Liver-related events after direct-acting antiviral therapy in patients with hepatitis C virus-associated cirrhosis.


Journal

Journal of gastroenterology
ISSN: 1435-5922
Titre abrégé: J Gastroenterol
Pays: Japan
ID NLM: 9430794

Informations de publication

Date de publication:
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

120-132

Informations 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

Auteurs

Yuki Tahata (Y)

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Hayato Hikita (H)

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Satoshi Mochida (S)

Department of Gastroenterology and Hepatology, Saitama Medical University, Saitama, Japan.

Nobuyuki Enomoto (N)

First Department of Internal Medicine, Faculty of Medicine, University of Yamanashi, Yamanashi, Japan.

Norifumi Kawada (N)

Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan.

Masayuki Kurosaki (M)

Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.

Akio Ido (A)

Digestive and Lifestyle Diseases, Department of Human and Environmental Sciences, Kagoshima University Graduate School of Medicine and Dental Sciences, Kagoshima, Japan.

Daiki Miki (D)

Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.

Hitoshi Yoshiji (H)

Department of Gastroenterology, Nara Medical University, Nara, Japan.

Yasuhiro Takikawa (Y)

Division of Hepatology, Department of Internal Medicine, Iwate Medical University, Iwate, Japan.

Ryotaro Sakamori (R)

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Yoichi Hiasa (Y)

Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan.

Kazuhiko Nakao (K)

Department of Gastroenterology and Hepatology, Nagasaki University of Graduate School of Biomedical Sciences, Nagasaki, Japan.

Naoya Kato (N)

Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan.

Yoshiyuki Ueno (Y)

Department of Gastroenterology, Faculty of Medicine, Yamagata University, Yamagata, Japan.

Hiroshi Yatsuhashi (H)

Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.

Yoshito Itoh (Y)

Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Ryosuke Tateishi (R)

Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

Goki Suda (G)

Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.

Taro Takami (T)

Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan.

Yasunari Nakamoto (Y)

Second Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.

Yasuhiro Asahina (Y)

Department of Gastroenterology and Hepatology, Department of Liver Disease Control, Tokyo Medical and Dental University, Tokyo, Japan.

Kentaro Matsuura (K)

Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Taro Yamashita (T)

Department of General Medicine, Kanazawa University Hospital, Kanazawa, Japan.

Tatsuya Kanto (T)

The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Chiba, Japan.

Norio Akuta (N)

Department of Hepatology, Toranomon Hospital, Tokyo, Japan.

Shuji Terai (S)

Division of Gastroenterology and Hepatology, Graduate School of Medicine and Dental Sciences, Niigata University, Niigata, Japan.

Masahito Shimizu (M)

Department of Gastroenterology/Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.

Satoshi Sobue (S)

Department of Gastroenterology, Kasugai Municipal Hospital, Kasugai, Japan.

Tomokatsu Miyaki (T)

Department of Gastroenterology, Toyokawa City Hospital, Toyokawa, Japan.

Akihiro Moriuchi (A)

Department of Gastroenterology, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan.

Ryoko Yamada (R)

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Takahiro Kodama (T)

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Tomohide Tatsumi (T)

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Tomomi Yamada (T)

Department of Medical Innovation, Osaka University Hospital, Suita, Osaka, Japan.

Tetsuo Takehara (T)

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. takehara@gh.med.osaka-u.ac.jp.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH