Hepatitis C, Chronic
Conditions
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.
Interventions
None listed
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Spain
Outcome results
None listed