patients. The most common Division of AIDS Grade ≥2 adverse events were anaemia (13%), nausea (10%) and hyperbilirubinaemia (9%). In conclusion, faldaprevir plus Peg IFN / RBV achieved clinically meaningful SVR 12 rates in patients who failed Peg IFN / RBV in a prior trial, with response rates higher among prior relapsers than among prior nonresponders. The adverse event profile was consistent with the known safety profile of faldaprevir.