Recombinant interferon-alpha therapy for acute hepatitis B: a randomized, double-blind, placebo-controlled trial
| Autor: | Stephanos J. Hadziyannis, H. Polychronaki, M. Koutelou, N. C. Tassopoulos, M. Paraloglou-Ioannides |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Adult
Male medicine.medical_specialty Hepatitis B vaccine Adolescent Placebo-controlled study Interferon alpha-2 medicine.disease_cause Placebo Antiviral Agents Gastroenterology law.invention Leukocyte Count Double-Blind Method Liver Function Tests Randomized controlled trial law Virology Internal medicine Humans Medicine Hepatitis B Antibodies Hepatitis B virus Hepatitis B Surface Antigens Hepatology medicine.diagnostic_test business.industry Interferon-alpha Middle Aged Hepatitis B Recombinant Proteins Surgery Discontinuation Clinical trial Treatment Outcome Infectious Diseases Acute Disease Female business Liver function tests |
| Zdroj: | Journal of Viral Hepatitis. 4:387-394 |
| ISSN: | 1365-2893 1352-0504 |
| DOI: | 10.1046/j.1365-2893.1997.00072.x |
| Popis: | In spite of the availability of hepatitis B vaccine, acute hepatitis B continues to be a worldwide problem for which no specific therapy is available. We investigated the safety and the effectiveness of recombinant interferon-alpha2b (rIFN-alpha2b) in the treatment of acute hepatitis B by determining overall severity and duration of symptoms, time required to clear viral antigens and hepatitis B virus (HBV) DNA, and titre of antibodies to hepatitis B surface antigen (HBsAb), 24 weeks after the onset of therapy. One hundred patients were randomly assigned to treatment with either 3 million units (MU) (n = 34) or 10 MU (n = 33) rIFN-alpha2b or to placebo (n = 33), three times weekly for 3 weeks. Follow-up was for 24 weeks. A significantly shorter duration of the symptoms and signs of acute hepatitis was observed in patients who received 3 MU rIFN-alpha2b compared with those who received 10 MU rIFN-alpha2b or placebo. Twenty-one weeks post-therapy, patients treated with 10 MU rIFN-alpha2b showed a significantly higher geometric mean HBsAb titre than those treated with placebo (85.1 vs 35.5 IU l-1, P < 0.05). rIFN-alpha2b administration was well tolerated even in jaundiced patients. No serious side-effects were observed necessitating reduction in dose or discontinuation of the drug. The effect of rIFN-alpha2b on transition of HBV infection to chronicity could not be evaluated in this trial because such an unfavourable course was not seen in any of the treated or the control patients. In conclusion, rIFN-alpha2b was safe in acute hepatitis B, and at low dose was found to ameliorate symptoms and to shorten significantly the duration of illness. |
| Databáze: | OpenAIRE |
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