Hepatotoxicity induced by isoniazid in patients with Latent tuberculosis infection: a metanalysis
Gastroenterology and Hepatology from Bed to Bench,
,
https://doi.org/10.22037/ghfbb.v16i1.2685
Abstract
Introduction
The frequency of hepatotoxicity (drug-induced liver injury: DILI) of antituberculosis drugs has been studied, especially when isoniazid (INH), rifampin, and pyrazinamide are co-administered. However, little is known about the frequency of DILI in patients with latent tuberculosis infection (LTBI), where INH preventative therapy (IPT) is indicated. The aim of the present study was to conduct a meta-analysis of the frequency of isoniazid-induced liver injury (INH-ILI) in patients receiving IPT.
Methods
We searched PubMed, Google Scholar and the Cochrane Database of Systematic Reviews for studies reporting the frequency of INH-ILI in patients with IPT, using of one or more diagnostic indicators included in the criteria of the DILI Expert Working Group.
Results
Thirty-five studies comprising a total of 22193 participants were included. The overall average frequency of INH-ILI was 2.6% (95% CI, 1.7-3.7%). The mortality associated with INH-DILI was 0.02% (4/22193). In the subgroup analysis, no significant differences were found in the frequency of INH-ILI in patients older or younger than 50 years, children, patients with HIV, candidates to liver, kidney or lung transplant, or according to the type of study design.
Conclusions
The frequency of INH-ILI in patients receiving IPT is low. Studies on INH-ILI are needed where the current DILI criteria are used.
- isoniazid
- Latent tuberculosis
- drug induced liver injury
- adverse drug reaction
- liver injury
How to Cite
References
2. WHO consolidated guidelines on tuberculosis. Module 1: prevention – tuberculosis preventive treatment. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.
3. Tostmann, A. et al. Antituberculosis drug-induced hepatotoxicity: Concise up-to-date review. J. Gastroenterol. Hepatol. 23, 192–202 (2008).
4. Mølhave, M. & Wejse, C. Historical review of studies on the effect of treating latent tuberculosis. Int. J. Infect. Dis. 92, S31–S36 (2020).
5. Saukkonen, J. J. et al. An Official ATS Statement: Hepatotoxicity of Antituberculosis Therapy. Am. J. Respir. Crit. Care Med. 174, 935–952 (2006).
6. Aithal, G. P. et al. Case Definition and Phenotype Standardization in Drug-Induced Liver Injury. Clin. Pharmacol. Ther. 89, 806–815 (2011).
7. Moher, D., Liberati, A., Tetzlaff, J. & Altman, D. G. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339, b2535–b2535 (2009).
8. Steele, M. A., Burk, R. F. & DesPrez, R. M. Toxic Hepatitis with Isoniazid and Rifampin. Chest 99, 465–471 (1991).
9. Aithal, G. P. et al. Case Definition and Phenotype Standardization in Drug-Induced Liver Injury. Clin. Pharmacol. Ther. 89, 806–815 (2011).
10. von Elm, E. et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies. Int. J. Surg. 12, 1495–1499 (2014).
11. Schulz, K. F., Altman, D. G. & Moher, D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 8, 18 (2010).
12. Mansfield, K. E., Sim, J., Jordan, J. L. & Jordan, K. P. A systematic review and meta-analysis of the prevalence of chronic widespread pain in the general population. Pain 157, 55–64 (2016).
13. DerSimonian, R. & Laird, N. Meta-analysis in clinical trials. Control. Clin. Trials 7, 177–188 (1986).
14. Gupta, A. et al. Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. N. Engl. J. Med. 381, 1333–1346 (2019).
15. Simkins, J., Abbo, L. M., Camargo, J. F., Rosa, R. & Morris, M. I. Twelve-Week Rifapentine Plus Isoniazid Versus 9-Month Isoniazid for the Treatment of Latent Tuberculosis in Renal Transplant Candidates. Transplantation 101, 1468–1472 (2017).
16. Yamin, A., Bornstein, E., Hensel, R., Mohamed, O. & Kempker, R. R. Predictors of Latent Tuberculosis Infection Treatment After Introduction of a New Regimen: A Retrospective Cohort Study at an Inner City Clinic. Open Forum Infect. Dis. 3, (2016).
