Pegylated Interferon

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  • Pegylated Interferon α2b pharmacokinetics pharmacodynamics safety and preliminary efficacy data
    Clinical Pharmacology & Therapeutics, 2000
    Co-Authors: Paul Glue, Jane W S Fang, Regine Rouzierpanis, Claude Raffanel, Ron Sabo, Samir K Gupta, Margaret Salfi, Sheila Jacobs
    Abstract:

    Aims The objectives of this study were to assess the safety, pharmacokinetic and pharmacodynamic profiles, and antiviral efficacy of Pegylated Interferon-α2b monotherapy in patients with chronic hepatitis C. Methods Fifty-eight patients (38 men, 20 women; age range, 25 to 65 years) with compensated chronic hepatitis C were enrolled in this open-label, randomized, active controlled study. Patients received 0.035 to 2.0 μg/kg Pegylated Interferon-α2b subcutaneously weekly or the active control, Interferon-α2b 3 million IU subcutaneously three times/week, for 24 weeks. Safety and antiviral efficacy assessments were performed during treatment and in a subsequent 4-week follow-up period. Detailed pharmacokinetic assessments were performed at weeks 1 and 4. Results Pegylated Interferon-α2b produced dose-related reductions in white blood cells, neutrophils, and platelets, and dose-related increases in oral temperature, serum neopterin, and serum 2′5′-oligoadenylate synthetase activity, which were qualitatively similar to those produced by nonPegylated Interferon-α2b. Reported adverse events (flu-like symptoms, asthenia) were qualitatively similar in Pegylated Interferon-α2b– and nonPegylated Interferon-α2b–treated groups. Dose-related antiviral activity, as measured by loss of detectable serum hepatitis C virus RNA (<100 copies/mL), was noted at the end of treatment and after 4 weeks of follow-up. Both Pegylated and nonPegylated Interferon-α2b were rapidly absorbed, with maximal concentrations occurring ~8 to 12 hours after dose administration. Pegylated Interferon-α2b had sustained maximal serum concentrations for 48 to 72 hours after dose administration, whereas nonPegylated Interferon-α2b concentrations declined rapidly. Volume of distribution for both compounds was similar (~1 L/kg). Pegylated Interferon-α2b elimination half-life was approximately 10-fold greater, and mean apparent clearance was one tenth that of nonPegylated Interferon-α2b. Conclusions Pegylated and nonPegylated Interferon-α2b safety and pharmacodynamic profiles were comparable. Pegylated Interferon-α2b demonstrated delayed clearance compared with nonPegylated Interferon-α2b, consistent with once-weekly administration. Clinical Pharmacology & Therapeutics (2000) 68, 556–567; doi: 10.1067/mcp.2000.110973

  • Pegylated Interferon-α2b : Pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data
    Clinical pharmacology and therapeutics, 2000
    Co-Authors: Paul Glue, Jane W S Fang, Claude Raffanel, Ron Sabo, Samir K Gupta, Margaret Salfi, Regine Rouzier‐panis, Sheila Jacobs
    Abstract:

    Aims The objectives of this study were to assess the safety, pharmacokinetic and pharmacodynamic profiles, and antiviral efficacy of Pegylated Interferon-α2b monotherapy in patients with chronic hepatitis C. Methods Fifty-eight patients (38 men, 20 women; age range, 25 to 65 years) with compensated chronic hepatitis C were enrolled in this open-label, randomized, active controlled study. Patients received 0.035 to 2.0 μg/kg Pegylated Interferon-α2b subcutaneously weekly or the active control, Interferon-α2b 3 million IU subcutaneously three times/week, for 24 weeks. Safety and antiviral efficacy assessments were performed during treatment and in a subsequent 4-week follow-up period. Detailed pharmacokinetic assessments were performed at weeks 1 and 4. Results Pegylated Interferon-α2b produced dose-related reductions in white blood cells, neutrophils, and platelets, and dose-related increases in oral temperature, serum neopterin, and serum 2′5′-oligoadenylate synthetase activity, which were qualitatively similar to those produced by nonPegylated Interferon-α2b. Reported adverse events (flu-like symptoms, asthenia) were qualitatively similar in Pegylated Interferon-α2b– and nonPegylated Interferon-α2b–treated groups. Dose-related antiviral activity, as measured by loss of detectable serum hepatitis C virus RNA (

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Paul Glue - One of the best experts on this subject based on the ideXlab platform.

