南非公共部门三线抗逆转录病毒治疗方案：队列描述和病毒学结果。
Third-Line Antiretroviral Therapy Program in the South African Public Sector: Cohort Description and Virological Outcomes.
机构信息
Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa.
出版信息
J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):73-78. doi: 10.1097/QAI.0000000000001883.
BACKGROUND
The World Health Organization recommends that antiretroviral therapy (ART) programs in resource-limited settings develop third-line ART policies. South Africa developed a national third-line ART program for patients who have failed both first-line non-nucleoside reverse transcriptase inhibitor-based ART and second-line protease inhibitor (PI)-based ART. We report on this program.
METHODS
Third-line ART in South Africa is accessed through a national committee that assesses eligibility and makes individual regimen recommendations. Criteria for third-line include the following: ≥1 year on PI-based ART with virologic failure, despite adherence optimization, and genotypic antiretroviral resistance test showing PI resistance. We describe baseline characteristics and resistance patterns of this cohort and present longitudinal data on virological suppression rates.
RESULTS
Between August 2013 and July 2014, 144 patients were approved for third-line ART. Median age was 41 years [interquartile range (IQR): 19-47]; 60% were women (N = 85). Median CD4 count and viral load were 172 (IQR: 128-351) and 14,759 (IQR: 314-90,378), respectively. About 2.8% started PI-based ART before 2004; 11.1% from 2004 to 2007; 31.3% from 2008 to 2011; and 6.3% from 2012 to 2014 (48.6% unknown start date). Of the 144 patients, 97% and 98% had resistance to lopinavir and atazanavir, respectively; 57% had resistance to darunavir. All were initiated on a regimen containing darunavir, with raltegravir in 101, and etravirine in 33. Among those with at least 1 viral load at least 6 months after third-line approval (n = 118), a large proportion (83%, n = 98) suppressed to <1000 copies per milliliter, and 79% (n = 93) to <400 copies per milliliter.
CONCLUSION
A high proportion of third-line patients with follow-up viral loads are virologically suppressed.
背景
世界卫生组织建议资源有限地区的抗逆转录病毒治疗（ART）项目制定三线 ART 政策。南非为那些一线无核苷类逆转录酶抑制剂为基础的 ART 和二线蛋白酶抑制剂（PI）为基础的 ART 均失败的患者制定了国家三线 ART 方案。我们报告了该方案。
方法
南非的三线 ART 通过国家委员会评估资格并提出个体化方案建议。三线治疗的标准包括：基于 PI 的 ART 治疗 1 年以上，病毒学失败，尽管优化了依从性，且基因型抗逆转录病毒耐药性检测显示 PI 耐药。我们描述了该队列的基线特征和耐药模式，并提供了病毒学抑制率的纵向数据。
结果
2013 年 8 月至 2014 年 7 月期间，有 144 名患者获得三线 ART 批准。中位年龄为 41 岁[四分位间距（IQR）：19-47]；60%为女性（N=85）。中位 CD4 计数和病毒载量分别为 172（IQR：128-351）和 14759（IQR：314-90378）。约 2.8%的患者在 2004 年前开始接受 PI 为基础的 ART；11.1%从 2004 年到 2007 年；31.3%从 2008 年到 2011 年；6.3%从 2012 年到 2014 年（48.6%的患者起始日期未知）。144 名患者中，97%和 98%对洛匹那韦和阿扎那韦分别具有耐药性；57%对达鲁那韦具有耐药性。所有患者均开始使用包含达鲁那韦的方案，其中 101 例使用拉替拉韦，33 例使用依曲韦林。在至少有 1 次病毒载量在三线治疗批准后至少 6 个月的患者中（n=118），很大一部分（83%，n=98）病毒载量降至<1000 拷贝/毫升，79%（n=93）降至<400 拷贝/毫升。
结论
有大量接受三线治疗后随访病毒载量的患者病毒学抑制。
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