Hepatitis C Antiviral Resistance in African-Americans

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: peginterferon alfa-2a Drug: Ribavirin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

401 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Nov 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interferon and rivavirin 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 Drug: Ribavirin

Arm

Intervention/Treatment

Experimental: Interferon and rivavirin

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

Drug: Ribavirin

Outcome Measures

Primary Outcome Measures

Sustained Virologic Response (SVR) [24 weeks after therapy is discontinued]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143
2	University of Miami School of Medicine	Miami	Florida	United States	33136
3	Rush University	Chicago	Illinois	United States	60612
4	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
5	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
6	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
7	New York-Presbyterian Medical Center	New York	New York	United States	10032
8	University of North Carolina	Chapel Hill	North Carolina	United States	27599