Antiviral therapy · 2010
Hydroxyurea suppresses HCV replication in humans: a Phase I trial of oral hydroxyurea in chronic hepatitis C patients.
Клиническое исследование I фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Nozaki Akito, Numata Kazushi, Morimoto Manabu, Kondo Masaaki, Sugimori Kazuya, Morita Satoshi, Miyajima Eiji, Ikeda Masanori, Kato Nobuyuki, Maeda Shin, Tanaka Katsuaki
Аннотация
BACKGROUND: HCV is the main causative agent of chronic liver disease, which could progress to liver cirrhosis and hepatocellular carcinoma. By using a recently developed genome-length HCV RNA replication reporter assay system, we found that hydroxyurea (HU), an inhibitor of DNA synthesis, inhibited HCV RNA replication.
METHODS: To test the hypothesis that HU suppresses HCV replication in humans, we conducted a Phase I trial involving Japanese patients with chronic hepatitis C (CHC) and investigated the safety and effectiveness of a 4-week course of oral HU.
RESULTS: A total of nine patients were treated with an HU dose level of 500 mg three times daily. Dose-limiting toxicity was not observed at this dose level. Of the nine patients, eight exhibited a moderate decrease in serum HCV RNA levels during the trial. A decrease in HCV RNA levels to nadir levels was achieved for the eight patients (median -0.27 log(10) IU/ml [range -0.08--0.44]) at various times during the 4 weeks after therapy initiation.
CONCLUSIONS: The results of this Phase I trial suggest that HU has potential as an anti-HCV agent that could be effective for the treatment of CHC patients.
METHODS: To test the hypothesis that HU suppresses HCV replication in humans, we conducted a Phase I trial involving Japanese patients with chronic hepatitis C (CHC) and investigated the safety and effectiveness of a 4-week course of oral HU.
RESULTS: A total of nine patients were treated with an HU dose level of 500 mg three times daily. Dose-limiting toxicity was not observed at this dose level. Of the nine patients, eight exhibited a moderate decrease in serum HCV RNA levels during the trial. A decrease in HCV RNA levels to nadir levels was achieved for the eight patients (median -0.27 log(10) IU/ml [range -0.08--0.44]) at various times during the 4 weeks after therapy initiation.
CONCLUSIONS: The results of this Phase I trial suggest that HU has potential as an anti-HCV agent that could be effective for the treatment of CHC patients.