Science Links Japan | A Pharmacokinetic Study of SCH 18908 (Ribavirin) in Concomitant Use with Interferon .ALPHA.-2b in Treating Chronic Hepatitis C of Genotype 1b and High Viral Load.

A Pharmacokinetic Study of SCH 18908 (Ribavirin) in Concomitant Use with Interferon .ALPHA.-2b in Treating Chronic Hepatitis C of Genotype 1b and High Viral Load.

Accession number;02A0429248

Title;A Pharmacokinetic Study of SCH 18908 (Ribavirin) in Concomitant Use with Interferon .ALPHA.-2b in Treating Chronic Hepatitis C of Genotype 1b and High Viral Load.

Author; KUMADA HIROMITSU (Fed. of Natl. Public Serv. and Affil. Personnel Mutual Aid Assoc., Toranomon Hosp.) IZUMI NAMIKI (Musashino Red Cross Hosp.) HIROSE YUICHI (Yamanashikenchuobyoin Naika)

Journal Title;Journal of Clinical Therapeutics & Medicines

Journal Code:Y0906A

ISSN:0910-8211

VOL.18;NO.4;PAGE.593-614(2002)

Figure&Table&Reference;FIG.7, TBL.8, REF.19

Pub. Country;Japan

Language;Japanese

Abstract;Multiple doses of Ribavirin and IFN .ALPHA.-2b were administered to 28 patients with chronic hepatitis C of genotype 1b and high viral load. Trough levels of serum ribavirin and pharmacokinetic changes after administration on the first day and on the final day of administration were determined. Ribavirin at 800mg/day was given daily over the administration period of 24 weeks. IFN .ALPHA.-2b at 6 million IU/day was given 6 days a week for the first 2 weeks, then 3 times a week for the remaining 22 weeks. Serum levels of ribavirin from 8 weeks after the start of administration did not show any further increase, indicating that a steady state had been achieved. Accumutalion idices of Cmax, C12hr, and AUC0-12hr, were 5.24, 14.2, and 8.11, respectively. Since the elimination half-life of serum ribavirin at the time of the administration of the final dose was 10 times longer than at the start of administration (29.3 to 291 hours), it is inadvisable to use measurements made after a single administration to predict steady state levels achieved during repeated administration. The most common subjective and objective adverse effects included fever, malaise, headache, and arthralgia. Commonly observed abnormalities in laboratory data were leucopenia, neutropenia, and reticuloendothelial disorders as well as ribavirin-specific red blood cell disorders such as erythrocytopenia and decreases in hematocrit and hemoglobin levels. (author abst.)

Related Articles;