Use of M/XDR-TB Regimen in Pre-existing liver disease

In various DR-TB regimens under the National TB Elimination Programme (NTEP); Rifampicin, Isoniazid, Pyrazinamide, PAS, Ethionamide and Bedaquiline are potentially hepatotoxic drugs.​

• Pyrazinamide is the most hepatotoxic of the three first-line drugs and hepatitis occurs rarely with fluoroquinolones.​
• The potential for hepatotoxicity is increased in the elderly, alcoholics, malnourished and patients with pre-existing liver disease.​
• In general, most second-line drugs can be safely used in the presence of mild hepatic impairment as they are relatively less hepatotoxic than first-line drugs.​

Exclude other causes of hepatitis such as viral hepatitis, alcoholic hepatitis, drug-induced hepatitis by non-TB drugs etc.​

• Multi-drug Resistant (MDR)/ Rifampicin-resistant TB (RR-TB) patients having deranged Liver Function Tests (LFT) during pretreatment evaluation should be strictly monitored as clinically indicated while on treatment.​
• However, routine LFT is not recommended in all patients.​ 

​In patients with pre-existing liver disease with persistently abnormal liver function tests, a shorter oral MDR/ RR-TB regimen should be avoided due to the presence of high dose isoniazid (H^h), Ethionamide (Eto) and Pyrazinamide (Z).​

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Resources​

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021. 
• WHO Consolidated Guidelines On Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.
• Technical and Operational Guidelines for TB in India, 2016.
• Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-resistant Tuberculosis, 2014.

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