|Title:||Peginterferon Lambda-1a/ribavirin with daclatasvir or peginterferon alfa-2a/ribavirin with telaprevir for chronic hepatitis c genotype 1b||Authors:||Flisiak R.
|Keywords:||Clinical trial; Daclatasvir; Hepatitis c; Interferon lambda-1a; Ribavirin||Issue Date:||2016||Publisher:||Mary Ann Liebert Inc.||Journal Volume:||36||Journal Issue:||11||Start page/Pages:||635-643||Source:||Journal of Interferon and Cytokine Research||Abstract:||
The study objective was to compare the efficacy and safety of peginterferon lambda-1a combined with ribavirin/ daclatasvir (Lambda/RBV/DCV), versus peginterferon alfa-2a combined with ribavirin/telaprevir (Alfa/RBV/TVR), in patients chronically infectedwith hepatitis C virus (HCV), genotype 1b. This was a prospective, randomized, openlabel, phase 3 study (NCT01718158) in adults (aged ?18 years) who were treatment na?ve or prior relapsers to peginterferon alfa/ribavirin therapy. The primary endpoint was sustained virologic response at post-Treatment followupweek 12 (SVR12). Patients were randomized in a 2:1 ratio to receive 24weeks of Lambda/RBV/DCV or responseguided 24 or 48weeks ofAlfa/RBV/TVR.Overall, 440 patientswere treated (294with Lambda/RBV/DCV; 146 with Alfa/RBV/TVR). The proportion of patients achieving SVR12 was 88.8%in the Lambda/RBV/DCV arm and 70.5% in theAlfa/RBV/TVRarm(difference between arms: 18.3%; 95%confidence interval: 9.9-25.7;P< 0.0001). Patients in the Lambda/RBV/DCV group had fewer rash-related adverse events (AEs), cytopenic abnormalities, flu-like symptoms, serious AEs, and discontinuations due toAEs, but more liver abnormalities than those in theAlfa/RBV/TVR group. In conclusion, treatment with Lambda/RBV/DCV led to higher SVR12 rates and amore favorable safety profile than Alfa/RBV/TVR in patients with chronic HCV, genotype 1b infection. ? Mary Ann Liebert, Inc.
|ISSN:||1079-9907||DOI:||10.1089/jir.2015.0173||SDG/Keyword:||alanine aminotransferase; aspartate aminotransferase; bilirubin; daclatasvir; gamma glutamyltransferase; peginterferon alpha2a; peginterferon lambda; ribavirin; telaprevir; alpha interferon; antivirus agent; BMS-790052; imidazole derivative; macrogol derivative; oligopeptide; peginterferon alpha2a; recombinant protein; ribavirin; telaprevir; adult; aged; alanine aminotransferase blood level; anemia; arthralgia; Article; aspartate aminotransferase blood level; backache; bilirubin blood level; chill; chronic hepatitis C; controlled study; drug efficacy; drug safety; drug withdrawal; faintness; female; fever; flu like syndrome; follow up; gamma glutamyl transferase blood level; genotype; human; jaundice; kidney failure; leukopenia; lymphocytopenia; major clinical study; malaise; male; middle aged; myalgia; neutropenia; open study; outcome assessment; pain; phase 3 clinical trial; priority journal; prospective study; randomized controlled trial; rash; relapse; side effect; thrombocytopenia; treatment duration; treatment indication; treatment response; clinical trial; combination drug therapy; dose response; genetics; Hepacivirus; Hepatitis C, Chronic; virology; young adult; Adult; Aged; Antiviral Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Interferon-alpha; Male; Middle Aged; Oligopeptides; Polyethylene Glycols; Prospective Studies; Recombinant Proteins; Ribavirin; Young Adult
|Appears in Collections:||臨床醫學研究所|
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