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

Turn off MathJax

Article Contents

Abstract

References

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

PDF( 2213 KB)

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)

More Information

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

FullText(HTML)

References(22)

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.

Relative Articles

[1]	Li LIU, Lixian CHANG, Zhiyong CHEN, Junyi LI, Chunyun LIU. Efficacy and safety of sofosbuvir/velpatasvir alone or in combination with ribavirin in treatment of patients with genotype 3B HCV/HIV infection[J]. Journal of Clinical Hepatology, 2024, 40(2): 271-277. doi: 10.12449/JCH240209
[2]	Mengying ZHU, Ping YU, Guohong GE, Yuqi MA, Xiling FU, Jiabao CHANG. Efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous direct-acting antiviral agent failure[J]. Journal of Clinical Hepatology, 2024, 40(11): 2201-2204. doi: 10.12449/JCH241112
[3]	Tao WANG, Fenghui LI, Jing LIANG, Huiling XIANG, Fang LIU, Hongmin LYU, Baoxin QIAN, Jiajun TIAN. Clinical effect of direct-acting antiviral agents in treatment of chronic hepatitis C patients with thrombocytopenia[J]. Journal of Clinical Hepatology, 2022, 38(1): 91-96. doi: 10.3969/j.issn.1001-5256.2022.01.014
[4]	Bianli DANG, Wenzhen KANG, Mingyuan BI, Jianhui LI, Zhaoyun CHEN, Shupeng LI, Qing LIU, Yongtao SUN, Weiping CAI, Wen KANG. Efficacy of switching to co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide combined with sofosbuvir/velpatasvir in treatment of previously untreated chronic hepatitis C patients with HIV/HCV co-infection and its influence on blood lipid levels[J]. Journal of Clinical Hepatology, 2022, 38(3): 541-546. doi: 10.3969/j.issn.1001-5256.2022.03.010
[5]	Ling QING, Weiqiang HUANG, Xiaohe LI, Feng CHEN, Yingxia LIU. Efficacy of antiviral therapy for chronic hepatitis B with nonalcoholic fatty liver disease[J]. Journal of Clinical Hepatology, 2021, 37(9): 2075-2080. doi: 10.3969/j.issn.1001-5256.2021.09.015
[6]	Lixia QIU, Jingjing SONG, Shan LIANG, Yali LIU, Jing ZHANG. The cut off value of liver stiffness measurement needs to be lowered to predict liver fibrosis after sustained virologic response in chronic hepatitis C patients[J]. Journal of Clinical Hepatology, 2021, 37(12): 2808-2812. doi: 10.3969/j.issn.1001-5256.2021.12.016
[7]	Jinfeng XU, Lixia QIU, Haibin YU, Yirong LIU, Jing ZHANG, Yali LIU, Wei LIN. Association of inosine triphosphate pyrophosphatase gene polymorphisms with ribavirin combined with direct-acting antiviral agent in treatment of hepatitis C patients with hemolytic anemia[J]. Journal of Clinical Hepatology, 2021, 37(10): 2320-2323. doi: 10.3969/j.issn.1001-5256.2021.10.012
[8]	Hongyu CHEN, Qian KANG, Hao LUO, Ning TAN, Jiali PAN, Ran CHENG, Yifan HAN, Yuqing YANG, Dan LIU, Hongli XI, Min YU, Xiaoyuan XU. Virological response to direct-acting antiviral therapy and changes in liver fibrosis indices in chronic hepatitis C patients with different alanine aminotransferase and aspartate aminotransferase levels in a real-world setting[J]. Journal of Clinical Hepatology, 2021, 37(2): 314-317. doi: 10.3969/j.issn.1001-5256.2021.02.014
[9]	Yang YuPing, Zhuang KangMin, Li JinYing, Huang Wei. Research advances in fecal microbiota transplantation for the treatment of HBeAg-positive chronic hepatitis B[J]. Journal of Clinical Hepatology, 2020, 36(2): 414-416. doi: 10.3969/j.issn.1001-5256.2020.02.039
