Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

NCT ID: NCT03226717

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-10
• Study Completion Date: 2017-12-10

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.

Conditions

Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatitis C patients

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

Antiviral agents

Intervention Type: DRUG

combination therapy consists of Sofosbuvir,daclatasvir and ribavirin

Interventions

Antiviral agents

combination therapy consists of Sofosbuvir,daclatasvir and ribavirin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin abd elazim mohamed turkey

principle investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

yasmin AbdElazim Mohamed Turkey

Asyut, , Egypt

Countries

Egypt

Central Contacts

yasmin M Turkey

Role: CONTACT

jasmin.turkey589@yahoo.com

01060497881

Other Identifiers

HCVDAV

Identifier Type: -

Identifier Source: org_study_id