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The incidence of, and risk factors for, liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a South African private sector managed care cohort

Introduction Hospital surveys found that drug-induced liver injury is a leading adverse reaction resulting in hospitalization and death in people living with HIV (PLHIV) in South Africa. Objectives To determine incidence of, and risk factors for, liver injury and liver injury-related hospitalization...

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Main Author: Sinha, Suniti
Other Authors: De Waal, Renee
Format: Thesis
Language:English
English
Published: Department of Public Health and Family Medicine 2026
Subjects:
Drug Safety journal
Pharmacoepidemiology
HIV
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access_status_str Open Access
author Sinha, Suniti
author2 De Waal, Renee
author_browse De Waal, Renee
Sinha, Suniti
author_facet De Waal, Renee
Sinha, Suniti
author_sort Sinha, Suniti
collection Thesis
description Introduction Hospital surveys found that drug-induced liver injury is a leading adverse reaction resulting in hospitalization and death in people living with HIV (PLHIV) in South Africa. Objectives To determine incidence of, and risk factors for, liver injury and liver injury-related hospitalizations in PLHIV on antiretroviral treatment (ART). Methods We described the incidence of, and associations with, ALT³120 IU/L, ALT³200 IU/L, and hospitalizations with raised ALT in PLHIV aged >18 years in the Aid for AIDS private sector cohort (comprising medical scheme beneficiaries) commencing ART between 2011–2018. Results We included 92,757 PLHIV; median age was 38.4 years; 42.5% were male, and 88.6% were on efavirenz-based ART. Incidence per 100 person years (95% confidence interval (CI)) of ALT³120IU/L, ALT³200IU/L, hospitalization with ALT³120IU/L, and hospitalization with ALT³200IU/L was 0.93 (0.89-0.97), 0.38 (0.36-0.41), 0.06 (0.05-0.07), and 0.04 (0.03-0.05), respectively. Adjusted hazard ratios (aHRs) (95% CI) for ALT³120IU/L and hospitalization with ALT≥120IU/L respectively were 15.3 (12.1-19.3) and 6.27 (3.11-12.6) for antituberculosis drug exposure; 1.63 (1.31-2.02) and 1.50 (0.70-3.20) for efavirenz; and 2.74 (2.04-3.69) and 3.48 (1.24-9.73) for nevirapine, compared to protease inhibitors. AHRs (95%CI) for ALT³200IU/L and hospitalization with ALT≥200IU/L respectively were 12.6 (9.31-17.1) and 5.68 (2.58-12.5) for antituberculosis drug exposure; 1.74 (1.28-2.37) and 1.97 (0.69-5.58) for efavirenz; and 3.01 (1.97-4.61) and 3.56 (0.93-13.65) for nevirapine. Suniti Sinha SNHSUN002 All HRs adjusted for age, sex, CD4 count and viral load at ART initiation, and alcohol-induced pathology. Conclusions Exposure to antituberculosis drugs was strongly associated with liver injury. Safer antituberculosis treatment regimens are needed for PLHIV.
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language English
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last_indexed 2026-06-10T12:33:05.164Z
license_str Not specified — see source repository
provenance_str_mv Harvested via OAI-PMH from UCTD — University of Cape Town Open Access Repository
publishDate 2026
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spelling oai:open.uct.ac.za:11427/43203 The incidence of, and risk factors for, liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a South African private sector managed care cohort Sinha, Suniti De Waal, Renee Cohen, Karen Mouton, Johannes Drug Safety journal Pharmacoepidemiology HIV Introduction Hospital surveys found that drug-induced liver injury is a leading adverse reaction resulting in hospitalization and death in people living with HIV (PLHIV) in South Africa. Objectives To determine incidence of, and risk factors for, liver injury and liver injury-related hospitalizations in PLHIV on antiretroviral treatment (ART). Methods We described the incidence of, and associations with, ALT³120 IU/L, ALT³200 IU/L, and hospitalizations with raised ALT in PLHIV aged >18 years in the Aid for AIDS private sector cohort (comprising medical scheme beneficiaries) commencing ART between 2011–2018. Results We included 92,757 PLHIV; median age was 38.4 years; 42.5% were male, and 88.6% were on efavirenz-based ART. Incidence per 100 person years (95% confidence interval (CI)) of ALT³120IU/L, ALT³200IU/L, hospitalization with ALT³120IU/L, and hospitalization with ALT³200IU/L was 0.93 (0.89-0.97), 0.38 (0.36-0.41), 0.06 (0.05-0.07), and 0.04 (0.03-0.05), respectively. Adjusted hazard ratios (aHRs) (95% CI) for ALT³120IU/L and hospitalization with ALT≥120IU/L respectively were 15.3 (12.1-19.3) and 6.27 (3.11-12.6) for antituberculosis drug exposure; 1.63 (1.31-2.02) and 1.50 (0.70-3.20) for efavirenz; and 2.74 (2.04-3.69) and 3.48 (1.24-9.73) for nevirapine, compared to protease inhibitors. AHRs (95%CI) for ALT³200IU/L and hospitalization with ALT≥200IU/L respectively were 12.6 (9.31-17.1) and 5.68 (2.58-12.5) for antituberculosis drug exposure; 1.74 (1.28-2.37) and 1.97 (0.69-5.58) for efavirenz; and 3.01 (1.97-4.61) and 3.56 (0.93-13.65) for nevirapine. Suniti Sinha SNHSUN002 All HRs adjusted for age, sex, CD4 count and viral load at ART initiation, and alcohol-induced pathology. Conclusions Exposure to antituberculosis drugs was strongly associated with liver injury. Safer antituberculosis treatment regimens are needed for PLHIV. 2026-05-08T08:14:31Z 2026-05-08T08:14:31Z 2023 2026-05-08T07:35:59Z Thesis / Dissertation Masters Masters http://hdl.handle.net/11427/43203 en eng application/pdf Department of Public Health and Family Medicine Faculty of Health Sciences University of Cape Town
spellingShingle Drug Safety journal
Pharmacoepidemiology
HIV
Sinha, Suniti
The incidence of, and risk factors for, liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a South African private sector managed care cohort
thesis_degree_str Master's
title The incidence of, and risk factors for, liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a South African private sector managed care cohort
title_full The incidence of, and risk factors for, liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a South African private sector managed care cohort
title_fullStr The incidence of, and risk factors for, liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a South African private sector managed care cohort
title_full_unstemmed The incidence of, and risk factors for, liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a South African private sector managed care cohort
title_short The incidence of, and risk factors for, liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a South African private sector managed care cohort
title_sort incidence of and risk factors for liver injury in adults living with human immunodeficiency virus initiating antiretroviral therapy in a south african private sector managed care cohort
topic Drug Safety journal
Pharmacoepidemiology
HIV
url http://hdl.handle.net/11427/43203
work_keys_str_mv AT sinhasuniti theincidenceofandriskfactorsforliverinjuryinadultslivingwithhumanimmunodeficiencyvirusinitiatingantiretroviraltherapyinasouthafricanprivatesectormanagedcarecohort
AT sinhasuniti incidenceofandriskfactorsforliverinjuryinadultslivingwithhumanimmunodeficiencyvirusinitiatingantiretroviraltherapyinasouthafricanprivatesectormanagedcarecohort

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