Multidisciplinary Support Program in Chronic Hepatitis C

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a multidìsciplinary Support Program in the Adherence and Efficacy of Peginterferon Alfa-2a and Ribavirin Therapy in Chronic Hepatitis C.

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Other: Multidisciplinary support program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program | |
| Validation cohort<br>Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program. | Other: Multidisciplinary support program<br>* Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.<br>|
| Pilot cohort<br>Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program. | Other: Multidisciplinary support program<br>* Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Treatment | 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). | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Treatment Measured by Sustained Virological Response | 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. | baseline and 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C virus infection (CHC)