Elizabeth C Verna1, Giuseppe Morelli2, Norah A Terrault3, Anna S Lok4, Joseph K Lim5, Adrian M Di Bisceglie6, Stefan Zeuzem7, Charles S Landis8, Paul Kwo9, Mohamed Hassan10, Michael P Manns11, Monika Vainorius12, Lucy Akushevich13, David R Nelson14, Michael W Fried15, K Rajender Reddy16. 1. Columbia University, New York, NY. 2. Division of Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, FL. 3. University of Southern California, Los Angeles, CA. 4. Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI. 5. Viral Hepatitis Program, Yale University School of Medicine, New Haven, CT. 6. Chief of Hepatology, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Saint Louis University School of Medicine, Saint Louis, MO. 7. Department of Medicine, Goethe University Hospital, Frankfurt, Germany. 8. Department of Gastroenterology, University of Washington, Seattle, WA. 9. Department of Hepatology, Stanford University, Stanford, CA. 10. Division of Gastroenterology Hepatology and Nutrition, University of Minnesota, Minneapolis, MN. 11. Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. 12. Biometrics and Data Quality HCV-TARGET Data Coordinating Center, University of North Carolina at Chapel Hill, Chapel Hill, NC. 13. University of North Carolina at Chapel Hill, Chapel Hill, NC. 14. Department of Medicine, University of Florida, Gainesville, FL. 15. Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, NC. 16. Professor, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA. Electronic address: ReddyR@pennmedicine.upenn.edu.
Abstract
BACKGROUND & AIMS: Direct-acting antiviral (DAA) therapy is used in patients with HCV-related decompensated cirrhosis with the expectation of improving hepatic function. However, little is known about the long-term hepatic benefit of successful antiviral treatment. METHODS: Patients with advanced/decompensated cirrhosis (model for end-stage liver disease [MELD] ≥10), in whom NS5A-containing DAA therapy was initiated prior to September 2018, were included (from the HCV-TARGET cohort). Treatment outcomes and the impact of treatment on short-term and long-term hepatic function were examined. RESULTS: A total of 642 patients were analyzed. The mean age was 60 years, 68% were male. The median baseline MELD was 12 (range 10-39) and 64% had prior decompensation. Among patients with available virologic outcomes, 90.5% achieved a sustained virologic response at 12 weeks (SVR12). Eighty (24%) patients achieved a clinically significant decrease in MELD by ≥3 points during short-term follow-up (9-26 weeks after the end of treatment). However, in long-term follow-up (median of 4 years after treatment), mean changes in MELD (-0.30 points), total bilirubin (+0.23 mg/dl) and albumin (+0.36 g/dl) were marginal. Fifty-one patients died and 22 underwent liver transplant. In long-term follow-up, a clinically meaningful decrease in MELD of ≥3 occurred in 29% and a final MELD score of <10 was achieved in 25%. CONCLUSION: In a large real-world experience of patients with advanced/decompensated HCV-related cirrhosis treated with DAAs, there were only marginal improvements in MELD, total bilirubin, or albumin at long-term follow-up (after achieving SVR12). These patients may remain at high risk of decompensation and must continue to be closely monitored. CLINICALTRIALS.GOV: NCT01474811. LAY SUMMARY: Hepatitis C virus infection can now be cured with medications, even in patients who have advanced scarring of the liver (cirrhosis). In this study, we evaluated whether liver function improves or deteriorates in the long-term, following successful treatment of hepatitis C in patients with cirrhosis. We found that overall liver function was relatively stable with only 29% of patients achieving a clinically meaningful improvement in liver function, and we therefore believe that these patients require ongoing monitoring.
BACKGROUND & AIMS: Direct-acting antiviral (DAA) therapy is used in patients with HCV-related decompensated cirrhosis with the expectation of improving hepatic function. However, little is known about the long-term hepatic benefit of successful antiviral treatment. METHODS:Patients with advanced/decompensated cirrhosis (model for end-stage liver disease [MELD] ≥10), in whom NS5A-containing DAA therapy was initiated prior to September 2018, were included (from the HCV-TARGET cohort). Treatment outcomes and the impact of treatment on short-term and long-term hepatic function were examined. RESULTS: A total of 642 patients were analyzed. The mean age was 60 years, 68% were male. The median baseline MELD was 12 (range 10-39) and 64% had prior decompensation. Among patients with available virologic outcomes, 90.5% achieved a sustained virologic response at 12 weeks (SVR12). Eighty (24%) patients achieved a clinically significant decrease in MELD by ≥3 points during short-term follow-up (9-26 weeks after the end of treatment). However, in long-term follow-up (median of 4 years after treatment), mean changes in MELD (-0.30 points), total bilirubin (+0.23 mg/dl) and albumin (+0.36 g/dl) were marginal. Fifty-one patientsdied and 22 underwent liver transplant. In long-term follow-up, a clinically meaningful decrease in MELD of ≥3 occurred in 29% and a final MELD score of <10 was achieved in 25%. CONCLUSION: In a large real-world experience of patients with advanced/decompensated HCV-related cirrhosis treated with DAAs, there were only marginal improvements in MELD, total bilirubin, or albumin at long-term follow-up (after achieving SVR12). These patients may remain at high risk of decompensation and must continue to be closely monitored. CLINICALTRIALS.GOV: NCT01474811. LAY SUMMARY: Hepatitis C virus infection can now be cured with medications, even in patients who have advanced scarring of the liver (cirrhosis). In this study, we evaluated whether liver function improves or deteriorates in the long-term, following successful treatment of hepatitis C in patients with cirrhosis. We found that overall liver function was relatively stable with only 29% of patients achieving a clinically meaningful improvement in liver function, and we therefore believe that these patients require ongoing monitoring.
Authors: Marion G Peters; Shyam Kottilil; Norah Terrault; Dominic Amara; Jennifer Husson; Shirish Huprikar; Sander Florman; Mark S Sulkowski; Christine M Durand; Anne F Luetkemeyer; Rodney Rogers; Joshua Grab; Brandy Haydel; Emily Blumberg; Lorna Dove; Jean Emond; Kim Olthoff; Coleman Smith; Thomas Fishbein; Henry Masur; Peter G Stock Journal: Am J Transplant Date: 2020-12-23 Impact factor: 8.086
Authors: Sara Cuesta-Sancho; Mercedes Márquez-Coello; Francisco Illanes-Álvarez; Denisse Márquez-Ruiz; Ana Arizcorreta; Fátima Galán-Sánchez; Natalia Montiel; Manuel Rodriguez-Iglesias; José-Antonio Girón-González Journal: World J Hepatol Date: 2022-01-27