title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Subrat K
authors.initials: SK
authors.lastname: Acharya
authors.affiliation: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: V
authors.initials: V
authors.lastname: Sreenivas
authors.affiliation: Department of Pathology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Siddharth Datta
authors.initials: SD
authors.lastname: Gupta
authors.affiliation: Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Shakti
authors.initials: S
authors.lastname: Kumar
authors.affiliation: Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Yogesh K
authors.initials: YK
authors.lastname: Chawla
authors.affiliation: Department of Gastroenterology, Metro Centre for Liver and Digestive Diseases, Noida, Uttar Pradesh, India.
authors.forename: Anurag
authors.initials: A
authors.lastname: Tandon
authors.affiliation: Centre for Liver Research and Diagnostics, Deccan College of Medical Sciences and Allied Hospital, Hyderabad, Andhra Pradesh, India.
authors.forename: Aejaz
authors.initials: A
authors.lastname: Habeeb
authors.affiliation: Department of Medicine, Maulana Azad Medical College, New Delhi, India.
authors.forename: Premashish
authors.initials: P
authors.lastname: Kar
authors.affiliation: Department of Gastroenterology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
authors.forename: Abhijit
authors.initials: A
authors.lastname: Chowdhury
authors.affiliation: Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute for Medical Education and Research, Lucknow, India.
authors.forename: Gourdas
authors.initials: G
authors.lastname: Choudhuri
authors.affiliation: Department of Gastroenterology, GB Pant Hospital, New Delhi, India.
authors.forename: Shiv K
authors.initials: SK
authors.lastname: Sarin
authors.affiliation: Department of Gastroenterology, Bombay Hospital and Medical Research Centre, Mumbai, Maharashtra, India.
authors.forename: Dn
authors.initials: D
authors.lastname: Amarapurkar
authors.affiliation: Department of Virology, National Institute of Virology, Pune, Maharashtra, India.
authors.forename: Vidya
authors.initials: V
authors.lastname: Arankalle
authors.affiliation: National Institute of Epidemiology, Chennai, Tamil Nadu, India.
authors.forename: Mohan D
authors.initials: MD
authors.lastname: Gupte
authors.affiliation: Indian Council of Medical Research, New Delhi, India.
authors.forename: Sushma
authors.initials: S
authors.lastname: Gupta
authors.affiliation: Indian Council of Medical Research, New Delhi, India.
authors.forename: Deepali
authors.initials: D
authors.lastname: Mukherjee
authors.affiliation: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Divya
authors.initials: D
authors.lastname: Seth
authors.affiliation: Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Rohit
authors.initials: R
authors.lastname: Goyal
authors.affiliation: Digestive Diseases Foundation, Noida, Uttar Pradesh, India.
authors.forename: Badri N
authors.initials: BN
authors.lastname: Tandon
keywords: ALT, alanine aminotransferase; CHC, chronic hepatitis C; CLD, chronic liver disease; ELISA, enzyme-linked immunosorbent assay; ETVR, end of treatment viral response; Glycyrrhizin; HAI, histological activity index; HCV, hepatitis C virus; HR, histological response; PEG-IFN, pegylated-interferon; RVR, rapid viral response; SVR, sustained viral response; hepatitis C virus; interferon alfa-2b; ribavirin; treatment