Randomized, placebo-controlled, double-blind trial with interferon-alpha with and without amantadine sulphate in primary interferon-alpha nonresponders with chronic hepatitis C
| Autor: | Thomas Berg, Uta Naumann, Jochen Raedle, S. Brinkmann, Stefan Zeuzem, Gerlinde Teuber, Uwe Hopf |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Male medicine.medical_specialty Combination therapy Adolescent Amantadine sulphate Pharmacology Interferon alpha-2 Placebo Profile of mood states Gastroenterology Antiviral Agents Double blind Chronic hepatitis Double-Blind Method Virology Internal medicine Interferon α medicine Amantadine Humans chronic hepatitis C Prospective Studies Adverse effect interferon‐α/amantadine retreatment Aged Hepatology business.industry Interferon-alpha interferon nonresponder Original Articles Hepatitis C Chronic Middle Aged Recombinant Proteins Infectious Diseases Quality of Life RNA Viral Drug Therapy Combination Female business |
| Zdroj: | Journal of Viral Hepatitis |
| ISSN: | 1352-0504 |
| Popis: | In primary interferon-alpha (IFN-alpha) nonresponders with chronic hepatitis C, retreatment with IFN-alpha has only limited efficacy with sustained response rates below 10%. Therefore, the aims of the present study were to compare the efficacy and safety of IFN-alpha alone or in combination with amantadine sulphate in nonresponders to previous IFN-alpha monotherapy. Fifty-five IFN-alpha nonresponders with chronic hepatitis C (mean age: 46.6 years) received IFN-alpha 6 MIU thrice weekly for 24 weeks followed by 3 MIU thrice weekly for additional 24 weeks. Amantadine sulphate (n=26) or a matched placebo (n=29) was given orally twice daily for 48 weeks. Because of a low initial response rate at week 12 (13/55 patients) and a high breakthrough rate (8/13 patients) after IFN-alpha dose reduction in week 24, a virological end-of-treatment response with undetectable serum HCV-RNA (< 1000 copies/mL) was achieved in only five patients (IFN-alpha/amantadine sulphate, one patient; IFN-alpha/placebo, four patients). After 24 weeks follow-up a sustained virological response was observed in only two patients receiving IFN-alpha and placebo. Health-related quality-of-life analysis showed a substantial improvement of the Profile of Mood States (POMS) scale concerning the subscales fatigue (P < 0.05) and vigor (P < 0.05) in patients receiving combined IFN-alpha/amantadine sulphate treatment compared with those treated with IFN-alpha alone. IFN-alpha/amantadine sulphate combination therapy was well tolerated without any serious adverse events. In conclusion, retreatment with IFN-alpha and amantadine sulphate does not increase the low sustained virological response rates of IFN-alpha therapy in primary IFN-alpha nonresponders with chronic hepatitis C, but may lead to a sustained improvement of health-related quality-of-life. |
| Databáze: | OpenAIRE |
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