17. Young, H., Wessolossky, M., Ellis, J., Kaminski, M. & Daly, J. S. A Retrospective Evaluation of Completion Rates, Total Cost, and Adverse Effects for Treatment of Latent Tuberculosis Infection in a Public Health Clinic in Central Massachusetts. Clin. Infect. Dis. 49, 424–427 (2009).
18. EKOCHIN, L. H., MANADAN, A. M., AGGARWAL, R., SEQUEIRA, W. & BLOCK, J. A. Absence of Transaminase Elevation During Concomitant Methotrexate and Isoniazid Therapy. J. Rheumatol. 36, 2127.1-2127 (2009).
19. Jahng, A. W., Tran, T., Bui, L. & Joyner, J. L. Safety of Treatment of Latent Tuberculosis Infection in Compensated Cirrhotic Patients During Transplant Candidacy Period. Transplantation 83, 1557–1562 (2007).
20. Page, K. R. et al. Improved Adherence and Less Toxicity With Rifampin vs Isoniazid for Treatment of Latent Tuberculosis. Arch. Intern. Med. 166, 1863 (2006).
21. McNeill, L., Allen, M., Estrada, C. & Cook, P. Pyrazinamide and Rifampin vs Isoniazid for the Treatment of Latent Tuberculosis. Chest 123, 102–106 (2003).
22. Jasmer, R. M. et al. Short-Course Rifampin and Pyrazinamide Compared with Isoniazid for Latent Tuberculosis Infection: A Multicenter Clinical Trial. Ann. Intern. Med. 137, 640 (2002).
23. Sadaphal, P. et al. Isoniazid Preventive Therapy, Hepatitis C Virus Infection, and Hepatotoxicity among Injection Drug Users Infected with Mycobacterium tuberculosis. Clin. Infect. Dis. 33, 1687–1691 (2001).
24. Chang, S.-H., Nahid, P. & Eitzman, S. R. Hepatotoxicity in Children Receiving Isoniazid Therapy for Latent Tuberculosis Infection. J. Pediatric Infect. Dis. Soc. 3, 221–227 (2014).
25. Jiménez-Fuentes, M. A., de Souza-Galvao, M. L., Mila Augé, C., Solsona Peiró, J. & Altet-Gómez, M. N. Rifampicin plus isoniazid for the prevention of tuberculosis in an immigrant population. Int. J. Tuberc. Lung Dis. 17, 326–332 (2013).
26. Geijo, MP., Herranz, CR., Vaño, D., García, ÁJ., García, M.Geijo, M. P., Herranz, C. R., Vaño, D., García, Á. J., García, M., Dimas, J. F. Pauta corta de isoniazida y rifampicina comparada con isoniazida para la infección latente de tuberculosis. Ensayo clínico aleatorizado. Enferm. Infecc. Microbiol. Clin. 25, 300-304. (2007).
27. Fernandez‐Villar, A. et al. Isoniazid Hepatotoxicity among Drug Users: The Role of Hepatitis C. Clin. Infect. Dis. 36, 293–298 (2003).
28. Tortajada, C. et al. Is the combination of pyrazinamide plus rifampicin safe for treating latent tuberculosis infection in persons not infected by the human immunodeficiency virus? Int. J. Tuberc. Lung Dis. 9, 276–81 (2005).
29. Rangaka, M. X. et al. Isoniazid plus antiretroviral therapy to prevent tuberculosis: a randomised double-blind, placebo-controlled trial. Lancet 384, 682–690 (2014).
30. Gray, D. et al. Low Rates of Hepatotoxicity in HIV-infected Children on Anti-retroviral Therapy with and without Isoniazid Prophylaxis. J. Trop. Pediatr. 56, 159–165 (2010).
31. Taylor, A. W. et al. Pregnancy Outcomes in HIV-Infected Women Receiving Long-Term Isoniazid Prophylaxis for Tuberculosis and Antiretroviral Therapy. Infect. Dis. Obstet. Gynecol. 2013, 1–5 (2013).
32. Samandari, T. et al. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial. Lancet 377, 1588–1598 (2011).
33. Stucchi, R. S. B. et al. Is Isoniazid Safe for Liver Transplant Candidates With Latent Tuberculosis? Transplant. Proc. 44, 2406–2410 (2012).
34. Leung, C. C. et al. Initial Experience on Rifampin and Pyrazinamide vs Isoniazid in the Treatment of Latent Tuberculosis Infection Among Patients With Silicosis in Hong Kong. Chest 124, 2112–2118 (2003).
