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Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women

BACKGROUND: The prevalence of pre-treatment drug resistance (PDR) to non-nucleoside reverse-transcriptase inhibitor (NNRTI) agents is increasing in sub-Saharan Africa, which may decrease the effectiveness of efavirenz-based antiretroviral therapy (ART) programs. However, due to recent safety concern...

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Autores principales: Duarte, Horacio A., Babigumira, Joseph B., Enns, Eva A., Stauffer, David C., Shafer, Robert W., Beck, Ingrid A., Garrison, Louis P., Chung, Michael H., Frenkel, Lisa M., Bendavid, Eran
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256304/
https://www.ncbi.nlm.nih.gov/pubmed/32490370
http://dx.doi.org/10.1016/j.eclinm.2020.100355
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author Duarte, Horacio A.
Babigumira, Joseph B.
Enns, Eva A.
Stauffer, David C.
Shafer, Robert W.
Beck, Ingrid A.
Garrison, Louis P.
Chung, Michael H.
Frenkel, Lisa M.
Bendavid, Eran
author_facet Duarte, Horacio A.
Babigumira, Joseph B.
Enns, Eva A.
Stauffer, David C.
Shafer, Robert W.
Beck, Ingrid A.
Garrison, Louis P.
Chung, Michael H.
Frenkel, Lisa M.
Bendavid, Eran
author_sort Duarte, Horacio A.
collection PubMed
description BACKGROUND: The prevalence of pre-treatment drug resistance (PDR) to non-nucleoside reverse-transcriptase inhibitor (NNRTI) agents is increasing in sub-Saharan Africa, which may decrease the effectiveness of efavirenz-based antiretroviral therapy (ART) programs. However, due to recent safety concerns, there has been hesitancy to replace efavirenz-based ART with dolutegravir in women of reproductive potential. Our objective was to evaluate whether PDR testing for women not initiating dolutegravir-based ART would be a cost-effective strategy to address the challenges posed by PDR. METHODS: We developed an HIV drug resistance model that simulates the emergence and transmission of resistance mutations, calibrated to the Kenyan epidemic. We modeled three care strategies for PDR testing among women not initiating dolutegravir-based ART: no PDR testing, PDR testing with a low-cost point mutation assay, known as oligonucleotide ligation assay (OLA), and PDR testing with consensus sequencing. Using a health sector perspective, this model was used to evaluate the health outcomes, lifetime costs, and cost-effectiveness under each strategy over a 15-year time horizon starting in 2019. FINDINGS: OLA and CS PDR testing were projected to have incremental cost-effectiveness ratios (ICER) of $10,741/QALY gained and $134,396/QALY gained, respectively, which are not cost-effective by national income standards. Viral suppression rates among women at 12 months after ART initiation were 87·8%, 89·0%, and 89·3% with no testing, OLA testing, and CS testing, respectively. PDR testing with OLA and CS were associated with a 0.5% and 0.6% reduction in incidence rate compared to no PDR testing. Initial PDR prevalence among women was 13.1% in 2019. By 2034, this prevalence was 17·6%, 17·4%, and 17·3% with no testing, OLA testing, and CS testing, respectively. INTERPRETATION: PDR testing for women is unlikely to be cost-effective in Kenya whether one uses a low-cost assay, such as OLA, or consensus sequencing. FUNDING: National Institutes of Health, Gilead Sciences.
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spelling pubmed-72563042020-06-01 Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women Duarte, Horacio A. Babigumira, Joseph B. Enns, Eva A. Stauffer, David C. Shafer, Robert W. Beck, Ingrid A. Garrison, Louis P. Chung, Michael H. Frenkel, Lisa M. Bendavid, Eran EClinicalMedicine Research paper BACKGROUND: The prevalence of pre-treatment drug resistance (PDR) to non-nucleoside reverse-transcriptase inhibitor (NNRTI) agents is increasing in sub-Saharan Africa, which may decrease the effectiveness of efavirenz-based antiretroviral therapy (ART) programs. However, due to recent safety concerns, there has been hesitancy to replace efavirenz-based ART with dolutegravir in women of reproductive potential. Our objective was to evaluate whether PDR testing for women not initiating dolutegravir-based ART would be a cost-effective strategy to address the challenges posed by PDR. METHODS: We developed an HIV drug resistance model that simulates the emergence and transmission of resistance mutations, calibrated to the Kenyan epidemic. We modeled three care strategies for PDR testing among women not initiating dolutegravir-based ART: no PDR testing, PDR testing with a low-cost point mutation assay, known as oligonucleotide ligation assay (OLA), and PDR testing with consensus sequencing. Using a health sector perspective, this model was used to evaluate the health outcomes, lifetime costs, and cost-effectiveness under each strategy over a 15-year time horizon starting in 2019. FINDINGS: OLA and CS PDR testing were projected to have incremental cost-effectiveness ratios (ICER) of $10,741/QALY gained and $134,396/QALY gained, respectively, which are not cost-effective by national income standards. Viral suppression rates among women at 12 months after ART initiation were 87·8%, 89·0%, and 89·3% with no testing, OLA testing, and CS testing, respectively. PDR testing with OLA and CS were associated with a 0.5% and 0.6% reduction in incidence rate compared to no PDR testing. Initial PDR prevalence among women was 13.1% in 2019. By 2034, this prevalence was 17·6%, 17·4%, and 17·3% with no testing, OLA testing, and CS testing, respectively. INTERPRETATION: PDR testing for women is unlikely to be cost-effective in Kenya whether one uses a low-cost assay, such as OLA, or consensus sequencing. FUNDING: National Institutes of Health, Gilead Sciences. Elsevier 2020-05-22 /pmc/articles/PMC7256304/ /pubmed/32490370 http://dx.doi.org/10.1016/j.eclinm.2020.100355 Text en © 2020 The Author(s) http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Research paper
Duarte, Horacio A.
Babigumira, Joseph B.
Enns, Eva A.
Stauffer, David C.
Shafer, Robert W.
Beck, Ingrid A.
Garrison, Louis P.
Chung, Michael H.
Frenkel, Lisa M.
Bendavid, Eran
Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women
title Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women
title_full Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women
title_fullStr Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women
title_full_unstemmed Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women
title_short Cost-effectiveness analysis of pre-ART HIV drug resistance testing in Kenyan women
title_sort cost-effectiveness analysis of pre-art hiv drug resistance testing in kenyan women
topic Research paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256304/
https://www.ncbi.nlm.nih.gov/pubmed/32490370
http://dx.doi.org/10.1016/j.eclinm.2020.100355
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