Clinical trial NCT05601518: Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.
Official title: Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C Infection
Keywords: hepatitis C infection
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic hepatitis C infection (positive serum anti-HCV antibodies, detection of HCV RNA in serum)

Brief summary: Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Chronic HCV infection can lead to chronic inflammatory necrosis and fibrosis in the liver, and in some patients can develop into hepatic cirrhosis and even hepatocellular carcinoma (HCC), endangering the health and life of patients.

The development of direct-acting antiviral agents (DAAs) since 2011 markedly improved antiviral efficacy and significantly shortened treatment cycle, making the drugs convenient for clinical use. Small molecule DAAs exert target-specific effects on proteins involved in the HCV life cycle and have been included in the treatment guidelines by leading associations for the study of liver diseases worldwide.

Treatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets:

Coblopasvir hydrochloride capsule is an NS5A inhibitor that inhibits the replication and assembly of HCV, and sofosbuvir tablet is a NS5B polymerase inhibitor. The primary efficacy results (sustained virologic response 12 weeks post-treatment, SVR12) were comparable between the phase II and III clinical studies: the overall SVR12 in subjects was 97%. The SVR12 after coblopasvir hydrochloride capsules combined with sofosbuvir tablets in genotype 3 infection with cirrhosis and genotype 3b infection with cirrhosis were superior to the results of sofosbuvir and velpatasvir tablets obtained in clinical studies in Asia (83% vs. 72%; 67% vs. 50%).

Coblopasvir hydrochloride capsule and sofosbuvir tablet were approved for marketing by National Medical Products Administration of China in Feb. 2020 and Mar. 2020, respectively. This study is designed to evaluate the safety and efficacy of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in clinical practice after marketing.


Eligibility criteria: Inclusion Criteria:

1. Chronic hepatitis C infection
2. Age 18 years and over
3. Patients who treated with coblopasvir hydrochloride capsules/sofosbuvir tablets;

Exclusion Criteria:

1. Patients who are receiving other DAAs drugs at the same time;
2. Subjects with poor compliance who are unable to complete treatment or follow-up.

Primary outcomes:
measure: Sustained virologic response (SVR)
timeFrame: 24 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bejing Tsinghua Changgung Hospital
state: Bejing
Study officials:
References:
citation: AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015 Sep;62(3):932-54. doi: 10.1002/hep.27950. Epub 2015 Aug 4. No abstract available.
citation: Wei L, Xie Q, Hou JL, Jia J, Li W, Xu M, Li J, Wu S, Cheng J, Jiang J, Wang G, Yang Y, Mou Z, Gao ZL, Gong G, Niu JQ, Hu P, Tang H, Lin F, Dou X, Li L, Zhang LL, Nan Y, Massetto B, Yang JC, Knox SJ, Kersey K, German P, Mo H, Jiang D, Brainard DM, Jiang J, Ning Q, Duan Z. Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China. J Gastroenterol Hepatol. 2018 Jun;33(6):1168-1176. doi: 10.1111/jgh.14102. Epub 2018 Mar 25.