35. Vikrant, S. et al. Prospective randomized control trial of isoniazid chemoprophylaxis during renal replacement therapy. Transpl. Infect. Dis. 7, 99–108 (2005).
36. Codecasa, L. R. et al. Isoniazid preventive treatment: predictors of adverse events and treatment completion. Int. J. Tuberc. Lung Dis. 17, 903–908 (2013).
37. Chung, S. J. et al. Adherence to nine-month isoniazid for latent tuberculosis infection in healthcare workers: a prospective study in a tertiary hospital. Sci. Rep. 10, 6462 (2020).
38. Noh, C. S. et al. Completion rate of latent tuberculosis infection treatment in patients aged 65 years and older. Respir. Med. 157, 52–58 (2019).
39. Naqvi, R. et al. Use of isoniazid chemoprophylaxis in renal transplant recipients. Nephrol. Dial. Transplant. 25, 634–637 (2010).
40. Korayem, G. B. et al. Empiric vs screening‐based use of isoniazid for tuberculosis prophylaxis: Safety and effectiveness in lung transplant recipients in Saudi Arabia. Transpl. Infect. Dis. 23, (2021).
41. Frésard, I., Bridevaux, P., Rochat, T. & Janssens, J. Adverse effects and adherence to treatment of rifampicine 4 months vs isoniazid 6 months for latent tuberculosis. Swiss Med. Wkly. (2011) doi:10.4414/smw.2011.13240.
42. Vuilleumier, N. et al. CYP2E1 genotype and isoniazid-induced hepatotoxicity in patients treated for latent tuberculosis. Eur. J. Clin. Pharmacol. 62, 423–429 (2006).
43. Sun, H.-Y. et al. Twelve-dose weekly rifapentine plus isoniazid for latent tuberculosis infection: A multicentre randomised controlled trial in Taiwan. Tuberculosis 111, 121–126 (2018).
44. Chan, P.-C. et al. Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial. Int. J. Tuberc. Lung Dis. 16, 633–638 (2012).
45. Devrim, İ., Olukman, Ö., Can, D. & Dizdarer, C. Risk Factors for Isoniazid Hepatotoxicity in Children With Latent TB and TB: Difference From Adults. Chest 137, 737–738 (2010).
46. Gray, E. L. & Goldberg, H. F. Baseline abnormal liver function tests are more important than age in the development of isoniazid-induced hepatoxicity for patients receiving preventive therapy for latent tuberculosis infection. Intern. Med. J. 46, 281–287 (2016).
47. Mudzviti, T. et al. Tolerability of Isoniazid Preventive Therapy in an HIV-Infected Cohort of Paediatric and Adolescent Patients on Antiretroviral Therapy from a Resource-Limited Setting: A Retrospective Cohort Study. Drugs - Real World Outcomes 6, 37–42 (2019).
48. Menzies, D. et al. Adverse Events with 4 Months of Rifampin Therapy or 9 Months of Isoniazid Therapy for Latent Tuberculosis Infection. Ann. Intern. Med. 149, 689 (2008).
49. Sharma, S. K., Sharma, A., Kadhiravan, T. & Tharyan, P. Rifamycins (rifampicin, rifabutin and rifapentine) compared to isoniazid for preventing tuberculosis in HIV-negative people at risk of active TB. Cochrane Database Syst. Rev. (2013) doi:10.1002/14651858.CD007545.pub2.
50. National Cancer Institute. Common terminology criteria for adverse events, version 2.0. Bethesda, MD, USA: NCI, 2003 https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf. Accessed octubre 2022.
51. Holty, J.-E. C., Gould, M. K., Meinke, L., Keeffe, E. B. & Ruoss, S. J. Tuberculosis in liver transplant recipients: A systematic review and meta-analysis of individual patient data. Liver Transplant. 15, 894–906 (2009).
52. Salpeter, S. R. Fatal isoniazid-induced hepatitis. Its risk during chemoprophylaxis. West. J. Med. 159, 560–4 (1993).
53. Hosford, J. D. et al. Hepatotoxicity from antituberculous therapy in the elderly: A systematic review. Tuberculosis 95, 112–122 (2015).
54. Bliven-Sizemore, E. E. et al. Three months of weekly rifapentine plus isoniazid is less hepatotoxic than nine months of daily isoniazid for LTBI. Int. J. Tuberc. Lung Dis. 19, 1039–1044 (2015).
- Abstract Viewed: 0 times