Impact of the Sustained Viral Response of Chronic Hepatitis c After Treatment With Direct Action Antivirals

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT05062408
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

The purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals.

Detailed Description

This open study includes patients with chronic hepatitis C who received treatment with the new direct-acting antivirals between November 1, 2014 and December 31, 2017, who achieved a sustained viral response at week 12.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-03-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-30
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• Patients with chronic liver disease caused by virus C.
• Have received treatment with the new DAAs between November 1, 2014 and December 1, 2017.
• Patients diagnosed with advanced fibrosis and liver cirrhosis. Advanced fibrosis was defined as a Fibroscan> 10 kPa, an APRI index> 1.5 and / or a FIB-4 index> 3.25. For its part, cirrhosis was defined such as a Fibroscan> 12.5 kPa and / or presence of esophagogastric varices in the endoscopic study and / or data portal hypertension ultrasound.

Exclusion Criteria

• Coinfection by virus B or HIV.
• Development of HCC before or during treatment.
• Abuse of alcohol intake or addiction to parenteral drugs.
• Liver disease of non-viral etiology (autoimmune, toxic, metabolic).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with a progression of liver injury.	Up to 4 weeks	To assess the evolution of liver injury with fibrosis data in patients who achieved SVR after treatment with direct-acting antivirals.

Secondary Outcome Measures

Name	Time	Method
Rate of risk factors presented by patients.	Up to 4 weeks.	Identify risk factors in patients who develop liver complications after achieving sustained viral response.
Absence of improvement in non-invasive fibrosis parameters vs the development of liver complications.	Up to 4 weeks.	To determine if there is a relationship between the absence of improvement in non-invasive fibrosis parameters and the development of liver complications.
Clinical and fibrosis data.	Up to 4 weeks.	To compare the clinical and fibrosis data between patients who develop liver complications and those who do not.
Identify patients who develop liver-related events (liver decompensation, hepatocellular carcinoma, and death) after achieving sustained viral response.	Up to 4 weeks.	Development of hepatic decompensation, defined as a patient with ascites, spontaneous bacterial peritonitis (PBR), digestive bleeding of varicose origin, or hepatic encephalopathy at some point in the evolution from SVR until the end of study follow-up.

Trial Locations

Locations (1)

Hospital Universitario Virgen macarena; 🇪🇸 Sevilla, Spain