Abstract | 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)-alpha 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-alpha 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-alpha 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-alpha 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.
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Authors | Rakesh Kumar, Sudheer Kumar, Barjesh Chander Sharma, Jagdeep Singh, Shiv K Sarin |
Journal | Journal of gastroenterology and hepatology
(J Gastroenterol Hepatol)
Vol. 20
Issue 4
Pg. 527-35
(Apr 2005)
ISSN: 0815-9319 [Print] Australia |
PMID | 15836700
(Publication Type: Journal Article)
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Chemical References |
- Antiviral Agents
- Interferon-alpha
- Ribavirin
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Topics |
- Antiviral Agents
(adverse effects, therapeutic use)
- Drug Therapy, Combination
- Female
- Hepatitis C, Chronic
(drug therapy)
- Humans
- Interferon-alpha
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Pilot Projects
- Ribavirin
(adverse effects, therapeutic use)
- Statistics, Nonparametric
- Survival Rate
- Treatment Outcome
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