A real-world study of the efficacy and safety of sofosbuvir and velpatasvir in the treatment of HCV-infected patients in a county in northern China.
10.3760/cma.j.cn501113-20200729-00430
- VernacularTitle:一项索磷布韦维帕他韦治疗中国北方某县HCV感染者有效性和安全性的真实世界研究
- Author:
Li Xia QIU
1
;
Hai Bin YU
1
;
Wei LIN
1
;
Yi Rong LIU
1
;
Yun Dong QIU
2
;
Zhong Jie HU
1
;
Xing Huo PANG
3
;
Jing ZHANG
1
;
Ya Li LIU
1
Author Information
1. The Third Unit, Department of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.
2. General Hospital of Gu'an County, Langfang City, Hebei 065500, China.
3. Beijing Center for Disease Control and Prevention, Beijing 100013, China.
- Publication Type:Journal Article
- MeSH:
Antiviral Agents/therapeutic use*;
Carbamates;
Drug Therapy, Combination;
Genotype;
Hepacivirus/genetics*;
Hepatitis C/drug therapy*;
Hepatitis C, Chronic/drug therapy*;
Heterocyclic Compounds, 4 or More Rings;
Humans;
Liver Cirrhosis/complications*;
Prospective Studies;
RNA;
Ribavirin/therapeutic use*;
Sofosbuvir/adverse effects*;
Sustained Virologic Response;
Treatment Outcome
- From:
Chinese Journal of Hepatology
2022;30(4):395-401
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To evaluate the real-world efficacy and safety of sofosbuvir and velpatasvir (SOF/VEL) tablets in the treatment of Chinese patients with chronic HCV infection. Methods: An open-label, single-center, prospective clinical study was conducted in a county in northern China. A total of 299 cases were enrolled. Of these, 161 cases with chronic hepatitis C and 73 cases with compensated cirrhosis received SOF/VEL for 12 weeks. 65 cases with decompensated cirrhosis received SOF/VEL combined with ribavirin for 12 weeks (22 cases) or SOF/VEL for 24 weeks (43 cases). Virological indicators, liver and renal function indexes, and liver stiffness measurement were detected at baseline, the fourth week of treatment, the end of treatment, and the 12-weeks of follow-up. Adverse reactions and laboratory abnormalities were observed during the course of treatment . The primary endpoint was undetectable rate of HCV RNA (SVR12) at 12 weeks of follow-up with the use of modified intention-to-treat (mITT) approach. Measurement data between two groups were compared using t-test. One Way ANOVA was used for comparison between multiple groups. Enumeration data were analyzed by chi-square test or Fisher's exact test. Results: 291 cases had completed treatment. HCV RNA was undetectable after 12 weeks of follow-up, and the SVR12 rate was 97.3% (95% confidence interval: 95.4%-99.3%). Among them, 97.4% of genotype 1b, 96.4% of genotype 2a, and 100% of those with undetected genotype achieved SVR12. The SVR12 rates in patients with chronic hepatitis C, compensated and decompensated liver cirrhosis were 98.1%, 98.6% and 93.8%, respectively. An improvement in alanine aminotransferase, aspartate aminotransferase and other liver biochemical indicators accompanied with virological clearance and reduced liver stiffness measurement was observed in patients with compensated cirrhosis, with statistically significant difference. There was no significant abnormality in renal function before and after treatment. The most common adverse reactions were fatigue, headache, epigastric discomfort and mild diarrhea. The overall adverse reactions were mild. One patient died of decompensated liver cirrhosis combined with massive upper gastrointestinal bleeding, which was unrelated to antiviral treatment. Four patients discontinued treatment prematurely due to adverse events. Relapse was occurred in four cases, and drug-resistance related mutations were detected in three cases. Conclusion: Sofosbuvir and velpatasvir tablets in Chinese HCV-infected patients with different genotypes, different clinical stages or previously treated with pegylated interferon combined with ribavirin resulted in higher SVR12, indicating that the treatment safety profile is good.
