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

Monday, May 19, 2008 General News J E 4
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SAN DIEGO, Calif., May 18 Roche today announced resultsfrom the LATINO study, the largest prospective study to evaluate the responseof Latino whites infected with genotype 1 hepatitis C virus (HCV) tocombination therapy with pegylated interferon plus ribavirin. The resultsshowed PEGASYS(R) (peginterferon alfa-2a) in combination with COPEGUS(R)(ribavirin) was beneficial in this hard-to-treat population. These data werepresented today at the 39th Annual Digestive Disease Week(R) (DDW(R)) in SanDiego, CA.

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

The study was conducted to help gain a better understanding of hepatitis Ctreatment in a patient population that has been under-represented in clinicaltrials and has been known to have lower sustained SVR rates than non-Latinowhites.

"We know that Latino patients with hepatitis C face different challengeswhen treating this disease. It has been reported that Latinos have moreaggressive inflammatory activity and fibrosis progression rates than innon-Latino whites," said Maribel Rodriguez-Torres, M.D., of the Fundacion deInvestigacion de Diego in Puerto Rico. "Data from studies like LATINO areimportant for gaining a better understanding about how patients will respondto treatment and for developing culturally-specific education programs andtreatment regimens."

The LATINO study also provided information about factors associated withachieving SVR among the Latino patients who participated in this study. Thisinformation is important because it may lead to ways for healthcareprofessionals to better treat Latino patients.

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

Specific factors associated with achieving SVR among Latino patients inthis study included low baseline levels (less than or equal to 3X the upperlimit of normal [ULN], odds ratio [OR] 1.786, P=0.0797) of alanineaminotransferase (ALT), a liver enzyme; low baseline HCV RNA (less than orequal 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-Latinowhites 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-randomizedtrial, was designed to compare the efficacy of PEGASYS plus COPEGUS in 269Latino whites versus 300 non-Latino whites between the ages of 18 and 65infected with HCV genotype 1. All patients were treatment naive and weretreated with PEGASYS 180 mcg/wk plus COPEGUS 1,000 or 1,200 mg/wk for 48weeks.

In the LATINO study, combination therapy with PEGASYS plus COPEGUS wasgenerally safe in both populations with the expected number of adverse eventsreported. There were no differences in the percent of withdrawals between thegroups for safety reasons
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