| |
Pegasys Approved for Coinfection in Europe
|
| |
| |
Roche distributed the press announcement this morning:
News Alert -- February 3, 2005
Pegasys combination therapy approved for the treatment of hepatitis C and HIV co-infection in Europe
Pegasys becomes the first and only approved hepatitis C treatment in Europe for patients suffering from both hepatitis C and HIV
Roche announced today that the European Medicines Agency (EMEA) has approved Pegasys® (peginterferon alfa-2a) and ribavirin for the treatment of chronic hepatitis C (HCV) in clinically stable patients co-infected with HIV. This European Commission Decision comes only one month after the Positive Opinion was granted by the European Medicines Agency (EMEA), and Pegasys combination therapy is now the first hepatitis C treatment to be indicated in HIV-HCV co-infected patients in the European Union.
Roche submitted a file with the FDA in August 2004 for an indication for Pegasys and Copegus (ribavirin, USP) for the treatment of chronic hepatitis C in patients co-infected with HIV. The file has been granted priority review by the FDA because the indication would address an important unmet medical need.
It is estimated that 30 percent of people infected with HIV are also co-infected with hepatitis C. Currently, no HCV therapies have been approved in the U.S. for the treatment of chronic hepatitis C in co-infected patients.
The European approval and U.S. file are based on the findings from APRICOT (AIDS Pegasys Ribavirin International Co-infection Trial), the largest study conducted to date evaluating chronic hepatitis C. The safety and efficacy findings from this study can only be applied to Pegasys and Copegus.
"Given the unique and complex medical challenges that people with HIV face, making evidence-based treatment decisions for this population is particularly important. Roche is dedicated to continuing its hepatitis C research to provide data to better guide treatment decisions for patients, particularly those with unmet needs," said Juan Carlos Lopez-Talavera, M.D., Ph.D., Senior Medical Director, Roche.
###
Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus
Indication
• Pegasys®, a pegylated alpha interferon, alone or in combination with Copegus® (ribavirin, USP) is indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been 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).
Dosing and Administration
• Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous injection once a week. Copegus, available as a 200mg tablet, is administered at 800 to 1200mg taken twice daily as a split dose. The two products are sold separately.
Combination Therapy Clinical Studies
- The two combination therapy pivotal study findings:
- Study 5, published in the March 2, 2004 Annals of Internal Medicine, including 1,284 patients receiving medication, showed that patients with certain genotypes (strains) of the hepatitis C virus should be treated with different dosing regimens of Pegasys and Copegus. The treatment regimens and resulting sustained virological response rates for these groups treated with Pegasys and Copegus therapy were:
- Genotype 1: 48 week duration with 1000 -- 1200mg Copegus: 51 percent
- Genotype non-1: 24 week duration with 800mg Copegus: 82 percent
• Study 4, published in the September 26, 2002 New England Journal of Medicine, including 1,121 patients receiving medication, showed that Pegasys and Copegus combination therapy is a more effective treatment for chronic hepatitis C than interferon alfa-2b and ribavirin. The sustained virological response rate in the Pegasys and Copegus treated patients was 53 percent compared to 44 percent in the interferon alfa-2b and ribavirin group. Sustained virological response refers to a patient's continued undetectable serum hepatitis C RNA levels 24 weeks after finishing a course of treatment.
Adverse Events
- Alpha interferons, including Pegasys, 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 CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in complete product information).
- 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 worsening of cardiac disease. Ribavirin is genotoxic, mutagenic, and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in complete product information).
- Pegasys is contraindicated in patients with hypersensitivity to Pegasys or any of its components, autoimmune hepatitis, and decompensated hepatic disease (Child-Pugh class B and C) before or during treatment with Pegasys. Pegasys is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. Pegasys and Copegus therapy is additionally contraindicated in patients with a hypersensitivity to Copegus or any of its components, women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
- COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the six months after treatment has concluded. Routine monthly pregnancy test must be performed during this time. If pregnancy should occur during treatment or during six months post-therapy, the patient must be advised of the significant teratogenic risk of Copegus therapy to the fetus. Physicians and patients are strongly encouraged to report any pregnancies that do occur to Roche by calling 1-800-526-6367.
- The most common adverse events reported for Pegasys and Copegus combination therapy, observed in clinical trials (n=451), were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%).
- Serious adverse events include neuropsychiatric disorders (suicidal ideation and suicide attempt), serious and severe bacterial infections, bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including psoriasis and lupus), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).
- The complete package inserts for Pegasys and Copegus are available at www.pegasys.com, or by calling 1-877-PEGASYS.
# # #
|
|
| |
| |
|
|
|
