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Roche Announces First Major Study to Examine Efficacy of Hepatitis C Treatment in Latinos
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Information on Pegasys(R) study sites available through 1-800-526-6367
NUTLEY, N.J., Nov. 22 /PRNewswire/ -- Roche today announced that the company will conduct the largest study to date comparing hepatitis C treatment response rates in Latinos and Non-Latino Caucasians with Pegasys(R) (peginterferon alfa-2a) plus Copegus(R) (ribavirin, USP), the most prescribed hepatitis C combination treatment in the United States.
Hepatitis C, a blood-borne infectious disease of the liver, can lead to cirrhosis, liver failure, and liver cancer. Latinos are disproportionately affected by hepatitis C; 2.1 percent of all Latinos, compared to 1.5 percent of all Non-Latino Caucasians have the disease. In addition, recent studies have presented evidence that hepatitis C may progress faster to cirrhosis and liver failure in Latinos compared to Non-Latino Caucasians and African Americans.
"According to the most recent U.S. census figures, more than 13 percent of the U.S. population is Latino. Yet, Latinos have been underrepresented in clinical trials. Roche made a decision to conduct this study because we believe that it will answer several important questions about hepatitis C in Latinos," said Salvatore Badalamenti, M.D., Medical Director, Roche.
The Latino study, which began enrolling in September 2004, will compare response rates to Pegasys combination therapy in Latino patients and Non- Latino Caucasian patients. Previous studies with pegylated interferon combination therapy for chronic hepatitis C have shown that African Americans are less likely to respond to treatment than Caucasians. This study is designed to determine if differences in response rates exist between Latinos and Non-Latino Caucasians.
"This is a very exciting study for the Latino community and we commend Roche for investing in this innovative study," said Debbie Delgado Vega, Founder/CEO of the Latino Organization for Liver Awareness. "We know Latinos are more likely to be impacted by hepatitis C and soon we will be able to answer the question of whether or not Latinos can expect the same results from hepatitis C therapy as non-Latinos,"
The Latino study will enroll approximately 540 patients; 270 Latinos and 270 Non-Latino Caucasians. The study will include 45 trial sites throughout the U.S. and Puerto Rico. Eligible patients for the Latino group will include those who are either from, or descendants of those from, Spanish-speaking countries in North, South and Central America.
All patients must be interferon-naove and over 18 years of age. They will receive 180 mcg subcutaneously of Pegasys, once weekly, along with either 1000 or 1200 mg/day of Copegus, depending on their weight, for 48 weeks, with 24 weeks of treatment-free follow-up.
For more information about this trial and to locate a study site call 1-800-526-6367.
About Pegasys
Pegasys, a pegylated alpha interferon, and Copegus, an oral antiviral, 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.
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, diagnostics and vitamins. 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 alpha interferon. 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, 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. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.
* 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. SOURCE Roche
Web site: http://www.rocheusa.com
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