Abstract

BackgroundAntiretroviral 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.MethodsAn 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.ResultsA 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.ConclusionsGenotypic 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.

Highlights

  • Antiretroviral drug resistance is becoming increasingly common with the expansion of human immunodeficiency virus (HIV) treatment programmes in high prevalence settings

  • The number of resistance tests requested per medical officer varied substantially, due in part to varied lengths of service within the programme and in part to differences in doctors’ roles in relation to the intervention: those medical officers who requested resistance tests opportunistically in primary health care clinics enrolled between 17 and 32 participants each, whereas two medical officers who were more directly involved in the treatment failure support camps enrolled 168 and 99 participants respectively

  • This paper describes our HIV-Treatment failure clinic (TFC) model for management of antiretroviral therapy (ART) failure incorporating the use of genotypic resistance testing within a primary health care (PHC) programme in rural KwaZulu-Natal

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Summary

Introduction

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. The rapid expansion of public health human immunodeficiency virus (HIV) programmes in the past decade has led to over eight million people accessing antiretroviral therapy (ART) in low- and middle-income countries [1]. In South Africa, the national antiretroviral treatment guidelines incorporate recommendations for genotypic resistance testing in certain situations (e.g. failure of second-line ART in adults and children) [7]. The Southern African HIV Clinicians Society guidelines go further in recommending genotypic resistance testing at time of firstline ART failure in adults [8]

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