Multidisciplinary Support Program in Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850745
• Other study ID #: HMAR-MSP-CHC
• Status: Completed
• Start date: January 2003
• Est. completion date: January 2010

Study information

• Verified date: May 2013
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: January 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Other:
• Multidisciplinary support program
Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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