Wang Xia, Yang Liting, Li Huiqin, Zuo La, Liang Shujia, Liu Wei, Dong Yonghui, Yang Shaomin, Shang Hong, Li Jingyun, Kang Laiyi, Zhong Ping, Zheng Wei, Liao Lingjie, Xing Hui, Chen Ray Y, Ruan Yuhua, Shao Yiming
State Key Laboratory for Infectious Disease Prevention and Control, and National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
Curr HIV Res. 2011 Mar;9(2):103-11. doi: 10.2174/157016211795569122.
Emerging HIV drug resistance (HIVDR) poses a growing threat to the long-term success and durability of highly active antiretroviral therapy (HAART).
To understand the incidence of HIVDR and estimate the proportion of potential HIVDR and its associated risk factors among the patients on HAART for one year.
Antiretroviral-naïve patients ≥ 18 years old were invited to participate in this one-year prospective study from seven clinics in Yunnan, Guangxi, and Xinjiang provinces. A questionnaire and blood draw were collected at baseline and 12 month follow-up. The protocol used was modified slightly from the WHO Protocol for Surveys of HIV Drug Resistance Emerging During Treatment and Related Program Factors in Sentinel ART Sites in Resource-limited Settings.
435 subjects were included in the final analysis, with median baseline CD4 cell count 139 cells/mm3. Of the total 417 patients who fall under WHO guidelines for 'Classification of outcomes based on endpoints' (on ART at 12 months, switch, lost to follow-up, and stop), 90 (21.6%) did not have any drug resistant mutations (potential HIVDR) and 17 (4.1%) did (HIVDR, Table 2). The remaining 310 (75.3%) had a viral load <1000 copies/ml (HIVDR prevention). Among 351 patients retained at 12 months, 41 (11.7%) had a viral load >1000 copies/ml.Patients who self-reported missing doses in the previous month were 6.2 fold (95% CI 2.5-15.7) more likely to fail than those who did not. and those from Xinjiang were 12.1 fold (95% CI 5.2-28.1) more likely to fail compared to those from Yunnan and Guangxi. Why Xinjiang was associated with virologic failure was not clear but may be related to the demographics of the participants from Xinjiang, being significantly more IDUs, poorer, and less adherent than those from Yunnan and Guangxi.
Although successful virologic outcomes were seen in the vast majority (75.3%) of those treated at one year, virologic failure continues to be a problem particularly among those less adherent and from Xinjiang. Additional data are needed to understand the generalizability of these results, particularly those related to Xinjiang. For IDUs, enhancing adherence to HAART and considering the treatment of drug addiction as an integral part of the treatment for HIV infection should be considered. As China's National Free Antiretroviral Treament Program continues to mature and improve, ramping up treatment in these settings may be important considerations to the long-term success of the program.
新出现的HIV耐药性（HIVDR）对高效抗逆转录病毒疗法（HAART）的长期成功和持久性构成了日益严重的威胁。
了解HIVDR的发生率，并估计接受HAART一年的患者中潜在HIVDR的比例及其相关危险因素。
邀请年龄≥18岁且未接受过抗逆转录病毒治疗的患者参加这项为期一年的前瞻性研究，该研究来自云南、广西和新疆的7家诊所。在基线和12个月随访时收集问卷和血样。所使用的方案是在世界卫生组织《资源有限环境中哨点抗逆转录病毒治疗场所治疗期间出现的HIV耐药性及相关项目因素调查方案》的基础上稍作修改。
435名受试者纳入最终分析，基线CD4细胞计数中位数为139个细胞/mm³。在符合世界卫生组织“基于终点的结果分类”指南的417例患者（12个月时接受抗逆转录病毒治疗、换药、失访和停药）中，90例（21.6%）没有任何耐药突变（潜在HIVDR），17例（4.1%）有耐药突变（HIVDR，表2）。其余310例（75.3%）的病毒载量<1000拷贝/ml（预防HIVDR）。在12个月时仍参与研究的351例患者中，41例（11.7%）的病毒载量>1000拷贝/ml。上个月自我报告有漏服药物情况的患者治疗失败的可能性是未漏服患者的6.2倍（95%CI 2.5 - 15.7）。与来自云南和广西的患者相比，来自新疆的患者治疗失败的可能性高12.1倍（95%CI 5.2 - 28.1）。尚不清楚新疆为何与病毒学失败相关，但可能与来自新疆的参与者的人口统计学特征有关，他们中的注射吸毒者明显更多，更贫困，依从性也比来自云南和广西的患者差。
尽管在接受治疗一年的绝大多数患者（75.3%）中观察到了成功的病毒学结果，但病毒学失败仍然是一个问题，特别是在依从性较差的患者和来自新疆的患者中。需要更多数据来了解这些结果的普遍性，特别是与新疆相关的结果。对于注射吸毒者，应考虑加强对HAART的依从性，并将药物成瘾治疗作为HIV感染治疗的一个组成部分。随着中国国家免费抗逆转录病毒治疗项目不断成熟和完善，在这些地区加强治疗可能是该项目长期成功的重要考虑因素。
