Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
Hepatotoxicity Among People With HIV and Receiving Isoniazid Preventive Therapy in Pregnancy and Postpartum: The Role of Antiretroviral Regimen and Pharmacogenetics.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Outcomes of isoniazid preventive therapy in pregnant women living with HIV: A systematic review and meta-analysis.International journal of immunopathology and pharmacologyPooled it
- Validation of an UHPLC-MS/MS Assay for the Quantification of Isoniazid and Four Major Metabolites in Human Plasma.Biomedical chromatography : BMC · 2026Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundTB APPRISE (IMPAACT P1078), a Phase IV randomized, multi-country non-inferiority trial assessing the safety of 28 weeks of isoniazid preventive therapy (IPT) initiated during pregnancy (immediate IPT) versus deferring to week 12 postpartum (deferred IPT) in people with HIV on antiretroviral therapy, showed higher than expected hepatotoxicity. We investigated the potential roles of antiretrovirals, isoniazid, pharmacogenetics and other factors.
methodsHepatotoxicity was defined as Grade ≥3 liver enzyme elevations; or Grade ≥2 enzyme elevations with elevated bilirubin or symptomatic hepatitis. We performed Poisson regression of all-cause hepatotoxicity on study arm, antiretroviral regimen, pharmacogenetics of isoniazid and efavirenz metabolism (NAT2, CYP2B6) and other participant characteristics. Adjusted models included study arm and covariates with P < .25 in unadjusted models. Antiretroviral regimen and pharmacogenetics interactions with study arm were evaluated.
resultsAll 945 pregnant participants with follow-up liver function measurements were on antiretrovirals (85% with efavirenz, 13% with nevirapine); 63 (6%) experienced hepatotoxicity events; 29 (6%) in immediate, and 34 (7%) in deferred arm; only 5 events (8%) occurred in pregnancy; 49 (78%) occurred between delivery and 24 weeks postpartum. Higher risk of hepatotoxicity was observed with nevirapine use in the immediate arm, but there was no difference by study arm in participants on efavirenz. Slow efavirenz metabolizers had increased risk of hepatotoxicity.
conclusionsIt is critical to monitor for hepatotoxicity in early postpartum, where there is higher risk compared to antepartum. ARV regimen and pharmacogenetics should also be considered in making decisions on when to initiate IPT in pregnant and postpartum populations.
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