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
- Conditions
- Hepatitis C Virus InfectionInflammatory Bowel Diseases
- Interventions
- 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.
- Registration Number
- NCT05452187
- Lead Sponsor
- Hospital Mutua de Terrassa
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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.
- Spontaneous cure of HCV without treatment
- HCV treatment outside the study period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 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. Cohort patients with IBD and chronic HCV infection treated with DAAs and/or interferon collected from the ENEIDA database. Patients with IBD and chronic HCV infection treated with DAAs and/or interferon. Assess the effectiveness and safety of DAAs in patients with IBD. Cohort patients with IBD and chronic HCV infection treated with DAAs and/or interferon collected from the ENEIDA database. Patients with IBD and chronic HCV infection treated with DAAs and/or interferon. Assessment of the impact of DAAs on the course of IBD. Cohort patients with IBD and chronic HCV infection treated with DAAs and/or interferon collected from the ENEIDA database.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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).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 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).
Trial Locations
- Locations (1)
Hospital Universitari Mutua Terrassa
🇪🇸Terrassa, Barcelona, Spain