Relapse rates in chronic hepatitis B naïve patients after discontinuation of antiviral therapy with entecavir.

Abstract

Registration studies show entecavir (ETV) to be effective and safe in NUC-naïve patients with chronic hepatitis B, but relapse rates after treatment discontinuation have not been well established. Relapse rates and predictors of relapse were evaluated in naïve HBeAg-positive and HBeAg-negative patients treated with ETV. Treatment duration was defined according to international guidelines. Virological relapse was defined as reappearance in serum of hepatitis B virus (HBV) DNA to >2000 IU/mL after discontinuation of treatment. A hundred and sixty-nine consecutive patients were treated for a median 181 weeks. 61% were HBeAg positive, 23% had cirrhosis, and mean HBV DNA level was 6.88 ± 1.74 log10 IU/mL. Ninety-two per cent became HBV DNA negative; 71% of HBeAg+ve patients became HBeAg negative and 68% anti-HBe positive; 14% became HBsAg negative and 13% anti-HBs positive. At the end of the study, 36 patients discontinued treatment: one due to breakthrough associated with resistant variants and 35 (20%) due to sustained virological response; 33 of these patients developed HBeAg seroconversion and 18 HBsAg seroconversion. Median off-treatment time was 69 weeks. Nine patients (26%), all HBeAg positive at baseline, developed virological relapse after a median 48 weeks off-treatment, 3 of them showed HBeAg reversion and 4 lost anti-HBe. No patient with HBsAg seroconversion relapsed. HBeAg clearance after week 48 of treatment was associated with an increase risk of relapse. After ETV discontinuation, HBsAg seroconversion was maintained in 100% of the patients, HBeAg seroconversion maintained in 90%, and virological relapse rate was 24%.

• Authors: E Ridruejo, S Marciano, O Galdame, M V Reggiardo, A E Muñoz, R Adrover, D Cocozzella, N Fernandez, C Estepo, M Mendizábal, G A Romero, D Levi, T Schroder, S Paz, H Fainboim, O G Mandó, A C Gadano, M O Silva
• Journal: Journal of viral hepatitis (J Viral Hepat) Vol. 21 Issue 8 Pg. 590-6 (Aug 2014) ISSN: 1365-2893 [Electronic] England
• PMID: 24188363 (Publication Type: Journal Article)
• Copyright: © 2013 John Wiley & Sons Ltd.

Chemical References

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

Topics

• Adult
• Aged
• Aged, 80 and over
• Antiviral Agents (therapeutic use)
• Cohort Studies
• DNA, Viral (blood)
• Female
• Guanine (analogs & derivatives, therapeutic use)
• Hepatitis B Surface Antigens (blood)
• Hepatitis B virus (isolation & purification)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Longitudinal Studies
• Male
• Middle Aged
• Recurrence
• Retrospective Studies
• Young Adult