Department of Infectious Diseases;
Ther Clin Risk Manag. 2009 Feb;5(1):99-116. Epub 2009 Mar 26.
Atazanavir (ATV) is one of the latest protease inhibitors (PI) approved for the treatment of HIV infection. The drug has a relatively long-life (~7 h) and large inhibitory quotient which allows once daily administration. It is generally well tolerated and the main side effect is hyperbilirubinemia, since ATV inhibits the hepatic uridin-glucoronyl-transferase. A signature mutation at the protease gene, I50L, may confer loss of susceptibility to the drug. Interestingly, it produces hypersusceptibility to all other PIs. When ATV is pharmacokinetically boosted with ritonavir (r) 100 mg/day, a greater genetic barrier for resistance is achieved, and generally more than 3 major PI resistance associated mutations are needed to result in ATV resistance. In drug-naïve subjects, regimens based on ATV/r have shown non-inferiority compared to lopinavir (LPV)/r (CASTLE study) or fosamprenavir/r (ALERT trial), generally with improved tolerance (less diarrhea and dyslipidemia). Given its good tolerance and convenience, ATV has been proven to be successful as a simplification strategy in switch studies (ie, SWAN and SLOAT) conducted in patients with complete virological suppression under other PI-based regimens. Finally, ATV/r-based combinations have shown to be equivalent in terms of viral response to other PI/r-containing regimens, including LPV/r, in rescue interventions in patients failing other PI regimens (ie, studies AI424-045 and NADIS).
阿扎那韦(ATV)是最新批准用于治疗 HIV 感染的蛋白酶抑制剂(PI)之一。该药物的半衰期相对较长(~7 小时),抑制指数较大,允许每日给药一次。它通常具有良好的耐受性,主要副作用是高胆红素血症,因为 ATV 抑制了肝尿苷-葡糖醛酸基转移酶。蛋白酶基因的标志性突变 I50L 可能导致对药物的敏感性丧失。有趣的是,它使所有其他 PI 产生超敏性。当阿扎那韦与利托那韦(r)100mg/天联合使用时,其耐药性的遗传屏障更大,通常需要 3 种以上主要的 PI 相关耐药突变才能导致 ATV 耐药。在未接受过药物治疗的患者中,基于 ATV/r 的方案与洛匹那韦/利托那韦(CASTLE 研究)或福沙那韦/利托那韦(ALERT 试验)相比,显示出非劣效性,通常具有更好的耐受性(腹泻和血脂异常较少)。鉴于其良好的耐受性和便利性,在其他基于 PI 的方案下完全病毒学抑制的患者中进行的转换研究(即 SWAN 和 SLOAT)中,ATV 已被证明是一种成功的简化策略。最后,基于 ATV/r 的联合方案在病毒学应答方面与其他包含 PI/r 的方案(包括 LPV/r)等效,包括在其他 PI 方案失败的患者中进行挽救干预的研究(即 AI424-045 和 NADIS 研究)。