Liver-related events after direct-acting antiviral therapy in patients with hepatitis C virus-associated cirrhosis.
Decompensated cirrhotic event
Hepatocellular carcinoma
Liver cirrhosis
Prognosis
Survival
Journal
Journal of gastroenterology
ISSN: 1435-5922
Titre abrégé: J Gastroenterol
Pays: Japan
ID NLM: 9430794
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
13
09
2021
accepted:
20
12
2021
pubmed:
22
1
2022
medline:
24
3
2022
entrez:
21
1
2022
Statut:
ppublish
Résumé
Direct-acting antiviral (DAA) therapy enables a high rate of sustained virologic response (SVR) in patients with hepatitis C virus associated cirrhosis. However, the impact of DAA therapy on liver-related events in patients with cirrhosis is unclear. A total of 350 patients with compensated and decompensated cirrhosis administered DAA therapy at 29 Japanese hospitals were enrolled (Child-Pugh class A [CP-A]: 195 patients, CP-B: 131 patients and CP-C: 24 patients). The SVR rates of patients with CP-A, CP-B and CP-C were 96.9%, 93.1% and 83.3%, respectively (p = 0.006). Seventy patients developed hepatocellular carcinoma (HCC), and male sex, previous HCC treatment, platelet counts < 10.0 × 10 HCC development and mortality in patients with CP-B were not different from those with CP-A. On the other hand, in patients with CP-C, the development of HCC and decompensated cirrhotic events requiring hospital admission, and death were frequent. University Hospital Medical Information Network (UMIN000036150).
Sections du résumé
BACKGROUND
Direct-acting antiviral (DAA) therapy enables a high rate of sustained virologic response (SVR) in patients with hepatitis C virus associated cirrhosis. However, the impact of DAA therapy on liver-related events in patients with cirrhosis is unclear.
METHODS
A total of 350 patients with compensated and decompensated cirrhosis administered DAA therapy at 29 Japanese hospitals were enrolled (Child-Pugh class A [CP-A]: 195 patients, CP-B: 131 patients and CP-C: 24 patients).
RESULTS
The SVR rates of patients with CP-A, CP-B and CP-C were 96.9%, 93.1% and 83.3%, respectively (p = 0.006). Seventy patients developed hepatocellular carcinoma (HCC), and male sex, previous HCC treatment, platelet counts < 10.0 × 10
CONCLUSIONS
HCC development and mortality in patients with CP-B were not different from those with CP-A. On the other hand, in patients with CP-C, the development of HCC and decompensated cirrhotic events requiring hospital admission, and death were frequent.
TRIAL REGISTRATION
University Hospital Medical Information Network (UMIN000036150).
Identifiants
pubmed: 35059853
doi: 10.1007/s00535-021-01845-5
pii: 10.1007/s00535-021-01845-5
doi:
Substances chimiques
Antiviral Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
120-132Informations de copyright
© 2022. Japanese Society of Gastroenterology.
Références
Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889–98.
doi: 10.1056/NEJMoa1402454
Feld JJ, Jacobson IM, Hezode C, et al. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 infection. N Engl J Med. 2015;373:2599–607.
doi: 10.1056/NEJMoa1512610
Forns X, Lee SS, Valdes J, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet Infect Dis. 2017;17:1062–8.
doi: 10.1016/S1473-3099(17)30496-6
Tahata Y, Sakamori R, Urabe A, et al. Liver fibrosis is associated with corrected QT prolongation during Ledipasvir/Sofosbuvir treatment for patients with chronic hepatitis C. Hepatol Commun. 2018;2:884–92.
doi: 10.1002/hep4.1206
Mashiba T, Joko K, Kurosaki M, et al. Real-world efficacy of elbasvir and grazoprevir for hepatitis C virus (genotype 1): a nationwide, multicenter study by the Japanese Red Cross Hospital Liver Study Group. Hepatol Res. 2019;49:1114–20.
