Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

Completed

• Conditions: Hepatitis C, Chronic; Mixed Cryoglobulinemia
• Interventions: Drug: DAA treatment

• Registration Number: NCT03342261
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.

Detailed Description

We focused on HCV patients with or without HIV with MC who had at least one cryoglobulin level assessment before and after DAA therapy and investigated the impact of DAA therapy on cryoglobulin clearance.

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-11
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-09
• Last Update Submitted: 2017-11-09
• Study First Posted: 2017-11-14
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• hepatitis C virus (HCV) infected patients
• symptomatic or asymptomatic mixed cryoglobulinemia
• coinfected or not with HIV
• treated by direct-acting antiviral (DAA) treatment
• at least one cryoglobulin measurement before and after DAA

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCV patients with mixed cryoglobulinemia	DAA treatment	HCV patients with or without HIV presenting a mixed cryoglobulinemia and treated with direct-acting antiviral agents

Primary Outcome Measures

Name	Time	Method
Cryoglobulin level at the end of therapy	End of treatment (12 or 24 weeks)	The primary outcome was the cryoglobulin level at the end of direct-acting antiviral treatment (week 12 or 24 according to treatment duration)

Trial Locations

Locations (1)

Hospices Civils de Lyon - Croix-Rousse Hospital; 🇫🇷 Lyon, France