title: Long-term outcome of hepatitis B virus-related Chronic Hepatitis under protracted nucleos(t)ide analogues.
abstract: Long-term outcome of patients with chronic hepatitis B virus (HBV) infection under continuous nucleos(t)ide analogues (NUCs) has been poorly elucidated. We enrolled 121 anti-HBe-positive patients into a prospective surveillance programme while on (>36 months) NUCs therapy. HBV-DNA clearance, add-on therapy and safety were evaluated. Development of cirrhosis, events of liver decompensation and hepatocellular carcinoma (HCC) during the follow-up were the main endpoints, as the complication-free survival. At baseline, 74 patients (61%) had chronic hepatitis, the remainders a cirrhotic liver. HBV-DNA levels >38 000 IU/mL were discovered in 103 patients. At enrolment, 79 patients were naïve to NUCs treatment. Lamivudine monotherapy (n = 70) or a different NUC (n = 51) was administered. At month 6 of therapy, HBV-DNA clearance was documented in 88 patients (73%). Treatment schedule was modified in 52 patients due to breakthrough or suboptimal response. During a mean follow-up of 6 ± 3 years, viral clearance was achieved in the majority of patients. Ten of 74 patients (13.5%) with chronic hepatitis progressed to cirrhosis, 1 patient developed a HCC. In the 47 patients with cirrhosis at presentation, HCC occurred in 14 (30%) and liver decompensation in 5 (11%). The 5 and 10-year event-free survivals were, respectively, 89.3% (95% CI, 81.7 -96.9) and 75.6% (95% CI, 61.5 -89.7) for patients with chronic hepatitis, and 70.2% (95% CI, 56.3 -84.1) and 40.4% (95% CI, 16.9 -63.9) for those with cirrhosis. Protracted, effective treatment with oral NUCs affects the natural history of chronic HBV infection by reducing the incidence of cirrhosis and risk of complications, but does not guarantee against the development of HCC in cirrhosis at presentation.
authors.affiliation: Division of Gastroenterology, "Casa Sollievo Sofferenza" Hospital, IRCCS, San Giovanni Rotondo, Italy. g.niro@operapadrepio.it
authors.forename: G A
authors.initials: GA
authors.lastname: Niro
authors.forename: A M
authors.initials: AM
authors.lastname: Ippolito
authors.forename: R
authors.initials: R
authors.lastname: Fontana
authors.forename: M R
authors.initials: MR
authors.lastname: Valvano
authors.forename: D
authors.initials: D
authors.lastname: Gioffreda
authors.forename: A
authors.initials: A
authors.lastname: Iacobellis
authors.forename: A
authors.initials: A
authors.lastname: Merla
authors.forename: M
authors.initials: M
authors.lastname: Durazzo
authors.forename: G
authors.initials: G
authors.lastname: Lotti
authors.forename: L
authors.initials: L
authors.lastname: Di Mauro
authors.forename: A
authors.initials: A
authors.lastname: Andriulli
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000453:epidemiology / Q000517:prevention & control; D004279:DNA, Viral / Q000097:blood; D005260:Female; D048550:Hepatic Insufficiency / Q000453:epidemiology / Q000517:prevention & control; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D008103:Liver Cirrhosis / Q000453:epidemiology / Q000517:prevention & control; D008113:Liver Neoplasms / Q000453:epidemiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009705:Nucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D009705:Nucleosides