Efficacy and safety of coblopasvir hydrochloride capsules/sofosbuvir tablets with or without ribavirin tablets in treatment of patients with chronic hepatitis C virus infection
- VernacularTitle:盐酸可洛派韦和索磷布韦联合或不联合利巴韦林治疗慢性HCV感染者的效果和安全性分析
- Author:
Chunyan MOU
1
;
Danqing XU
1
;
Huan MU
1
;
Jiangyan ZHANG
1
;
Lixian CHANG
1
;
Yuanqiang HE
1
;
Yingyuan ZHANG
1
;
Weikun LI
1
;
Xiuling ZHANG
1
;
Xiliang HE
1
;
Qin PENG
1
;
Li LIU
1
Author Information
- Publication Type:Journal Article
- Keywords: Hepatitis C， Chronic; Coblopasvir Hydrochloride; Sofosbuvir; Ribavirin; Treatment Outcome
- From: Journal of Clinical Hepatology 2025;41(9):1779-1787
- CountryChina
- Language:Chinese
- Abstract: ObjectiveTo investigate the therapeutic efficacy， influencing factors， and safety of a treatment regimen based on coblopasvir hydrochloride capsules/sofosbuvir tablets in patients with chronic hepatitis C virus （HCV） infection in a real-world setting. MethodsA total of 253 patients who attended The Third People’s Hospital of Kunming from September 1， 2021 to May 31， 2024 were enrolled， among whom there were 86 patients with compensated liver cirrhosis （CLC group） and 167 patients with chronic hepatitis C （CHC group）. The patients were treated with coblopasvir hydrochloride capsules （60 mg）/sofosbuvir tablets （400 mg） with or without ribavirin tablets for 12 weeks， and they were followed up for 12 weeks after drug withdrawal. The primary outcome measures were the rate of sustained virologic response at week 12 after treatment （SVR12） and safety， and the secondary outcome measures were the changes in liver function， renal function， blood routine， and liver stiffness measurements （LSM） after 4 weeks of treatment， after 12 weeks of treatment， and at 12 weeks after drug withdrawal. The independent-samples t test and the Mann-Whitney U test were used for comparison of continuous data between two groups， and the Friedman test was used for comparison between multiple groups， while the Bonferroni method was used for paired comparison within each group； the chi-square test was used for comparison of categorical data between two groups. The Logistic analysis was used to investigate related influencing factors. ResultsThe 253 patients with chronic HCV infection had a mean age of 49.38±8.65 years， and there were 151 male patients （59.7%）. Of all patients， 33.99% （86/253） had liver cirrhosis， 25.69% （65/253） had hypertension， 10.67% （27/253） had HIV infection， 8.70% （22/253） had diabetes， 3.95% （10/253） had liver cancer， 1.98% （5/253） had chronic hepatitis B， and 7.91% （20/253） were treatment-experienced patients. As for genotype distribution， 2.77% （7/253） had genotype 1， 12.65% （32/253） had genotype 2， 66.01% （167/253） had genotype 3， 16.60% （42/253） had genotype 6， and 1.98% （5/253） had unknown genotype. The patients had an overall SVR12 rate of 92.09%， with an SVR12 rate of 93.02% in the CLC group and 91.02% in the CHC group. The multivariate logistic regression analysis showed that age （odds ratio ［OR］=1.086， 95% confidence interval ［CI］： 1.007 — 1.170， P=0.032） and HCC （OR=9.178， 95%CI： 1.722 — 48.912， P=0.009） were independent influencing factors for sustained virologic response. Compared with baseline data， the CLC group had significant reductions in alanine aminotransferase （ALT） （χ2=107.103， P0.05）， aspartate aminotransferase （AST） （χ2=90.602， P0.05）， and LSM （χ2=42.235， P0.05） after 12 weeks of treatment， while the CHC group had significant reductions in total bilirubin （χ2=15.113， P0.05）， ALT （χ2=202.237， P0.05）， AST （χ2=161.193， P0.05）， and LSM （χ2=37.606， P0.05）. The incidence rate of serious adverse events was 1.58%， and none of the patients withdrew from drug therapy； the patients with such events were relieved after active symptomatic treatment. The incidence rate of all adverse events was 23.72%， among which fatigue （17.39%） and nausea （2.37%） were the most common adverse events， and these events often disappeared within 2 weeks or were gradually relieved after symptomatic treatment. ConclusionCoblopasvir hydrochloride capsules/sofosbuvir tablets with or without ribavirin tablets has good efficacy and safety in the treatment of chronic HCV infection.
