Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial

Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial

To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).

Tuberculosis is one of the most important infectious diseases and treatment related hepatitis from anti-TB drug was observed for 5-28%. Slow acetylator status in the N-acetyltransferase 2 (NAT2) genotype is a significant risk factor of anti-tuberculosis drug-induced liver injury (AT-DILI). We assessed the effect of N-acetylcysteine to prevent hepatitis from anti-TB drug in Thai population.

Inclusion Criteria:

• Newly diagnosed TB
• Received standard dose of anti-TB drugs regimen (National Tuberculosis Control Programme guideline Thailand 2018)
• Aged ≥18 years
• Informed consent

Exclusion Criteria:

• Previous TB infection or MDR TB
• TB liver
• Allergy to NAC
• Abnormal baseline LFT
• (AST or ALT>2.5 times UNL, ALP> 2 times UNL, TB> 1.5 mg/dl)
• Chronic hepatitis B, C infection
• Decompensated cirrhosis
• HIV infection
• Active malignancy
• Pregnancy or lactation
• Severe co-morbidity i.e. severe heart diseases, severe lung diseases, ESRD