A new model to predict response to direct-acting antiviral therapy in decompensated cirrhotics due to hepatitis C virus

Introduction
Decompensated hepatitis C virus (HCV) cirrhosis is a difficult to treat cohort, and there is no gold standard predictor of response to direct-acting antiviral (DAA) therapy. We conducted this study to look for factors responsible for improvement in post-therapy status, i.e. attainment of Child-Turcotte-Pugh (CTP) class A from B or C, and devise a new model to predict post-therapy response.

Material and methods
Prospective analysis of data from decompensated HCV cirrhotics was done and association of each parameter with patient outcomes at 36 weeks after treatment was assessed.

Results
34 patients (54.8%) attained CTP class A after treatment. Factors that were independently associated with disease outcome included albumin (odds ratio [OR] = 4.84, 95% confidence interval [CI]: 1.43-20.15, p = 0.018), alanine transaminase (ALT) (OR = 1.02, 95% CI: 1-1.04, p = 0.049), bilirubin (OR = 0.41, 95% CI: 0.2-0.75, p = 0.007) and estimated glomerular filtration rate (eGFR) (OR = 1.03, 95% CI: 1.0-1.06, p = 0.045). On multivariate analysis, bilirubin was significantly associated with treatment outcome (OR = 0.28, 95% CI: 0.1-0.64, p = 0.006). A composite model was devised using demographic, biochemical, and clinical features, which has sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 67.86%, 79.41%, 73.08%, 75%, and 73.63% respectively in predicting response to therapy. Only 7.6% of patients with a Model for End-Stage Liver Disease (MELD) score > 15 and none of the patients with CTP class C met the primary end-point of our study.

Conclusions
55% of our cohort met the primary end-point at 36 weeks. Patients with CTP class C and a MELD score > 15 should be referred for liver transplantation followed by DAA therapy. Our model was good at predicting improvement in post-therapy liver function.