Treatment with direct-acting antivirals improves the clinical outcome in patients with HCV-related decompensated cirrhosis: results from an Italian real-life cohort (Liver Network Activity—LINA cohort)
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Direct-acting antivirals (DAAs) are safe and effective for the treatment of HCV infection. However, data regarding their efficacy in patients with Child–Pugh B cirrhosis are scarce and their capability in improving liver function is debated. The aim of our study was to assess the clinical benefits of treatment with DAA in subjects with Child–Pugh B cirrhosis.
We conducted a prospective multicentre study among patients with Child–Pugh B cirrhosis of an Italian real-life HCV cohort (LINA cohort) who received treatment with DAAs.
Among 89 patients enrolled, the rate of sustained virologic response 12 was 95.5%. No discontinuation occurred, no patient died during treatment. Most patients had Genotype 1 (1b 61.8%, 1a 11.2%). Conversely, 22.5%, 1.1% and 3.4% of patients had Genotype 2, 3 and 4, respectively. At last observation, 61.8% of patients switched to a Class A cirrhosis, 33.7% remained in Class B and 4.5 worsened to Child C (p < 0.001). Liver parameters significantly improved from baseline to 12 weeks after the end of treatment. Previous anti-HCV treatments and the presence of decompensated cirrhosis at 1 month of treatment were significantly associated with a decompensated cirrhosis at the last observation.
Treatment with DAA in patients with Child–Pugh B cirrhosis is safe and leads to a very high rate of viral clearance, a significant rate of re-compensation and an improvement in liver function. Further studies are needed to assess the impact of treatment on survival and quality of life in long-term follow-up.
KeywordsDirect-acting antivirals Hepatitis C virus Decompensated cirrhosis
Compliance with ethical standards
Conflict of interest
Ivan Gentile was consultant for Abbvie, Merck Sharp & Dohme and Cardiome. He received a grant (in the framework of Fellowship program) from Gilead Sciences. Guglielmo Borgia was consultant for Abbvie. He received grants from Abbvie, Merck Sharp & Dohme, Pfizer. Nicola Coppola received grants from ViiV Healthcare, Janssen-Cilag, and Gilead Sciences; personal fees from Gilead Sciences, Abbvie, Bristol-Myers Squibb and Merck Sharp & Dohme. Riccardo Scotto, Carmine Coppola, Laura Staiano, Daniela Caterina Amoruso, Teresa De Simone, Federica Portunato, Stefania De Pascalis, Salvatore Martini, Margherita Macera, Giulio Viceconte, Grazia Tosone and Antonio Riccardo Buonomo have no conflict of interest to declare.
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.
Informed consent was obtained from all patients for being included in the study.
- 6.Bonora S, Puoti M. Use of daclatasvir in HCV/HIV-coinfected patients in a real-life setting. AIDS Rev 2017;19(1):24–34Google Scholar
- 7.Hezode C, Asselah T, Reddy KR, et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet (London, England) 2015;385(9986):2502–2509CrossRefGoogle Scholar
- 10.Gheorghe L, Iacob S, Curescu M, et al. Real-life use of 3 direct-acting antiviral regimen in a large cohort of patients with genotype-1b HCV compensated cirrhosis. J Gastrointest Liver Dis JGLD 2017;26(3):275–281Google Scholar
- 13.Younossi ZM, Stepanova M, Charlton M, et al. Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial. Lancet Gastroenterol Hepatol 2016;1(2):122–132CrossRefGoogle Scholar
- 15.Maan R, van Tilborg M, Deterding K, et al. Safety and effectiveness of direct-acting antiviral agents for treatment of patients with chronic hepatitis C virus infection and cirrhosis. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc 2016;14(12):1821–1830Google Scholar
- 18.Buonomo AR, Scotto R, Pinchera B, et al. Epidemiology and risk factors for hepatitis C virus genotypes in a high prevalence region in Italy. New Microbiol 2018;41(1):26–29Google Scholar
- 19.National Institutes of Health. Common terminology criteria for adverse events (CTCAE) version 4.0. https://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed Aug 2018
- 23.Roberts S, Gordon A, McLean C, et al. Effect of sustained viral response on hepatic venous pressure gradient in hepatitis C-related cirrhosis. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc 2007;5(8):932–937Google Scholar
- 31.World Health Organization. Combating hepatitis B and C to reach elimination by 2030. Advocacy Brief. 2016. http://apps.who.int/iris/bitstream/10665/206453/1/WHO_HIV_2016.04_eng.pdf?ua=1. Accessed Mar 2018