title: Treatment of chronic hepatitis C with pegylated interferon plus ribavirin in treatment-naïve 'real-life' patients in India.
abstract: OBJECTIVE
  Results of treatment of chronic hepatitis C (CHC) with pegylated interferon plus ribavirin (PEG-RBV) are mainly available from well-designed clinical trials, and only few 'real-life' studies which give a true picture of success of therapy are available. Such data in Indian patients is scarce. This prospective study aimed to evaluate the efficacy, safety, and factors associated with sustained virological response (SVR) in Indian CHC patients treated with PEG-RBV in 'real-life' setting.
  
  
  METHODS
  All treatment-naïve patients with CHC/compensated cirrhosis treated with PEG-RBV between January 2004 and December 2010 were included.
  
  
  RESULTS
  Of 592 patients started on treatment, 524 (88.5 %) completed therapy (mean ± SD age-42.0 ± 12.1 years; 74.3 % males). Genotype 3 (73.6 %) was the commonest, followed by genotype 1 (19.3 %). In intention to treat analysis, SVR rates for 'all' patients, genotype 1 and genotype 3 patients were 72.3 % (428/592), 57 % (65/114), and 78.2 % (341/436), respectively (in per-protocol analysis-81.7 %, 69.1 %, and 85.3 %, respectively). Noncirrhotics had better SVR rates compared to cirrhotics treated for the same duration. About 20 % patients had both low viral load and achieved rapid virological response (RVR). Factors significantly associated with SVR were age <40 years, absence of cirrhosis, RVR, and no reduction in interferon dose.
  
  
  CONCLUSIONS
  SVR rates in CHC patients treated in 'real-life' setting in India were better than those reported in western population. Therapy should be prolonged for patients with cirrhosis, while one-fifth of patients may qualify for abbreviated therapy. Factors significantly associated with SVR were age <40 years, absence of cirrhosis, RVR, and no reduction in interferon dose.
authors.affiliation: Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India, ajitsood10@sify.com.
authors.forename: Ajit
authors.initials: A
authors.lastname: Sood
authors.forename: Vandana
authors.initials: V
authors.lastname: Midha
authors.forename: Omesh
authors.initials: O
authors.lastname: Goyal
authors.forename: Syed
authors.initials: S
authors.lastname: Hissar
authors.forename: Suresh Kumar
authors.initials: SK
authors.lastname: Sharma
authors.forename: Pankaj
authors.initials: P
authors.lastname: Khanna
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007194:India; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a