Hepatitis C Antiviral Resistance in African-Americans

Study Overview
=================
Brief Summary
-----------------
This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.

Official Title
-----------------
Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Age between 18 and 70 years at screening Black/African American or White/Caucasian Born in the United States Quantifiable Serum HCV RNA Hepatitis C genotype 1 Liver biopsy consistent with chronic hepatitis C Negative urine pregnancy test Males and Females must be using two reliable forms of effective contraception while on drug and during follow-up. Exclusion: Previous treatment with interferon or ribavirin Positive test at screening for anti-HIV Positive test for HBsAg Alcohol consumption of more than two drinks/day History of other chronic liver disease Pregnant or breast-feeding women Male partners of women who are pregnant or contemplating pregnancy Neutrophil count <1000 cells/mm3 Hgb <11 g/dl in women or 12 g/dl in men Platelet count <75,000 cells/mm3. Thalassemia, spherocytosis, history of GI bleeding or those at increased risk of anemia Serum creatinine level >1.5 times the upper limit of normal at screening or CrCl < 75cc/min Current dialysis Alcohol or drug abuse within 6 months Current (<6 months)severe psychiatric disorder History of immunologically mediated disease Decompensated liver disease High risk cardiovascular/coronary artery disease Severe seizure disorder or anticonvulsant use Solid organ or bone marrow transplantation Thyroid disease poorly controlled on prescribed medications History or other evidence of retinopathy Chronic use of oral steroids Inability or unwillingness to provide informed consent or abide by the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interferon and rivavirin<br>All patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of >75 kg) daily. | Drug: peginterferon alfa-2a<br> <br> Drug: Ribavirin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response (SVR) | The primary end point of therapy was an SVR that was definied as the absences of detectable HCV RNA in serum 24 weeks after therapy was stopped. | 24 weeks after therapy is discontinued | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Interferon, Ribavirin, Efficacy, Viral load, Genetics, Cytokines, Immunology