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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Other

Identifiers

NCT05062408

FIS-ANT- 2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 321 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

321 participants in 1 patient group

cases

Description:

Patients treated with direct-acting antivirals.