Hepatitis C Antiviral Resistance in African-Americans

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: peginterferon alfa-2a; Drug: Ribavirin

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00038974

Virahep-C (completed)

U01DK060335 (U.S. NIH Grant/Contract)

U01DK060324 (U.S. NIH Grant/Contract)

U01DK060349 (U.S. NIH Grant/Contract)

U01DK060346 (U.S. NIH Grant/Contract)

U01DK060327 (U.S. NIH Grant/Contract)

U01DK060344 (U.S. NIH Grant/Contract)

U01DK060340 (U.S. NIH Grant/Contract)

U01DK060309 (U.S. NIH Grant/Contract)

U01DK060329 (U.S. NIH Grant/Contract)

U01DK060345 (U.S. NIH Grant/Contract)

U01DK060342 (U.S. NIH Grant/Contract)

U01DK060341 (U.S. NIH Grant/Contract)

U01DK060352 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 401 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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401 participants in 1 patient group

Interferon and rivavirin

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a