Liu Pengtao, Liao Lingjie, Xu Wei, Yan Jing, Zuo Zhongbao, Leng Xuebing, Wang Jing, Kan Wei, You Yinghui, Xing Hui, Ruan Yuhua, Shao Yiming
Weifang Medical University, Weifang, Shandong Province.
State Key Laboratory for Infectious Disease Prevention and Control, National Center for AIDS/STD Control and Prevention (NCAIDS), Chinese Center for Disease Control and Prevention (China CDC), Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Beijing.
Medicine (Baltimore). 2018 Dec;97(50):e13555. doi: 10.1097/MD.0000000000013555.
Stavudine (D4T), zidovudine (AZT), and tenofovir (TDF) along with lamivudine (3TC) are the most widely used HIV treatment regimens in China. China's National Free Antiretroviral Treatment Programme (NFATP) has replaced D4T with AZT or TDF in the standard first-line regimens since 2010. Few studies have evaluated the adherence, virological outcome, and drug resistance in HIV patients receiving first-line antiretroviral therapy (ART) from 2011 to 2015 due to changes in ART regimen.From 2011 to 2015, 2787 HIV patients were examined, with 364, 1453, and 970 patients having initiated D4T-, AZT-, and TDF-based first-line ART regimens, respectively. The Cochran-Armitage test was used to examine the trends in clinical and virological outcomes during 2011 to 2015. Logistic regression was used to examine the effects of different regimens after 9 to 24 months of ART.From 2011 to 2014-2015, adverse drug reactions decreased from 18.9% to 6.7%, missed doses decreased from 9.9% to 4.6%, virological failure decreased from 16.2% to 6.4%, and drug resistance rates also significantly decreased from 5.4% to 1.1%. These successes were strongly associated with the standardized use of TDF- or AZT-based regimens in place of the D4T-based regimen. Poor adherence decreased from 11.3% in patients who initiated D4T-based regimens to 4.9% in those who initiated TDF-based regimens, adverse drug reactions decreased from 32.4% to 6.7%, virological failure reduced from 18.7% to 8.6%, and drug resistance reduced from 5.8% to 2.9%. Compared with patients who initiated AZT-based regimens, patients who initiated TDF-based regiments showed significant reductions in adherence issues, adverse drug reactions, virological outcomes, and drug resistance. Significant differences were also observed between those who initiated D4T- and AZT-based regimens.The good control of HIV replication and drug resistance was attributed to the success of China's NFATP from 2011 to 2015. This study provided real world evidence for further scaling up ART and minimizing the emergence of drug resistance in the "Three 90" era.
司他夫定（D4T）、齐多夫定（AZT）、替诺福韦（TDF）以及拉米夫定（3TC）是中国使用最广泛的抗艾滋病病毒治疗方案。自2010年起，中国国家免费抗逆转录病毒治疗项目（NFATP）已在标准一线治疗方案中用AZT或TDF取代了D4T。由于抗逆转录病毒治疗方案的变化，很少有研究评估2011年至2015年接受一线抗逆转录病毒治疗（ART）的艾滋病病毒患者的依从性、病毒学结果和耐药性。
2011年至2015年，对2787例艾滋病病毒患者进行了检查，分别有364例、1453例和970例患者开始了基于D4T、AZT和TDF的一线抗逆转录病毒治疗方案。采用 Cochr an-Armitage检验来研究2011年至2015年期间临床和病毒学结果的趋势。采用逻辑回归分析来研究抗逆转录病毒治疗9至24个月后不同治疗方案的效果。
从2011年到2014 - 2015年，药物不良反应从18.9%降至6.7%，漏服剂量从9.9%降至4.6%，病毒学失败从16.2%降至6.4%，耐药率也从5.4%显著降至1.1%。这些成功与采用基于TDF或AZT的方案标准化使用以取代基于D4T的方案密切相关。依从性差的情况从开始基于D4T方案的患者中的11.3%降至开始基于TDF方案的患者中的4.9%，药物不良反应从32.4%降至6.7%，病毒学失败从18.7%降至8.6%，耐药性从5.8%降至2.9%。与开始基于AZT方案的患者相比，开始基于TDF方案的患者在依从性问题、药物不良反应、病毒学结果和耐药性方面有显著降低。在开始基于D4T和AZT方案的患者之间也观察到了显著差异。
艾滋病病毒复制和耐药性的良好控制归因于2011年至2015年中国国家免费抗逆转录病毒治疗项目的成功。本研究为在“三个90”时代进一步扩大抗逆转录病毒治疗规模和最大限度减少耐药性的出现提供了真实世界的证据。
