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http://dx.doi.org/10.24304/kjcp.2022.32.3.191

Assessing the Effectiveness and Safety of Direct-acting Antiviral Treatment in Korean Patients with Hepatitis C Virus Genotype 1b or 2 at a Tertiary Care Hospital  

Park, Mi Seon (Department of Pharmacy, College of Pharmacy, Chosun University)
Yang, Young-Mo (Department of Pharmacy, College of Pharmacy, Chosun University)
Park, Ki Hyun (Department of Pharmacy, College of Pharmacy, Chosun University)
Yoon, Hyonok (Department of Pharmacy, Research Institute of Pharmaceutical Sciences, Gyeongsang National University)
Kim, Ju Sin (Department of Pharmacy, Jeonbuk National University Hospital)
Choi, Eun Joo (Department of Pharmacy, College of Pharmacy, Chosun University)
Publication Information
Korean Journal of Clinical Pharmacy / v.32, no.3, 2022 , pp. 191-203 More about this Journal
Abstract
Background: Direct-acting antivirals are recommended for the treatment of chronic hepatitis C virus in Korea. However, evaluation of direct-acting antiviral regimens in a real-world setting is limited. The aims of this study were to investigate the effectiveness and safety of direct-acting antiviral treatment in Korean patients infected with chronic hepatitis C virus genotype 1b or 2 at a tertiary care hospital. Methods: This was a retrospective study conducted with patient data obtained between August 2015 and August 2019 at Jeonbuk National University Hospital. The primary effectiveness endpoint was sustained virological response 12 weeks post-treatment (SVR12) via intention-to-treat (ITT) and modified intention-to-treat (mITT) analyses. Results: Of the 270 patients, 47.0% were infected with genotype 1b and 53.0% with genotype 2. ITT analysis revealed that SVR12 was achieved in 78.9% of all patients, 77.2% in genotype 1b patients, and 80.4% in genotype 2 patients. Of the 21.1% of all patients who did not achieve SVR12, the majority of treatment failures were non-virologic failures (19.7%). mITT analysis revealed that SVR12 was achieved in 98.2% of all patients, 98.0% in genotype 1b patients, and 98.3% in genotype 2 patients. Almost half of all patients experienced one or more adverse events (43.3%), leading to 2.6% discontinuing scheduled treatment. The most common adverse event was anemia. Conclusions: Direct-acting antiviral-based treatment regimens showed high effectiveness and safety. Non-virological factors, such as premature treatment discontinuation due to adverse events or loss of follow-up, were the major disruptors in achieving SVR12.
Keywords
Direct-acting antiviral treatment; effectiveness; hepatitis C virus; safety; sustained virological response (SVR);
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1 Conti F, Buonfiglioli F, Scuteri A, et al. Early occurrence and recurrence of hepatocellular carcinoma in HCV-related cirrhosis treated with direct-acting antivirals. J Hepatol 2016;65(4):727-33.   DOI
2 Reig M, Marino Z, Perello C, et al. Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy. J Hepatol 2016;65(4):719-26.   DOI
3 Su F, Ioannou GN. Hepatocellular carcinoma risk after direct-acting antiviral therapy. Clin Liver Dis (Hoboken) 2019;13(1):6-12.   DOI
4 Ravi S, Axley P, Jones D, et al. Unusually high rates of hepatocellular carcinoma after treatment with direct-acting antiviral therapy for hepatitis C related cirrhosis. Gastroenterology 2017;152(4):911-2.   DOI
5 Zeuzem S, Foster GR, Wang S, et al. Glecaprevir-Pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med 2018;378(4):354-69.   DOI
6 World Health Organization. Hepatitis C (Newsroom/fact sheets). Available from http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed February 27, 2020.
7 World Health Organization. Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C infection - July 2018. Available from https://www.who.int/publications/i/item/9789241550345. Accessed March 19, 2022.
8 World Health Organization. Global hepatitis report, 2017. Available from http://www.who.int/hepatitis/publications/global-hepatitisreport2017/en/. Accessed February 27, 2020.
9 Ahmad T, Yin P, Saffitz J, et al. Cardiac dysfunction associated with a nucleotide polymerase inhibitor for treatment of hepatitis C. Hepatology 2015;62(2):409-16.   DOI
10 Yang YM, Choi EJ. Efficacy and safety outcomes of sofosbuvirbased treatment regimens for hepatitis C virus-infected patients with or without cirrhosis from phase III clinical trials. Ther Clin Risk Manag 2017;13:477-97.   DOI
11 Bourliere M, Gordon SC, Flamm SL, et al. Sofosbuvir, velpatasvir, and voxilaprevir for previously treated HCV Infection. N Engl J Med 2017;376(22):2134-46.   DOI
12 Poordad F, Felizarta F, Asatryan A, et al. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology 2017;66(2):389-97.   DOI
13 Korean Association for the Study of the Liver (KASL). KASL clinical practice guidelines: management of hepatitis C. Clin Mol Hepatol 2016;22(1):76-139.   DOI
14 Kamath PS, Wiesner RH, Malinchoc M, et al. A model to predict survival in patients with end-stage liver disease. Hepatology 2001;33(2):464-70.   DOI
15 Gayam V, Hossain MR, Khalid M, et al. Real-world clinical efficacy and tolerability of direct-acting antivirals in hepatitis C monoinfection compared to hepatitis C/human immunodeficiency virus coinfection in a community care setting. Gut Liver 2018;12(6):694-703.   DOI
16 Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009;150(9):604-12.   DOI
17 Miotto N, Mendes LC, Zanaga LP, et al. All-oral direct antiviral treatment for hepatitis C chronic infection in a real-life cohort: The role of cirrhosis and comorbidities in treatment response. PLoS One 2018;13(7):e0199941.   DOI
18 Chen P, Ma A, Liu Q. Cost-effectiveness of elbasvir/grazoprevir versus daclatasvir plus asunaprevir in patients with chronic hepatitis C virus genotype 1b infection in China. Clin Drug Investig 2018;38(11):1031-9.   DOI
19 Darvishian M, Wong S, Binka M, et al. Loss to follow-up: A significant barrier in the treatment cascade with direct-acting therapies. J Viral Hepat 2020;27(3):243-60.   DOI
20 Levin JM, Dabirshahsahebi S, Bauer M, Huckins E. Retrospective analysis of hepatitis C infected patients treated through an integrated care model. World J Gastroenterol 2016;22(38):8558-67.   DOI
21 Costa VD, Pellegrini P, Rotman V, et al. Resistance mutations A30K and Y93N associated with treatment failure with sofosbuvir and daclatasvir for hepatitis C virus infection non-responder patients: case reports. Viruses 2019;11(11):1004.   DOI
22 Olea Jr. A, Grochowski J, Luetkemeyer AF, Robb V, Saberi P. Role of a clinical pharmacist as part of a multidisciplinary care team in the treatment of HCV in patients living with HIV/HCV coinfection. Integr Pharm Res Pract 2018;7:105-11.   DOI
23 Cotter TG, Jensen DM. Glecaprevir/pibrentasvir for the treatment of chronic hepatitis C: design, development, and place in therapy. Drug Des Devel Ther 2019;13:2565-77.   DOI
24 Jeong SH, Jang ES, Choi HY, Kim KA, Chung WK, Ki M. Current status of hepatitis C virus infection and countermeasures in South Korea. Epidemiol Health 2017;39:e2017017.   DOI
25 Ahmed AM, Doheim MF, Mattar OM, et al. Beclabuvir in combination with asunaprevir and daclatasvir for hepatitis C virus genotype 1 infection: A systematic review and meta-analysis. J Med Virol 2018;90(5):907-18.   DOI
26 Jacobson IM, Lawitz E, Gane EJ, et al. Efficacy of 8 weeks of sofosbuvir, velpatasvir, and voxilaprevir in patients with chronic HCV Infection: 2 phase 3 randomized trials. Gastroenterology 2017;153(1):113-22.   DOI
27 Korean Association for the Study of the Liver (KASL). 2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C. Clin Mol Hepatol 2018;24(3):169-229.   DOI
28 Yang Y, Wu FP, Wang WJ, et al. Real life efficacy and safety of direct-acting antiviral therapy for treatment of patients infected with hepatitis C virus genotypes 1, 2 and 3 in northwest China. World J Gastroenterol 2019;25(44):6551-60.   DOI
29 Yamamoto H, Ikesue H, Ikemura M, et al. Evaluation of pharmaceutical intervention in direct-acting antiviral agents for hepatitis C virus infected patients in an ambulatory setting: a retrospective analysis. J Pharm Health Care Sci 2018;4(1):1-8.   DOI
30 Yu ML, Hung CH, Huang YH, et al. Efficacy and safety of 12 weeks of daclatasvir, asunaprevir plus ribavirin for HCV genotype-1b infection without NS5A resistance-associated substitutions. J Formos Med Assoc 2019;118(2):556-64.   DOI