Trial reportJournal of acquired immune deficiency syndromes (1999)2018
Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.
What it found
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The trial behind it
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
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.
- Prevalence of hepatitis B, C, and D virus infection in Haiti: A systematic review and meta-analysis.Frontiers in public health · 2022Pooled it
- Tuberculosis preventive therapy for people living with HIV: A systematic review and network meta-analysis.PLoS medicine · 2021Pooled 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
- Financial incentives for reduced alcohol use and increased isoniazid adherence during tuberculosis preventive therapy among people with HIV in Uganda: an open-label, factorial randomised controlled trial.The Lancet. Global health · 2023Trial
- Isoniazid preventive therapy-related adverse events among Malawian adults on antiretroviral therapy: A cohort study.Medicine · 2022Trial
- Article
- Liver Injury Following Isoniazid Preventive Therapy in HIV Patients Attending Halibet National Referral Hospital, Eritrea: A Prospective Cohort Study.Drugs - real world outcomes · 2023Article
- The Correlated Risk Factors for Severe Liver Damage Among HIV-Positive Inpatients With Abnormal Liver Tests.Frontiers in medicine · 2022Article
- Article
- Effectiveness of isoniazid preventive therapy on incidence of tuberculosis among HIV-infected adults in programme setting.The Indian journal of medical research · 2020Article
- Tuberculosis preventive therapy (TPT) to prevent tuberculosis co-infection among adults with HIV-associated cryptococcal meningitis: A clinician's perspective.Journal of clinical tuberculosis and other mycobacterial diseases · 2020Article
- Signatures in drug-induced liver injury.Current opinion in gastroenterology · 2020Review
- Abnormal Levels of Liver Enzymes and Hepatotoxicity in HIV-Positive, TB, and HIV/TB-Coinfected Patients on Treatment in Fako Division, Southwest Region of Cameroon.BioMed research international · 2020Article
- TB preventive therapy for people living with HIV: key considerations for scale-up in resource-limited settings.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2018Article
Corrections and comments
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Authors and funding
13 authors at 6 institutions in 4 countries.
Funding
Abstract
backgroundHepatotoxicity associated with isoniazid preventive therapy (IPT) and antiretroviral therapy (ART) has not been well studied in severely immunosuppressed people with HIV. Our objective was to determine risk factors for hepatotoxicity in severely immunosuppressed individuals taking IPT and ART.
settingMulticenter study in resource-limited settings with high burden of tuberculosis.
methodsWe conducted a secondary analysis of data from 1 randomized arm of the REMEMBER trial. The analysis includes participants with pre-ART CD4 cell counts of <50 cells/μL receiving IPT and ART for 24 weeks. Hepatotoxicity was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 × upper limit of normal or symptomatic hepatitis during IPT and ART. Logistic regression was used to identify baseline risk factors for hepatotoxicity. Time to occurrence of hepatotoxicity was estimated by the Kaplan-Meier method.
resultsAmong 426 participants (53% male, median age 35 years, median CD4 count 19 cells/µL), 31 developed hepatotoxicity (7.3%). Raised pretreatment AST/ALT (odds ratio [OR] 3.6, 95% confidence interval [CI]: 1.7 to 7.7) and hepatitis B surface antigen (HBsAg) seropositivity at baseline (OR 4.7, 95% CI: 1.7 to 12.9) were significantly associated with an increased risk of developing hepatotoxicity. Participants with both raised AST/ALT and positive HBsAg had a higher risk (OR 19.9, 95% CI: 5.3 to 74.3) and earlier onset of hepatotoxicity than participants who did not have these conditions at baseline.
conclusionsThe incidence of hepatotoxicity during IPT and ART was high. Severely immunosuppressed individuals with raised pretreatment AST/ALT or HBsAg seropositivity need closer monitoring for hepatotoxicity.
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