title: Long-term suppression of hepatitis B e antigen-negative chronic hepatitis B by 24-month interferon therapy.
abstract: To assess whether extended treatment with interferon improves the outcome of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B, 101 consecutive patients were treated with 6 MU of interferon alfa 2b 3 times weekly for 24 months. During the 68-month study, 30 patients (30%) had a sustained response (i.e., normal serum transaminase levels and undetectable hepatitis B virus DNA by non-polymerase chain reaction [PCR] assays), and 15 cleared serum surface antigen. Twenty-five nonresponders, 16 relapsers, and 30 who discontinued treatment were considered treatment failures. Multivariate analysis predicted a sustained response for young age (odds ratio, 0.94; 95% confidence interval, 0.89-0.99; P =.041) and high pretreatment serum levels of immunoglobulin M (IgM) anti-hepatitis B core antigen (HBc) (odds ratio, 4.52; 95% confidence interval, 1.63-12.5; P =.004). Liver disease progressed in none of the sustained responders but in 16 with treatment failure (0% vs. 22%, P =.002); hepatocellular carcinoma (HCC) developed with similar frequency in both groups (7%). Overall, estimated 8-year complication-free survival was longer for the 30 sustained responders than the 71 patients with treatment failure (90% vs. 60%, P <.001), but 8-year patient survival was similar in the 2 groups (100% and 90%). Short complication-free survival was predicted by failure to respond to interferon (hazard ratio, 7.8; 95% confidence interval, 1.8-34.0; P =.006) and high scores for liver fibrosis (hazard ratio, 1.71; 95% confidence interval, 1.17-2.50; P =.005). In conclusion, 24 months of treatment with interferon alfa 2b led to sustained disease suppression in a significant proportion of patients with HBeAg-negative chronic hepatitis B.
authors.affiliation: Division of Hepatology and Fondazione Italiana Ricerca Cancro Liver Cancer Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Maggiore Policlinico Hospital, University of Milan, Milan, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Lampertico
authors.forename: Ersilio
authors.initials: E
authors.lastname: Del Ninno
authors.forename: Mauro
authors.initials: M
authors.lastname: Viganò
authors.forename: Raffaella
authors.initials: R
authors.lastname: Romeo
authors.forename: Maria Francesca
authors.initials: MF
authors.lastname: Donato
authors.forename: Erwin
authors.initials: E
authors.lastname: Sablon
authors.forename: Alberto
authors.initials: A
authors.lastname: Morabito
authors.forename: Massimo
authors.initials: M
authors.lastname: Colombo
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D004279:DNA, Viral / Q000378:metabolism; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006513:Hepatitis B e Antigens / Q000032:analysis*; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000410:Alanine Transaminase