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A randomized trial of a 4 vs 12-week daily interferon dose regimen combined with ribavirin in treatment of patients with chronic hepatitis C |
Shiv K. Sarin, Ankur Goyal, Sudheer Kumar, Rajkumar C. Guptan, Abid Zaffar Hashmi, Pooja Sakhuja and Veena Malhotra |
New Delhi, India
Author Affiliations: Departments of Gastroenterology (Sarin SK, Goyal A, Kumar S, Guptan RC and Hashmi AZ) and Pathology (Sakhuja P and Malhotra V), G.B. Pant Hospital, New Delhi 110002, India
Corresponding Author: Shiv K. Sarin, MD, DM, Department of Gastroenterology, G.B. Pant Hospital, New Delhi 110002, India (Tel: 91-11-23232013; Fax: 91-11-23239171; Email: sksarin@nda.vsnl.net.in) |
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Abstract BACKGROUND: Standard combination-therapy of ribavirin with alternate day interferon (IFN) in patients with chronic hepatitis C (CHC) has been reported to achieve 30%-55% sustained viral response. Early reduction of viral load by daily dosage of IFN could enhance viral clearance. However, the duration of daily dosage protocol and the likely side-effects have not been well studied. We compared the efficacy and safety of a 4 vs 12-week daily IFN dosage in patients with CHC.
METHODS: Fifty-nine, histologically proven CHC patients having ALT levels >1.5×ULN were divided randomly into 2 groups, group I was given IFN 3 MIU daily for 4 weeks, followed by tiw up to 12 months and group II was given IFN 3 MIU daily for 12 weeks, followed by tiw up to 12 months. Ribavirin was given in a dose of 800-1200 mg/d for 12 months.
RESULTS: Fifty-two of the 59 patients (group I=28; group II=24) completed the study. The pretreatment variables and the prevalence of HCV genotype 1 were comparable between the groups. Nine patients (29%) in group I and 6 (25%) in group II had stage 3, 4 fibrosis. At the end of 4, 12, 24 and 52 weeks, HCV RNA negativity was observed in 27%, 54%, 65% and 71% in group I and 38%, 54%, 71% and 75% in group II, respectively (P=ns). Four of the eight (50%) patients with genotype 1 and 30 (69.8%) of 43 patients with genotype non-1 responded to therapy (P=ns). Sustained viral response was achieved in 61% and 71% in groups I and II, respectively. None of the variables predicted non-response precisely. No serious adverse effects were observed and they were comparable between the two groups.
CONCLUSION: Daily IFN dosage with ribavirin is safe and can achieve response in up to 65% patients. Since the efficacy of a 4-week daily dosage of IFN is comparable to a 12-week schedule, we recommend the former regimen.
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Cite this article: |
Sarin SK,
Goyal A,
Kumar S,
et al.
A randomized trial of a 4 vs 12-week daily interferon dose regimen combined with ribavirin in treatment of patients with chronic hepatitis C.
Hepatobiliary Pancreat Dis Int
2004;
3(1):
42-48. DOI:
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URL: |
http://dx.doi.org/ OR http://www.hbpdint.com/EN/Y2004/V3/I1/42 |
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