| Combination alpha-interferon and lamivudine therapy for alpha-interferon-resistant chronic hepatitis B infection: results of a pilot study. | |
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MedLine Citation:
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PMID: 9672165 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Clinical Trial; Clinical Trial, Phase II; Controlled Clinical Trial; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Journal of hepatology Volume: 28 ISSN: 0168-8278 ISO Abbreviation: J. Hepatol. Publication Date: 1998 Jun |
Date Detail:
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Created Date: 1998-09-25 Completed Date: 1998-09-25 Revised Date: 2010-03-24 |
Medline Journal Info:
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Nlm Unique ID: 8503886 Medline TA: J Hepatol Country: DENMARK |
Other Details:
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Languages: eng Pagination: 923-9 Citation Subset: IM; X |
Affiliation:
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Liver and Hepatobiliary Unit, Queen Elizabeth Hospital, Birmingham, UK. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Alanine Transaminase / blood Amylases / blood Antiviral Agents / adverse effects, pharmacokinetics, therapeutic use* DNA, Viral / blood Double-Blind Method Drug Therapy, Combination Female Hepatitis B e Antigens / blood Hepatitis B virus / isolation & purification Hepatitis B, Chronic / therapy* Humans Interferon Alfa-2b / adverse effects, pharmacokinetics, therapeutic use* Lamivudine / adverse effects, pharmacokinetics, therapeutic use* Male Metabolic Clearance Rate Middle Aged Pilot Projects Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Antiviral Agents; 0/DNA, Viral; 0/Hepatitis B e Antigens; 134678-17-4/Lamivudine; 99210-65-8/Interferon Alfa-2b; EC 2.6.1.2/Alanine Transaminase; EC 3.2.1.-/Amylases |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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