Lessells Richard J, Stott Katharine E, Manasa Justen, Naidu Kevindra K, Skingsley Andrew, Rossouw Theresa, de Oliveira Tulio
Africa Centre for Health and Population Studies, University of KwaZulu-Natal, PO Box 198, Mtubatuba, KwaZulu-Natal 3935, South Africa.
BMC Health Serv Res. 2014 Mar 7;14:116. doi: 10.1186/1472-6963-14-116.
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.
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.
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.
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.
随着人类免疫缺陷病毒(HIV)治疗项目在高流行地区的扩大,抗逆转录病毒药物耐药性变得越来越普遍。基因型耐药性检测可能有助于指导个体层面的治疗决策,但在低收入和中等收入国家提供耐药性检测的成功模式尚未见报道。
在南非夸祖鲁-纳塔尔省北部的一个大型初级卫生保健HIV治疗项目中实施了HIV治疗失败诊所模式。为一线抗逆转录病毒治疗出现病毒学失败的成年人(≥16岁)提供基因型耐药性检测(在标准一线治疗方案至少治疗12个月后,病毒载量>1000拷贝/ml)。由HIV专科临床医生生成一份带有治疗建议的基因型耐药性检测报告,并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,以确定该模式的实施方式,并提供有关实施过程中的障碍和挑战的反馈。
在2011年4月8日至2013年1月31日期间,共提交了508份标本进行基因分型;在438例(86.2%)病例中,一份带有专科临床医生建议的完整基因型报告被发送给了医务人员。从标本采集到收到最终报告的中位周转时间为18天(四分位间距(IQR)13 - 29天)。在114例(26.0%)病例中,推荐的治疗方案与无耐药性检测时的治疗方案不同。在大多数病例(n = 315,71.9%)中,后续开出的治疗方案与报告建议一致。
基因型耐药性检测在这个大型初级卫生保健HIV项目中成功实施,该系统运行良好,其结果能够实时影响临床管理决策。进一步的研究将探索不同实施模式在不同环境中的影响和成本效益。