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

Inflammatory Bowel Diseases Clinical Trial

— MIC project  

Official title:

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 (MIC Project).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05452187
• Other study ID #: MIC2020
• Status: Completed
• Start date: March 12, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: July 2022
• Source: Hospital Mutua de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 20, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Virus Diseases

Intervention

Drug:
• 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).
• Evaluate the interaction of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.
Variables evaluated: Interactions.

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Mutua Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Mutua de Terrassa

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Zabana Y, Panés J, Nos P, Gomollón F, Esteve M, García-Sánchez V, Gisbert JP, Barreiro-de-Acosta M, Domènech E; en representación 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of sustained viral response (effectiveness) in patients with IBD and HCV infection treated with DAAs.		8 weeks
Primary	Number and description of adverse events (safety) and possible interactions of DAAs with IBD drugs, particularly immunosuppressants and/or biologics.		8 weeks
Secondary	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.	Harvey Bradshaw Index (HBI) for Crohn's disease (CD): The minimum score obtainable is 0, which indicates the absence of disease. The maximum attainable score depends on the number of stools the patient identifies per day, however, it is in the range of 18.; HBI score interpretation: < 5 remission, 5-7 points (mild activity), 8-16 points (moderate activity), > 16 points (severe activity).	8 weeks
Secondary	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.	Partial Mayo Score in ulcerative colitis (UC): The minimum score obtainable is 0, which indicates the absence of disease. The maximum attainable score is 9.; Partial Mayo score interpretation: < 2 remission, 2-4 points (mild activity), 5-7 points (moderate activity), >7 points (severe activity).	8 weeks