Efficacy and safety of modified anti-tubercular treatment(ATT) regimens in treatment of tuberculosis(TB) in patients with underlying chronic liver disease(CLD)

Introduction There is paucity of data on safety, efficacy and outcomes of modified ATT regimens in patients with CLD. Aims and Objectives To study the efficacy and safety of treatment regimens for compensated (Group 1) and decompensated (group 2) liver disease group. Methods This was a randomized open labelled pilot study. Patients were given 6 months of ATT randomized to Isoniazid + Rifampicin + pyrazinamide + Ethambutol (HRZE) or Isoniazid + Rifampicin + Levofloxacin + Ethambutol (HRLE) in group 1 and 9 months of ATT randomized to Isoniazid + Levofloxacin + Ethambutol (HLE) or Rifampicin + Levofloxacin + Ethambutol (RLE) in group 2 respectively. Successful completion of ATT, development of hepatotoxicity, therapeutic response and overall survival was monitored. Results A total of 129 patients -60 in Group1 and 69 in Group 2 were included. Around 80 and 75 percent of patients in group 1 and 2 respectively were successfully treated with these regimens. The 6 month survival and incidence of hepatotoxicity was 98% vs 81% and 12.7% vs 13% in group 1 and 2 respectively (p-0.347). Mean therapeutic response was seen in 80 days vs 112 days (p-0.023) in group 1 and 2 respectively. High baseline AST and development of hepatotoxicity in HLE arm were found to be inversely correlated with survival (p Conclusions Treatment of TB in CLD is difficult and challenging, nevertheless success can be achieved with carefully planned treatment regimens and close monitoring. Low dose pyrazinamide can be used safely in compensated CLD; although the findings needs to be substantiated in further well controlled studies.