title: 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.affiliation: Hepatology Section, Department of Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno 'CEMIC', Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina; Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Provincia de Buenos Aires, Pilar, Argentina.
authors.forename: E
authors.initials: E
authors.lastname: Ridruejo
authors.forename: S
authors.initials: S
authors.lastname: Marciano
authors.forename: O
authors.initials: O
authors.lastname: Galdame
authors.forename: M V
authors.initials: MV
authors.lastname: Reggiardo
authors.forename: A E
authors.initials: AE
authors.lastname: Muñoz
authors.forename: R
authors.initials: R
authors.lastname: Adrover
authors.forename: D
authors.initials: D
authors.lastname: Cocozzella
authors.forename: N
authors.initials: N
authors.lastname: Fernandez
authors.forename: C
authors.initials: C
authors.lastname: Estepo
authors.forename: M
authors.initials: M
authors.lastname: Mendizábal
authors.forename: G A
authors.initials: GA
authors.lastname: Romero
authors.forename: D
authors.initials: D
authors.lastname: Levi
authors.forename: T
authors.initials: T
authors.lastname: Schroder
authors.forename: S
authors.initials: S
authors.lastname: Paz
authors.forename: H
authors.initials: H
authors.lastname: Fainboim
authors.forename: O G
authors.initials: OG
authors.lastname: Mandó
authors.forename: A C
authors.initials: AC
authors.lastname: Gadano
authors.forename: M O
authors.initials: MO
authors.lastname: Silva
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000302:isolation & purification*; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; C413685:entecavir; D006147:Guanine
keywords: chronic hepatitis B; entecavir; routine clinical practice; treatment; virological relapse