Document Detail

Combination alpha-interferon and lamivudine therapy for alpha-interferon-resistant chronic hepatitis B infection: results of a pilot study.
MedLine Citation:
PMID:  9672165     Owner:  NLM     Status:  MEDLINE    
BACKGROUND/AIMS: Alpha-interferon achieves seroconversion in about one third of naive patients. Attempts to achieve seroconversion in patients who have previously failed alpha-interferon have proved disappointing. Combination chemotherapy (alpha-interferon with a nucleoside analogue) might provide a treatment alternative for these patients. We have undertaken a phase 2 study in 20 patients who had previously failed at least one course of alpha-interferon. The study was designed to assess the safety, tolerability and efficacy of the combination. METHODS: All patients were treated for 16 weeks with alpha-interferon in combination with 12 or 16 weeks of Lamivudine (3'TC). Patients were followed for 16 weeks post-treatment. Pharmacokinetic studies were performed to identify/exclude significant pharmacokinetic drug interaction. RESULTS: The combination was well tolerated, and side-effects of the combination were indistinguishable from the recognised side-effects of alpha-interferon. Pharmacokinetic studies performed on days 1 and 29 did not show any significant interaction. All patients achieved HBV DNA clearance during treatment, but 19 relapsed at the end of treatment. HBeAg/anti-HBe seroconversion was observed for four patients, but was sustained for a single patient (who also had sustained DNA clearance). CONCLUSIONS: Combination therapy with alpha-interferon and lamivudine given for 16 weeks appears safe and is well tolerated. However, for this group of patients who had previously failed interferon monotherapy, the efficacy of combination interferon/lamivudine therapy appears disappointing, and other treatment strategies should be investigated.
D Mutimer; N Naoumov; P Honkoop; G Marinos; M Ahmed; R de Man; P McPhillips; M Johnson; R Williams; E Elias; S Schalm
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Controlled Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of hepatology     Volume:  28     ISSN:  0168-8278     ISO Abbreviation:  J. Hepatol.     Publication Date:  1998 Jun 
Date Detail:
Created Date:  1998-09-25     Completed Date:  1998-09-25     Revised Date:  2010-03-24    
Medline Journal Info:
Nlm Unique ID:  8503886     Medline TA:  J Hepatol     Country:  DENMARK    
Other Details:
Languages:  eng     Pagination:  923-9     Citation Subset:  IM; X    
Liver and Hepatobiliary Unit, Queen Elizabeth Hospital, Birmingham, UK.
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MeSH Terms
Alanine Transaminase / blood
Amylases / blood
Antiviral Agents / adverse effects,  pharmacokinetics,  therapeutic use*
DNA, Viral / blood
Double-Blind Method
Drug Therapy, Combination
Hepatitis B e Antigens / blood
Hepatitis B virus / isolation & purification
Hepatitis B, Chronic / therapy*
Interferon Alfa-2b / adverse effects,  pharmacokinetics,  therapeutic use*
Lamivudine / adverse effects,  pharmacokinetics,  therapeutic use*
Metabolic Clearance Rate
Middle Aged
Pilot Projects
Time Factors
Reg. No./Substance:
0/Antiviral Agents; 0/DNA, Viral; 0/Hepatitis B e Antigens; 134678-17-4/Lamivudine; 99210-65-8/Interferon Alfa-2b; EC Transaminase; EC 3.2.1.-/Amylases

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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