Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection

Study Overview
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Brief Summary
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This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV infection. The study will be done at Tropical medicine department , Tanta university. It will be conducted between June2014 and November 2014. The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous extrahepatic manifestations of HCV infection.

Detailed Description
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Hepatitis C virus is a common cause of chronic liver disease worldwide and represent public health problem. The Egyptian Demographic Health Survey (EDHS), a cross sectional survey including hepatitis C virus (HCV) biomarkers, was conducted in 2008 on a large nationally representative sample. It estimated HCV prevalence among the 15-59 years age group to be 14.7% . Accordingly, Egypt has the highest HCV prevalence in the world. Although HCV is a hepatotropic virus, in some patients the primary manifestations of infection occur outside the liver. There is a growing body of evidence to support the idea that HCV can replicate efficiently in extrahepatic tissues including the Peripheral blood mononuclear cells (PBMC). Autoimmune manifestations are common in patients chronically infected by HCV . These manifestations can be dominant, whereas the hepatic disease can be quiescent or mild. More recently, there has been growing interest in the relationship between HCV and Sjogren's syndrome (SS), rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE). Of those , this article is interested in cutaneous and mucous membrane manifestations where many reports have shown that cutaneous manifestations are often the first signs of chronic HCV infection and these are indicated in 20-40% of the patients presenting to the dermatology clinics, therefore dermatologists must be aware of skin disorders associated with viral infection. The most commonly encountered dermatological manifestations of HCV infection includes mixed cryoglobulinemia (MC), porphyria cutanea tarda (PCT), cutaneous and/or oral lichen planus (LP), urticaria, pruritus, thrombocytopenic purpura and cutaneous vasculitis. Although majority of skin manifestations of chronic HCV infection represent the clinical impression of autoimmune phenomena, however, precise pathogenesis of these extra-hepatic complications is not well understood. The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous extrahepatic manifestations of HCV infection This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV infection. The study will be done at Tropical medicine department , Tanta university. It will be conducted between June2014 and November 2014.

Official Title
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Randomized Controlled Study of Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection

Conditions
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Hepatitis C, Lichen Planus, Vasculitis, Autoimmune Diseases

Intervention / Treatment
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* Drug: Ribavirin
* Drug: Betamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with evidence of HCV infection and mucocutaneous complaint and contraindicated to have standard antiviral therapy. Exclusion Criteria: Hypersensitivity to Ribavirin Pregnant & Lactating women Male partners of pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ribavirin and Betamethasone<br>A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses. It will be used along with Topical steroids; Betamethasone | Drug: Ribavirin<br>* A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses. It will be used along with Topical steroids; Betamethasone<br>* Other names: Copegus;Drug: Betamethasone<br>* Topical Steroids alone will be used; Betamethasone<br>* Other names: Corticosteroid;|
| Experimental: Betamethasone alone<br>Topical steroids alone will be used; Betamethasone. | Drug: Betamethasone<br>* Topical Steroids alone will be used; Betamethasone<br>* Other names: Corticosteroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids. |  | 6 months |