Thao Vu Phuong, Quang Vo Minh, Wolbers Marcel, Anh Nguyen Duc, Shikuma Cecilia, Farrar Jeremy, Dunstan Sarah, Chau Nguyen Van Vinh, Day Jeremy, Thwaites Guy, Le Thuy
From the Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit (VPT, MW, NDA, JF, JD, GT, TLE); Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam (VMQ, NVVC); Hawaii Centre for AIDS, University of Hawaii at Manoa, Honolulu, Hawaii (CS, TLE); and Peter Doherty Institute for Infection and Immunity, The University of Melbourne, Melbourne, Australia (SD).
Medicine (Baltimore). 2015 Oct;94(43):e1715. doi: 10.1097/MD.0000000000001715.
The growing numbers of HIV-infected patients requiring second-line antiretroviral therapy (ART) in Vietnam make essential the evaluation of treatment efficacy to guide treatment strategies.We evaluated all patients aged ≥15 years who initiated second-line ART after documented failure of first-line therapy at the Hospital for Tropical Diseases in Ho Chi Minh City. The primary outcome was time from second-line ART initiation to death, or to a new or reoccurrence of a WHO-defined immunological or clinical failure event, whichever occurred first. Risks of treatment failure and death were evaluated using Cox proportional hazards modeling.Data from 326 of 373 patients initiating second-line ART between November 2006 and August 2011 were included in this analysis. The median age was 32 years (IQR: 28-36). Eighty one percent were men. The median CD4 count was 44 cells/μL (IQR: 16-84). During a median follow-up of 29 months (IQR: 15-44), 60 (18.4%) patients experienced treatment failure, including 12 immunological failures, 4 WHO stage IV AIDS events, and 44 deaths (13.5%). Sixty percent of deaths occurred during the first 6-12 months. The Kaplan-Meier estimates of treatment failure after 1, 2, 3, and 4 years were 13.1% (95% CI: 9.2-16.8), 18.6% (95% CI: 14.0-23.1), 20.4% (95% CI: 15.4-25.1), and 22.8% (95% CI: 17.2-28.1), respectively. Older age, history of injection drug use, lower CD4 count, medication adherence <95%, and previous protease inhibitor use independently predicted treatment failure.While treatment efficacy was similar to that reported from other resource-limited settings, mortality was higher. Early deaths may be averted by prioritizing second-line therapy for those with lower CD4 counts and by improving treatment adherence support.
在越南，需要接受二线抗逆转录病毒疗法（ART）的艾滋病毒感染患者数量不断增加，因此评估治疗效果以指导治疗策略至关重要。我们评估了胡志明市热带病医院所有年龄≥15岁且在一线治疗记录失败后开始二线ART的患者。主要结局是从开始二线ART到死亡，或到世界卫生组织定义的免疫或临床失败事件的新发生或复发，以先发生者为准。使用Cox比例风险模型评估治疗失败和死亡风险。本分析纳入了2006年11月至2011年8月期间开始二线ART的373例患者中的326例数据。中位年龄为32岁（四分位间距：28 - 36岁）。男性占81%。CD4细胞计数中位数为44个/μL（四分位间距：16 - 84个）。在中位随访29个月（四分位间距：15 - 44个月）期间，60例（18.4%）患者出现治疗失败，包括12例免疫失败、4例世界卫生组织IV期艾滋病事件和44例死亡（13.5%）。60%的死亡发生在最初6 - 12个月。1年、2年、3年和4年后治疗失败的Kaplan - Meier估计值分别为13.1%（95%置信区间：9.2 - 16.8%）、18.6%（95%置信区间：14.0 - 23.1%）、20.4%（95%置信区间：15.4 - 25.1%）和22.8%（95%置信区间：17.2 - 28.1%）。年龄较大、有注射吸毒史、CD4计数较低、药物依从性<95%以及先前使用过蛋白酶抑制剂是治疗失败的独立预测因素。虽然治疗效果与其他资源有限地区报告的相似，但死亡率更高。通过优先为CD4计数较低的患者提供二线治疗并改善治疗依从性支持，可能避免早期死亡。
