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

RIDRUEJO, E.; MARCIANO, S.; GALDAME, O.; REGGIARDO, M. V.; MUÑOZ, A. E.; ADROVER, R.; COCOZZELLA, D.; FERNANDEZ, N.; ESTEPO, C.; MENDIZÁBAL, M.; ROMERO, G. A.; LEVI, D.; SCHRODER, T.; PAZ, S.; FAINBOIM, H.; MANDÓ, O. G.; GADANO, A. C.; SILVA, M. O.

JOURNAL OF VIRAL HEPATITIS.

WILEY-BLACKWELL PUBLISHING, INC

Año: 2014 vol. 21 p. 590 - 596

1352-0504

Registration studies show entecavir (ETV) to be effective and safe in NUC-na?ıve 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 na?ıve HBeAg-positive and HBeAgnegative patients treated with ETV. Treatment duration was defined according to international guidelines. Virological relapse was defined as reappearance in serum of hepatitis Bvirus (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 HBVDNA 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 HBsAgseroconversion 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%.