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Original Research: Chest Infections |

Isoniazid-Associated Hepatitis in Adults Infected With HIV Receiving 36 Months of Isoniazid Prophylaxis in BotswanaIsoniazid-Associated Hepatitis in HIV

Zegabriel Tedla, MD; Minh-Ly Nguyen, MD; Thabisa Sibanda, MBChB; Samba Nyirenda, MD; Tefera B. Agizew, MPhil, MD; Sonali Girde, MD; Charles E. Rose, PhD; Taraz Samandari, MD, PhD
Author and Funding Information

From the CDC Botswana (Drs Tedla, Sibanda, Agizew, and Samandari), Gaborone, Botswana; the Centers for Disease Control and Prevention, Division of Tuberculosis Elimination (Drs Nguyen and Samandari) and Division of HIV/AIDS Prevention (Drs Girde and Rose), Atlanta, GA; the CDC Botswana (Dr Nyirenda), Francistown, Botswana; and ICF International, Inc (Dr Girde), Atlanta, GA.

CORRESPONDENCE TO: Taraz Samandari, MD, PhD, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Mailstop E-45, Atlanta, GA 30329; e-mail: tts0@cdc.gov


FUNDING/SUPPORT: This study was funded by the US Centers for Disease Control and Prevention and the US Agency for International Development.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;147(5):1376-1384. doi:10.1378/chest.14-0215
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BACKGROUND:  The World Health Organization recommends 36 months of isoniazid preventive therapy (36IPT) for adults infected with HIV living in TB-endemic countries. We determined the rates and risk factors for isoniazid-associated hepatitis with the use of 36IPT.

METHODS:  One thousand six adults infected with HIV received 36IPT during a pragmatic randomized trial set in Botswana public health clinics providing HIV care. Enrollment exclusion criteria included jaundice or elevations of serum transaminases (ESTs) > 2.5-fold the upper limit of normal (ULN). Participants with any CD4+ lymphocyte count were eligible and received antiretroviral therapy (ART) when CD4+ < 200 cells/μL. 36IPT was stopped for severe hepatitis (more than fivefold ULN EST) but not for moderate hepatitis (2.5-fold to fivefold ULN EST).

RESULTS:  Pharmacy refill records showed 2,237 person-years of isoniazid receipt; 48% of participants initiated ART by 36 months. A total of 1.9% (19 of 1,006) of participants were diagnosed with severe hepatitis; three had jaundice and two of these developed hepatic encephalopathy. Another 3.1% (31 of 1,006) of participants experienced moderate hepatitis. Thirty-eight percent (19 of 50) of participants with moderate to severe hepatitis concomitantly received ART. Forty percent (20 of 50) of moderate to severe cases occurred within the first 2 months of IPT and during this period were not associated with receipt of ART at baseline (hazard ratio, 1.49; 95% CI, 0.20-11.1; P = .70).

CONCLUSIONS:  Adults infected with HIV receiving 36IPT did not have an increased incidence of moderate to severe hepatitis or hepatic encephalopathy compared with published reports among people infected with HIV, people not infected with HIV in trials or public health programs. Compared with participants not receiving ART, the risk of moderate to severe hepatitis was not increased by ART.

TRIAL REGISTRY:  ClinicalTrials.gov; No.: NCT00164281; URL: www.clinicaltrials.gov

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