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
| Autor: | Carlo Fabbri, A. Miracolo, Enrico Roda, Marco Montagnani, Davide Festi, Giuseppe Mazzella, Antonio Colecchia, S. Marchetto, Silvia Giovanelli, F. Ferrara, G. Nigro, S. Liva, Francesco Azzaroli, M. Francesca Jaboli, Letizia Bacchi Reggiani |
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| Přispěvatelé: | Jaboli M.F., Fabbri C., Liva S., Azzaroli F., Nigro G., Giovanelli S., Ferrara F., Miracolo A., Marchetto S., Montagnani M., Colecchia A., Festi D., Reggiani L.B., Roda E., Mazzella G. |
| Předmět: |
Adult
Male medicine.medical_specialty Combination therapy Viral Hepatitis Alpha interferon Hepatitis B HBV interferon lamivudine long term therapy trial Antiviral Agents Gastroenterology Transaminase law.invention Hepatitis B Chronic Randomized controlled trial law Interferon Statistical significance Internal medicine Humans Medicine business.industry Interferon-alpha Lamivudine General Medicine Middle Aged Regimen Treatment Outcome Immunology Reverse Transcriptase Inhibitors Drug Therapy Combination Female business medicine.drug |
| Zdroj: | Scopus-Elsevier |
| Popis: | Aim: 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. Conclusion: 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. |
| Databáze: | OpenAIRE |
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