|Title:||Boceprevir-based triple therapy to rescue HCV genotype 1/HBV dually infected patients refractory to peginterferon plus ribavirin combination therapy in Taiwan||Authors:||Hsieh M.-H.
|Issue Date:||2018||Publisher:||Elsevier B.V.||Journal Volume:||117||Journal Issue:||6||Start page/Pages:||497-504||Source:||Journal of the Formosan Medical Association||Abstract:||
Background/purpose: The role of directly-acting antivirals (DAA)-containing regimens in the treatment of patients dually-infected with hepatitis C virus (HCV) and hepatitis B virus (HBV) remains unclear. The pilot study aimed to explore the safety and efficacy of a protease inhibitor, boceprevir, in combination with peginterferon/ribavirin for HCV genotype 1 (HCV-1)/HBV dually-infected patients refractory to prior peginterferon/ribavirin. Methods: Twelve peginterferon-experienced patients dually-infected with HCV-1/HBV were assigned to receive boceprevir 800 mg, twice a day, plus peginterferon-α 2b 1.5 μg/kg/week and ribavirin 800-1400 mg/day for 36 or 48 weeks. The primary endpoint was HCV sustained virological response (SVR, HCV RNA undetectable 24 weeks after end-of-treatment). Results: Five patients terminated treatment early due to adverse events (one at week 4, one at week 46), virological failures (one non-response and one breakthrough), and patient request (n = 1). Eight patients achieved HCV SVR (66.7% in full-analysis set and 72.7% in modified intention-to-treat population). The HCV SVR rate was 71.4% (5/7) in prior relapsers, 60.0% (3/5) in prior null responder; 75% in non-cirrhotic and 50% in cirrhotic patients. All four patients of prior non-cirrhotic relapsers received 36-week regimen and achieved HCV SVR. There was no HBV-related hepatic flare. All patients experienced at least one adverse event. Two had serious adverse events. Conclusion: Boceprevir plus peginterferon/ribavirin is effective in the treatment of HCV-1/HBV dually infected patients’ refractory to prior peginterferon/ribavirin combination therapy. ? 2017
|ISSN:||0929-6646||DOI:||10.1016/j.jfma.2017.06.007||SDG/Keyword:||boceprevir; erythropoietin; peginterferon alpha2b; ribavirin; alpha interferon; antivirus agent; macrogol; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alpha2b; proline; recombinant protein; ribavirin; adult; anemia; Article; blood transfusion; clinical article; cytopenia; decompensated liver cirrhosis; disease exacerbation; drug dose reduction; drug efficacy; drug safety; drug treatment failure; drug withdrawal; dyspnea; female; fever; gastrointestinal symptom; hepatitis B; Hepatitis B virus; hepatitis C; Hepatitis C virus genotype 1; human; infection; liver cirrhosis; male; mixed infection; neutropenia; pilot study; skin manifestation; Taiwan; treatment duration; treatment response; analogs and derivatives; combination drug therapy; complication; genetics; Hepacivirus; hepatitis B; hepatitis C; middle aged; recurrent disease; sustained virologic response; virus load; young adult; Adult; Antiviral Agents; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis B; Hepatitis B virus; Hepatitis C; Humans; Interferon-alpha; Male; Middle Aged; Pilot Projects; Polyethylene Glycols; Proline; Recombinant Proteins; Recurrence; Ribavirin; Sustained Virologic Response; Taiwan; Viral Load; Young Adult
|Appears in Collections:||臨床醫學研究所|
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