BOX WARNING
Alpha interferons, including PEG-Intron, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-Intron therapy. See WARNINGS, ADVERSE REACTIONS. Use with Ribavirin. Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen. (See REBETOL package insert for additional information and other warnings).
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PEG-INTRON SUMMARY
PEG-Intron® , peginterferon alfa-2b, Powder for Injection is a covalent conjugate of recombinant alfa-2b interferon with monomethoxypolyethylene glycol (PEG).
PEG-Intron, peginterferon alfa-2b, is indicated for use alone or in combination with REBETOL (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.
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NEWS HIGHLIGHTS
Published Studies Related to PEG-Intron (Peginterferon Alfa-2B)
Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. [2009.08.06]
BACKGROUND: Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared... CONCLUSIONS: In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon-ribavirin regimens or between the two doses of peginterferon alfa-2b. (ClinicalTrials.gov number, NCT00081770.) 2009 Massachusetts Medical Society
Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. [2009.06.20]
PURPOSE: Interferon (IFN) -based adjuvant therapy in melanoma is associated with significant side effects, which necessitates evaluation of health-related quality of life (HRQOL). Our trial examined the HRQOL effects of adjuvant pegylated IFN-alpha-2b (PEG-IFN-alpha-2b) versus observation in patients with stage III melanoma... CONCLUSION: PEG-IFN-alpha-2b leads to a significant and sustained improvement in RFS. There is an expected negative effect on global HRQOL and selected symptoms when patients undergo PEG-IFN-alpha-2b treatment.
Retreating chronic hepatitis C with daily interferon alfacon-1/ribavirin after nonresponse to pegylated interferon/ribavirin: DIRECT results. [2009.06]
CONCLUSION: Retreatment of PEG-IFN and RBV nonresponders with CIFN and RBV is safe and efficacious and can be considered a retreatment strategy for patients failing previous therapy with PEG-IFN/RBV, especially in interferon-sensitive patients with lower baseline fibrosis scores.
Re-treatment of patients with chronic hepatitis C who do not respond to peginterferon-alpha2b: a randomized trial. [2009.04.21]
BACKGROUND: Many patients with chronic hepatitis C have not responded to therapy with pegylated interferon plus ribavirin. OBJECTIVE: To evaluate use of peginterferon-alpha2a plus ribavirin to re-treat nonresponders to peginterferon-alpha2b plus ribavirin... CONCLUSION: Re-treating nonresponders to therapy with peginterferon-alpha2b plus ribavirin for 72 weeks significantly increases SVR rates compared with re-treating them for 48 weeks. The overall SVR rate was low, but patients who are most likely to respond to re-treatment can be identified at week 12. PRIMARY FUNDING SOURCE: Roche.
Dose comparison study of pegylated interferon-alpha-2b plus ribavirin in naive Japanese patients with hepatitis C virus genotype 2: a randomized clinical trial. [2009.03]
BACKGROUND AND AIM: To compare the efficacy and safety of pegylated interferon (PEG-I) at 1 and 1.5 microg/kg, and in combination with ribavirin (RBV) for 24 weeks in naive Japanese patients infected with hepatitis C virus genotype 2... CONCLUSION: The dose of PEG-I to be used at the start of therapy should be 1.5-microg/kg BW in naive Japanese patients infected with hepatitis C virus genotype 2.
Clinical Trials Related to PEG-Intron (Peginterferon Alfa-2B)
Three Regimens of PEG-Intron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548AM2)(COMPLETED) [Completed]
This is a randomized, open-label, multinational study designed to evaluate the "standard"
regimen, PEG-Intron 1. 5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily
(Arm A), compared to a lower dose regimen, PEG-Intron 1. 0 µg/kg subcutaneously once weekly
plus ribavirin 800-1200 mg daily (Arm B), using a 24 week treatment duration for both arms.
Additionally, the study will examine the efficacy of reduced treatment duration: PEG-Intron
1. 5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks (Arm C).
Peg-Ifn Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471AM1)(COMPLETED) [Completed]
The objective is to compare the safety and efficacy of the following three treatment regimens
in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1)
PEG-Intron 1. 5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2)
PEG-Intron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3)
PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538AM1)(COMPLETED) [Completed]
The primary objective is to assess the safety, efficacy and tolerability of the combination
of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary
objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in
pediatric subjects with chronic hepatitis C.
Extended Treatment With PEG-Intron and Rebetol in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685AM3) [Active, not recruiting]
This is a controlled, randomized, parallel-groups, open-label, multinational study designed
to evaluate the efficacy and safety of PEG-Intron plus Rebetol in subjects with chronic
hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus
Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic
hepatitis C who exhibit a slow response to treatment.
PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML [Active, not recruiting]
The goal of this clinical research study is to see if a new interferon which is given only
once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety
of this treatment will also be studied. In some patients, extra blood samples will be taken
to measure the effect of treatment on leukemia cells.
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Page last updated: 2009-10-20
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