Direct-acting antivirals for HCV treatment in older patients: A systematic review and meta-analysis.
direct-acting antivirals
hepatitis C
older adults
viral hepatitis
Journal
Journal of viral hepatitis
ISSN: 1365-2893
Titre abrégé: J Viral Hepat
Pays: England
ID NLM: 9435672
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
12
04
2019
revised:
14
05
2019
accepted:
15
05
2019
pubmed:
28
6
2019
medline:
21
7
2020
entrez:
28
6
2019
Statut:
ppublish
Résumé
The advent of highly effective and well-tolerated direct antiviral antivirals (DAAs) has dramatically changed the landscape of chronic hepatitis C. The effect of DAAs in older adults is difficult to determine since patients aged ≥ 65 years were too few in most clinical trials and data mainly come from observational studies. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of DAAs in patients aged 65 and older. PubMed, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, HCV-Trials.com databases were searched for literature published until 1 December 2017. English language articles reporting results of phase 2 or 3 randomized controlled trials (RCTs), single-arm clinical trials (SATs) and observational studies were included in the final analysis. All studies included subgroups of older patients and compared their outcomes with younger individuals. By using a random-effects or fixed-effects model, odds ratio (OR) was calculated for the efficacy and safety. Heterogeneity was tested using I
Substances chimiques
Antiviral Agents
0
Types de publication
Journal Article
Meta-Analysis
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1249-1256Informations de copyright
© 2019 The Authors. Journal of Viral Hepatitis published by John Wiley & Sons Ltd.
Références
van der Meer AJ, Veldt BJ, Feld JJ, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012;308(24):2584-2593.
https://www.cdc.gov/hepatitis/populations/1945-1965.htm.
Limketkai BN, Mehta SH, Sutcliffe CG, et al. Relationship of liver disease stage and antiviral therapy with liver-related events and death in adults coinfected with HIV/HCV. JAMA. 2012;308(4):370-378.
Chhatwal J, Chen Q, Ayer T, et al. Hepatitis C virus re-treatment in the era of direct-acting antivirals: projections in the USA. Aliment Pharmacol Ther. 2018;47(7):1023-1031.
Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370(16):1483-1493.
Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370(20):1889-1898.
Poordad F, Hezode C, Trinh R, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014;370(21):1973-1982.
Lawitz E, Sulkowski MS, Ghalib R, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014;384(9956):1756-1765.
Forns X, Gordon SC, Zuckerman E, et al. Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent. J Hepatol. 2015;63(3):564-572.
Mizokami M, Yokosuka O, Takehara T, et al. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial. Lancet Infect Dis. 2015;15(6):645-653.
Feld JJ, Jacobson IM, Hézode C, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med. 2015;373(27):2599-2607.
Bourlière M, Bronowicki J-P, de Ledinghen V, et al. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis. 2015;15(4):397-404.
Vermehren J, Peiffer K-H, Welsch C, et al. The efficacy and safety of direct acting antiviral treatment and clinical significance of drug-drug interactions in elderly patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2016;44(8):856-865.
Thabut D, Le Calvez S, Thibault V, et al. Hepatitis C in 6,865 patients 65 yr or older: a severe and neglected curable disease? Am J Gastroenterol. 2006;101(6):1260-1267.
Carrion AF, Martin P. Viral hepatitis in the elderly. Am J Gastroenterol. 2012;107(5):691-697.
Marcus EL, Tur-Kaspa R. Viral hepatitis in older adults. J Am Geriatr Soc. 1997;45(6):755-763.
Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151(4):264-269, W264.
Collaboration TC. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0. London. 2011.
Sterne JAC, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.
Zorzela L, Loke YK, Ioannidis JP, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016;352:i157.
Akuta N, Sezaki H, Suzuki F, et al. Favorable efficacy of daclatasvir plus asunaprevir in treatment of elderly Japanese patients infected with HCV genotype 1b aged 70 and older. J Med Virol. 2017;89(1):91-98.
Atsukawa M, Tsubota A, Kondo C, et al. Effectiveness and safety of community-based treatment with sofosbuvir plus ribavirin for elderly patients with genotype 2 chronic hepatitis C. Dig Liver Dis. 2017;49(9):1029-1035.
Conti F, Brillanti S, Buonfiglioli F, et al. Safety and efficacy of direct-acting antivirals for the treatment of chronic hepatitis C in a real-world population aged 65 years and older. J Viral Hepat. 2017;24(6):454-463.
Ogawa E, Furusyo N, Nomura H, et al. Effectiveness and safety of sofosbuvir plus ribavirin for HCV genotype 2 patients 65 and over with or without cirrhosis. Antiviral Res. 2016;136:37-44.
Ogawa E, Furusyo N, Yamashita N, et al. Effectiveness and safety of daclatasvir plus asunaprevir for patients with hepatitis C virus genotype 1b aged 75 years and over with or without cirrhosis. Hepatol Res. 2017;47(3):E120-E131.
Urabe A, Sakamori R, Tatsumi T, et al. Efficacy and safety of sofosbuvir-based therapy for aged patients with chronic hepatitis C. Hepatology. 2016;64:996a-997a.
Toyoda H, Kumada T, Tada T, et al. Efficacy and tolerability of an IFN-free regimen with DCV/ASV for elderly patients infected with HCV genotype 1B. J Hepatol. 2017;66(3):521-527.
Omata M, Nishiguchi S, Ueno Y, et al. Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open-label, phase 3 trial. J Viral Hepat. 2014;21(11):762-768.
Sherigar JM, Gayam V, Khan A, et al. Clinical efficacy and tolerability of direct-acting antivirals in elderly patients with chronic hepatitis C. Eur J Gastroenterol Hepatol. 2017;29(7):767-776.
Taki S, Tamai H, Ida Y, et al. The real-world safety and efficacy of daclatasvir and asunaprevir for elderly patients. Gut Liv. 2018;12(1):86-93.
Tarao K, Tanaka K, Nozaki A, et al. Efficacy and safety of dual therapy with daclatasvir and asunaprevir in elderly patients. World J Hepatol. 2017;9(11):544-550.
Fox DS, McGinnis JJ, Tonnu-Mihara IQ, McCombs JS. Comparative treatment effectiveness of direct acting antiviral regimens for hepatitis C: data from the Veterans administration. J Gastroenterol Hepatol. 2017;32(6):1136-1142.
Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370(20):1879-1888.
Roth D, Nelson DR, Bruchfeld A, et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015;386(10003):1537-1545.
Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. 2015;373(27):2608-2617.
Ruane PJ, Ain D, Stryker R, et al. Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry. J Hepatol. 2015;62(5):1040-1046.
Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373(8):714-725.
Gane EJ, Kowdley KV, Pound D, et al. Efficacy of sofosbuvir, velpatasvir, and GS-9857 in patients with hepatitis C virus genotype 2, 3, 4, or 6 infections in an open-label, phase 2 trial. Gastroenterology. 2016;151(5):902-909.
Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Comparative effectiveness of ledipasvir/sofosbuvir +/- ribavirin vs. ombitasvir/paritaprevir/ritonavir + dasabuvir +/- ribavirin in 6961 genotype 1 patients treated in routine medical practice. Aliment Pharmacol Ther. 2016;44(4):400-410.
Bhattacharya D, Belperio PS, Shahoumian TA, et al. Effectiveness of all-oral antiviral regimens in 996 human immunodeficiency virus/hepatitis C virus genotype 1-coinfected patients treated in routine practice. Clin Infect Dis. 2017;64(12):1711-1720.
Fujii H, Umemura A, Nishikawa T, et al. Real-world efficacy of daclatasvir and asunaprevir with respect to resistance-associated substitutions. World J Hepatol. 2017;9(25):1064-1072.
Kowdley KV, Sundaram V, Jeon CY, et al. Eight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infection. Hepatology. 2017;65(4):1094-1103.
Latt NL, Yanny BT, Gharibian D, Gevorkyan R, Sahota AK. Eight-week ledipasvir/sofosbuvir in non-cirrhotic, treatment-naive hepatitis C genotype-1 patients with hepatitis C virus-RNA < 6 million: Single center, real world effectiveness and safety. World J Gastroenterol. 2017;23(26):4759-4766.
Tapper EB, Bacon BR, Curry MP, et al. Real-world effectiveness for 12 weeks of ledipasvir-sofosbuvir for genotype 1 hepatitis C: the Trio Health study. J Viral Hepat. 2017;24(1):22-27.
Cainelli F. Hepatitis C virus infection in the elderly: epidemiology, natural history and management. Drugs Aging. 2008;25(1):9-18.
Drazilova S, Gazda J, Janicko M, Jarcuska P. Chronic hepatitis C association with diabetes mellitus and cardiovascular risk in the era of DAA therapy. Can J Gastroenterol Hepatol. 2018;2018:6150861.
Dawood AA, Nooh MZ, Elgamal AA. Factors associated with improved glycemic control by direct-acting antiviral agent treatment in egyptian type 2 diabetes mellitus patients with chronic hepatitis C genotype 4. Diabetes Metab J. 2017;41(4):316-321.
Hum J, Jou JH, Green PK, et al. Improvement in glycemic control of type 2 diabetes after successful treatment of hepatitis C virus. Diabetes Care. 2017;40(9):1173-1180.
Ikeda A, Ikeda K, Takai A, et al. Hepatitis C treatment with sofosbuvir and ledipasvir accompanied by immediate improvement in hemoglobin A1c. Digestion. 2017;96(4):228-230.
Beig J, Orr D, Harrison B, Gane E. Hepatitis C virus eradication with new interferon-free treatment improves metabolic profile in hepatitis C virus-related liver transplant recipients. Liver Transpl. 2018;24(8):1031-1039.