doi: 10.1111/hepr.13362
Ogawa E, Furusyo N, Nakamuta M, et al. Glecaprevir and pibrentasvir for Japanese patients with chronic hepatitis C genotype 1 or 2 infection: Results from a multicenter, real-world cohort study. Hepatol Res. 2019;49:617–26.
doi: 10.1111/hepr.13328
Waziry R, Hajarizadeh B, Grebely J, et al. Hepatocellular carcinoma risk following direct-acting antiviral HCV therapy: a systematic review, meta-analyses, and meta-regression. J Hepatol. 2017;67:1204–12.
doi: 10.1016/j.jhep.2017.07.025
Nagata H, Nakagawa M, Asahina Y, et al. Effect of interferon-based and -free therapy on early occurrence and recurrence of hepatocellular carcinoma in chronic hepatitis C. J Hepatol. 2017;67:933–9.
doi: 10.1016/j.jhep.2017.05.028
Tahata Y, Sakamori R, Urabe A, et al. Hepatocellular carcinoma occurrence does not differ between interferon-based and interferon-free treatment with liver histological assessment. Hepatol Res. 2020;50:313–20.
doi: 10.1111/hepr.13454
Tahata Y, Sakamori R, Urabe A, et al. Clinical outcomes of direct-acting antiviral treatments for patients with hepatitis C after hepatocellular carcinoma are equivalent to interferon treatment. Hepatol Res. 2020;50:1118–27.
doi: 10.1111/hepr.13547
Backus LI, Belperio PS, Shahoumian TA, et al. Direct-acting antiviral sustained virologic response: impact on mortality in patients without advanced liver disease. Hepatology. 2018;68:827–38.
doi: 10.1002/hep.29811
Ioannou GN, Green PK, Berry K. HCV eradication induced by direct-acting antiviral agents reduces the risk of hepatocellular carcinoma. J Hepatol. 2017. https://doi.org/10.1016/j.jhep.2017.08.030 .
doi: 10.1016/j.jhep.2017.08.030
pubmed: 28939134
pmcid: 5837901
Curry MP, O’Leary JG, Bzowej N, et al. Sofosbuvir and Velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med. 2015;373:2618–28.
doi: 10.1056/NEJMoa1512614
Takehara T, Sakamoto N, Nishiguchi S, et al. Efficacy and safety of sofosbuvir-velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial. J Gastroenterol. 2019;54:87–95.
doi: 10.1007/s00535-018-1503-x
Panel A-IHG. Hepatitis C Guidance. Update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Clin Infect Dis. 2018;2018(67):1477–92.
European Association for the Study of the Liver (2018) Electronic address eee, European Association for the Study of the L. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol 69: 461–511
Tanaka A (2020) Drafting Committee for Hepatitis Management Guidelines tJSoH. JSH Guidelines for the Management of Hepatitis C Virus Infection: 2019 Update. Hepatol Res
Gentile I, Scotto R, Coppola C, et al. 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). Hepatol Int. 2019;13:66–74.
doi: 10.1007/s12072-018-9914-6
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. 2016;14:1821–30.
doi: 10.1016/j.cgh.2016.07.001
Tahata Y, Hikita H, Mochida S, et al. Sofosbuvir plus velpatasvir treatment for hepatitis C virus in patients with decompensated cirrhosis: a Japanese real-world multicenter study. J Gastroenterol. 2021;56:67–77.
doi: 10.1007/s00535-020-01733-4
Takaoka Y, Miura K, Morimoto N, et al. Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for patients with decompensated liver cirrhosis caused by hepatitis C virus infection. Hepatol Res. 2021;51:51–61.
doi: 10.1111/hepr.13576
Ohya K, Imamura M, Teraoka Y, et al. Real-world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus-related decompensated cirrhosis. Hepatol Res. 2020;50:1234–43.
doi: 10.1111/hepr.13555
Verna EC, Morelli G, Terrault NA, et al. DAA therapy and long-term hepatic function in advanced/decompensated cirrhosis: real-world experience from HCV-TARGET cohort. J Hepatol. 2020;73:540–8.
doi: 10.1016/j.jhep.2020.03.031
Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–81.
doi: 10.1016/j.jbi.2008.08.010
Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019;95:103208.
doi: 10.1016/j.jbi.2019.103208
Kokudo N, Takemura N, Hasegawa K, et al. Clinical practice guidelines for hepatocellular carcinoma: the Japan Society of Hepatology 2017 (4th JSH-HCC guidelines) 2019 update. Hepatol Res. 2019;49:1109–13.
doi: 10.1111/hepr.13411
Maesaka K, Sakamori R, Yamada R, et al. Clinical course of hepatitis C virus-positive patients with decompensated liver cirrhosis in the era of direct-acting antiviral treatment. Hepatol Res. 2021;51:517–27.
doi: 10.1111/hepr.13623
Examination Committee of Criteria for 'Obesity Disease' in J (2002) Japan Society for the Study of O. New criteria for 'obesity disease' in Japan. Circ J 66: 987–992
Ogata F, Kobayashi M, Akuta N, et al. Outcome of all-oral direct-acting antiviral regimens on the rate of development of hepatocellular carcinoma in patients with hepatitis C virus genotype 1-related chronic liver disease. Oncology. 2017;93:92–8.
doi: 10.1159/000470910
Akuta N, Suzuki F, Sezaki H, et al. Complex association of virus- and host-related factors with hepatocellular carcinoma rate following hepatitis C virus clearance. J Clin Microbiol. 2019. https://doi.org/10.1128/JCM.01463-18 .
doi: 10.1128/JCM.01463-18
pubmed: 30381417
pmcid: 6322466
Tahata Y, Sakamori R, Yamada R, et al. Prediction model for hepatocellular carcinoma occurrence in patients with hepatitis C in the era of direct-acting anti-virals. Aliment Pharmacol Ther. 2021. https://doi.org/10.1111/apt.16632 .
doi: 10.1111/apt.16632
pubmed: 34812502
Kanda Y. Investigation of the freely available easy-to-use software “EZR” for medical statistics. Bone Marrow Transplant. 2013;48:452–8.
doi: 10.1038/bmt.2012.244
Degasperi E, D’Ambrosio R, Iavarone M, et al. Factors associated with increased risk of De Novo or recurrent hepatocellular carcinoma in patients with cirrhosis treated with direct-acting antivirals for HCV infection. Clin Gastroenterol Hepatol. 2019;17:1183–91.
doi: 10.1016/j.cgh.2018.10.038
Calvaruso V, Cabibbo G, Cacciola I, et al. Incidence of hepatocellular carcinoma in patients with HCV-associated cirrhosis treated with direct-acting antiviral agents. Gastroenterology. 2018;155:411–21.
doi: 10.1053/j.gastro.2018.04.008
Lens S, Baiges A, Alvarado-Tapias E, et al. Clinical outcome and hemodynamic changes following HCV eradication with oral antiviral therapy in patients with clinically significant portal hypertension. J Hepatol. 2020;73:1415–24.
doi: 10.1016/j.jhep.2020.05.050
Mandorfer M, Kozbial K, Schwabl P, et al. Changes in hepatic venous pressure gradient predict hepatic decompensation in patients who achieved sustained virologic response to interferon-free therapy. Hepatology. 2020;71:1023–36.
doi: 10.1002/hep.30885
Schneider AW, Kalk JF, Klein CP. Hepatic arterial pulsatility index in cirrhosis: correlation with portal pressure. J Hepatol. 1999;30:876–81.
doi: 10.1016/S0168-8278(99)80142-1
Krassenburg LAP, Maan R, Ramji A, et al. Clinical outcomes following DAA therapy in patients with HCV-related cirrhosis depend on disease severity. J Hepatol. 2021;74:1053–63.
doi: 10.1016/j.jhep.2020.11.021