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Roche Will Expand Study Comparing Hepatitis C Response Rates
in Latinos and Non-Latino Caucasians Treated with Pegasys
Plus Copegus
 Roche
announced that the company is investing more resources in
treating the Latino community by expanding the largest study
to date comparing hepatitis C treatment response rates in
Latinos
and non-Latino Caucasians treated with Pegasys
(peginterferon alfa-2a) plus Copegus
(ribavirin, USP).
This
study is one of the first conducted among this population,
and will help researchers understand the response to hepatitis
C treatment among the Latino community. Following are
excerpts from the Roche announcement:
“To
recruit additional patients, Roche has increased the number
of trial sites to 60 (up from 45) throughout the United
States and Puerto
Rico. When recruitment is complete, the
study will enroll a total of 540 patients – 270 Latinos and
270 non-Latino Caucasians.
“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 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.
“This
study will be an important benchmark in understanding the
Latino population’s response to hepatitis C treatment,” said
James Thommes, M.D., Senior Medical
Director, Roche. “Expanding
the study by increasing the number of trial sites will enable
us to make the study as effective as possible and get us one
step closer to answering the many questions that exist about
treating hepatitis C in Latinos.”
“Roche
is committed to conducting clinical trials to expand the efficacy
of Pegasys and provide high quality
treatment options for all patient populations.
“This
study, which began enrolling in September 2004, is comparing
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, but there has never been a study
of this kind conducted with the Latino community.
“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.
“Until
now, Latinos have been underrepresented in clinical trials,
despite making up approximately 13 percent of the United
States population,” said
Debbie Delgado Vega, Founder/CEO of the Latino Organization
for Liver Awareness (LOLA). “We commend Roche for investing
in this innovative study and expanding the trial sites to
make it more convenient for Latino patients to enroll into
the trial and receive treatment.”
“All
patients must be interferon-naïve and over 18 years of age.
They will receive 180 mcg subcutaneously of Pegasys,
once weekly, along with either 1000 or 1200 mg/day of Copegus,
depending on their weight, for 48 weeks, with 24 weeks of
treatment-free follow-up.
For
more information about this trial and to locate a study site
call 1-800-526-6367.
About
Pegasys
Pegasys, a pegylated alpha interferon,
and Copegus, an oral antiviral,
were approved by the FDA in December 2002 for use in combination
for the treatment of adults with chronic hepatitis C who have
compensated liver disease and have not previously been treated
with interferon alpha. Patients in whom efficacy was
demonstrated included patients with compensated liver disease
and histological evidence of cirrhosis.
HIV
and Hepatitis.com
- Articles
on Pegasys Plus
Copegus
- Prescribing
information on Pegasys and Copegus
11/04/05
Source
www.rocheusa.com
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