PEGASYS(R)/COPEGUS(R) Show Benefit in Hard-to-Treat Latino Population with Hepatitis C

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: 75.47, +0.04, +0.05%) (peginterferon alfa-2a) in combination with COPEGUS(R: 75.47, +0.04, +0.05%) (ribavirin) was beneficial in this hard-to-treat population. These data were presented today at the 39th Annual Digestive Disease Week(R: 75.47, +0.04, +0.05%) (DDW(R: 75.47, +0.04, +0.05%)) in San Diego, CA.

The results showed that 33.5 percent (90/269) of the Latino patients achieved sustained virological response (SVR: 22.22, -0.13, -0.58%) 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”*

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