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A Randomized Trial of Standard vs. Dose-Escalation Dosing of Ribavirin in Combination Therapy for Chronic Hepatitis C Patients with Genotype 1 and High Viral Load
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Reported by Jules Levin
DDW, May 17-22, 2008, San Diego
Yoshiaki Iwasaki1, Yasuyuki Araki2, Ryo-ichi Okamoto2, Hideaki Taniguchi3, Yasuhiro Makino4, Tohru Ohnishi5, Hiroyuki Shimomura6, Minoru Tomita7, Kazuhisa Yabushita8, Yasushi Ishii9, Masaharu Ando5, Kuniaki Hashimoto7, Hiroshi Ikeda6, Kouichi Takaguchi10, Akinobu Takaki1, Haruhiko Kobashi1, Kohsaku Sakaguchi1, Yasushi Shiratori1, Kazuhide Yamamoto1
1. Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan, 2. Department of Medicine, Hiroshima City Hospital, Hiroshima, Japan, 3. Department of Internal Medicine, Tsuyama Central Hospital, Tsuyama, Japan, 4. Department of Medicine, National Iwakuni Clinical Center, Iwakuni, Japan, 5. Department of Medicine, Mitoyo General Hospital, Mitoyo, Japan, 6. Department of Gastroenterology, Kurashiki Central Hospital, Kurashiki, Japan, 7. Department of Medicine, Mihara Red Cross Hospital, Mihara, Japan, 8. Department of Medicine, Fukuyama City Hospital, Fukuyama, Japan, 9. Department of Medicine, Tottori City Hospital, Tottori, Japan, 10. Department of Medicine, Kagawa Prefectural Central Hospital, Takamatsu, Japan
Background/Aims: In a country like Japan with average age of patients to be treated by antivirals sometimes exceeding 60, the standard combination therapy is not well tolerated as we have recently reported. In this randomized, controlled trial, we sought a possibility of the dose-escalation of ribavirin dosing for the difficult-to-treat patients.
Methods: A total of 62 patients chronically infected with HCV-1 and high viral load (±100 KIU/mL) were treated with peginterferon alpha-2b (1.5 _g/weight kg/week). Patients were randomized for standard (group A) or dose-escalation (group B) of ribavirin dosing. Patients in group A received weight-based standard dose of ribavirin, whereas those in group B received 200 mg lower dose of ribavirin as a starting dose, followed by increase of ribavirin dose by 100 mg at 4- and 8-week of therapy, if hemoglobin levels were 12 g/dL or higher.
Results: Thirty three and 29 patients were randomly assigned for group A and B, respectively. There was no significant difference at baseline background between the groups. Rates of negative HCV RNA results during therapy were 26%, 63%, 77%, and 75% in group A, and 18%, 63%, 75%, and 73% in group B by intention-to-treat analysis, respectively. Sustained virological response rates in group A and B were 53% and 50%, respectively.
There was no significant difference in response to therapy between the groups. Completion of therapy without dose reduction and discontinuation of therapy was more frequent in group B (30%) than in group A (16%), although there was no statistically significant difference (P = 0.27).
Dose reduction of ribavirin was significantly more frequent in group A (58%) than in group B (20%) (P < 0.02).
Conclusions: Dose-escalation of ribavirin in combination therapy with peginterferon was feasible in terms of safety without compromising treatment efficacy.
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