Combination alpha-interferon and lamivudine therapy for alpha-interferon-resistant chronic hepatitis B infection: results of a pilot study
| Autor: | Robert A. de Man, David Mutimer, Roger Williams, Mark R. Johnson, Solko W. Schalm, Elwyn Elias, Monz Ahmed, George Marinos, Penny McPhillips, Nikolai V. Naoumov, P. Honkoop |
|---|---|
| Přispěvatelé: | Internal Medicine |
| Rok vydání: | 1998 |
| Předmět: |
Adult
Male medicine.medical_specialty Hepatitis B virus Time Factors Combination therapy Metabolic Clearance Rate Alpha interferon Phases of clinical research Pilot Projects Interferon alpha-2 Gastroenterology Antiviral Agents Hepatitis B Chronic Double-Blind Method SDG 3 - Good Health and Well-being Internal medicine medicine Humans Hepatitis B e Antigens Seroconversion Interferon alfa Aged Hepatology business.industry Lamivudine Interferon-alpha Combination chemotherapy Alanine Transaminase Middle Aged Recombinant Proteins Tolerability Immunology Amylases DNA Viral Drug Therapy Combination Female business medicine.drug |
| Zdroj: | Journal of Hepatology, 28, 923-929. Elsevier |
| ISSN: | 0168-8278 |
| Popis: | 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 monotheraphy appears disappointing, and other treatment strategies should be investigated. |
| Databáze: | OpenAIRE |
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