Kaiser Permanente-Infectious Diseases, Los Angeles, CA 90027, USA.
J Acquir Immune Defic Syndr. 2010 Apr;53(5):614-8. doi: 10.1097/QAI.0b013e3181cdebb1.
Etravirine, a nonnucleoside reverse transcriptase inhibitor, was provided through an international early access program (EAP) prior to regulatory approval.
The Phase III, nonrandomized, open-label EAP investigated etravirine 200 mg twice daily plus a background regimen (BR) in patients who had failed multiple antiretroviral regimens. Efficacy and safety are reported for HIV-infected adults from the United States through week 48, including subgroups receiving etravirine +/- darunavir/ritonavir and/or raltegravir.
The intent-to-treat population included 2578 patients; 62.4% and 56.7% of patients received darunavir/ritonavir and raltegravir, respectively, in their BR. At week 48, 62.3% of patients achieved viral loads <75 copies per milliliter; responses across subgroups were similar. Median CD4 count increase from baseline was >100 cells per cubic millimeter. No unexpected safety concerns emerged; serious AEs and deaths due to AEs, considered possibly related to etravirine, occurred in 2.0% and 0.3% of patients, respectively. Discontinuations due to AEs were low overall (4.4%) and comparable across subgroups.
Etravirine combined with a BR, often including other new antiretrovirals, such as darunavir/ritonavir and/or raltegravir, provided an effective treatment option in treatment-experienced patients with HIV-1.
依曲韦林，一种非核苷类逆转录酶抑制剂，在监管批准前通过国际早期获取方案（EAP）提供。
这项 III 期、非随机、开放性 EAP 研究了依曲韦林 200mg 每日两次联合背景治疗方案（BR）在多重抗逆转录病毒治疗方案失败的患者中的疗效。本研究报告了来自美国的 HIV 感染成年人在第 48 周时的疗效和安全性，包括接受依曲韦林 +/- 达芦那韦/利托那韦和/或拉替拉韦的亚组。
意向治疗人群包括 2578 名患者；62.4%和 56.7%的患者在 BR 中分别接受了达芦那韦/利托那韦和拉替拉韦。第 48 周时，62.3%的患者病毒载量<75 拷贝/毫升；各亚组的应答情况相似。从基线开始的中位 CD4 计数增加超过 100 个细胞/立方毫米。未出现新的安全性问题；严重不良事件和与不良事件相关的死亡分别发生在 2.0%和 0.3%的患者中。因不良事件而停药的比例总体较低（4.4%），各亚组之间相似。
依曲韦林联合 BR，通常包括其他新型抗逆转录病毒药物，如达芦那韦/利托那韦和/或拉替拉韦，为治疗经验丰富的 HIV-1 患者提供了一种有效的治疗选择。
