Multidisciplinary Support Program in Chronic Hepatitis C

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Other: Multidisciplinary support program

• Registration Number: NCT01850745
• Lead Sponsor: Parc de Salut Mar

Brief Summary

Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131), and MSP-validation group (recruited 2007-2009, n=169).

Detailed Description

Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (follow-up 2002-2004, n= 147), MSP-pilot group (follow-up 2005-2006, n=131), and MSP-validation group (follow-up 2007-2009, n=169).A cost-effectiveness analysis was performed using a Markov model.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2009-01
• Study Completion: 2010-01
• Status Verified: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-09
• Results First Submitted: 2017-09-22
• Results First Submitted QC: 2017-09-22
• Results First Posted: 2018-07-13
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

• Patients with chronic hepatitis C eligible to receive antiviral treatment.

Exclusion Criteria

• Patients who had undergone previous antiviral treatment, those with human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection, and individuals included in other treatment protocols.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation cohort	Multidisciplinary support program	Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.
Pilot cohort	Multidisciplinary support program	Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.

Primary Outcome Measures

Name	Time	Method
Adherence to Treatment	48 months	Adherent patients were defined as those receiving equal or more than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during equal o more than 80% of duration treatment (48 weeks).; Non-adherent patients were defined as those receiving less than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during less than 80% of duration treatment (48 weeks).

Secondary Outcome Measures

Name	Time	Method
Efficacy of Treatment Measured by Sustained Virological Response	baseline and 72 weeks	The secondary efficacy end point was to evaluate the sustained virological response (SVR) of antiviral treatment.; SVR was defined as undetectable hepatitis C virus viral load (\<15 IU/ml) 24 weeks after treatment completion.; Non-SVR was defined as detectable hepatitis C virus viral load (\>15 IU/ml) 24 weeks after treatment completion.

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain