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HCV‐related advanced fibrosis/cirrhosis: randomized controlled trial of pegylated interferon α ‐2a and ribavirin
Author(s) -
Helbling Beat,
Jochum Wolfram,
Stamenic Ivan,
Knöpfli Marina,
Cerny Andreas,
Borovicka J.,
Gonvers JeanJacques,
Wilhelmi Martin,
Dinges Sabine,
Müllhaupt Beat,
Esteban Alicia,
MeyerWyss Beat,
Renner Eberhard L.
Publication year - 2006
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/j.1365-2893.2006.00753.x
Subject(s) - medicine , ribavirin , pegylated interferon , gastroenterology , tolerability , cirrhosis , hepatitis c virus , hepatitis c , adverse effect , randomized controlled trial , immunology , virus
Summary. In patients with hepatitis C virus (HCV)‐related advanced fibrosis/cirrhosis, 30% of sustained HCV clearance has been reported with pegylated interferon α ‐2a (PEG‐IFN) alone, but the efficacy and tolerability of the PEG‐IFN/ribavirin (RBV) combination remain poorly defined. A total of 124 treatment‐naïve patients with biopsy proved HCV‐related advanced fibrosis/cirrhosis (Ishak score F4–F6, Child–Pugh score ≤7) were randomized to 48 weeks of PEG‐IFN (180 μ g sc weekly) and standard dose of RBV (1000/1200 mg po daily, STD) or PEG‐IFN (180 μ g sc weekly) and low‐dose of RBV (600/800 mg po daily, LOW). Sustained virologic response (SVR) rates with PEG‐IFN/STD RBV (52%) were higher – albeit not significantly – than that with PEG‐IFN/LOW RBV (38%, P = 0.153). In multivariate analysis, genotype 2/3 and a baseline platelet count ≥150 × 10 9 /L were independently associated with SVR. The likelihood of SVR was <7% if viraemia had not declined by ≥2 log or to undetectable levels after 12 weeks. Nine adverse events in the STD RBV and 15 in the LOW RBV group were classified as severe (including two deaths); dose reductions for intolerance were required in 78% and 57% ( P = 0.013), and treatment was terminated early in 23% and 27% of patients ( P = n.s.). The benefit/risk ratio of treating compensated HCV‐cirrhotics with STD PEG‐IFN/RBV is favourable.