Evaluation of the Safety and Effectiveness of Direct-acting Antiviral Drugs in the Treatment of Hepatitis C in Patients With Inflammatory Bowel Disease: National Multicenter Study

NCT05452187 | Completed

• 1 other identifier: MIC2020
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates \>90%, represent a radical change from interferon-based therapies. The ECCO (European Crohn's and Colitis Organisation) guidelines (Kucharzik T, Ellul P, Greuter T, et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohn's Colitis. 2021;15(6):879-913) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence. The project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of DAAs for HCV eradication in patients with IBD. The Eneida database (Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring, and functions. Gastroenterol y Hepatol. 2020;43(9):551-8.) of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is an adequate registry to identify patients with HCV infection. The serological status of the infection is frequently recorded in the ENEIDA database, and it is generally evaluated at the time of IBD diagnosis, before starting immunosuppressive treatment. The ENEIDA registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised. This multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of HCV in patients with IBD.

Conditions

Inflammatory Bowel Diseases; Hepatitis C Virus Infection

Keywords

Inflammatory Bowel Diseases; Hepatitis C Virus Infection; Direct-acting antiviral drugs

Outcome Measures

Primary Outcomes (2)

• Percentage of sustained viral response (effectiveness) in patients with IBD and HCV infection treated with DAAs.

  8 weeks

• Number and description of adverse events (safety) and possible interactions of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.

  8 weeks

Secondary Outcomes (2)

• Compare the clinical Crohn's disease activity (measured by Harvey Bradshaw Index) before and during the treatment with DAAs, to assess the impact of DAAs on the course of IBD.

  8 weeks

• Compare the clinical ulcerative colitis activity (measured by Partial Mayo Score) before and during the treatment with DAAs, to assess the impact of DAAs on the course of IBD.

  8 weeks

Study Arms (1)

Patients with IBD and chronic HCV infection treated with DAAs and/or interferon.

Cohort patients with IBD and chronic HCV infection treated with DAAs and/or interferon collected from the ENEIDA database.

Drug: Assess the effectiveness and safety of DAAs in patients with IBD.; Drug: Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.; Other: Assessment of the impact of DAAs on the course of IBD.

Interventions

Assess the effectiveness and safety of DAAs in patients with IBD. DRUG

Variables evaluated: age, gender, location, extent, phenotype, and activity of IBD, treatments, anti-HCV and viral load, DAA treatment and duration, fibrosis and hepatic decompensation and adverse effects (AE).

Also known as: Direct-acting antiviral (DAA) to treat hepatitis C virus (HCV) infection in inflammatory bowel disease (IBD) patients.

Patients with IBD and chronic HCV infection treated with DAAs and/or interferon.

Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics. DRUG

Variables evaluated: Interactions.

Patients with IBD and chronic HCV infection treated with DAAs and/or interferon.

Assessment of the impact of DAAs on the course of IBD. OTHER

Qualitative variables will be expressed as a percentage and 95% confidence interval and quantitative variables as median and interquartile range. A priori it is difficult to determine which statistical analysis should be performed. It is basically a descriptive study, and the subsequent statistical analysis will depend on the evolution that the patients have presented in relation to the DAA treatment. If the drugs have been well tolerated without adverse effects, further statistical analysis will not be necessary. Instead, if the DAAs trigger activity outbreaks, variables related to the appearance of these outbreaks will be evaluated (type of DAA, immunomodulator, ...). To compare whether there are differences between the established groups, Chi Square (in qualitative independent variables), a t-student or ANOVA or their corresponding non-parametric tests (in quantitative independent variables) will be used. Statistical significance has been set at a probability level of \<0.05.

Patients with IBD and chronic HCV infection treated with DAAs and/or interferon.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with HCV Ab (positive/negative) and with RNA (detectable/undetectable) will be identified using the ENEIDA database.

You may qualify if:

• All individuals diagnosed with IBD according to the ECCO criteria and chronic HCV infection (positive HCV Ab and detectable RNA) treated with DAAs and/or interferon collected in the ENEIDA database, and who have properly completed the fields of age, gender, treatment, location, and phenotype of IBD, will be included in the study.
• Study period: Patients treated with DAAs between January 1, 2011 - February 28, 2021.

You may not qualify if:

• Spontaneous cure of HCV without treatment
• HCV treatment outside the study period.

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Related Publications (2)

• Kucharzik T, Ellul P, Greuter T, Rahier JF, Verstockt B, Abreu C, Albuquerque A, Allocca M, Esteve M, Farraye FA, Gordon H, Karmiris K, Kopylov U, Kirchgesner J, MacMahon E, Magro F, Maaser C, de Ridder L, Taxonera C, Toruner M, Tremblay L, Scharl M, Viget N, Zabana Y, Vavricka S. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jun 22;15(6):879-913. doi: 10.1093/ecco-jcc/jjab052. No abstract available.

  PMID: 33730753 BACKGROUND

• Zabana Y, Panes J, Nos P, Gomollon F, Esteve M, Garcia-Sanchez V, Gisbert JP, Barreiro-de-Acosta M, Domenech E; en representacion de GETECCU. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring and functions. Gastroenterol Hepatol. 2020 Nov;43(9):551-558. doi: 10.1016/j.gastrohep.2020.05.007. Epub 2020 Jul 14. English, Spanish.

  PMID: 32674882 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Hepatitis C

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases

Study Officials

• Maria Esteve, PhD, MD

  Hospital Universitari Mútua Terrassa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: July 11, 2022
• Study Start: March 12, 2021
• Primary Completion: July 30, 2021
• Study Completion: December 20, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)