  • Pegylated Interferon α2b pharmacokinetics pharmacodynamics safety and preliminary efficacy data
    Clinical Pharmacology & Therapeutics, 2000
    Co-Authors: Paul Glue, Jane W S Fang, Regine Rouzierpanis, Claude Raffanel, Ron Sabo, Samir K Gupta, Margaret Salfi, Sheila Jacobs
    Abstract:

    Aims The objectives of this study were to assess the safety, pharmacokinetic and pharmacodynamic profiles, and antiviral efficacy of Pegylated Interferon-α2b monotherapy in patients with chronic hepatitis C. Methods Fifty-eight patients (38 men, 20 women; age range, 25 to 65 years) with compensated chronic hepatitis C were enrolled in this open-label, randomized, active controlled study. Patients received 0.035 to 2.0 μg/kg Pegylated Interferon-α2b subcutaneously weekly or the active control, Interferon-α2b 3 million IU subcutaneously three times/week, for 24 weeks. Safety and antiviral efficacy assessments were performed during treatment and in a subsequent 4-week follow-up period. Detailed pharmacokinetic assessments were performed at weeks 1 and 4. Results Pegylated Interferon-α2b produced dose-related reductions in white blood cells, neutrophils, and platelets, and dose-related increases in oral temperature, serum neopterin, and serum 2′5′-oligoadenylate synthetase activity, which were qualitatively similar to those produced by nonPegylated Interferon-α2b. Reported adverse events (flu-like symptoms, asthenia) were qualitatively similar in Pegylated Interferon-α2b– and nonPegylated Interferon-α2b–treated groups. Dose-related antiviral activity, as measured by loss of detectable serum hepatitis C virus RNA (<100 copies/mL), was noted at the end of treatment and after 4 weeks of follow-up. Both Pegylated and nonPegylated Interferon-α2b were rapidly absorbed, with maximal concentrations occurring ~8 to 12 hours after dose administration. Pegylated Interferon-α2b had sustained maximal serum concentrations for 48 to 72 hours after dose administration, whereas nonPegylated Interferon-α2b concentrations declined rapidly. Volume of distribution for both compounds was similar (~1 L/kg). Pegylated Interferon-α2b elimination half-life was approximately 10-fold greater, and mean apparent clearance was one tenth that of nonPegylated Interferon-α2b. Conclusions Pegylated and nonPegylated Interferon-α2b safety and pharmacodynamic profiles were comparable. Pegylated Interferon-α2b demonstrated delayed clearance compared with nonPegylated Interferon-α2b, consistent with once-weekly administration. Clinical Pharmacology & Therapeutics (2000) 68, 556–567; doi: 10.1067/mcp.2000.110973

  • Pegylated Interferon-α2b : Pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data
    Clinical pharmacology and therapeutics, 2000
    Co-Authors: Paul Glue, Jane W S Fang, Claude Raffanel, Ron Sabo, Samir K Gupta, Margaret Salfi, Regine Rouzier‐panis, Sheila Jacobs
    Abstract:

    Aims The objectives of this study were to assess the safety, pharmacokinetic and pharmacodynamic profiles, and antiviral efficacy of Pegylated Interferon-α2b monotherapy in patients with chronic hepatitis C. Methods Fifty-eight patients (38 men, 20 women; age range, 25 to 65 years) with compensated chronic hepatitis C were enrolled in this open-label, randomized, active controlled study. Patients received 0.035 to 2.0 μg/kg Pegylated Interferon-α2b subcutaneously weekly or the active control, Interferon-α2b 3 million IU subcutaneously three times/week, for 24 weeks. Safety and antiviral efficacy assessments were performed during treatment and in a subsequent 4-week follow-up period. Detailed pharmacokinetic assessments were performed at weeks 1 and 4. Results Pegylated Interferon-α2b produced dose-related reductions in white blood cells, neutrophils, and platelets, and dose-related increases in oral temperature, serum neopterin, and serum 2′5′-oligoadenylate synthetase activity, which were qualitatively similar to those produced by nonPegylated Interferon-α2b. Reported adverse events (flu-like symptoms, asthenia) were qualitatively similar in Pegylated Interferon-α2b– and nonPegylated Interferon-α2b–treated groups. Dose-related antiviral activity, as measured by loss of detectable serum hepatitis C virus RNA (

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