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Journal of Clinical and Experimental Hepatology logoLink to Journal of Clinical and Experimental Hepatology
. 2012 Apr 12;2(1):10–18. doi: 10.1016/S0973-6883(12)60079-6

Treatment of Chronic Hepatitis due to Hepatitis C Virus (CH-C) in India: A Randomized Controlled Trial Comparing Daily Interferon-alfa-2b and Ribavirin with Daily Interferon-alfa-2b and Glycyrrhizin—A Multicenter Study

Subrat K Acharya a, V Sreenivas b, Siddharth Datta Gupta c, Shakti Kumar a, Yogesh K Chawla d, Anurag Tandon e, Aejaz Habeeb f, Premashish Kar g, Abhijit Chowdhury h, Gourdas Choudhuri i, Shiv K Sarin j, DN Amarapurkar k, Vidya Arankalle l, Mohan D Gupte m, Sushma Gupta n, Deepali Mukherjee n, Divya Seth b, Rohit Goyal a, Badri N Tandon o,*
PMCID: PMC3940339  PMID: 25755401

Abstract

Background and Aim

Pegylated-interferon-alfa (PEG-IFN-α) with ribavirin is an established treatment in chronic hepatitis due to hepatitis C virus (HCV) (CH-C). Such treatment is expensive and in resource-poor countries such as India, alternative less expensive therapy is needed.

Methods

Multicenter randomized controlled trial comparing two treatment regimens (interferon-alfa-2b [IFN-α-2b] 3 million unit/day [MU/day] and ribavirin 1000 mg/day [I+R] vs IFN-α-2b 3 MU/day and glycyrrhizin 250 mg [I+G]) in CH-C. Viral, host characteristics and therapeutic responses were assessed (ICMR—6 months trial for chronic hepatitis—CTRI/2008/091/000105).

Results

One hundred and thirty-one patients meeting the inclusion criteria were randomized to I + G (n=64) or I+R (n=67) during the period February 2002 to May 2005. About 85% (I+G=53, I+R=58) completed 6 months of treatment and 89% of them (I+G=46, I+R=53) completed 6 months of follow-up after completion of treatment. Hepatitis C virus genotype 3 was the major type detected (71% patients). The mean log10 viral load (copies/mL), histological activity index, and fibrosis stage for all patients were 5.1 ± 0.98, 5 ± 2, and 2± 1.5, respectively. Sustained viral response (SVR) was significantly higher in I + R group than in I + G group (65.7% vs 46.9%, OR=2.2, P = 0.03). Treatment with I + G was associated with significantly lower frequencies of leukopenia (2% vs 17%, P <0.01) and anemia (8% vs 40%, P <0.001) as compared to treatment with I + R.

Conclusion

Genotype 3 HCV infection with low viral load is prevalent in India. Daily IFN with ribavirin showed significantly better responses. Leukopenia and anemia were significantly more in ribavirin group. Responses observed with IFN + ribavirin were similar to the reported response rates with PEG-IFN suggesting that this modality may be considered as a cheaper alternative of treatment for chronic hepatitis C.

Keywords: Glycyrrhizin, hepatitis C virus, interferon alfa-2b, ribavirin, treatment

Abbreviations: ALT, alanine aminotransferase; CHC, chronic hepatitis C; CLD, chronic liver disease; ELISA, enzyme-linked immunosorbent assay; ETVR, end of treatment viral response; HAI, histological activity index; HCV, hepatitis C virus; HR, histological response; PEG-IFN, pegylated-interferon; RVR, rapid viral response; SVR, sustained viral response

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