Pegasys/Copegus Show Benefit in Hard-to-Treat Latino Population with Hepatitis C

- Largest prospective study in under-treated and under-studied population (The LATINO Study) provides important insights -

SAN DIEGO, Calif., May 18, 2008 /PRNewswire/ -- Roche today announced results from the LATINO study, the largest prospective study to evaluate the response of Latino whites infected with genotype 1 hepatitis C virus (HCV) to combination therapy with pegylated interferon plus ribavirin. The results showed PEGASYS(R) (peginterferon alfa-2a) in combination with COPEGUS(R) (ribavirin) was beneficial in this hard-to-treat population. These data were presented today at the 39th Annual Digestive Disease Week(R) (DDW(R)) in San Diego, CA.

The results showed that 33.5 percent (90/269) of the Latino patients achieved sustained virological response (SVR) when treated with PEGASYS plus COPEGUS. In comparison, 49.3 percent (148/300) of patients in the non-Latino group achieved SVR, a difference of 15.8 percent, highlighting that Latino patients with hepatitis C are more difficult to treat (p < 0.0001). SVR was defined as undetectable HCV RNA 24 weeks after the end of treatment. Additionally, the data provided important information about factors that may predict SVR for Latino patients with hepatitis C.

The study was conducted to help gain a better understanding of hepatitis C treatment in a patient population that has been under-represented in clinical trials and has been known to have lower sustained SVR rates than non-Latino whites.

"We know that Latino patients with hepatitis C face different challenges when treating this disease. It has been reported that Latinos have more aggressive inflammatory activity and fibrosis progression rates than in non-Latino whites," said Maribel Rodriguez-Torres, M.D., of the Fundacion de Investigacion de Diego in Puerto Rico. "Data from studies like LATINO are important for gaining a better understanding about how patients will respond to treatment and for developing culturally-specific education programs and treatment regimens."

The LATINO study also provided information about factors associated with achieving SVR among the Latino patients who participated in this study. This information is important because it may lead to ways for healthcare professionals to better treat Latino patients.

"Roche is committed to advancing the understanding of the treatment of hepatitis C in all patient communities and we felt it was important to conduct a study like LATINO, the first ever prospective trial evaluating hepatitis C treatment response in the Latino population," said Steven C. Sembler, vice president of Commercial Operations, Roche. "These data not only deepen our understanding of PEGASYS in treating hepatitis C, they also provide insight into ways to evaluate new treatment strategies that address the needs of the Latino hepatitis C community."

Specific factors associated with achieving SVR among Latino patients in this study included low baseline levels (less than or equal to 3X the upper limit of normal [ULN], odds ratio [OR] 1.786, P=0.0797) of alanine aminotransferase (ALT), a liver enzyme; low baseline HCV RNA (less than or equal to 400,000 IU/mL [OR 2.617, p=0.0080]) and non-cirrhosis classification (OR 2.130, p=0.0959). Factors associated with achieving SVR in non-Latino whites included male sex (OR 1.95, p=0.0664), high ALT ( >3X ULN, OR 2.330, p=0.0126) and low baseline HCV RNA levels (OR 3.108, p=0.0016).

About LATINO

The LATINO study, a prospective, multicenter, open-label, non-randomized trial, was designed to compare the efficacy of PEGASYS plus COPEGUS in 269 Latino whites versus 300 non-Latino whites between the ages of 18 and 65 infected with HCV genotype 1. All patients were treatment naive and were treated with PEGASYS 180 mcg/wk plus COPEGUS 1,000 or 1,200 mg/wk for 48 weeks.

In the LATINO study, combination therapy with PEGASYS plus COPEGUS was generally safe in both populations with the expected number of adverse events reported. There were no differences in the percent of withdrawals between the groups for safety reasons.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis, liver cancer and the need for liver transplants. According to the Centers for Disease Control and Prevention (CDC), an estimated 4.1 million Americans (1.6 percent) have been infected with hepatitis C; 3.2 million are chronically infected. The number of new infections per year has declined from an average of 240,000 in the 1980s to about 26,000 in 2004. CDC estimates the number of hepatitis C-related deaths could increase to 38,000 annually by the year 2010, surpassing annual HIV/AIDS deaths.

About PEGASYS

PEGASYS, in combination with COPEGUS (ribavirin), 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. Efficacy has been demonstrated in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that are clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). In addition, PEGASYS in combination with COPEGUS is the first and only FDA-approved regimen for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV. PEGASYS is the only pegylated interferon indicated for the treatment of adult patients with chronic hepatitis B (HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation).

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, and patients who have failed to respond to previous therapy.

IMPORTANT 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).

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. 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. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and causal relationship between interferon alfa-based therapies and these events is difficult to establish.

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%). Serious adverse events in hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt, suicide, psychotic disorder and hallucinations), 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). Adverse reactions reported during post-approval use of PEGASYS therapy, with and without ribavirin, include hearing impairment, hearing loss, serious skin reactions, including erythema multiforme major, and infections (bacterial, viral and fungal).

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2007 Roche was named Top Company of the Year by Med Ad News, one of the Top 20 Employers (Science) and ranked the No. 1 Company to Sell For (Selling Power). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America (Fortune). For additional information about the U.S. pharmaceuticals business, visit our website http://www.rocheusa.com. Product and treatment information for U.S. healthcare professionals is available at www.RocheExchange.com.

About Digestive Disease Week

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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    Contacts: Linda Dyson

              Roche

              973-562-2231 (office)

              973-986-5973 (mobile)

              Linda.Dyson@roche.com


              Catherine Falcetti

              Manning Selvage & Lee

              212-468-4337 (office)

              646-246-1843 (mobile)

              Catherine.Falcetti@mslpr.com

CONTACT: Linda Dyson of Roche, +1-973-562-2231, +1-973-986-5973 (mobile),; Catherine Falcetti of Manning Selvage & Lee,+1-212-468-4337, +1-646-246-1843 (mobile), Linda.Dyson@roche.com Catherine.Falcetti@mslpr.com

Web site: http://www.rocheusa.com/http://www.RocheExchange.com/http://www.ddw.org/

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Posted: May 2008

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