Prediction of Liver-related Outcomes After HCV Cure

NCT04460157 | Unknown

• 1 other identifier: GEHEP-011
• Study Type: observational
• Target: 1,035
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To develop and validate a predictive model, applicable to daily practice, of liver complications emergence in hepatitis C virus (HCV)-infected patients and advanced fibrosis, who have achieved sustained viral response (SVR) with direct-acting antivirals (DAA)-based therapy. Methods: Design: Mulsite prospective multicenter cohort study. Study subjects: HCV-monoinfected and HIV/HCV-coinfected individuals recruited from two parallel cohorts (GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292(HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Patients who fullfilled the following inclusion criteria are included in this study: 1) Have received a regimen with one or more DAA; 2) Have achieved SVR 12 weeks after treatment; 3) Have an evaluable liver stiffness (LS) of more than 9.5 kPa in the three months prior to the start of treatment. Follow-up: The baseline time point is the date of SVR. All participants are evaluated by a common protocol every six months. At every visit, clinical and laboratory examination focusing on the early detection of liver complications are carried out. LS is assessed by vibration-controlled transient elastography, according to a standardized procedure, every 12 months. In patients with cirrhosis, liver ultrasound and plasma alpha-fetoprotein determination are conducted for hepatocellular carcinoma screening, every six months. Variables and data analysis: The primary outcome variable of the study will be the emergence of liver complication (hepatic decompensation or hepatocellular carcinoma) or liver transplant. Predictive models will be develop with clinical, analytical, and genetic variables independently associated with the primary variable in a Cox regression for competitive risks applied to a developmental subpopulation. The performance of the model will be evaluated using COR curves. Sensitivity, specificity, and positive and negative predictive values will be calculated, both in the developmental population and in a validation population.

Conditions

Hepatitis C, Chronic; Sustained Virological Response; Direct-acting Antivirals; Hepatocellular Carcinoma; Hepatic Decompensation

Outcome Measures

Primary Outcomes (1)

• Liver complications emergence

  Appearance of hepatocellular carcinoma, portal hypertensive gastrointestinal bleeding, ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorrenal syndrome and acute on chronic liver failure after SVR

  From the inclusion until death, liver transplant, HCV reinfection or the censoring date (final study date)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV/HCV-coinfected and HCV-monoinfected individuals from two parallel cohorts (HEPAVIR-DAA Cohort clinicaltrials.gov ID: NCT02057003; GEHEP-MONO Cohort clinicaltrials.gov ID: NCT02333292). These cohorts enrolled patients with HCV infection, treated with DAA-based regimens after October 2011, at the units of infectious diseases of 18 hospitals throughout Spain. Subjects were included if they fulfilled the inclusion criteria.

You may qualify if:

• Had achieved SVR 12 weeks after DAA-based regimen, either with or without Peg-interferon
• Showed liver stiffness (LS) value ≥9.5 kPa prior to treatment
• Had LS measurement available at SVR time-point

You may not qualify if:

• Individuals seropositive for HBsAg
• Individuals who refuse to participate
• Individuals under 18 years old

Sponsors & Collaborators

• Hospital Universitario de Valme: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitario de Valme

Seville, 41014, Spain

RECRUITING

Related Publications (2)

• Gonzalez-Serna A, Corma-Gomez A, Cano M, Rubio-Sanchez R, Martin-Sierra C, Rincon P, Martin-Carmona J, Perez M, Pineda JA, Real LM, Macias J. Influence of Cellular Aging on Liver Stiffness in Patients With Hepatitis C Virus Achieving Sustained Viral Response. J Infect Dis. 2025 Jun 2;231(5):e846-e852. doi: 10.1093/infdis/jiaf087.

  PMID: 39970137 DERIVED

• Martin-Carmona J, Corma-Gomez A, Tellez F, Arenga-Barrios D, Serrano-Fuentes M, Morano L, Corona-Mata D, Navarrete Lorite MN, Vera-Mendez FJ, Alados JC, Palacios R, de Los Santos I, Geijo P, Imaz A, Merino D, Reus-Banuls SJ, Galindo MJ, Lopez-Ruz MA, Galera C, Pineda JA, Macias J. No Impact of HIV Coinfection on Mortality in Patients With Hepatitis C Virus Infection After Sustained Virological Response. Clin Infect Dis. 2025 Apr 30;80(4):835-841. doi: 10.1093/cid/ciae473.

  PMID: 39293030 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Central Study Contacts

Anais Corma-Gomez, MD

CONTACT

955015799; anais.corgo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: October 1, 2011
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

ES (1)