Cost analysis of implementing HIV drug resistance testing in Kenya: a case study of a service delivery site at a tertiary level hospital in Kenya

Abstract

Background: HIV drug resistance (HIVDR) threatens progress achieved in response to the HIV epidemic. Understanding the costs of implementing HIVDR testing programs for patient management and surveillance in resource-limited settings is critical in optimizing resource allocation. Here, we estimate the unit cost of HIVDR testing and identify major cost drivers while documenting challenges and lessons learnt in implementation of HIVDR testing at a tertiary level hospital in Kenya. Methods: We employed a mixed costing approach to estimate the costs associated with performing a HIVDR test from the provider’s perspective. Data collection involved a time and motion study of laboratory procedures and interviewing laboratory personnel and the management personnel. Cost analysis was based on estimated 1000 HIVDR tests per year. Data entry and analysis were done using Microsoft Excel and costs converted to US dollars (2019). Results: The estimated unit cost for a HIVDR test was $271.78 per test. The main cost drivers included capital ($102.42, 37.68%) and reagents (101.50, 37.35%). Other costs included: personnel ($46.81, 17.22%), utilities ($14.69, 5.41%), equipment maintenance costs ($2.37, 0.87%) and quality assurance program ($4, 1.47%). Costs in relation to specific laboratory processes were as follows: sample collection ($2.41, 0.89%), RNA extraction ($22.79, 8.38%), amplification ($56.14, 20.66%), gel electrophoresis ($10.34, 3.80%), sequencing ($160.94, 59.22%), and sequence analysis ($19.16, 7.05%). A user-initiated modification of halving reagent volumes for some laboratory processes (amplification and sequencing) reduced the unit cost for a HIVDR test to $233.81 (13.97%) reduction. Conclusions: Capital expenditure and reagents remain the most expensive components of HIVDR testing. This cost is bound to change as the sequencing platform is utilized towards maximum capacity or leveraged for use with other tests. Cost saving in offering HIVDR testing services is also possible through reagent volume reduction without compromising on the quality of test results.

A low-cost in-house HIV integrase strand transfer inhibitor drug resistance test for resource-limited settings

“…The expanded use of DTG-based treatment for first-line regimen in all PLHIV-1 necessitates access to affordable and effective DRT for monitoring of drug resistance to INSTIs both as a public health surveillance tool and for individual patient care and treatment (Gachogo et al, 2020;World Health Organization, 2017a). In the current study, we demonstrate the performance characteristics of a low cost in-house HIV drug resistance test using WHO guidelines for assay validation (World Health Organization, 2018).…”

“…This underscores the need to develop affordable alternatives, such as in-house tests. In-house assays reduce costs by use of less-costly reagents, reagent miniaturization, reduction of number of primers and amplification steps, negotiating with suppliers for best prices or by collaborating with not-for-profit manufacturers (Gachogo, Mwai, & Onyambu, 2020;Inzaule et al, 2016;Magomere et al, 2019;Manasa et al, 2014). Nevertheless, substantial effort and resources are required for optimization of the various procedures in the development of in-house assays (Chaturbhuj et al, 2014;World Health Organization, 2018).…”

Current ARTs, Virologic Failure, and Implications for AIDS Management: A Systematic Review

“…However, a crucial challenge in this field is determining the ideal threshold for detecting mutations with NGS that correlates with clinically significant resistance [ 126 ]. Another challenge lies in the cost (about US $380 per test), which constitutes a significant barrier for HIV genotyping in resource-limited settings (RLS), and this can hinder the effective therapeutic management of HIV/AIDS patients in such settings [ 128 ]. Collaborative partnerships were initiated in some resource-limited countries to develop discounted in-house HIVDR genotyping assays that could be commercially affordable for such settings or similar countries [ 129 , 130 , 131 ].…”

HIV-1 Drug Resistance Genotyping in Resource Limited Settings: Current and Future Perspectives in Sequencing Technologies

“…However, there is currently one commercially available Sanger sequencing assay approved by the US Food and Drug Administration (FDA) for HIVDR genotyping, namely ViroSeq HIV-1 Genotyping kit [23][24][25][26]. The kit is relatively expensive, costing approximately US$380 per test, making it less affordable for RLS [27]. This makes laboratories resort to developing low-cost in-house assays, and in some cases modifying commercial assays to reduce costs [28].…”