Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

NCT03226717 | Unknown

• 1 other identifier: HCVDAV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• rate of Improvement of manifestations of arthropathy

  Improvement of manifestations of arthropathy in hepatitis C patients after treatment by assessment through pain scale

  3_6 months

Study Arms (1)

Hepatitis C patients

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

Drug: Antiviral agents

Interventions

Antiviral agents DRUG

combination therapy consists of Sofosbuvir,daclatasvir and ribavirin

Hepatitis C patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with hepatitis C virus

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

yasmin AbdElazim Mohamed Turkey

Asyut, Egypt

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Antiviral Agents

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

yasmin M Turkey

CONTACT

01060497881; jasmin.turkey589@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator.

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: July 24, 2017
• Study Start: August 10, 2017
• Primary Completion: September 10, 2017
• Study Completion: December 10, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

EG (1)