-- Signals Major Step Toward Satisfying Unmet Medical Need --
NUTLEY, N.J., Oct. 6 /PRNewswire/ -- The U.S. Food and Drug Administration
(FDA) has granted a six-month Priority Review Status to the supplemental new
biologics license application (sBLA) for Roche's combination therapy of
Pegasys(R) (peginterferon alfa-2a) in combination with Copegus(R) (ribavirin,
USP) for the treatment of chronic hepatitis C in patients co-infected with
HIV. Roche submitted this file with the FDA in August 2004.
Pegasys, the most prescribed hepatitis C medication in the U.S., is
approved for use alone and in combination with Copegus for the treatment of
adults with chronic hepatitis C. Priority review designation was granted for
the Pegasys and Copegus submission in co-infected patients because the
indication would address an unmet medical need.
"There are currently no approved treatments for the approximately 300,000
people in the United States with HIV who are infected with hepatitis C," said
Juan Carlos Lopez-Talavera, M.D., Ph.D., Senior Medical Director, Roche.
"Roche invested in the research to pursue an indication for Pegasys
combination therapy in co-infected patients because we recognized that the
need is urgent. Liver failure resulting from chronic hepatitis C is now one
of the leading causes of death in people with HIV."
HCV and HIV are the two most prevalent blood-borne infections in the
United States, and HCV/HIV co-infection is increasingly recognized as a
growing public health problem. According to the Centers for Disease Control,
hepatitis C has become a major cause of death for people with HIV.
Almost four million Americans are believed to have chronic hepatitis C.
The file submitted to the FDA includes results from APRICOT (AIDS Pegasys
Ribavirin International Co-infection Trial), the largest study conducted to
date evaluating chronic hepatitis C treatment in patients co-infected with HIV
and HCV. APRICOT is one of the six Pegasys studies published in The New
England Journal of Medicine. The results showed that 40 percent of patients
treated with Pegasys and Copegus achieved a sustained virological response
(SVR). SVR refers to a patient's continued undetectable hepatitis C virus
levels in the blood 24 weeks after finishing a course of treatment.
About Pegasys
Pegasys, a pegylated alpha interferon, and Copegus were approved by the
FDA in December 2002 for use in combination 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.
Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week.
Copegus is available as a 200mg tablet, and is administered orally two times a
day as a split dose.
Roche has backed Pegasys with the most extensive clinical research program
ever undertaken in hepatitis C, with major studies initiated to advance
treatment for hepatitis C patients with unmet needs, including patients co-
infected with HIV and HCV, African Americans, patients with cirrhosis,
patients with normal ALT levels, and patients who have failed to respond to
previous therapy.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
prescription drug unit of the Roche Group, a leading research-based health
care enterprise that ranks among the world's leaders in pharmaceuticals and
diagnostics. Roche discovers, develops, manufactures and markets numerous
important prescription drugs that enhance people's health, well-being and
quality of life. Among the company's areas of therapeutic interest are:
dermatology; genitourinary disease; infectious diseases, including influenza;
inflammation, including arthritis and osteoporosis; metabolic diseases,
including obesity and diabetes; neurology; oncology; transplantation; vascular
diseases; and virology, including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in the United
States, visit the company's web site at: http://www.rocheusa.com
Facts About Pegasys (Peginterferon alfa-2a) in Combination with
Copegus Indication
* Pegasys(R), a pegylated alpha interferon, alone or in combination with
Copegus(R) (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
http://www.pegasys.com , or by calling 1-877-PEGASYS.
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