期刊
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
卷 51, 期 9, 页码 3104-3110出版社
AMER SOC MICROBIOLOGY
DOI: 10.1128/AAC.00341-07
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资金
- NCRR NIH HHS [M01 RR000034, RR000034, M01 RR000095, RR00095] Funding Source: Medline
- NIAID NIH HHS [U01 AI069439, U01 AI038855, UM1 AI069439, AI069439, AI32775, AI068636, U01 AI038858, U01 AI032775, U01 AI068636, UM1 AI069474, AI38855, UM1 AI068636, AI38858, AI069474, AI68636, U01 AI069474] Funding Source: Medline
The potent induction of hepatic cytochrome P450 3A isoforms by rifampin complicates therapy for coinfection with human immunodeficiency virus (HIV) and Mycobacterium tuberculosis. We performed an open-label, single-arm study to assess the safety and pharmacokinetic interactions of the HIV protease inhibitor atazanavir coadministered with rifampin. Ten healthy HIV-negative subjects completed pharmacokinetic sampling at steady state while receiving 300 mg atazanavir every 12 111 without rifampin (period 1), 300 mg atazanavir every 12 h with 600 mg rifampin every 24 111 (period 2), and 400 mg atazanavir every 12 111 with 600 mg rifampin every 24 h (period 3). During period 1, the mean concentration of drug in serum at 12 h (C-12 h) was 811 ng/ml (range, 363 to 2,484 ng/ml) for atazanavir, similar to historic seronegative data for once-daily treatment with 300 mg atazanavir boosted with 100 mg ritonavir. During periods 2 and 3, the mean C-12 h values for atazanavir were 44 ng/ml (range, <25 to 187 ng/ml) and 113 ng/ml (range, 39 to 260 ng/ml), respectively, well below historic seronegative data for once-daily treatment with 400 mg atazanavir without ritonavir. Although safe and generally well tolerated, 300 mg or 400 mg atazanavir administered every 12 h did not maintain adequate plasma exposure when coadministered with rifampin.
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