Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug-Induced Hepatitis: A Randomized Controlled Trial

What this Trial Is About

Tuberculosis (TB) remains a major health concern worldwide, especially in tropical regions like Thailand, where both pulmonary and extrapulmonary TB affect many people. Treatment requires multiple drugs taken for at least six months, but these can cause side effects such as liver damage, known as hepatotoxicity. This risk is higher in individuals with a specific NAT2 gene type called slow acetylators. Previous research suggests that N-acetylcysteine (NAC) may help reduce liver damage, particularly in these slow acetylators, prompting further study of this approach compared to standard treatment. This trial compares two groups of TB patients: one group undergoes NAT2 gene testing before starting treatment, and if identified as slow acetylators, they receive NAC at 600 mg twice daily for eight weeks along with standard anti-TB drugs. Rapid or intermediate acetylators in this group receive only standard treatment. The other group receives standard anti-TB medication without gene testing or NAC. The study monitors the effects of adding NAC guided by gene testing on liver health during TB treatment. Participants will be followed for eight weeks to assess liver health, with hepatitis rates measured at two and eight weeks after treatment begins. Researchers will conduct regular evaluations including liver function tests and monitor for any side effects or adverse reactions. The study aims to determine whether NAC can lower the occurrence of drug-induced liver injury in TB patients, especially those genetically at higher risk. Overall participation lasts at least eight weeks, during which safety and treatment responses will be closely tracked.

Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis