PEGASYS® Proven Effective as Hepatitis C Treatment for Latino Patients, According to Article in The New England Journal of Medicine

-- Largest Prospective Study Demonstrates Treatment Success, and Highlights Potential Factors that Affect Health Outcomes, in Latino Population Suffering from Chronic Hepatitis C--

Results from the LATINO study, the largest study conducted to-date in Latino patients with the hepatitis C virus (HCV), were published today in The New England Journal of Medicine (NEJM). This Roche study demonstrated that HCV can be successfully treated among Latino patients, a patient population that is historically difficult to treat. The study, “Peginterferon Alfa-2a and Ribavirin in Latino and Non-Latino Whites with Hepatitis C,” was conducted to better understand how previously untreated Latino patients with HCV genotype 1, the most difficult-to-treat genotype, responded to treatment with PEGASYS® (peginterferon alfa-2a) plus COPEGUS® (ribavirin) as compared to non-Latino whites.

“We know that the hepatitis C virus affects Latino patients differently than non-Latino patients, but there was little data available to support what we have seen clinically. The LATINO data are important because, for the first time, a large-scale study was conducted that focused on Latino patients, providing insight into this growing population,” said Maribel Rodriguez-Torres, M.D., of the Fundación de Investigación de Diego in Puerto Rico. “We hope that this landmark LATINO study will be the beginning of more clinical trials with greater numbers of Latino patients, which will help address the unmet medical need of this population.”

The data showed that Latino patients achieved sustained virological response (SVR) at a lower rate than non-Latino whites, and demonstrated that there were differences in predictors of SVR between the two patient populations. The results of this study add to a growing body of evidence of differences in treatment responses among ethnic groups and underscore the need to optimize treatment strategies in order to improve the rate of SVR among Latino patients infected with HCV genotype 1.

“As leaders in hepatology, we are proud to have conducted the largest prospective study of the Latino population with hepatitis C,” said Dr. Lars Birgerson, Head of Global Medical Affairs, Roche. “We look forward to further investigating unmet medical needs and providing future treatment options, for Latinos and other hard-to-treat populations, through our clinical research program.”

These findings point to an important public health issue, since Latinos, the fastest-growing minority population in the United States, have a higher prevalence of HCV and more rapid fibrosis progression than non-Latino whites, and a mortality rate of nearly twice that of non-Latino whites. The predicted expansion of the number of Latinos in the United States suggests that the prevalence of HCV infection will increase. These factors are likely to contribute to the already increasing rates of morbidity and mortality among Latinos due to liver disease.

The LATINO study, a prospective, multicenter, open-label, nonrandomized trial, was designed to compare the efficacy of PEGASYS plus COPEGUS in 269 Latino whites and 300 non-Latino whites infected with HCV genotype 1 who had not been previously treated. The primary endpoint of the study was SVR. All patients, between the ages of 18 and 65, were treated with PEGASYS 180 mcg/wk plus COPEGUS 1,000 or 1,200 mg/day for 48 weeks. Patients were then followed through 72 weeks. Latinos were required to have two generations of Latino ancestry with Spanish as a primary language, and non-white Latinos were excluded.

The results from LATINO showed that 34 percent (90/269) of the Latino patients achieved SVR when treated with PEGASYS plus COPEGUS. In comparison, 49 percent (148/300) of patients in the non-Latino group achieved SVR, a difference of 16 percent, highlighting that Latino patients with HCV are more difficult to treat. SVR was defined as undetectable HCV RNA 24 weeks after the end of treatment. Combination therapy with PEGASYS plus COPEGUS was generally well tolerated, with similar rates of withdrawals between the groups for serious adverse events, with fatigue, fever and flu-like symptoms being the most common adverse events.

These results contribute to a growing body of evidence that PEGASYS provides a successful outcome for many patients with HCV. PEGASYS has consistently demonstrated efficacy in a broad range of patient types, even those with poor prognostic factors, including African Americans and patients co-infected with HIV. Two independent, investigator-initiated, single-center Italian studies with PEGASYS have shown reproducible efficacy in HCV patients with genotype 1 and 4 compared to peginterferon alfa-2b. In genotypes 1 and 4 – the most difficult-to-treat patient group – 55 percent of patients taking PEGASYS achieved SVR, compared to 40 percent of patients in the peginterferon alfa-2b group. Results of another study found significantly higher SVR rates in patients treated with PEGASYS and ribavirin compared to those treated with peginterferon alfa-2b and ribavirin (66 percent vs. 54 percent). The difference was sustained in patients with the most difficult to treat forms of the virus, those infected with genotypes 1 or 4 (48 percent vs. 32 percent).

As the current foundation of HCV treatment, PEGASYS is the pegylated interferon therapy of choice for most HCV antiviral agents in development. These collaborations position Roche as a leader in the next evolution of HCV treatment, and the LATINO study underscores Roche’s role as a pioneer in the advancement of understanding HCV.