Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

• Conditions: Hepatitis C
• Interventions: Drug: Antiviral agents

• Registration Number: NCT03226717
• Lead Sponsor: Assiut University

Brief Summary

The prevalence of HCV infection in Egypt is 14.7%. HCV is both a hepatotropic and a lymphotropic virus, it may exert a chronic stimulus on the immune system with both T and B lymphocyte alterations. In addition to cryoglobulinaemic vasculitis, HCV may trigger different immune-mediated extrahepatic disorders. A variable combination of HCV with other unknown enviromental and/or hostgenetic cofactors may lead to different clinical phenotypes that characterise HCV syndrome. Patients who have HCV -related arthropathy are accounted for by 2 clinical subsits: Rheumatoid-like arthritis and Cryoglobulin-related arthritis. Patients with mild arthritis, conservative manegement using analgesics with anti- inflammatory activity is recommended. In patients who have contraindications to their use, short term low dose prednisone is an option. In HCV infection with concomitant RA, ACR guidelines published in 2008 provided recommendations pertaining to these of DMARDs that are based on the severity of liver disease using the child- pugh- turcotte classification. For patients with severe cryoglobulinaemia such as severe debilitating disease or systemic in improvement, a combination of immunosuppressive and antiviral therapy is preferred. It has been found that antiviral therapy with interferon immunosuppressive and antiviral therapy is preferred. It has been found that antiviral therapy with interferon improves the musculoskeletal manifestations in HCV arthropathy. The DIrect antiviral agents seems very promising in treatment of HCV arthropathy. As HCV genotype 4 is the most common genotype in Egypt, the effective optional antiviral agents are sofosbuvir, daclatasvir, ledipasvir, paritaprevir, velpatasvir, ombitasvir and simeprevir.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-18
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-19
• Last Update Submitted: 2017-07-19
• Study First Posted: 2017-07-24
• Last Update Posted: 2017-07-24
• Study Start: 2017-08-10
• Primary Completion: 2017-09-10
• Study Completion: 2017-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Antiviral patients with arthropathy concomitant HCV (proved by PCR testing).

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Exclusion Criteria

• patients with child-pugh B and child-pugh C decompensated cirrhosis.
• patients more that 60 years.
• patients with chronic infection e.g.(pulmonary T.B).
• patients with organ failure e.g.( heart failure, respiratory failure).
• patients with CKD with GFR lead that 60 ml/ ministry/1.73m2.
• patients on immunosuppressive agents.
• patients with HBV- coinfection.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatitis C patients	Antiviral agents	Antiviral agents (sofosbuvir,daclatasvir,ribavirin) will be given to hepatitis C patients with arthropathy.

Primary Outcome Measures

Name	Time	Method
rate of Improvement of manifestations of arthropathy	3_6 months	Improvement of manifestations of arthropathy in hepatitis C patients after treatment by assessment through pain scale

Trial Locations

Locations (1)

yasmin AbdElazim Mohamed Turkey; 🇪🇬 Assiut, Egypt