Clinical trial NCT00038974: Hepatitis C Antiviral Resistance in African-Americans
Official title: Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Hepatitis C
Interferon
Ribavirin
Efficacy
Viral load
Genetics
Cytokines
Immunology
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Cancer Institute (NCI)
name: National Center for Advancing Translational Sciences (NCATS)
name: Hoffmann-La Roche
First posted: 2002-06-10
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Sustained Virologic Response (SVR)
timeFrame: 24 weeks after therapy is discontinued
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: New York
country: United States
facility: New York-Presbyterian Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Patricia Robuck
role: STUDY_DIRECTOR
References:
citation: Conjeevaram HS, Fried MW, Jeffers LJ, Terrault NA, Wiley-Lucas TE, Afdhal N, Brown RS, Belle SH, Hoofnagle JH, Kleiner DE, Howell CD; Virahep-C Study Group. Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroenterology. 2006 Aug;131(2):470-7. doi: 10.1053/j.gastro.2006.06.008.
citation: Sarkar S, Jiang Z, Evon DM, Wahed AS, Hoofnagle JH. Fatigue before, during and after antiviral therapy of chronic hepatitis C: results from the Virahep-C study. J Hepatol. 2012 Nov;57(5):946-52. doi: 10.1016/j.jhep.2012.06.030. Epub 2012 Jul 1.
citation: Dove LM, Rosen RC, Ramcharran D, Wahed AS, Belle SH, Brown RS, Hoofnagle JH; Virahep-C Study Group. Decline in male sexual desire, function, and satisfaction during and after antiviral therapy for chronic hepatitis C. Gastroenterology. 2009 Sep;137(3):873-84, 884.e1. doi: 10.1053/j.gastro.2009.05.060. Epub 2009 Jun 13.
citation: Hoofnagle JH, Wahed AS, Brown RS Jr, Howell CD, Belle SH; Virahep-C Study Group. Early changes in hepatitis C virus (HCV) levels in response to peginterferon and ribavirin treatment in patients with chronic HCV genotype 1 infection. J Infect Dis. 2009 Apr 15;199(8):1112-20. doi: 10.1086/597384.
citation: Cannon NA, Donlin MJ, Fan X, Aurora R, Tavis JE; Virahep-C Study Group. Hepatitis C virus diversity and evolution in the full open-reading frame during antiviral therapy. PLoS One. 2008 May 7;3(5):e2123. doi: 10.1371/journal.pone.0002123.