Study To Examine Hepatitis C Treatment In Latinos.

Roche 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 (peginterferon alfa-2a) plus Copegus (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.

For more information at http://www.rocheusa.com