Comparison of Ribavirin (SCH 18908) and Interferon .ALPHA.-2b Combination Therapy and Interferon .ALPHA.-2b Monotherapy in Chronic Hepatitis C Patients of Genotype 1b and High Viral Load. A Double Blind Parallel Study to Determine Dosage and Administration.
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Accession number;02A0429247
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| Title;Comparison of Ribavirin (SCH 18908) and Interferon .ALPHA.-2b Combination Therapy and Interferon .ALPHA.-2b Monotherapy in Chronic Hepatitis C Patients of Genotype 1b and High Viral Load. A Double Blind Parallel Study to Determine Dosage and Administration. |
| Author;
IINO SHIRO
(Seimariannaidai Naikarinshokensaigaku)
MATSUSHIMA TAKASHI
(Hakodate City Hosp.)
KUMADA HIROMITSU
(Fed. of Natl. Public Serv. and Affil. Personnel Mutual Aid Assoc., Toranomon Hosp.)
KIYOSAWA KENDO
(Shinshu Univ., Fac. of Med.)
KAKUMU SHIN'ICHI
(Aichi Med. Univ., JPN)
MIZOKAMI MASASHI
(Nagoyashidai Daininaika)
HAYASHI NORIO
(Osakadai Daiichinaika)
SATA MICHIO
(Kurumedai Daininaika)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.18;NO.4;PAGE.565-591(2002)
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| Figure&Table&Reference;FIG.8, TBL.12, REF.16 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy and safety of combination therapy with ribavirin and interferon(IFN) .ALPHA.-2b and monotherapy with IFN .ALPHA.-2b were compared in the treatment of chronic hepatitis C of genotype 1b and high viral load. The number of the subjects was 269 (89 for group I, 92 for group II, and 88 for group III). The administration period was 24 weeks. The subjects in group I were orally given ribavirin at 600 or 800mg/day, twice daily for 24 weeks, and intramuscularly given IFN .ALPHA.-2b (low dose) of 6 million IU 6 times weekly for 2 weeks followed by three times weekly for 22 weeks. Those in group II were orally given ribavirin at 600 or 800mg/day twice daily for 24 weeks, and intramuscularly given IFN .ALPHA.-2b (high dose) of 10 million IU 6 times weekly for 2 weeks followed by 6 million IU 3 times weekly for 22 weeks. Those in group III were orally given placebo twice daily for 24 weeks, and intramuscularly IFN .ALPHA.-2b (high dose) of 10 million IU 6 times weekly for 2 weeks followed by 6 million IU 3 times weekly for 22 weeks. A 24-week observation period followed the end of treatment. Improvement in viremia was evaluated at 24 weeks after completion of the administration as the primary endpoint. The efficacy rate was 21.2% in group I, 16.3% in group II, and 2.4% in group III, showing that the combination with ribavirin (groups I and II) was significantly superior to monotherapy with IFN .ALPHA.-2b (group III). Most of the adverse events observed were mild to moderate; but, adverse events were observed in all subjects. Discontinuation due to adverse events occurred in 12.5% (23/184) in the combination therapy groups, and 5.7% (5/88) in the monotherapy group. Common adverse events predominantly seen in the combination group included decreased hemoglobin, decreased hematocrit value, and decreased RBC, which are related to RBC disorder specific to ribavirin.... (author abst.) |
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