ArticleBritish journal of clinical pharmacology2021
MicroRNA-122 and cytokeratin-18 have potential as a biomarkers of drug-induced liver injury in European and African patients on treatment for mycobacterial infection.
Article in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 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.
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.
Assessing Antibiotic Induced Liver Injury for Stratification of Tuberculosis Patients
A Randomized, Four-arm Open Label Phase Two-b Clinical Trial to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of High Dose Rifampicin in TB-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- Biomarkers of idiosyncratic drug-induced liver injury (DILI) - a systematic review.Expert opinion on drug metabolism & toxicology · 2021Pooled it
- Cytokeratin-18 is a sensitive biomarker of alanine transaminase increase in a placebo-controlled, randomized, crossover trial of therapeutic paracetamol dosing (PATH-BP biomarker substudy).Toxicological sciences : an official journal of the Society of Toxicology · 2024Trial
- Analysis of serum microRNA-122 in a randomized controlled trial of N-acetylcysteine for treatment of antituberculosis drug-induced liver injury.British journal of clinical pharmacology · 2023Trial
- HBV/HCV coinfection and anti-tuberculosis drug-induced liver injury: from risk assessment and exploration of mechanisms to preventive considerations.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Review
- PstS1-loaded exosomes promote Mycobacterium tuberculosis infection via miR-122-mediated PI3K/AKT/mTOR activation and autophagy suppression.In vitro cellular & developmental biology. Animal · 2026Article
- Expression characteristics of serum exosomal microRNAs in patients with liver injury induced by anti-tuberculosis drugs.Acta biochimica et biophysica Sinica · 2026Article
- Anti-Tubercular Drug-Induced Liver Injury: Current Understanding and Emerging Directions.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
- A pharmacist-led framework for antibiotic-associated liver injury: from pharmacovigilance signals to bedside surveillance with the updated RUCAM and susceptibility markers.Frontiers in pharmacology · 2026Review
- A point-of-care diagnostic for drug-induced liver injury using surface-enhanced Raman scattering lateral flow immunoassay.Nature communications · 2025Article
- Study design for development of novel safety biomarkers of drug-induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case-control study.Diagnostic and prognostic research · 2023Article
- Challenges and Future of Drug-Induced Liver Injury Research-Laboratory Tests.International journal of molecular sciences · 2022Review
- Short-Term Safety of Repeated Acetaminophen Use in Patients With Compensated Cirrhosis.Hepatology communications · 2022Article
- MicroRNA-122 and cytokeratin-18 have potential as a biomarkers of drug-induced liver injury in European and African patients on treatment for mycobacterial infection.British journal of clinical pharmacology · 2021Article
Corrections and comments
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Authors and funding
10 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsPatients on antituberculosis (anti-TB) therapy are at risk of drug-induced liver injury (DILI). MicroRNA-122 (miR-122) and cytokeratin-18 (K18) are DILI biomarkers. To explore their utility in this global context, circulating miR-122 and K18 were measured in UK and Ugandan populations on anti-TB therapy for mycobacterial infection.
methodsHealthy subjects and patients receiving anti-TB therapy were recruited at the Royal Infirmary of Edinburgh, UK (ALISTER-ClinicalTrials.gov Identifier: NCT03211208). African patients with human immunodeficiency virus-TB coinfection were recruited at the Infectious Diseases Institute, Kampala, Uganda (SAEFRIF-NCT03982277). Serial blood samples, demographic and clinical data were collected. In ALISTER samples, MiR-122 was quantified using polymerase chain reaction. In ALISTER and SAEFRIF samples, K18 was quantified by enzyme-linked immunosorbent assay.
resultsThe study had 235 participants (healthy volunteers [n = 28]; ALISTER: active TB [n = 30], latent TB [n = 88], nontuberculous mycobacterial infection [n = 25]; SAEFRIF: human immunodeficiency virus-TB coinfection [n = 64]). In the absence of DILI, there was no difference in miR-122 and K18 across the groups. Both miR-122 and K18 correlated with alanine transaminase (ALT) activity (miR-122: R = .52, 95%CI = 0.42-0.61, P < .0001. K18: R =0.42, 95%CI = 0.34-0.49, P < .0001). miR-122 distinguished those patients with ALT>50 U/L with higher sensitivity/specificity than K18. There were 2 DILI cases: baseline ALT, 18 and 28 IU/L, peak ALT 431 and 194 IU/L; baseline K18, 58 and 219 U/L, peak K18 1247 and 3490 U/L; baseline miR-122 4 and 17 fM, peak miR-122 60 and 336 fM, respectively.
conclusionIn patients treated with anti-TB therapy, miR-122 and K18 correlated with ALT and increased with DILI. Further work should determine their diagnostic and prognostic utility in this global context-of-use.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.