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. 2021 May;74(5):1053-1063.
doi: 10.1016/j.jhep.2020.11.021. Epub 2020 Nov 23.

Clinical outcomes following DAA therapy in patients with HCV-related cirrhosis depend on disease severity

Lisette A P Krassenburg  1 , Raoel Maan  2 , Alnoor Ramji  3 , Michael P Manns  4 , Markus Cornberg  4 , Heiner Wedemeyer  5 , Robert J de Knegt  2 , Bettina E Hansen  6 , Harry L A Janssen  6 , Robert A de Man  2 , Jordan J Feld  6 , Adriaan J van der Meer  7
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Free article

Clinical outcomes following DAA therapy in patients with HCV-related cirrhosis depend on disease severity

Lisette A P Krassenburg et al. J Hepatol. 2021 May.
Free article

Abstract

Background & aims: HCV-infected patients with cirrhosis achieve high sustained virological response (SVR) rates with direct-acting antivirals (DAAs) even after hepatic decompensation. We aimed to assess the clinical outcome following DAAs among patients with compensated and decompensated cirrhosis in relation to SVR and changes in model for end-stage liver disease (MELD) score.

Methods: Consecutive DAA-treated chronic HCV-infected patients with cirrhosis from 4 hepatology clinics were included. The primary endpoint in survival analyses was clinical disease progression, defined as liver failure, hepatocellular carcinoma, liver transplantation or death.

Results: In total, 868 patients were included with a median age of 59 (IQR 54-65) years; 719 (83%) with Child-Pugh A cirrhosis and 149 (17%) with Child-Pugh B/C cirrhosis. SVR was attained by 647 (90%) Child-Pugh A patients and 120 (81%) Child-Pugh B/C patients. During a median follow-up of 28 (IQR 20-36) months, 102 (14%) Child-Pugh A patients and 96 (64%) Child-Pugh B/C patients experienced clinical disease progression. SVR was independently associated with an improved event-free survival in patients with Child-Pugh A cirrhosis (adjusted hazard ratio [HR] 0.47; 95% CI 0.27-0.82, p = 0.007), but not in patients with Child-Pugh B/C cirrhosis (adjusted HR 1.23; 95% CI 0.67-2.26; p = 0.51). Twelve weeks post-DAAs, 28 (19%) patients with Child-Pugh B/C cirrhosis had ≥2-point MELD decline, but their 2-year event-free survival did not differ from those with a stable MELD (47.9%; 95% CI 28.7-67.1 vs. 48.9%; 95% CI 38.1-59.7, respectively, p = 0.99).

Conclusions: Among patients with chronic HCV infection, DAA-induced SVR was associated with a reduced risk of clinical disease progression in patients with Child-Pugh A cirrhosis but not in patients with Child-Pugh B/C cirrhosis. In Child-Pugh B/C cirrhosis, a ≥2-point MELD decline did not translate into improved clinical outcome.

Lay summary: Chronic HCV infection can be cured with antiviral therapy. In this study, we evaluated the long-term effects of antiviral therapy on liver-related complications in patients with cirrhosis. Our results suggest that patients with compensated cirrhosis who were cured of their HCV infection have a lower rate of complications. In contrast, the rate of complications was not related to virological cure among those with decompensated cirrhosis. While these patients seem to remain in need of liver transplantation, antiviral therapy may lower their priority on the liver transplantation waiting list.

Keywords: Clinical outcome; DAAs; Decompensated cirrhosis; Delta MELD; HCV; MELD score.

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Conflict of interest statement

Conflict of interest LK, RdM no disclosures. RM received financial compensation for consultancy from AbbVie. AR received grants from AbbVie, Allergen, Assembly, Celgene, Gilead Sciences and Janssen, grants from AbbVie Gilead Sciences, Janssen, Novartis, Merck, and Springbanks. MM BMS, Gilead, Merck (MSD) and AbbVie. MC received personal fees from Abbvie, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Roche, Merck, MSD, Biogen, Falk Foundation, Boehringer Ingelheim, Siemens, and Spring Bank, grants from Roche. HW Grants and personal fees form Gilead Sciences, Abbott, Roche Diagnostics, Bristol-Myers Squibb, Novartis, Roche Diagnostics, Merck Sharp and Dohme, Eiger and Falk and Falk Foundation, personal pfees from Siemens and Janssen, investigator for transgene, non-financial support from MYR-GmbH. RJdK is a consultant and speaker for AbbVie, BMS, Gilead, Janssen, Merck, and Norgine and received grants from Abbvie, Gilead, Janssen, and BMS. HLAJ has received personal fees for consulting from Arbutus, Gilead, Janssen, MedImmune, Merck, Roche, Vir Biotechnology, Viral Clinics, Enyo, Arena, and GlaxoSmithKline, and research support from AbbVie, Arbutus, Bristol Myers Squibb, Gilead, Janssen, MedImmune, Merck, and Roche. BEH has received personal fees for consulting from Intercept, Cymabay, Mirum, Albireo, Chemomab, and Caliditas, and research support from Intercept, Cymabay, Mirum, and Albireo. JJF has received personal fees for consulting from AbbVie, Enanta, Gilead, Janssen, and Roche, and research funding from AbbVie, Abbott, Gilead, and FUJIFILM Wako Chemicals. AJM received financial compensation for lecture activities for Zambon and research funding from Gilead, MSD, AbbVie and Zambon All authors declare no competing interests. Please refer to the accompanying ICMJE disclosure forms for further details.

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