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 Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions.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).
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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).
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NEWS HIGHLIGHTSMedia Articles Related to Pegasys (Peginterferon Alfa-2a)
Epclusa Approved for Chronic Hepatitis C
Source: MedicineNet ribavirin Specialty [2016.06.29]
Title: Epclusa Approved for Chronic Hepatitis C
Category: Health News
Created: 6/28/2016 12:00:00 AM
Last Editorial Review: 6/29/2016 12:00:00 AM
Published Studies Related to Pegasys (Peginterferon Alfa-2a)
Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese
patients infected with hepatitis C genotype 1. [2014]
infection... CONCLUSIONS: Daclatasvir combined with alfa-2a/ribavirin in treatment-naive
Randomised clinical trial: efficacy of peginterferon alfa-2a in HBeAg positive chronic hepatitis B patients with lamivudine resistance. [2011.08]
BACKGROUND: Previous studies suggested that a finite course of peginterferon alfa-2a may offer an alternative rescue therapy for patients with lamivudine resistance. However, because of the limitation of study design and small sample size, it is difficult to make definitive conclusion. AIM: To explore the role of peginterferon alfa-2a, in the rescue treatment of HBeAg-positive chronic hepatitis B patients with lamivudine resistance... CONCLUSIONS: Overall, the response to peginterferon alfa-2a among patients with lamivudine resistance was suboptimal. HBeAg seroconversion rate at week 72 by 48 weeks peginterferon alfa-2a treatment was higher than continuous adefovir therapy. Monitoring HBsAg levels can help to predict response to peginterferon alfa-2a. (c) 2011 Blackwell Publishing Ltd.
Coffee consumption is associated with response to peginterferon and ribavirin therapy in patients with chronic hepatitis C. [2011.06]
BACKGROUND & AIMS: High-level coffee consumption has been associated with reduced progression of pre-existing liver diseases and lower risk of hepatocellular carcinoma. However, its relationship with therapy for hepatitis C virus infection has not been evaluated... CONCLUSIONS: High-level consumption of coffee (more than 3 cups per day) is an independent predictor of improved virologic response to peginterferon plus ribavirin in patients with hepatitis C. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
PHOENIX: A randomized controlled trial of peginterferon alfa-2a plus ribavirin as a prophylactic treatment after liver transplantation for hepatitis C virus. [2011.05]
The efficacy, tolerability, and safety of the prophylactic treatment of hepatitis C virus (HCV) after liver transplantation (LT) with peginterferon alfa-2a and ribavirin are not known. LT recipients with HCV were randomized to peginterferon alfa-2a/ribavirin treatment or observation 10 to 26 weeks post-LT.
Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children. [2011.05]
CONCLUSION: Overall QOL and psychosocial functioning are not deleteriously impacted by PEG 2a + RV or PL treatment of children with HCV. Copyright (c) 2011 American Association for the Study of Liver Diseases.
Clinical Trials Related to Pegasys (Peginterferon Alfa-2a)
Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) [Recruiting]
This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia
Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes
too many platelets and red blood cells to be made. Platelets are particles which circulate
in the blood stream and normally prevent bleeding and bruising. Having too many platelets in
the blood increases the risk of developing blood clots, which can result in life threatening
events like heart attacks and strokes. When the number of red blood cells is increased in PV
this will slow the speed of blood flow in the body and increases the risk of developing
blood clots.
The purpose of this study is to look at the effectiveness of giving participants who have
been diagnosed with ET or PV one of two different study regimens over time. The study
subject will be followed for their condition for about 5 years. The subject will be
randomized into one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or
Aspirin and Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed
or already receiving treatment for either PV or ET. Each of the study drugs used in this
study is already being used to treat subjects with ET or PV currently, but the investigators
are unsure which study drug is better.
Pegylated Interferon Alfa-2a Salvage Therapy in High Risk Polycythemia Vera (PV) or Essential Thrombocythemia (ET) [Recruiting]
The aim of this research is to look at two conditions, Essential Thrombocythemia (ET) and
Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets
and PV causes too many platelets and red blood cells to be made. Platelets are particles
which circulate in the blood stream and normally prevent bleeding and bruising. Having too
many platelets in the blood increases the risk of developing blood clots, which can result
in life threatening events like heart attacks and strokes. When the number of red blood
cells is increased in PV this will slow the speed of blood flow in the body and increases
the risk of developing blood clots.
It is important for patients with ET or PV who are at risk of blood clots to receive drugs
which will minimize the risks of developing these blood clots but at the moment the
investigators are not sure which drugs will best control the disorder.
The purpose of this study is to look at the effectiveness of giving patients who have been
diagnosed with ET and PV a study drug regimen using Aspirin and PEGASYS (also known as
Pegylated interferon alfa-2a, instead of the standard treatment drug called Hydroxyurea (or
hydroxycarbamide or Hydroxyurea), for whom this drug may not be suitable. The drug may not
be suitable either because it is not adequately controlling the number of blood cells or
some specific side effects occur.
Tailored Regimens of PEGASYSŪ and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1) [Recruiting]
The purposes of this study are:
1. To test if 36 weeks of standard dose of ribavirin with PEGASYSŪ is non-inferior to
standard dose of 48 weeks of ribavirin with PEGASYSŪ in SVR for patients with RVR and
HVL
2. To test if the 72 weeks of treatment with PEGASYSŪ plus standard dose ribavirin is
superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at
week 12
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance. [Completed]
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or
without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients
with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to
receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body
weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg
daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day +
pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years,
and the target sample size is 100-500 individuals.
Pegasys in Patients With Chronic Myeloid Leukemia (CML) [Terminated]
The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a
(Pegasys) to the TKI that you are already receiving can help to control CML. The safety of
this treatment combination will also be studied.
Pegasys is a form of the drug interferon. It is designed to help the body's immune system
to fight infections. It may also affect the body's response to cancer.
A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a
protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from
growing, and may cause them to die.
You are already receiving a TKI. This consent form will describe the administration of
Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys,
and any risks/benefits there may be from receiving Pegasys.
Reports of Suspected Pegasys (Peginterferon Alfa-2a) Side Effects
Anaemia (352),
Nausea (186),
Fatigue (180),
White Blood Cell Count Decreased (162),
Vomiting (133),
Asthenia (129),
Pyrexia (125),
Death (125),
Rash (124),
Dyspnoea (116), more >>
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Page last updated: 2016-06-29
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