title: 5-year efficacy of entecavir in Indian patients with chronic hepatitis B.
abstract: BACKGROUND
  Entecavir, a drug with high potency and genetic barrier against hepatitis B virus, was believed to become very effective in reducing the hepatitis B burden in India. Long-term studies on its treatment outcome are scarce.
  
  
  METHODS
  One hundred and six chronic hepatitis B (CHB) patients (17 cirrhotics of Child class A/B) who received entecavir therapy (0.5/1 mg/day) in a prospective open-label study from January 2010 to September 2015 were included in the analysis. Strict drug compliance was ensured. At least 1-year follow up was mandatory. Patients were followed up for HBV DNA negativity, e antigen seroconversion and hepatic events. Subgroup analysis for HBV DNA negativity was done for age (below and above 60 years), sex, HBV DNA level, e antigen status, cirrhosis and prior other modes of therapy.
  
  
  RESULTS
  One (0.94 %) patient had primary drug resistance. Mean follow up was 2.5 (1 to 5) years. Overall HBV DNA negativity was 89 % to 98 % at 1 to 5 years and e antigen seroconversion rate 18.2 % at 5 years. ALT normalization paralleled HBV DNA negativity. No flare, decompensation, hepatocellular cancer or adverse reaction to drug was observed. Most achieved HBV DNA negativity after 6 months of therapy with lower response in those with high HBV DNA level, cirrhosis and prior therapy at baseline but only up to 1 year. Relapse was universal after stoppage of therapy. None lost HBsAg.
  
  
  CONCLUSIONS
  Entecavir will need to be continued indefinitely in Indian patients with CHB.
authors.affiliation: Gastroenterology Unit, Department of Medicine, B R Singh Hospital, Kolkata, 700 014, India. gautam1910@yahoo.com.
authors.forename: Gautam
authors.initials: G
authors.lastname: Ray
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; C413685:entecavir; D006147:Guanine
keywords: Entecavir; Hepatitis B; India; Treatment