Abstract

Background:

Decentralized care, using free-of-charge generic direct-acting antiviral agents (DAAs) in patients with chronic hepatitis C (CHC) infection has resulted in cure rates of 91.6% in a large prospective multicentric population-based cohort from the state of Punjab, India. The rate of recompensation, as per BAVENO-VII criteria, in patients with decompensated CHC-related cirrhosis following DAAs, needs evaluation as part of public health policy to eliminate chronic hepatitis C in India.

Methods:

We evaluated patients with decompensated CHC-related cirrhosis treated at the PGIMER, Chandigarh and followed them up q6months for clinical events, viral, biochemical, endoscopic surveillance & imaging tests, and new evidence hepatocellular carcinoma (HCC). The diagnosis of cirrhosis was based on clinical evidence including AST-to-platelet ratio index (APRI ≥2.0) and FIB-4 score (>3.25) or on liver stiffness measurement (LSM) ≥12.5 kPa on Fibroscan. The rate of recompensation was noted. Progression of portal hypertension (PHT) was defined as the onset of varices needing treatment or PHT-related bleeding. Patients with HIV or HBV coinfection and HCC at presentation were excluded from analysis.

Results:

Between April 2018 and December 2022, of 6516 patients with cirrhosis who reported to the nodal centre, we enrolled 1152 with decompensated cirrhosis (mean age:53.2±11.5 years, 62.9% men, median MELDNa 18.5,73.5%-unsafe injection related,77.9% urban). The decompensation events included ascites (1098, 95.3%), hepatic encephalopathy (191,16.6%), and history of variceal bleeding (284, 24.7%) at enrolment. SVR-12 was 81.8%, due to referral of difficult-to-treat cases to PGIMER. Resolution of ascites was noted in 993(86.2%), but diuretic withdrawal achieved in 280 (24.3%). Recompensation was documented in 284(24.7%). On multivariate logistic regression only higher age (aHR 1.013 ,95%CI:1.003-1.048,P=0.042) and higher MELDNa (aHR 1.213,95%CI: 1.003-1.028,P=0.033) predicted failure to recompensate. Progression of PHT was noted in 158 patients: with rebleed in 45 (3.9%) during a follow-up period of 52 months (interquartile range, 18-68.5 months). Treatment failure (OR 1.8, 95%CI:1.3-4.9, P=0.002) and presence of HE (OR4.4, 95%CI:1.3-5.6, P=0.044) were associated with progression of PHT. Of 145 patients who died, and 6 underwent liver transplantation. In follow up at 2 years. A decrease in MELDNa of ≥3 occurred in 409(35.5%) and a final MELD score of <10 was achieved in 31.7%. On surveillance, 29(0.45%) new cases of HCC were diagnosed during follow up.

Conclusion:

The Punjab HCV Model demonstrates that recompensation of cirrhosis is achievable in 24% of decompensated cirrhosis, but these patients should remain on HCC surveillance. Patients with cirrhosis should be followed up following virological cure for new decompensations and HCC, which should be integrated in public healthcare policy for HCV elimination.