Lack of effect of concomitant zidovudine on rifabutin kinetics in patients with AIDS-related complex
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| Published in | Antimicrobial Agents and Chemotherapy Vol. 40; no. 6; pp. 1397 - 1402 |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
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Washington, DC
American Society for Microbiology
01.06.1996
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| AbstractList | The effect of concomitant dosing with the antiretroviral agent zidovudine (ZDV) on the pharmacokinetics of rifabutin (RBT) was investigated under steady-state conditions. Sixteen human immunodeficiency virus-positive patients with AIDS-related complex who had been maintained on stable ZDV therapy for > or = 6 weeks were administered RBT concomitantly for 12 days. Eight patients received daily doses of 300 or 450 mg of RBT. Administration of ZDV was discontinued on day 13, and RBT was given alone for 3 additional days. Four patients receiving 450 mg of RBT discontinued treatment. Under steady-state ZDV and RBT dosing, safety and kinetics assessments were performed on day 13 (ZDV plus RBT) and day 16 (RBT alone). Kinetics on days 13 and 16 demonstrated that RBT (300 or 450 mg) was readily absorbed, with the time at which the plasma concentration was maximal (Tmax) ranging between 2.6 and 2.9 h. At these two doses, the mean steady-state maximal plasma concentrations (Cmax) were 250 and 430 ng/ml on day 13 and 245 and 458 ng/ml on day 16, respectively. RBT kinetics at the two doses were proportional and similar on the basis of estimates of the ratios of the areas under the concentration-time curves over the dosing interval from 0 to 24 h (AUC0-24) (450 mg/300 mg), which were 1.5 and 1.4 for days 13 and 16, respectively. No significant differences were apparent in the mean oral clearance (CLs/F) estimates (range, 1.60 to 1.77 liters/h/kg), which were dose independent and similar for the 2 assessment days, as was the urinary recovery of RBT and its 25-deacetyl metabolite. Low urinary recovery of 25-deacetyl RBT and an AUC metabolite/parent ratio of 0.1 suggest that there is minimal metabolism of RBT via the deacetylation pathway. For RBT, pooled mean (95% confidence interval) ratio (day 13/day 16) estimates for Cmax, Tmax, AUC0-24, and CLs/F were 1.07 (range, 0.77 to 1.38), 1.08 (0.89 to 1.27), 0.97 (0.82 to 1.13), and 1.09 (0.92 to 1.26), respectively. In addition, no significant changes in any of the major safety parameters were detected throughout the study. Therefore, it is concluded that coadministration of ZDV and RBT does not affect the pharmacokinetics and/or safety of RBT in human immunodeficiency virus-positive patients. Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology. For an alternate route to AAC .asm.org, visit: AAC The effect of concomitant dosing with the antiretroviral agent zidovudine (ZDV) on the pharmacokinetics of rifabutin (RBT) was investigated under steady-state conditions. Sixteen human immunodeficiency virus-positive patients with AIDS-related complex who had been maintained on stable ZDV therapy for greater than or equal to 6 weeks were administered RBT concomitantly for 12 days. Eight patients received daily doses of 300 or 450 mg of RBT Administration of ZDV was discontinued on day 13, and RBT was given alone for 3 additional days. Four patients receiving 450 mg of RBT discontinued treatment. Under steady-state ZDV and RBT dosing, safety and kinetics assessments were performed on day 13 (ZDV plus RBT) and day 16 (RBT alone). Kinetics on days 13 and 16 demonstrated that RBT (300 or 450 mg) was readily absorbed, with the time at which the plasma concentration was maximal (T sub(max)) ranging between 2.6 and 2.9 h. At these two doses, the mean steady-state maximal plasma concentrations (C sub(max)) were 250 and 430 ng/ml on day 13 and 245 and 458 ng/ml on day 16, respectively. RBT kinetics at the two doses were proportional and similar on the basis of estimates of the ratios of the areas under the concentration-time curves over the dosing interval from 0 to 24 h (AUC sub(0-24)) (450 mg/300 mg), which were 1.5 and 1.4 for days 13 and 16, respectively. No significant differences were apparent in the mean oral clearance (CL sub(S)/F) estimates (range, 1.60 to 1.77 liters/h/kg), which were dose independent and similar for the 2 assessment days, as was the urinary of RBT and its 25-deacetyl metabolite. Low urinary recovery of 25-deacetyl RBT and an AUC metabolite/parent ratio of 0.1 suggest that there is minimal metabolism of RBT via the deacetylation pathway. For RBT, pooled mean (95% confidence interval) ratio (day 13/day 16) estimates for C sub(max), T sub(max), AUC sub(0-24), and CL sub(S)/F were 1.07 (range, 0.77 to 1.38), 1.08 (0.89 to 1.27), 0.97 (0.82 to 1.13), and 1.09 (0.92 to 1.26), respectively. In addition, no significant changes in any of the major safety parameters were detected throughout the study. Therefore, it is concluded that coadministration of ZDV and RBT does not affect the pharmacokinetics and/or safety of RBT in human immunodeficiency virus-positive patients. |
| Author | R C Lewis S Nightingale P K Narang R C Li D C Colborn |
| AuthorAffiliation | Department of Clinical Pharmacology/PK, Pharmacia & Upjohn, Inc., Columbus, Ohio 43216, USA |
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| Keywords | Human Drug combination Retroviridae Virus Antibiotic Lentivirinae Antiviral AIDS related complex Antituberculous agent Drug interaction Human immunodeficiency virus Antibacterial agent Pharmacokinetics Pyrimidine nucleoside |
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| References | 7693435 - Drugs. 1993 Sep;46(3):515-78 2552902 - Antimicrob Agents Chemother. 1989 Aug;33(8):1237-41 7695673 - N Engl J Med. 1994 May 5;330(18):1316-7 8395019 - N Engl J Med. 1993 Sep 16;329(12):898-904 8179648 - N Engl J Med. 1993 Sep 16;329(12):828-33 1665904 - Pharm Res. 1991 Nov;8(11):1434-40 1964448 - J Antimicrob Chemother. 1990 Dec;26(6):813-22 1493087 - Br J Clin Pharmacol. 1992 Dec;34(6):551-4 4073881 - Antimicrob Agents Chemother. 1985 Oct;28(4):570-5 8363370 - Antimicrob Agents Chemother. 1993 Jul;37(7):1426-31 1970466 - Ann Intern Med. 1990 May 15;112(10):727-37 8453821 - Clin Pharmacokinet. 1993 Feb;24(2):101-23 2177293 - Xenobiotica. 1990 Nov;20(11):1113-9 2582706 - Clin Pharmacol Ther. 1989 Nov;46(5):494-500 1588496 - J Acquir Immune Defic Syndr. 1992;5(6):619-26 |
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| SubjectTerms | Administration, Oral Adult AIDS-Related Complex AIDS-Related Complex - drug therapy AIDS-Related Complex - metabolism Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Biological and medical sciences Clinical Trial Drug Administration Schedule Drug Interactions Drug Therapy, Combination Female human immunodeficiency virus Humans Male Medical sciences Middle Aged Pharmacology. Drug treatments Rifabutin Rifabutin - administration & dosage Rifabutin - pharmacokinetics Zidovudine Zidovudine - administration & dosage Zidovudine - pharmacology |
| Title | Lack of effect of concomitant zidovudine on rifabutin kinetics in patients with AIDS-related complex |
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