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

NCT ID: NCT05452187

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2021-12-20

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.

Detailed Description

Hypothesis:

The use of DAAs for HCV eradication in patients with IBD is effective and safe. DAAs do not trigger IBD flares. DAAs probably do not present serious pharmacological interactions, with clinically relevant, with immunosuppressants and/or biological agents.

Conditions

Inflammatory Bowel Diseases; Hepatitis C Virus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

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

Intervention Type: 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).

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

Intervention Type: DRUG

Variables evaluated: Interactions.

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

Intervention Type: 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.

Interventions

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

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).

Intervention Type: DRUG

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

Variables evaluated: Interactions.

Intervention Type: DRUG

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

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.

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Mutua de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Esteve, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Mútua Terrassa

Locations

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 33730753 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32674882 (View on PubMed)

Other Identifiers

MIC2020

Identifier Type: -

Identifier Source: org_study_id