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Roche Announces Expansion of First Major Study to Examine Efficacy of Pegasys(R) in Hepatitis C Treatment in Latinos
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NUTLEY, N.J., Nov. 3 /PRNewswire/ -- Roche announced today that the company is investing more resources in treating the Latino community by expanding the largest study to date comparing hepatitis C treatment response rates in Latinos and non-Latino Caucasians treated with Pegasys(R) (peginterferon alfa-2a) plus Copegus(R) (ribavirin, USP). This study is one of the first conducted among this population, and will help researchers understand the response to hepatitis C treatment among the Latino community.
To recruit additional patients, Roche has increased the number of trial sites to 60 (up from 45) throughout the United States and Puerto Rico. When recruitment is complete, the study will enroll a total of 540 patients -- 270 Latinos and 270 non-Latino Caucasians.
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 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.
"This study will be an important benchmark in understanding the Latino population's response to hepatitis C treatment," said James Thommes, M.D., Senior Medical Director, Roche. "Expanding the study by increasing the number of trial sites will enable us to make the study as effective as possible and get us one step closer to answering the many questions that exist about treating hepatitis C in Latinos."
Roche is committed to conducting clinical trials to expand the efficacy of Pegasys and provide high quality treatment options for all patient populations. This study, which began enrolling in September 2004, is comparing 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, but there has never been a study of this kind conducted with the Latino community.
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.
"Until now, Latinos have been underrepresented in clinical trials, despite making up approximately 13 percent of the United States population," said Debbie Delgado Vega, Founder/CEO of the Latino Organization for Liver Awareness (LOLA). "We commend Roche for investing in this innovative study and expanding the trial sites to make it more convenient for Latino patients to enroll into the trial and receive treatment."
All patients must be interferon-naive 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 -- More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.
Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com and U.S.: http://www.roche.us).
HCV/HIV MD SAFETY INFORMATION
PEGASYS, 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) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy).
Alpha interferons, including PEGASYS(R) (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 CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
Use with Ribavirin. Ribavirin, including COPEGUS(R), 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 CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. Pegasys is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is 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, in 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 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 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.
Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score greater than or equal to 6) is observed.
The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials 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%). The adverse event profile of coinfected patients treated with PEGASYS and COPEGUS was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%) and mood alteration (9%).
Serious adverse events included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt and suicide), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis and ophthalmologic 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
11/03/2005 09:00 ET
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