Efficacy and Safety of Anti-Tubercular Regimens in Cirrhosis of Liver with Tuberculosis: A Randomised Controlled Trial

Abstract

Background: Patients with liver cirrhosis are susceptible to tuberculosis (TB) because of immune dysfunction. However, limited data is available regarding prevalence of TB in cirrhotics and its treatment. Aim: The aim of this study was to elucidate the prevalence and clinical characteristics of TB with liver cirrhosis and its treatment with different anti tubercular (ATT) regimens. Methods: Two eighty nine (289) patients with cirrhosis of liver were evaluated for evidence of tuberculosis during a period of 24 months (March 2011 to March 2013) in a tertiary care centre. Patients with evidence of tuberculosis were randomised into two different ATT regimens (Regimen A and B) after exclusion. Regimen A included initial phase of isoniazid (INH), rifampicin (RIF), and ethambutol (EMB) for 2 months followed by a continuation phase of INH and RIF for 7 months, for a total of 9 months and regimen B included EMB, a fluoroquinolone (ofloxacin), and RIF for 12 months. All drugs were given on weight based daily doses. Results: Forty two patients (14.5%) out of 289 with cirrhosis of liver were detected to have evidence of TB. Aetiological agents responsible for cirrhosis amongst these patients were alcohol (n=18, 42.8%), hepatitis B (n=11, 26.1%), hepatitis C (n=2, 2.6%) and other causes (11, 26.1%). The most common site of tuberculosis was pulmonary (n=20, 47.6%) followed by abdominal (n=11, 26.1%), peritoneum (n=8, 19.2%), intestinal (n=2, 4.6%) and small bowel (n=1, 2.3%). After exclusion of six patients, thirty Six (36) patients with cirrhosis of liver were randomised into two different groups (ATT regimen A and B). Two out of eighteen patients (11.11%) in Regimen A while none of 18 patients in regimen B developed ATT induced hepatotoxicity (p < 0.05). Conclusion: Prevalence of tuberculosis in patients with cirrhosis of liver in our study was 145.3 per 1000 patients (14.5 %) which was higher than the prevalence of all forms of tuberculosis in general population in India and alcoholic cirrhotic were highly vulnerable. Combination RIF, EMB and Ofloxacin (fluoroquinolone) was well tolerated in cirrhosis of liver, even in Child B cirrhosis.