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. CONCLUSION:
Entecavir will need to be continued indefinitely in Indian patients with CHB.
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Authors | Gautam Ray |
Journal | Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology
(Indian J Gastroenterol)
Vol. 35
Issue 3
Pg. 190-4
(May 2016)
ISSN: 0975-0711 [Electronic] India |
PMID | 27216583
(Publication Type: Journal Article)
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Chemical References |
- Antiviral Agents
- Biomarkers
- DNA, Viral
- entecavir
- Guanine
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Topics |
- Adolescent
- Adult
- Aged
- Antiviral Agents
(administration & dosage)
- Biomarkers
(blood)
- DNA, Viral
(blood)
- Female
- Guanine
(administration & dosage, analogs & derivatives)
- Hepatitis B virus
(genetics)
- Hepatitis B, Chronic
(drug therapy, virology)
- Humans
- India
- Male
- Middle Aged
- Prospective Studies
- Time Factors
- Treatment Outcome
- Young Adult
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