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Implementing antiretroviral resistance testing in a primary health care HIV treatment programme in rural KwaZulu-Natal, South Africa: early experiences, achievements and challenges

机译:在南非夸祖鲁-纳塔尔省农村地区的一项初级保健HIV治疗计划中实施抗逆转录病毒耐药性测试:早期经验,成就和挑战

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Background Antiretroviral drug resistance is becoming increasingly common with the expansion of human immunodeficiency virus (HIV) treatment programmes in high prevalence settings. Genotypic resistance testing could have benefit in guiding individual-level treatment decisions but successful models for delivering resistance testing in low- and middle-income countries have not been reported. Methods An HIV Treatment Failure Clinic model was implemented within a large primary health care HIV treatment programme in northern KwaZulu-Natal, South Africa. Genotypic resistance testing was offered to adults (≥16 years) with virological failure on first-line antiretroviral therapy (one viral load >1000 copies/ml after at least 12 months on a standard first-line regimen). A genotypic resistance test report was generated with treatment recommendations from a specialist HIV clinician and sent to medical officers at the clinics who were responsible for patient management. A quantitative process evaluation was conducted to determine how the model was implemented and to provide feedback regarding barriers and challenges to delivery. Results A total of 508 specimens were submitted for genotyping between 8 April 2011 and 31 January 2013; in 438 cases (86.2%) a complete genotype report with recommendations from the specialist clinician was sent to the medical officer. The median turnaround time from specimen collection to receipt of final report was 18 days (interquartile range (IQR) 13–29). In 114 (26.0%) cases the recommended treatment differed from what would be given in the absence of drug resistance testing. In the majority of cases (n?=?315, 71.9%), the subsequent treatment prescribed was in line with the recommendations of the report. Conclusions Genotypic resistance testing was successfully implemented in this large primary health care HIV programme and the system functioned well enough for the results to influence clinical management decisions in real time. Further research will explore the impact and cost-effectiveness of different implementation models in different settings.
机译:背景技术随着在高流行环境中人类免疫缺陷病毒(HIV)治疗计划的扩展,抗逆转录病毒药物耐药性变得越来越普遍。基因型耐药性测试可能有助于指导个体水平的治疗决策,但尚未报道在中低收入国家成功进行耐药性测试的模型。方法在南非夸祖鲁-纳塔尔省北部的大型初级卫生保健HIV治疗计划中实施了HIV治疗失败诊所模型。对一线抗逆转录病毒疗法(在标准一线治疗方案中至少12个月后,病毒载量> 1000拷贝/ ml)的病毒学失败的成年人(≥16岁)进行基因型耐药性测试。产生了基因型抗药性测试报告,其中包含来自专业HIV临床医生的治疗建议,并已发送给负责患者管理的诊所医务人员。进行了定量过程评估,以确定模型的实施方式并提供有关交付过程中的障碍和挑战的反馈。结果:从2011年4月8日至2013年1月31日,共有508个样本进行了基因分型。在438例病例中(占86.2%),将完整的基因型报告和专家临床医生的建议发送给了医务人员。从标本收集到收到最终报告的平均周转时间为18天(四分位间距(IQR)13-29)。在114例(26.0%)病例中,推荐的治疗方法与没有进行耐药性测试的情况有所不同。在大多数情况下(n = 315,71.9%),规定的后续治疗符合报告的建议。结论在这个大型的初级保健HIV计划中成功实施了基因型耐药性测试,该系统运行良好,足以实时地影响临床治疗决策。进一步的研究将探索不同环境中不同实施模型的影响和成本效益。

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