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Antiviral therapy in advanced chronic liver disease due to hepatitis C virus infection: Pilot study
Author(s) -
KUMAR RAKESH,
KUMAR SUDHEER,
SHARMA BARJESH CHANDER,
SINGH JAGDEEP,
SARIN SHIV K
Publication year - 2005
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.2005.03760.x
Subject(s) - medicine , ribavirin , adverse effect , tolerability , gastroenterology , liver disease , regimen , hepatitis c , hepatitis c virus , combination therapy , pegylated interferon , immunology , virus
Background: Antiviral therapy has not been adequately evaluated in patients with hepatitis C virus (HCV)‐related advanced liver disease due to apprehensions of adverse events and intolerance. The titrable dose of interferon (IFN)‐α and ribavirin was evaluated in a flexible regimen in a pilot study. Methods: Twenty‐five patients with HCV‐related advanced chronic liver disease received IFN‐α 1–3 MIU daily with ribavirin 200–600 mg daily for 9 months−3 years. Careful assessment of safety, tolerability and efficacy was made. Results: Improvement in Child–Pugh score (8.4 ± 1.2 to 7.4 ± 2.0; P = 0.010) and serum albumin (3.0 ± 0.5 g/dL to 3.6 ± 0.5 g/dL; P = 0.007) occurred at follow up after antiviral therapy (median dose and duration: IFN‐α 1.5 MIU/day for 12 months and ribavirin 400 mg/day for 7.5 months) as compared to baseline. Ascites regressed in 53% of patients (11/21). Thirteen patients (52%) lost HCV‐RNA on therapy and eight (32%) achieved sustained virological response (SVR). Death occurred in three patients (12%) while on therapy, in two due to infection. No patient died in the responder group compared to five deaths (29%) in the non‐responder group. However, there was no difference in the cumulative probability of survival in the sustained virological responder versus non‐responder ( P = 0.09). Adverse events were common (92%), but permanent withdrawal was required in only five patients (20%). Conclusions: Low and titrable dose IFN‐α and ribavirin therapy in patients with HCV‐related advanced chronic liver disease achieves improvement in hepatic synthetic function, Child–Pugh score and ascites. However, close monitoring for serious adverse events is warranted.