[10]	Liang Jing, Zhang YaPing, Liu Fang, Xiang HuiLing, Lu: HongMin, Han Tao. Efficacy of direct-acting antiviral agents in treatment of chronic hepatitis C and its effect on liver stiffness and aspartate aminotransferase-to-platelet ratio index[J]. Journal of Clinical Hepatology, 2020, 36(6): 1263-1267. doi: 10.3969/j.issn.1001-5256.2020.06.015
[11]	LIU GuangWen, GAO ZhenYue, YU Shuang, XUE JinLing, LIANG WenZhong, LAN Jing, YANG HaiMiao. Bioequivalence and safety of sofosbuvir tablets in the healthy Chinese subjects[J]. Journal of Clinical Hepatology, 2020, 36(12): 2688-2694. doi: 10.3969/j.issn.1001-5256.2020.12.010
[12]	Li Wei, Kang Yi, Ding GangQiang, Shang Jia, Zhou YuanPing. Clinical effect and safety of sofosbuvir-ledipasvir regimen in treatment of patients with HCV genotype 6a chronic hepatitis C[J]. Journal of Clinical Hepatology, 2019, 35(3): 526-529. doi: 10.3969/j.issn.1001-5256.2019.03.015
[13]	He CaiNi, Li Yu, Ge Heng, Wei Fu, Ma XiaoTao, Wang WenJun, Gao Ning, Duan ChaoYang, Ji FanPu. Clinical effect and safety of sofosbuvir-based regimens in treatment of hepatitis C virus-associated glomerulonephritis[J]. Journal of Clinical Hepatology, 2019, 35(8): 1714-1718. doi: 10.3969/j.issn.1001-5256.2019.08.013
[14]	Kou GuoXian, Wang Yu, Guo Jun, Liu Qian. Signal mining and analysis of the adverse drug reaction of digestive dysfunction caused by the new anti-HCV drug sofosbuvir[J]. Journal of Clinical Hepatology, 2018, 34(1): 68-72. doi: 10.3969/j.issn.1001-5256.2018.01.014
[15]	Wu YanQin, Shen LiJun, Yu JiHong, Sun YuShan. Clinical effect of entecavir in treatment of chronic hepatitis B complicated by hepatic steatosis[J]. Journal of Clinical Hepatology, 2017, 33(5): 849-852. doi: 10.3969/j.issn.1001-5256.2017.05.011
[16]	Liang XieEr, Chen YongPeng. Role of liver fibrosis assessment in decision-making and efficacy surveillance for antiviral therapy in patients with chronic hepatitis B[J]. Journal of Clinical Hepatology, 2016, 32(11): 2058-2061. doi: 10.3969/j.issn.1001-5256.2016.11.008
[17]	Ji HongBing, Chen ZhongHua. Therapeutic effect of gemcitabine hydrochloride combined with stereotactic radiotherapy for locally advanced pancre-atic cancer[J]. Journal of Clinical Hepatology, 2016, 32(3): 537-540. doi: 10.3969/j.issn.1001-5256.2016.03.030
[18]	Zhang Yue, Lu: Yang, Li Xu, Gao PuJun. Latest progress in treatment of chronic hepatitis B with tenofovir disoproxil fumarate[J]. Journal of Clinical Hepatology, 2015, 31(4): 599-602. doi: 10.3969/j.issn.1001-5256.2015.04.030
[19]	Xia ShuLin, He XiaoFeng. Efficacy of entecavir treatment for patients with chronic hepatitis B[J]. Journal of Clinical Hepatology, 2015, 31(4): 523-525. doi: 10.3969/j.issn.1001-5256.2015.04.011

Supplements(0)

Cited By

Cited by
Periodical cited type(1)
1. 卫高，秦鹏涛，刘冬峰，常留军. 医学营养治疗联合不同剂量阿托伐他汀钙片对2型糖尿病患者的疗效分析. 华北理工大学学报(医学版). 2023(06): 437-442 .
Other cited types(0)

Proportional views

Proportional views

通讯作者: 陈斌, bchen63@163.com

1.
沈阳化工大学材料科学与工程学院沈阳 110142

Figures(3) / Tables(4)

Get Citation

PDF

XML

Article Metrics

Article views (866) PDF downloads(121)

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

Abstract

References

Relative Articles

Cited by

Periodical cited type(1)

Other cited types(0)

Proportional views

Catalog

通讯作者: 陈斌, bchen63@163.com

Article Metrics

Proportional views

Related

About Journal

Submission Guideline

Journal Online

Hepatobiliary College

Guidelines

Export File

Citation

Format

Content