title: Long-term alpha interferon and lamivudine combination therapy in non-responder patients with anti-HBe-positive chronic hepatitis B: results of an open, controlled trial.
abstract: OBJECTIVE
  To investigate the safety and efficacy of long-term combination therapy with alpha interferon and lamivudine in non-responsive patients with anti-HBe-positive chronic hepatitis B.
  
  
  METHODS
  34 patients received combination treatment (1 month lamivudine, 12 month lamivudine+interferon, 6 month lamivudine), 24 received lamivudine (12 months), 24 received interferon (12 months). Interferon was administered at 6 MU tiw and lamivudine at 100 mg orally once daily. Patients were followed up for 6 months after treatment.
  
  
  RESULTS
  At the end of treatment, HBV DNA negativity rates were 88 % with lamivudine+interferon, 99 % with lamivudine and 55 % with interferon, (P=0.004, combination therapy vs. interferon, and P=0.001 lamivudine vs. interferon), and serum transaminase normalization rates were 84 %, 91 % and 53 % (P=0.01 combination therapy vs. interferon, and P=0.012 lamivudine vs. interferon). Six months later, HBV DNA negativity rates were 44 % with lamivudine+interferon, 33 % with lamivudine and 25 % with interferon, and serum transaminase normalization rates were 61 %, 42 % and 45 %, respectively, without statistical significance. No YMDD variants were observed with lamivudine+interferon (vs. 12 % with lamivudine). The combination therapy appeared to be safe.
  
  
  CONCLUSIONS
  Although viral clearance and transaminase normalization are slower with long-term lamivudine+interferon than that with lamivudine alone, the combination regimen seems to provide more lasting benefits and to protect against the appearance of YMDD variants. Studies with other regimens regarding sequence and duration are needed.
authors.affiliation: Department of Internal Medicine and Gastroenterology, University of Bologna, Italy.
authors.forename: M Francesca
authors.initials: MF
authors.lastname: Jaboli
authors.forename: Carlo
authors.initials: C
authors.lastname: Fabbri
authors.forename: Stefania
authors.initials: S
authors.lastname: Liva
authors.forename: Francesco
authors.initials: F
authors.lastname: Azzaroli
authors.forename: Giovanni
authors.initials: G
authors.lastname: Nigro
authors.forename: Silvia
authors.initials: S
authors.lastname: Giovanelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Ferrara
authors.forename: Anna
authors.initials: A
authors.lastname: Miracolo
authors.forename: Sabrina
authors.initials: S
authors.lastname: Marchetto
authors.forename: Marco
authors.initials: M
authors.lastname: Montagnani
authors.forename: Antonio
authors.initials: A
authors.lastname: Colecchia
authors.forename: Davide
authors.initials: D
authors.lastname: Festi
authors.forename: Letizia Bacchi
authors.initials: LB
authors.lastname: Reggiani
authors.forename: Enrico
authors.initials: E
authors.lastname: Roda
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mazzella
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine