Efficacy and safety of the 12-week sofosbuvir-coblopasvir regimen in treatment of chronic hepatitis C

Wei ZHANG; Song ZHAI; Hong DU; Fuchun JING; Limei WANG; Ye ZHANG; Bibo KANG; Jiuping WANG; Shuangsuo DANG; Jianqi LIAN; Hong JIANG

doi:10.3969/j.issn.1001-5256.2023.03.009

Volume 39 Issue 3

Mar. 2023

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Article Navigation > Journal of Clinical Hepatology > 2023 > 39(3): 539-545

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Efficacy and safety of the 12-week sofosbuvir-coblopasvir regimen in treatment of chronic hepatitis C

DOI: 10.3969/j.issn.1001-5256.2023.03.009

1.
Department of Infectious Diseases, The First Affiliated Hospital of Air Force Medical University, Xi'an 710032, China
2.
Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710004, China
3.
Department of Infectious Diseases, Baoji People's Hospital, Baoji, Shaanxi 721006, China
4.
Department of Infectious Diseases, The Second Affiliated Hospital of Air Force Medical University, Xi'an 710038, China
5.
Department of Microbiology and Pathogenic Biology, School of Basic Medical Sciences, Air Force Medical University, Xi'an 710032, China

Research funding:

National Natural Science Foundation of China (81671555)

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Corresponding author: JIANG Hong, jiangh518@126.com (ORCID: 0000-0003-2075-3272)
Received Date: 2022-08-27
Accepted Date: 2022-10-08
Published Date: 2023-03-20

Abstract

Abstract

Objective To investigate the efficacy and safety of the 12-week regimen with sofosbuvir and coblopasvir hydrochloride in the treatment of chronic hepatitis C (CHC) in northwest China. Methods This study enrolled 101 patients with CHC of any genotype who received sofosbuvir (400 mg) combined with coblopasvir hydrochloride (60 mg) for 12 weeks in The First Affiliated Hospital of Air Force Medical University, The Second Affiliated Hospital of Air Force Medical University, The Second Affiliated Hospital of Xi'an Jiaotong University, and Baoji Central Hospital from July 1 to December 31, 2021, among whom 13 had liver cirrhosis and 88 did not have live cirrhosis. Other antiviral drugs such as ribavirin were not added regardless of the presence or absence of liver cirrhosis or the genotype of CHC. Related clinical data ere extracted, including HCV RNA quantification and liver biochemical parameters at baseline, at week 12 of treatment, and at 12 weeks after drug withdrawal. The primary endpoints were sustained virologic response at 12 weeks after the end of treatment (SVR12) and safety at week 12 of treatment, and the secondary endpoint was the effect of the 12-week treatment on liver biochemical parameters. The non-normally distributed continuous data were expressed as M(P₂₅-P₇₅), and the Mann-Whitney U test was used for comparison between groups. Results A total of 101 patients were included in the analysis, among whom there were 55 male patients (54.5%) and 46 female patients, and the median age was 53 years. Among these patients, 12.8% had liver cirrhosis, 1.0% had liver cancer, 3.0% were treatment-experienced patients, and 3.0% had type 2 diabetes. As for genotype distribution, 8% had CHC genotype 1, 60% had CHC genotype 2, 19% had CHC genotype 3, and 6% had CHC genotype 6, and genotype was not tested for 7% of the patients. After 12 weeks of treatment, all 101 patients had a HCV RNA level of below the lower limit of detection and an SVR12 rate of 100%, with a significant reduction in the serum level of alanine aminotransferase (ALT) from baseline to week 12 of treatment (P < 0.05). Among these patients, 22.7% had concomitant medications such as atorvastatin calcium, aspirin, metformin, nifedipine, bicyclol, and compound glycyrrhizin. The incidence rate of adverse events was 16.8%, and fatigue (12.9%) was the most common adverse event. Conclusion The 12-week treatment with sofosbuvir and coblopasvir hydrochloride can obtain high SVR12 in CHC patients in northwest China and has good antiviral safety, with a significant improvement in abnormal serum ALT at week 12 of treatment.
- Hepatitis C, Chronic,
- Coblopasvir,
- Sofosbuvir,
- Treatment Outcome

