Heathcote, EJ and Shiffman, ML and Cooksley, WG and Dusheiko, GM and Lee, SS and Balart, L and Reindollar, R and Reddy, RK and Wright, TL and Lin, A and Hoffman, J and De Pamphilis, J (2000) Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. New England Journal of Medicine , 343 (23) 1673 - 1680.
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BACKGROUND: Chronic hepatitis C virus (HCV) infection in patients with cirrhosis is difficult to treat. In patients with chronic hepatitis C but without cirrhosis, once-weekly administration of interferon modified by the attachment of a 40-kd branched-chain polyethylene glycol moiety (peginterferon alfa-2a) is more efficacious than a regimen of unmodified interferon. We examined the efficacy and safety of peginterferon alfa-2a in patients with HCV-related cirrhosis or bridging fibrosis. METHODS: We randomly assigned 271 patients with cirrhosis or bridging fibrosis to receive subcutaneous treatment with 3 million units of interferon alfa-2a three times weekly (88 patients), 90 microg of peginterferon alfa-2a once weekly (96), or 180 microg of peginterferon alfa-2a once weekly (87). Treatment lasted 48 weeks and was followed by a 24-week follow-up period. We assessed efficacy by measuring HCV RNA and alanine aminotransferase and by evaluating liver- biopsy specimens. A histologic response was defined as a decrease of at least 2 points on the 22-point Histological Activity Index. RESULTS: In an intention-to-treat analysis, HCV RNA was undetectable at week 72 in 8 percent, 15 percent, and 30 percent of the patients treated with interferon alfa-2a and with 90 microg and 180 microg of peginterferon alfa-2a, respectively (P=0.001 for the comparison between 180 microg of peginterferon alfa-2a and interferon alfa-2a). At week 72, alanine aminotransferase concentrations had normalized in 15 percent, 20 percent, and 34 percent of patients, respectively (P=0.004 for the comparison between 180 microg of peginterferon alfa-2a and interferon alfa-2a). In the subgroup of 184 patients with paired liver-biopsy specimens, the rates of histologic response at week 72 were 31 percent, 44 percent, and 54 percent, respectively (P=0.02 for the comparison between 180 microg of peginterferon alfa-2a and interferon alfa-2a). All three treatments were similarly tolerated. CONCLUSIONS: In patients with chronic hepatitis C and cirrhosis or bridging fibrosis, 180 microg of peginterferon alfa-2a administered once weekly is significantly more effective than 3 million units of standard interferon alfa-2a administered three times weekly
|Title:||Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis|
|Additional information:||UI - 20537433 LA - eng RN - 0 (Antiviral Agents) RN - 0 (Polyethylene Glycols) RN - 0 (RNA, Viral) RN - 0 (Virus Inhibitors) RN - 0 (polyethylene glycol-interferon alfa-2A) RN - 76543-88-9 (Interferon Alfa-2a) PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DA - 20001121 IS - 0028-4793 SB - AIM SB - IM CY - UNITED STATES JC - NOW|
|Keywords:||00 - SCIDEC, 96, Administration, Alanine, analysis, As, Australia, bridging, Canada, CHRONIC HEPATITIS, Cirrhosis, comparison, EFFICACY, English, Fibrosis, FOLLOW UP, Follow-up, HCV, Hepatitis, Hepatitis C, Hepatitis C virus, Infection, INTERFERON, Interferon Alfa-2a, INTERFERON TREATMENT, liver, MED, Methods, NC, network, Patient, patients, response, Ribavirin, Rna, Roche, Safety, societies, STATE, subcutaneous, TIME, treatment, TRIAL, USA, VIRUS, Administration, adverse effects, AGENTS, Antiviral Agents, Biopsy, Blood, clinical, Clinical trial, Comparative Study, complications, CONTROLLED TRIAL, Drug Administration Schedule, drug therapy, etiology, Female, genetics, health, Chronic, Hepatitis C-Like Viruses, INHIBITOR, INHIBITORS, Injections, Subcutaneous, isolation & purification, Liver Cirrhosis, Male, medicine, Middle Age, MORTALITY, Multicenter Studies, Polyethylene Glycols, RANDOMIZED CONTROLLED TRIAL, Viral, STATES, Support, Non-U.S.Gov't, therapeutic use, United States, Virus Inhibitors|
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