BOX WARNING
Alpha interferons, including PEGASYS (peginterferon alfa-2a), 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. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see WARNINGS and ADVERSE REACTIONS). Use with Ribavirin. Ribavirin, including COPEGUS® , may cause birth defects and/or death of the fetus. 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 ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see COPEGUS Package Insert for additional information and other WARNINGS).
|
|
| |
PEGASYS SUMMARY
PEGASYS, peginterferon alfa-2a, is a covalent conjugate of recombinant alfa-2a interferon (approximate molecular weight [MW] 20,000 daltons) with a single branched bis-monomethoxy polyethylene glycol (PEG) chain (approximate MW 40,000 daltons).
PEGASYS, peginterferon alfa-2a, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
|
NEWS HIGHLIGHTSMedia Articles Related to Pegasys (Peginterferon Alfa-2a)
InterMune Announces Modification To On-Going Phase 2b Study Of ITMN-191 In Patients With Chronic HCV Infection
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.18]
InterMune, Inc. (Nasdaq: ITMN) announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified. The Phase 2b study has four dosage cohorts: SOC; 300mg q8h plus SOC; 600mg q12h plus SOC and 900mg q12h plus SOC. To date, approximately 175 patients have been enrolled in the study.
Schering-Plough Reports Potent Antiviral Activity With Narlaprevir (SCH 900518), An Investigational, Once-Daily Protease Inhibitor For Hepatitis C
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.03]
Schering-Plough Corporation (NYSE: SGP) reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.
Women Are At Greater Risk Than Men Of Graft Loss After Undergoing Liver Transplantation For Hepatitis C-related Liver Disease
Source: Transplants / Organ Donations News From Medical News Today [2009.10.30]
Although women with chronic hepatitis C virus (HCV) infection are at lower risk for developing cirrhosis, researchers who compared outcomes for men and women after having liver transplantation found that women have a significantly increased risk of overall graft loss and graft loss from recurrent HCV than men.
Published Studies Related to Pegasys (Peginterferon Alfa-2a)
Impact of high-dose peginterferon alfa-2A on virological response rates in patients with hepatitis C genotype 1: a randomized controlled trial. [2009.10]
CONCLUSION: Induction dosing with 360 microg/week PEG-IFNalpha-2a for 12 weeks was well tolerated and enhanced early virological response but not SVR rates. The high SVR rates in patients with minimal fibrosis highlight the benefit of early treatment in patients with hepatitis C virus genotype 1.
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
Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naive patients with genotype 1, chronic hepatitis C. [2009.07]
BACKGROUND/AIMS: Albinterferon alfa-2b is a novel, long-acting, fusion polypeptide that is dosed q2wk or q4wk. The predictive value of early virologic response during albinterferon alfa-2b or peginterferon alfa-2a treatment was investigated in interferon-naive patients with genotype 1, chronic hepatitis C... CONCLUSIONS: Improved SVR prediction was obtained by integrating absolute levels and reduction of HCV RNA at treatment week 2 and 4. Patients with RIVR had a high likelihood of achieving SVR.
Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a. [2009.06]
BACKGROUND & AIMS: Patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B treated with peginterferon alpha-2a with or without lamivudine achieve significantly higher 6-month posttreatment rates of response compared with those treated with lamivudine alone. The durability of <or=3-year posttreatment response was investigated in this study... CONCLUSIONS: Biochemical and virologic responses were sustained for <or=3 years in approximately 25% of patients given a 48-week course of peginterferon alpha-2a, with or without lamivudine. The increased rate of HBsAg clearance in patients with HBeAg-negative chronic hepatitis B supports the use of peginterferon alpha-2a as a first-line treatment.
Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. [2009.04.30]
BACKGROUND: In patients with chronic infection with hepatitis C virus (HCV) genotype 1, treatment with peginterferon alfa and ribavirin for 48 weeks results in rates of sustained virologic response of 40 to 50%. Telaprevir is a specific inhibitor of the HCV serine protease and could be of value in HCV treatment... CONCLUSIONS: In this phase 2 study of patients infected with HCV genotype 1 who had not been treated previously, one of the three telaprevir groups had a significantly higher rate of sustained virologic response than that with standard therapy. Response rates were lowest with the regimen that did not include ribavirin. (ClinicalTrials.gov number, NCT00372385.) 2009 Massachusetts Medical Society
Clinical Trials Related to Pegasys (Peginterferon Alfa-2a)
A Study of HCV Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection. [Active, not recruiting]
This 7 arm study will determine the optimal treatment combination, based on efficacy and
safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7
treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV
polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or
180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24
weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus
1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus
PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks,
those achieving a rapid virological response (RVR) will stop all medication, and non-RVR
patients will remain on triple combination for an additional 24 weeks. Group 7 will receive
SOC for 48 weeks. There will be a 24 week period of treatment-free follow-up for all
treatment groups. The anticipated time on study treatment is 3-12 months, and the target
sample size is 100-500 individuals.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC). [Completed]
The effects of treatment with different doses of PEGASYS in combination with different doses
of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer,
body weight greater than 85kg (187lbs) and no prior treatment with interferon. The
anticipated time on study treatment is 3-12 months and the target sample size is 100-500
individuals.
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C. [Active, not recruiting]
This 4 arm study will compare the efficacy and safety of PEGASYS induction and maintenance
dosing, versus standard fixed dosing in combination with Copegus,and the efficacy and safety
of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with
chronic hepatitis C genotype 1 infection of high viral titer, and baseline body weight
>=85kg, will be randomized to one of 4 groups, to receive a)PEGASYS 180 micrograms sc weekly
plus Copegus 1200mg po daily, b)PEGASYS 180 micrograms sc weekly plus Copegus 1400-1600mg po
daily, c)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly
(maintenance) plus Copegus 1200mg po daily or d)PEGASYS 360 micrograms sc weekly (induction)
followed by 180 micrograms sc weekly (maintenance) plus Copegus 1400-1600mg po daily.
Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The
anticipated time on study treatment is 3-12 months, and the target sample size is 500+
individuals.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection. [Active, not recruiting]
This 2 arm study will compare the efficacy and safety of treatment with Pegasys (180
micrograms sc weekly) plus Copegus (800mg po daily) and PEGASYS (180 micrograms sc weekly)
plus Copegus (1000-1200mg po daily) in interferon-naive patients with CHC genotype 1
co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be
followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months,
and the target sample size is 100-500 individuals.
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy [Completed]
This 4 arm study is designed for patients with CHC who have not responded to peginterferon
alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening
the duration of treatment, as well as including an initial 12-week period of high-dose
PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS
(180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment
is 1-2 years and the target sample size is 500+ individuals.
|
|
|
|
Page last updated: 2009-11-18
|