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References

[1]	EL-SERAG HB. Epidemiology of viral hepatitis and hepatocellular carcinoma[J]. Gastroenterology, 2012, 142(6): 1264-1273. e1. DOI: 10.1053/j.gastro.2011.12.061.
[2]	Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study[J]. Lancet Gastroenterol Hepatol, 2017, 2(3): 161-176. DOI: 10.1016/S2468-1253(16)30181-9.
[3]	KHAN H, PAESHUYSE J, MURAD S, et al. Assessment of the activity of directly acting antivirals and other products against different genotypes of hepatitis C virus prevalent in resource-poor countries[J]. Antiviral Res, 2016, 125: 43-45. DOI: 10.1016/j.antiviral.2015.10.008.
[4]	GAO LH, NIE QH, ZHAO XT. Drug-drug interactions of newly approved direct-acting antiviral agents in patients with hepatitis C[J]. Int J Gen Med, 2021, 14: 289-301. DOI: 10.2147/IJGM.S283910.
[5]	FU Z, DONG C, GE Z, et al. High SVR12 with 8-week course of direct-acting antivirals in adolescents and children with chronic hepatitis C: A comprehensive analysis[J]. Front Med (Lausanne), 2021, 8: 608760. DOI: 10.3389/fmed.2021.608760.
[6]	Chinese Society of Hepatology, Chinese Medical Association, Chinese Society of Infectious Diseases, Chinese Medical Association. Guidelines for the prevention and treatment of hepatitis C(2019 version)[J]. J Clin Hepatol, 2019, 35(12): 2670-2686. DOI: 10.3969/j.issn.1001-5256.2019.12.008. 中华医学会肝病学分会, 中华医学会感染病学分会. 丙型肝炎防治指南(2019年版)[J]. 临床肝胆病杂志, 2019, 35(12): 2670-2686. DOI: 10.3969/j.issn.1001-5256.2019.12.008.
[7]	RAO H, LIU H, WU E, et al. Comparison of clinical outcomes and impact of SVR in American and Chinese patients with chronic hepatitis C[J]. JHEP Rep, 2020, 2(4): 100136. DOI: 10.1016/j.jhepr.2020.100136.
[8]	LI C, LI X, ZHU X, et al. Pharmacokinetics, safety, and tolerability of ledipasvir/sofosbuvir and sofosbuvir/velpatasvir in healthy chinese subjects[J]. Clin Ther, 2020, 42(3): 448-457. DOI: 10.1016/j.clinthera.2020.01.013.
[9]	LI J, LI G, WANG J, et al. Efficacy and safety of elbasvir/grazoprevir treatment for Chinese patients with hepatitis C virus genotype 1b: a retrospective study[J]. Am J Transl Res, 2022, 14(6): 3995-4005.
[10]	HUANG CF, ⅡO E, JUN DW, et al. Direct-acting antivirals in East Asian hepatitis C patients: real-world experience from the REAL-C Consortium[J]. Hepatol Int, 2019, 13(5): 587-598. DOI: 10.1007/s12072-019-09974-z.
[11]	HUANG K, CHEN J, XU R, et al. Molecular evolution of hepatitis C virus in China: A nationwide study[J]. Virology, 2018, 516: 210-218. DOI: 10.1016/j.virol.2018.01.015.
[12]	PIECHA F, GÄNßLER JM, OZGA AK, et al. Treatment and re-treatment results of HCV patients in the DAA era[J]. PLoS One, 2020, 15(5): e0232773. DOI: 10.1371/journal.pone.0232773.
[13]	RAO H, WEI L, LOPEZ-TALAVERA JC, et al. Distribution and clinical correlates of viral and host genotypes in Chinese patients with chronic hepatitis C virus infection[J]. J Gastroenterol Hepatol, 2014, 29(3): 545-553. DOI: 10.1111/jgh.12398.
[14]	CHEN Y, YU C, YIN X, et al. Hepatitis C virus genotypes and subtypes circulating in Mainland China[J]. Emerg Microbes Infect, 2017, 6(11): e95. DOI: 10.1038/emi.2017.77.
[15]	WU N, RAO HY, YANG WB, et al. Impact of hepatitis C virus genotype 3 on liver disease progression in a Chinese national cohort[J]. Chin Med J (Engl), 2020, 133(3): 253-261. DOI: 10.1097/CM9.0000000000000629.
[16]	LU J, FENG Y, CHEN L, et al. Subtype-specific prevalence of hepatitis C virus NS5A resistance associated substitutions in Mainland China[J]. Front Microbiol, 2019. DOI: 10.3389/fmicb.2019.00535.
[17]	CHEN YS, HUANG KH, WANG PM, et al. The impact of direct-acting antiviral therapy on the risk of recurrence after curative resection in patients with hepatitis-C-virus-related early stage hepatocellular carcinoma[J]. Medicina (Kaunas), 2022, 58(2): 259. DOI: 10.3390/medicina58020259.
[18]	TANAKA S, SHINKAWA H, TAMORI A, et al. Surgical outcomes for hepatocellular carcinoma detected after hepatitis C virus eradiation by direct-acting antivirals[J]. J Surg Oncol, 2020, 122(8): 1543-1552. DOI: 10.1002/jso.26184.
[19]	KUO YH, WANG JH, CHANG KC, et al. The influence of direct-acting antivirals in hepatitis C virus related hepatocellular carcinoma after curative treatment[J]. Invest New Drugs, 2020, 38(1): 202-210. DOI: 10.1007/s10637-019-00870-9.
[20]	MONTALDO C, TERRI M, RICCIONI V, et al. Fibrogenic signals persist in DAA-treated HCV patients after sustained virological response[J]. J Hepatol, 2021, 75(6): 1301-1311. DOI: 10.1016/j.jhep.2021.07.003.
[21]	XIA H, ZHANG Y, ZAONGO SD, et al Direct-acting antiviral treatments display excellent outcomes even in older HCV-infected patients at increased risk of fibrosis[J]. Ann Transl Med, 2021, 9(10): 847. DOI: 10.21037/atm-21-1297.
[22]	KANDA T, LAU GKK, WEI L, et al. APASL clinical practice recommendation: how to treat HCV-infected patients with renal impairment?[J]. Hepatol Int, 2019, 13(2): 103-109. DOI: 10.1007/s12072-018-9915-5.

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Efficacy and safety of the 12-week sofosbuvir-coblopasvir regimen in treatment of chronic hepatitis C

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