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Undetectable HCV ‐ RNA at treatment‐week 8 results in high‐sustained virological response in HCV G1 treatment‐experienced patients with advanced liver disease: the International Italian/Spanish Boceprevir/Peginterferon/Ribavirin Name Patients Program
Author(s) -
Bruno S.,
Bollani S.,
Zignego A. L.,
Pascasio J. M.,
Magni C.,
Ciancio A.,
Caremani M.,
Mangia A.,
Marenco S.,
Piovesan S.,
Chemello L.,
Babudieri S.,
Moretti A.,
Gea F.,
Colletta C.,
PerezAlvarez R.,
Forns X.,
Larrubia J. R.,
Arenas J.,
Crespo J.,
Calvaruso V.,
Ceccherini Silberstein F.,
Maisonneuve P.,
Craxì A.,
Calleja J. L.
Publication year - 2015
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.12342
Subject(s) - medicine , gastroenterology , boceprevir , ribavirin , adverse effect , decompensation , sofosbuvir , hepatitis c virus , immunology , virus
Summary In many countries, first‐generation protease inhibitors ( PI s)/peginterferon/ribavirin ( P / R ) still represent the only treatment option for HCV ‐infected patients. Subjects with advanced disease and previous failure to P / R urgently need therapy, but they are under‐represented in clinical trials. All treatment‐experienced F 3/4 Metavir patients who received boceprevir ( BOC )+ P / R in the I talian– S panish N ame P atient P rogram have been included in this study. Multivariate logistic regression analysis ( MLR ) was used to identify baseline and on‐treatment predictors of SVR and adverse events ( AE s). Four hundred and sixteen patients, mean age 57.7 (range 25–78 years), 70% males, 69.5% (289/416) F 4, 14% (41/289) C hild– P ugh class A 6, 24% (70/289) with varices and 42% (173/416) prior null responders to P / R , were analysed. Overall, SVR rate (all 381 patients who received one dose of BOC ) was 49%, (58% in F3, 45% in F 4, 61% in relapsers, 51% in partial, 38% in null responders, and 72% in subjects with undetectable HCV ‐ RNA at treatment‐week ( TW )8. Among patients with TW 8 HCV ‐ RNA ≥ 1000 IU/L, SVR was 8% (negative predictive value = 92%). Death occurred in 3 (0.8%) patients, while decompensation and infections were observed in 2.9% and 11%, respectively. At MLR , SVR predictors were TW 4 HCV ‐ RNA ≥ 1log 10 ‐decline from baseline, undetectable TW 8 HCV ‐ RNA , prior relapse, albumin levels ≥3.5 g/ dL and platelet counts ≥100 000/μL. Metavir F 4, Child‐Pugh A6, albumin, platelets, age and female gender were associated with serious and haematological AE s. Among treatment‐experienced patients with advanced liver disease eligible for IFN ‐based therapy, TW 8 HCV ‐ RNA characterised the subset with either high or poor likelihood of achieving SVR . Using TW 8 HCV ‐ RNA as a futility rule, BOC / P / R appears to have a favourable benefit–risk profile.