A Randomized Controlled Trial of Intravenous N-Acetylcysteine in the Management of Anti-tuberculosis Drug–Induced Liver Injury

Abstract Background Liver injury is a common complication of anti-tuberculosis therapy. N-acetylcysteine (NAC) used in patients with paracetamol toxicity with limited evidence of benefit in liver injury due to other causes. Methods We conducted a randomized, double-blind, placebo-controlled trial to...

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Published in:Clinical infectious diseases 2021-11, Vol.73 (9), p.e3377-e3383
Main Authors: Moosa, Muhammed Shiraz, Maartens, Gary, Gunter, Hannah, Allie, Shaazia, Chughlay, Mohamed F, Setshedi, Mashiko, Wasserman, Sean, Stead, David F, Hickman, Nicole, Stewart, Annemie, Sonderup, Mark, Spearman, Catherine Wendy, Cohen, Karen
Format: Article
Language:English
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Summary:Abstract Background Liver injury is a common complication of anti-tuberculosis therapy. N-acetylcysteine (NAC) used in patients with paracetamol toxicity with limited evidence of benefit in liver injury due to other causes. Methods We conducted a randomized, double-blind, placebo-controlled trial to assess the efficacy of intravenous NAC in hospitalized adult patients with anti-tuberculosis drug–induced liver injury (AT-DILI). The primary endpoint was time for serum alanine aminotransferase (ALT) to fall below 100 U/L. Secondary endpoints included length of hospital stay, in-hospital mortality, and adverse events. Results Fifty-three participants were randomized to NAC and 49 to placebo. Mean age was 38 (SD±10) years, 58 (57%) were female, 89 (87%) were HIV positive. Median (IQR) serum ALT and bilirubin at presentation were 462 (266–790) U/L and 56 (25–100) μmol/L, respectively. Median time to ALT
ISSN:1058-4838
1537-6591
DOI:10.1093/cid/ciaa1255