The CORE Center, Chicago, IL, USA.
J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S62-7. doi: 10.1097/QAI.0b013e31820a820f.
The safety of buprenorphine/naloxone (bup/nx) in HIV-infected patients has not been established. Prior reports raise concern about hepatotoxicity and interactions with atazanavir.
We conducted a prospective cohort study of 303 opioid-dependent HIV-infected patients initiating bup/nx treatment. We assessed changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) over time. We compared bup/nx doses in patients receiving the antiretroviral atazanavir to those not receiving atazanavir. We conducted surveillance for pharmacodynamic interactions.
Median AST [37.0 vs. 37.0 units/liter (U/L) respective interquartile ranges (IQRs) 26-53 and 26-59] and ALT (33.0 vs. 33.0 U/L, respective IQRs 19-50 and 18-50) values did not change over time among 141 patients comparing pre-bup/nx exposure with post-bup/nx exposure measures. During bup/nx exposure, 207 subjects demonstrated no significant change in median AST (36.0 vs. 35.0 U/L, respective IQRs 25-57 and 25-61) and ALT (29.0 vs. 31.0 U/L, respective IQRs 19-50 and 18-50) values collected a median of 6 months apart. Analyses restricted to patients with hepatitis C and HIV co-infection yielded similar results, except a small but significant decrease in first to last AST, during treatment with bup/nx (P = 0.048). Mean bup/nx dose, ranging 16.0-17.8 mg, did not differ over time or with co-administration of atazanavir. No pharmacodynamic interactions were noted.
Buprenorphine/naloxone did not produce measurable hepatic toxicity or pharmacodynamic interaction with atazanavir in HIV-infected opioid-dependent patients.
在感染 HIV 的患者中，丁丙诺啡/纳洛酮（丁丙诺啡/纳洛酮）的安全性尚未确定。先前的报告令人担忧其肝毒性和与阿扎那韦的相互作用。
我们对 303 名开始接受丁丙诺啡/纳洛酮治疗的感染 HIV 的阿片类药物依赖患者进行了前瞻性队列研究。我们评估了随着时间的推移天门冬氨酸氨基转移酶（AST）和丙氨酸氨基转移酶（ALT）的变化。我们比较了接受抗逆转录病毒阿扎那韦和未接受阿扎那韦的患者的丁丙诺啡/纳洛酮剂量。我们对药效学相互作用进行了监测。
在 141 名患者中，比较丁丙诺啡/纳洛酮暴露前后的测量值，中位 AST[37.0 与 37.0 单位/升（U/L），各自的四分位距（IQR）为 26-53 和 26-59]和 ALT（33.0 与 33.0 U/L，各自的 IQR 为 19-50 和 18-50）值在时间上没有变化。在丁丙诺啡/纳洛酮暴露期间，207 名患者的中位 AST（36.0 与 35.0 U/L，各自的 IQR 为 25-57 和 25-61）和 ALT（29.0 与 31.0 U/L，各自的 IQR 为 19-50 和 18-50）值在中位时间为 6 个月的两次采集之间没有显著变化。在乙型肝炎病毒和 HIV 合并感染的患者中进行的分析得到了类似的结果，除了丁丙诺啡/纳洛酮治疗期间 AST（从第一次到最后一次）略有但显著下降（P=0.048）。丁丙诺啡/纳洛酮的平均剂量为 16.0-17.8mg，在时间上或与阿扎那韦联合使用时没有差异。未发现药效学相互作用。
在感染 HIV 的阿片类药物依赖患者中，丁丙诺啡/纳洛酮未产生可测量的肝毒性或与阿扎那韦的药效学相互作用。
