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Immune-mediated adverse drug reactions to HIV and TB treatments in South Africa: predict, prevent and improve long-term outcomes (IMARI SA study)

Award Number: R01AI152183
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/21/2020
PERIOD OF PERFORMANCE END DATE: 03/31/2026

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Immune-mediated adverse drug reactions to HIV and TB treatments in South Africa: predict, prevent and improve long-term outcomes (IMARI SA study) - PROJECT SUMMARY Immune-mediated adverse drug reactions (IM-ADRs) are a major obstacle to the successful treatment of both HIV and tuberculosis (TB) internationally. Their contribution to management complexity and economic burden is a particular problem in South Africa (SA) where 1 in 4 individuals in the population is HIV-infected and 1 in 5 patients with HIV develops a cutaneous adverse drug reaction during treatment. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) are severe IM-ADRs that have mortalities that can exceed 40% and lead to prolonged hospitalization, higher healthcare costs and significantly constricted treatment options. The specific effect that these IM-ADRs have on HIV treatment outcomes has not been adequately measured. In addition, the IM-ADRs themselves are known to be associated with significant long-term disability and physical and mental health complications that have not been measured in HIV and HIV/TB co-infected populations. Preventive efforts for severe IM-ADRs such as DRESS and SJS/TEN have been fueled by promising discoveries such as the strong association between the HLA class I allele HLA-B*15:02 and carbamazepine SJS/TEN which has led to pre-treatment screening for HLA- B*15:02 before carbamazepine prescription in some Southeast Asian countries. Members of our group were responsible for the translation of HLA-B*57:01 screening to prevent abacavir hypersensitivity and we recently described a strong association between HLA-C*04:01 and nevirapine SJS/TEN in SA suggesting that HLA class I associations are also important for drugs used in the treatment and prevention of HIV. However, the genetic risk factors for IM-ADRs in African HIV-infected populations are incompletely understood and there are significant gaps in understanding the risk factors for IM-ADRs in drug commonly used in African HIV-TB co-infected populations. In SA and other resource poor African settings, given the high burden of HIV and TB, there is an urgent need to identify management strategies for IM-ADRs that will help improve prevention efforts, earlier diagnosis and treatment protocols. Our hypothesis tested will be that we will identify HLA and other genetic associations between SJS/TEN as well as DRESS and drugs used to prevent, treat and manage HIV and its co- morbidities. In specific aim 1 we will create a biorepository of DNA and other samples from IM-ADR cases related to drugs used to treat HIV and TB that includes underserviced areas in South Africa. Existing and new IM-ADR cases will undergo specific phenotype validation and causality adjudication. In specific aim 2 we will define HLA and other genetic risk factors associated with IM-ADRs in HIV/TB endemic settings. In specific aim 3 we will determine short and long-term complications and outcomes amongst a cohort of patients who have experienced IM-ADR and the specific impacts on HIV care. Using the synergistic gain of an existing US-South African collaboration we predict that our discoveries will create a roadmap for the prevention and management of IM-ADRs in complex HIV populations in resource poor settings internationally.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $308,214 )
2025	2025	UNIVERSITY OF CAPE TOWN	LOVERS WALK	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	000	5	9/11/2025	NON-COMPETING CONTINUATION	$308,214
														Subtotal = $308,214

Issue Date FY: 2024 ( Subtotal = $319,378 )
2024	2024	UNIVERSITY OF CAPE TOWN	LOVERS WALK	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	003	4	7/15/2024	NON-COMPETING CONTINUATION	$0
2024	2024	UNIVERSITY OF CAPE TOWN	LOVERS WALK	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	002	4	4/18/2024	NON-COMPETING CONTINUATION	$319,378
2024	2021	UNIVERSITY OF CAPE TOWN	LOVERS WALK	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	001	2	3/21/2024	NON-COMPETING CONTINUATION	$0
2024	2020	UNIVERSITY OF CAPE TOWN	LOVERS WALK	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	000	1	3/14/2024	NEW	$0
														Subtotal = $319,378

Issue Date FY: 2023 ( Subtotal = $330,076 )
2023	2023	UNIVERSITY OF CAPE TOWN	LOVERS WALK	CAPE TOWN				ZAF	Allergy and Infectious Diseases Research	000	3	3/27/2023	NON-COMPETING CONTINUATION	$330,076
														Subtotal = $330,076

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	UNIVERSITY OF CAPE TOWN	LOVERS WALK	RONDEBOSCH				ZAF	Allergy and Infectious Diseases Research	000	2	4/27/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $340,382 )
2021	2021	UNIVERSITY OF CAPE TOWN	LOVERS WALK	RONDEBOSCH				ZAF	Allergy and Infectious Diseases Research	000	2	4/2/2021	NON-COMPETING CONTINUATION	$340,382
														Subtotal = $340,382

Issue Date FY: 2020 ( Subtotal = $349,915 )
2020	2020	UNIVERSITY OF CAPE TOWN	LOVERS WALK	RONDEBOSCH		007700		ZAF	Allergy and Infectious Diseases Research	000	1	4/21/2020	NEW	$349,915
														Subtotal = $349,915

Grand Total All Awards = $1,647,965

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Immune-mediated adverse drug reactions to HIV and TB treatments in South Africa: predict, prevent and improve long-term outcomes (IMARI SA study)

Award Number: R01AI152183

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/21/2020

PERIOD OF PERFORMANCE END DATE: 03/31/2026

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