Lopez-Cortes Luis F, Ruiz-Valderas Rosa, Ruiz-Morales Josefa, Leon Eva, de Campos Antonio Vergara, Marin-Niebla Ana, Marquez-Solero Manuel, Lozano Fernando, Valiente Rebeca
Infectious Diseases Service, Hospitales Universitarios, Virgen del Rocío, Seville, Spain.
J Antimicrob Chemother. 2006 Nov;58(5):1017-23. doi: 10.1093/jac/dkl357. Epub 2006 Sep 6.
To assess the safety and efficacy of efavirenz 800 mg daily in HIV-infected patients with tuberculosis receiving a rifampicin-containing regimen and to analyse whether a relationship exists between efavirenz Cmin and its virological efficacy.
Prospective, open-labelled study including HIV-infected patients on rifampicin and efavirenz 800 mg daily. Treatment adherence, adverse events (AEs), HIV-RNA levels, CD4 cell counts and efavirenz Cmin during and after finishing rifampicin treatment were evaluated.
Eighty patients met the inclusion criteria. A permanent drug withdrawal due to AEs occurred in 10 patients, 5 attributable to efavirenz, and 10 patients were lost to follow-up before the third month. Efavirenz Cmin levels with 800 mg plus rifampicin were similar to those with 600 mg after withdrawing rifampicin. Sixty patients were included in the efficacy analysis, eight experiencing virological failure. No relation was observed between the rate of virological failure and efavirenz Cmin, previous antiretroviral treatment or not, baseline CD4 counts or RNA-HIV. The only variable related to virological failure was irregular adherence [odds ratio, 81 (95% CI: 5-1280); P=0.002].
Given the lack of a demonstrated relationship between efavirenz Cmin and its efficacy in our study, a firm recommendation cannot be made to always increase the dose to 800 mg/day when concomitantly given with rifampicin, but it seems a cautious approach to maintain the same efavirenz plasma levels as with 600 mg daily without rifampicin. Patients weighing<55 kg and also black, Asian and Hispanic subjects in whom genetic-based increased efavirenz plasma levels and rates of AEs have been observed may benefit from a dose of 600 mg.
评估每日800毫克依非韦伦用于接受含利福平方案治疗的HIV感染合并结核病患者的安全性和疗效，并分析依非韦伦的血药浓度谷值（Cmin）与其病毒学疗效之间是否存在关联。
一项前瞻性、开放标签研究，纳入每日接受利福平和800毫克依非韦伦治疗的HIV感染患者。评估治疗依从性、不良事件（AE）、HIV-RNA水平、CD4细胞计数以及利福平治疗期间和结束后依非韦伦的Cmin。
80名患者符合纳入标准。10名患者因AE导致永久性停药，其中5例归因于依非韦伦，10名患者在第三个月前失访。停用利福平后，800毫克依非韦伦联合利福平的Cmin水平与600毫克时相似。60名患者纳入疗效分析，8例出现病毒学失败。未观察到病毒学失败率与依非韦伦Cmin、既往是否接受抗逆转录病毒治疗、基线CD4计数或HIV-RNA之间存在关联。与病毒学失败相关的唯一变量是不规则依从性[比值比，81（95%CI：5-1280）；P=0.002]。
鉴于在我们的研究中依非韦伦Cmin与其疗效之间缺乏明确关联，不能坚定推荐在与利福平同时使用时总是将剂量增加至800毫克/天，但维持与不使用利福平每日600毫克时相同的依非韦伦血浆水平似乎是一种谨慎的方法。体重<55公斤的患者以及观察到基于基因的依非韦伦血浆水平升高和AE发生率增加的黑人、亚洲人和西班牙裔受试者可能从600毫克剂量中获益。
