National AIDS Control Organisation, Government of India, Ministry of Health and Family Welfare, New Delhi, India.
J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):610-4. doi: 10.1097/QAI.0b013e3181f43a31.
The identification and management of first-line antiretroviral therapy (ART) failure is a key challenge for HIV programs in resource-limited settings. In 2008, the National AIDS Control Organisation, India piloted a national strategy to provide second-line ART. We assessed the National AIDS Control Organisation second-line ART evaluation algorithm.
Adult patients who had received 6 months or more of standard first-line ART were referred for second-line ART evaluation if they demonstrated CD4 decline to pre-ART values, CD4 drop to less than 50% of peak on-treatment value, failure to achieve CD4 greater than 100 c/mm(3), or development of a new World Health Organization Stage 3 or 4 AIDS-defining illness. Patients received HIV RNA testing, and those with HIV RNA 10,000 c/mL or greater qualified to switch to second-line ART. World Health Organization-defined clinical and CD4 criteria for ART failure were compared against virologic failure criteria.
Between January and June 2008, 154 patients met criteria for evaluation. Of 122 (79%) patients who had HIV RNA testing, 87 (71%) had viral load 10,000 c/mL or greater and were recommended to start second-line ART, 29 (24%) had viral load less than 400 c/mL, and six (5%) had viral load between 400 and 10,000 c/mL. The positive predictive value of World Health Organization clinical/immunologic criteria to detect virologic failure was 71% (95% confidence interval, 63% to 79%).
Second-line ART was initiated in the public sector in India using an approach combining clinical and immunologic evaluation with confirmation of virologic failure. Almost 25% of patients who met clinical/immunologic failure criteria demonstrated virologic suppression. Inclusion of targeted HIV RNA testing in the evaluation of treatment failure can prevent unnecessary switches to second-line ART.
在资源有限的环境中，识别和管理一线抗逆转录病毒治疗（ART）失败是 HIV 项目的一个关键挑战。2008 年，印度国家艾滋病控制组织（NACO）试点了一项提供二线 ART 的国家战略。我们评估了 NACO 二线 ART 评估算法。
接受标准一线 ART 治疗 6 个月或更长时间的成年患者，如果出现 CD4 下降至 ART 前水平、CD4 下降至治疗后峰值的 50%以下、未能达到 CD4 大于 100 个/mm(3)、或出现新的世界卫生组织（WHO）第三或第四期 AIDS 定义性疾病，则被转诊进行二线 ART 评估。患者接受 HIV RNA 检测，HIV RNA 大于 10,000 c/mL 的患者有资格切换至二线 ART。将 WHO 定义的 ART 失败的临床和 CD4 标准与病毒学失败标准进行比较。
2008 年 1 月至 6 月期间，有 154 名患者符合评估标准。在接受 HIV RNA 检测的 122 名（79%）患者中，有 87 名（71%）病毒载量大于 10,000 c/mL，建议开始二线 ART，29 名（24%）病毒载量小于 400 c/mL，6 名（5%）病毒载量在 400 至 10,000 c/mL 之间。WHO 临床/免疫标准检测病毒学失败的阳性预测值为 71%（95%置信区间，63%至 79%）。
印度公共部门使用结合临床和免疫评估与确认病毒学失败的方法，启动了二线 ART。近 25%符合临床/免疫失败标准的患者显示病毒学抑制。在治疗失败的评估中纳入有针对性的 HIV RNA 检测可以防止不必要地切换至二线 ART。
