Comparison of Interferon .ALPHA.-2b and Ribavirin (SCH 18908) Combination Therapy and Interferon .ALPHA.-2b monotherapy in Chronic Hepatitis C Patients who have not Responded or Relapsed to Previous Interferon Therapy. A Double-blind Comparative Study to Examine Concomitant Efficacy.
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Accession number;02A0429246
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| Title;Comparison of Interferon .ALPHA.-2b and Ribavirin (SCH 18908) Combination Therapy and Interferon .ALPHA.-2b monotherapy in Chronic Hepatitis C Patients who have not Responded or Relapsed to Previous Interferon Therapy. A Double-blind Comparative Study to Examine Concomitant Efficacy. |
| Author;
TOYODA JOJI
(Sapporo Kosei Hospital)
SAINOKAMI SHIGEHIKO
(Kisaragikurinikku)
YASUDA KIYOMI
(Seizankai Kiyokawabyoin Kanzobyokense)
IZUMI NAMIKI
(Musashino Red Cross Hosp.)
OTA HIROHIKO
(Toshiba Byoin)
SATO YUZURU
(Ntthigashinihon Kantobyoin Shokakinaika)
HIROSE YUICHI
(Yamanashikenchuobyoin Naika)
ICHIDA TAKAFUMI
(Niigatadai I Byoin Daisannaika)
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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.539-563(2002)
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| Figure&Table&Reference;FIG.6, TBL.13, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy and safety of concomitant use of interferon .ALPHA.-2b(IFN .ALPHA.-2b) and ribavirin were compared with those of IFN .ALPHA.-2b monotherapy for the treatment of chronic hepatitis C patients who had not responded to IFN or those with recurrent symptoms after IFN treatment. The subjects were stratified into 2 groups (Class A and Class B) according to virus genotype and viral load, and also randomly allocated to the concomitant therapy group (Group I) or monotherapy group (Group II). The total number of subjects was 126 (Group I: 62, Group II: 64), Class A was 83 (Group I: 41, Group II: 42), and Class B was 43 (Group I: 21, Group II: 22). The administration period was 24 weeks. The subjects in Group I received ribavirin orally at doses of 600 or 800mg/day, twice daily for 24 weeks, and IFN .ALPHA.-2b at the dose of 6 million IU/intramuscularly 6 times weekly for 2 weeks, followed with 3 times weekly for 22 weeks. The subjects in Group II received placebo orally twice daily for 24 weeks and IFN .ALPHA.-2b at the dose of 6 million IU/intramuscularly 6 times weekly for 2 weeks, followed with 3 times weekly for 22 weeks. The observation period was 24 weeks after completion of administration. 24 weeks after completion of administration, improvement in viremia was evaluated as the primary endpoint. The efficacy rate in FAS in Class A (genotype 1b with high viral load) was about 10% in Group I and 0% in Group II, and in Class B (those other than Class A), 70% in Group I and 29% in Group II, showing significant efficacy of the concomitant use group. In all the subjects who received the test drug, the efficacy rate was 14.6% in Group I and 0% in Group II in Class A, and 76.2% in Group I and 27.3% in Group II in Class B, also indicating superiority of Group I to Group II. Adverse events were mild to moderate and observed in all the subjects. Discontinuation due to adverse events was 6(9.7%)/62 in Group I and 4(6.3%)/64 in Group II.... (author abst.) |
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