The purpose of this study is to determine if the use of epoetin-alpha will allow patients with chronic hepatitis C virus infection to be treated with higher doses of peginterferon-alpha-2b and ribavirin, thus increasing chances at lower viral levels and raising sustained virologic response.
Chronic infection with hepatitis C virus (HCV) leads to cirrhosis, hepatocellular carcinoma and liver failure. The treatment for end stage liver disease is hepatic transplantation. It is therefore important the patients with chronic HCV infection be recognized and treated before they develop advanced disease. The most effective therapy for patients with chronic HCV appears to be the combination of peginterferon-alpha-2b (PEG-Intron) plus ribavirin. Overall, 54% of patients treated with these medications achieve sustained virologic response. Response to therapy is greatly enhanced in those patients who can tolerate this therapy and remain on treatment without the need for dose reduction. The single most common reason for reducing the dose of ribavirin is anemia. Ribavirin causes a dose dependent hemolytic anemia and this side effect is believed to be exacerbated by the marrow suppressive effects of interferon. Preliminary studies have suggested that anemia can be overcome with the use of erythropoetin. The present pilot study will test the hypothesis that treatment with Epoetin-alph will allow patients with chronic HCV to utilize higher doses of ribavirin along with PEG-Intron therapy and that this will lead to a more rapid decline in HCV RNA titer and an increase in sustained virologic response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.
Virginia Commonwealth University
Richmond, Virginia, United States
The mean dose of ribavirin utilized in each of the 3 treatment arms will be compared.
Time frame: 18 months
Number of patients in each group who required a dose reduction of ribavirin
Time frame: 18 months
Rate of virologic response and sustained virologic response observed in each group
Time frame: 18 months
Rate of decline in HCV RNA titer in each group
Time frame: 18 months
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