Signal detection of adverse reaction of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir based on FAERS database

doi:10.19803/j.1672-8629.20230248

Abstract

Abstract: Objective To provide reference for safe and rational use of sofosbuvir/velpatasvir（SOF/VEL） and ledipasvir/sofosbuvi（LED/SOF） by analyzing signals of post-marketing adverse drug reactions (ADR) of the two drugs. Methods Data on adverse events reported by the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between January 1, 2017 and September 30, 2021 was mined by adopting the reporting odds ratio (ROR) method and the information component (IC) method. Description terms of ADR in the reports were standardized using the medical dictionory for regulatory activities(MedDRA) terminology. ADR with signals were screened out and compared. Results A total of 16 signals of SOF/VEL and 18 signals of LED/SOF were finally obtained, including 7 overlapping signals which mainly involved systemic, gastrointestinal, hepatobiliary, neurological and mental system damage, and the risk of HBV reactivation. The specific ADR of SOF/VEL were increased appetite, alcohol use and heavy menstrual bleeding while those of LED/SOF were nonacute porphyria, cholangiocarcinoma and cryoglobulinaemia. Conclusion In this study, ROR and IC methods have been used to dig out the ADR risk signals of SOF/VEL and LED/SOF, which provides new evidence for their safe and rational use.

Key words: sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, signals, data mining, reporting odds ratio, information component, FAERS

CLC Number:

R978
R994.11

HAN Li, CHEN Li, CHEN Qian, XIAO Hongtao. Signal detection of adverse reaction of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2024, 21(4): 440-446.

Add to citation manager EndNote|Ris|BibTeX

URL: https://www.zgywjj.com/EN/10.19803/j.1672-8629.20230248

https://www.zgywjj.com/EN/Y2024/V21/I4/440

References

[1] LI JB, WANG Y, LI LY, et al.Chinese guideline for the prevention and control of hepatitis C virus healthcare-associated infection (2021 edition)[J]. Chin J Infect Control(中国感染控制杂志), 2021, 20(6): 487-493.
[2] WHO. Global Hepatitis Report(2017)[EB/OL]. (2017-04-19)[2023-04-20]. https://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/.
[3] WANG GQ, WANG Y, WANG FS, et al.Guidelines for the prevention and treatment of hepatitis C(2019 version)[J]. J Clin Hepato(临床肝胆病杂志), 2019, 35(12): 2670-2686.
[4] WHO. Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection[M]. Geneva: World Health Organization, 2018.
[5] 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): 167-176.
[6] WEI L, WANG Q.Treatment of chronic hepatitis C in the era of direct-acting antiviral agents: considerations of selection for different regimens[J]. Chin J Infect Dis(中华传染病杂志), 2018, 36(10): 577-586.
[7] HOU HY, DENG ZH.Analysis on therapeutic efficacy of direct-acting antiviral agents on liver diseases related to hepatitis C virus infection[J]. Int J Dig Dis(国际消化病杂志), 2016, 36(6): 329-332.
[8] ZHANG LY.Interleukin 11 involves in the molecular mechanism of hepatitis C virus replication and its innate immunity to host Cells[D]. Shanghai: Naval Medical University(海军军医大学), 2018.
[9] PAN L, PANG L.Antiviral treatment for hepatitis C among injecting drug users in the era of direct-acting antiviral agents[J]. Chin J Hepatol(中华肝脏病杂志), 2020, 28(10): 893-896.
[10] XIE Q.The efficacy and safety of direct-acting antiviral agents in the real world of hepatitis C[J].Chin J Exp Clin Infect Dis(中华实验和临床感染病杂志电子版), 2020, 14(2): 176.
[11] ZOU MN, CAI DC.Benefits of direct-acting antiviral agents for therapy of severe liver diseases related to hepatitis C virus infection[J]. Chin J Infect Dis(中华传染病杂志), 2020, 38(5): 320-323.
[12] WHO. Global Health Sector Strategy on Viral Hepatitis 2016-2021[M]. Geneva: World Health Organization, 2016.
[13] TANG R, LI LG, SUN WH, et al.Study on the application of common signal detection methods for adverse drug reaction reports[J]. China Pharmacy(中国药房), 2012, 23(14): 1309-1311.
[14] REN JT, WANG SF, HOU YF, et al.Common signal detection methods of adverse drug reaction[J]. Chinese Journal of Pharmacovigilanc(中国药物警戒), 2011, 8(5): 294-298.
[15] CAO X, SUN YQ, HUANG GM, et al.Signal mining and analysis of adverse reactions induced by tacrolimus and voriconazole[J]. Chinese Journal of Pharmacovigilanc(中国药物警戒), 2021, 18(5): 483-488.
[16] CHENG Y, CHEN Y, YU CF, et al.Mining and analysis of adverse drug reaction signals caused by tacrolimus based on the U.S. Food and Drug Administration adverse event reporting system database[J]. Evaluation and Analysis of Drug-Use in Hospitals of China(中国医院用药评价与分析), 2020, 20(5): 620-624.
[17] CHEN Y, GUO JF, JIANG DM, et al.Exploration and analysis of database mining and adverse drug reaction signals (Part 2)[J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2006, 15(2): 104-107.
[18] LI YY, ZHANG Y, CHEN AZ.Research progress in adverse drug reaction signal detection methods based on spontaneous reporting system[J]. Anhui Medical and Pharmaceutical Journal(安徽医药), 2015, 19(7): 1233-1236.
[19] ZHONG GZ, ZHANG N, WANG HL, et al.Detection and evaluation of the signals of amlodipine and lercanidipine based on FAERS database[J]. China Pharmacy(中国药房), 2022, 33(21): 2647-2653.
[20] VAN PUIJENBROEK E, DIEMONT W, VAN GROOTHEEST K.Appli-
cation of quantitative signal detection in the dutch spontaneous reporting system for adverse drug reactions[J]. Drug Saf, 2003, 26(5): 293-301.
[21] SUN L, SUN S, WANG T, et al.Parallel ADR detection based on spark and BCPNN[J]. Tsinghua Science and Technology(清华大学学报自然科学版英文版), 2019, 24(2): 195-206.
[22] MA P, GONG L, ZHANG N, et al.Detection and analysis of safety signals of lopinavir/ritonavir based on FDA adverse event database[J]. Chin J Appl Pharm(中国现在应用药学), 2020, 37(4): 406-413.
[23] SARBIYA·YNSAJ, XIONG DQ,WU B, et al. FAERS-based data mining study of glucocorticoid-drug related osteoporosis and osteonecrosis[J]. Herald of Medicine(医药导报), 2023, 42(4): 591-596.
[24] TIEC C, BREDER CD.A critical evaluation of safety signal analysis using algorithmic standardised MedDRA queries[J]. Drug Saf, 2018, 41(12): 1375-1385.
[25] CHEN Q, CHEN L, CHENG Y.Study on ADR signal detection of leuprolide and goserelin based on the US FAERS database[J]. Herald of Medicine(医药导报), 2020, 39(10): 1366-1374.
[26] ZHANG XL, XIA J.Brief discussion of safety signals and signal management in drug vigilance[J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2012, 21(2): 90-94.