BACKGROUND In our pilot study, we aimed to treat a group of HCV-infected HD patients with pegylated interferon (PEG-IFN) alpha-2a, a new and potentially efficacious therapeutic possibility. METHODS We treated 10 consecutively enrolled chronic hepatitis C hemodialysis (HD) patients (5 men, 5 women; ages 31-70 years; 7 with genotypes 1-4, 3 with genotypes 2-3) with PEG-IFN alpha-2a (135 μg/week) for 24 weeks (genotypes 2-3) or for 48 weeks (genotypes 1-4). Primary end points were sustained viral response (SVR) rate and safety and tolerability profiles. Secondary end points were rapid response (after 12 weeks of treatment), and response at the end of therapy. RESULTS Viral load reduction was observed in all the patients after 12 weeks of treatment. Seven were HCV-RNA negative and continued therapy. Five patients dropped out before the completion of therapy because of significant adverse events (pancytopenia, severe weight loss). PEG-IFN alpha-2a was reduced to 90 μg/week in 5 patients within the first 4 weeks of therapy. Overall, SVR was 20% at the end of follow-up. CONCLUSION PEG-IFN alpha-2a is efficacious in inducing a fast virological response (12 weeks of therapy) in 70% of HCV-infected HD patients and a considerable fall in liver cytolysis enzymes blood values. The use of granulocyte colony-stimulating factor for neutropenia, starting with lower initial doses of PEG-IFN alpha-2a (e.g., 90 μg/week) or in combination with ribavirin, after appropriate dose adjustment studies, should be evaluated in randomized prospective studies.
Monotherapy with Pegylated Interferon Alpha-2a in Hemodialyzed Patients with Chronic Hepatitis C
BASSO, MONICA;
2008
Abstract
BACKGROUND In our pilot study, we aimed to treat a group of HCV-infected HD patients with pegylated interferon (PEG-IFN) alpha-2a, a new and potentially efficacious therapeutic possibility. METHODS We treated 10 consecutively enrolled chronic hepatitis C hemodialysis (HD) patients (5 men, 5 women; ages 31-70 years; 7 with genotypes 1-4, 3 with genotypes 2-3) with PEG-IFN alpha-2a (135 μg/week) for 24 weeks (genotypes 2-3) or for 48 weeks (genotypes 1-4). Primary end points were sustained viral response (SVR) rate and safety and tolerability profiles. Secondary end points were rapid response (after 12 weeks of treatment), and response at the end of therapy. RESULTS Viral load reduction was observed in all the patients after 12 weeks of treatment. Seven were HCV-RNA negative and continued therapy. Five patients dropped out before the completion of therapy because of significant adverse events (pancytopenia, severe weight loss). PEG-IFN alpha-2a was reduced to 90 μg/week in 5 patients within the first 4 weeks of therapy. Overall, SVR was 20% at the end of follow-up. CONCLUSION PEG-IFN alpha-2a is efficacious in inducing a fast virological response (12 weeks of therapy) in 70% of HCV-infected HD patients and a considerable fall in liver cytolysis enzymes blood values. The use of granulocyte colony-stimulating factor for neutropenia, starting with lower initial doses of PEG-IFN alpha-2a (e.g., 90 μg/week) or in combination with ribavirin, after appropriate dose adjustment studies, should be evaluated in randomized prospective studies.
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