Efficacy and safety of long term entecavir in chronic hepatitis B treatment naïve patients in clinical practice.

Abstract

BACKGROUND AND AIMS:

Entecavir (ETV) is effective and safe in patients with chronic hepatitis B in the short term, but its long term efficacy and safety has not been established.

MATERIAL AND METHODS:

We evaluated HBV DNA clearance, HBeAg/antiHBe and HBsAg/antiHBs seroconversion rates in HBeAg-positive and negative NUC naïve HBV patients treated with ETV for more than 6 months, and predictors of response.

RESULTS:

A hundred and sixty nine consecutive patients were treated with ETV for a median of 181 weeks. 61% were HBeAg positive, 23% were cirrhotics, and mean HBV-DNA levels were 6,88 ± 1,74 log10 IU/mL. Overall, 156 (92%) patients became HBV DNA undetectable, 92 (88%) HBeAg positive and 64 (98%) HBeAg negative patients. Seventy four (71%) patients cleared HBeAg after a median of 48 weeks of treatment, 23 (14%) patients cleared HBsAg (19 HBeAg positive and 4 HBeAg negative, p 0.025) after a median of 96 weeks of treatment, and 22 (13%) patients developed protective titers of anti-HBs. At the end of the study, 35 (20%) patients had discontinued therapy: 33 HBeAg positive and 2 HBeAg negative; 9 of them (26%) developed virological relapse after a median of 48 weeks of stopping treatment. None of the patients had primary non response and one patient developed breakthrough. Two patients developed HCC, three underwent liver transplantation and 3 deaths were attributable to liver-related events. No serious adverse events were reported.

CONCLUSION:

Long term ETV treatment showed high virological response rates, and a favorable safety profile for NUC-naive HBeAg-positive and negative patients treated in clinical practice.

• Authors: Ezequiel Ridruejo, Sebastián Marciano, Omar Galdame, María V Reggiardo, Alberto E Muñoz, Raúl Adrover, Daniel Cocozzella, Nora Fernandez, Claudio Estepo, Manuel Mendizabal, Gustavo A Romero, Diana Levi, Teresa Schroder, Silvia Paz, Hugo Fainboim, Oscar G Mandó, Adrián C Gadano, Marcelo O Silva
• Journal: Annals of hepatology (Ann Hepatol) 2014 May-Jun Vol. 13 Issue 3 Pg. 327-36 ISSN: 1665-2681 [Print] Mexico
• PMID: 24756007 (Publication Type: Journal Article)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B Antibodies
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• entecavir
• Guanine

Topics

• Adult
• Aged
• Antiviral Agents (therapeutic use)
• Cohort Studies
• DNA, Viral (blood)
• Female
• Guanine (analogs & derivatives, therapeutic use)
• Hepatitis B Antibodies (immunology)
• Hepatitis B Surface Antigens (immunology)
• Hepatitis B e Antigens (immunology)
• Hepatitis B virus (genetics)
• Hepatitis B, Chronic (complications, drug therapy, immunology)
• Humans
• Liver Cirrhosis (etiology, surgery)
• Liver Transplantation
• Longitudinal Studies
• Male
• Middle Aged
• Retrospective Studies
• Treatment Outcome
• Viral Load