- Largest prospective study in under-treated and under-studied population
(The LATINO Study) provides important insights -
SAN DIEGO, Calif., May 18 /PRNewswire/ -- 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) (peginterferon alfa-2a) in combination with
COPEGUS(R) (ribavirin) was beneficial in this hard-to-treat population.
These data were presented today at the 39th Annual Digestive Disease
Week(R) (DDW(R)) in San Diego, CA.
The results showed that 33.5 percent (90/269) of the Latino patients
achieved sustained virological response (SVR) 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.
About PEGASYS
PEGASYS, in combination with COPEGUS (ribavirin), is indicated for the
treatment of adults with chronic hepatitis C who have compensated liver
disease and have not previously been treated with interferon alpha.
Efficacy has been demonstrated in patients with compensated liver disease
and histological evidence of cirrhosis (Child-Pugh class A) and patients
with HIV disease that are clinically stable (e.g., antiretroviral therapy
not required or receiving stable antiretroviral therapy). In addition,
PEGASYS in combination with COPEGUS is the first and only FDA-approved
regimen for the treatment of chronic hepatitis C in patients coinfected
with hepatitis C and HIV. PEGASYS is the only pegylated interferon
indicated for the treatment of adult patients with chronic hepatitis B
(HBeAg positive and HBeAg negative chronic hepatitis B who have compensated
liver disease and evidence of viral replication and liver inflammation).
PEGASYS is dosed at 180mcg as a subcutaneous injection taken once a
week. COPEGUS is available as a 200mg tablet, and is administered orally
two times a day as a split dose. Roche has backed PEGASYS with the most
extensive clinical research program ever undertaken in hepatitis C, with
major studies initiated to advance treatment for hepatitis C patients with
unmet needs, including patients co-infected with HIV and HCV, African
Americans, patients with cirrhosis, and patients who have failed to respond
to previous therapy.
IMPORTANT SAFETY INFORMATION
PEGASYS, alone or in combination with COPEGUS, is indicated for the
treatment of adults with chronic hepatitis C virus infection who have
compensated liver disease and have not been previously treated with
interferon alpha. Patients in whom efficacy was demonstrated included
patients with compensated liver disease and histological evidence of
cirrhosis (Child-Pugh class A).
Alpha interferons, including PEGASYS(R) (Peginterferon alfa-2a), may
cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune,
ischemic, and infectious disorders. Patients should be monitored closely
with periodic clinical and laboratory evaluations. Therapy should be
withdrawn in patients with persistently severe or worsening signs or
symptoms of these conditions. In many, but not all cases, these disorders
resolve after stopping PEGASYS therapy (see CONTRAINDICATIONS, WARNINGS,
PRECAUTIONS and ADVERSE REACTIONS in complete product information).
Use with Ribavirin. Ribavirin, including COPEGUS(R), may cause birth
defects and/or death of the fetus. Extreme care must be taken to avoid
pregnancy in female patients and in female partners of male patients.
Ribavirin causes hemolytic anemia. The anemia associated with ribavirin
therapy may result in a worsening of cardiac disease. Ribavirin is
genotoxic and mutagenic and should be considered a potential carcinogen
(see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in
complete product information).
PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS
or any of its components, autoimmune hepatitis, and hepatic decompensation
(Child-Pugh score greater than 6; class B and C) in cirrhotic CHC
monoinfected patients before or during treatment. PEGASYS is also
contraindicated in hepatic decompensation with Child-Pugh score greater
than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or
during treatment. PEGASYS is also contraindicated in neonates and infants
because it contains benzyl alcohol. Benzyl alcohol is associated with an
increased incidence of neurological and other complications in neonates and
infants, which are sometimes fatal. PEGASYS and COPEGUS therapy is
additionally contraindicated in patients with a hypersensitivity to COPEGUS
or any of its components, in women who are pregnant, men whose female
partners are pregnant, and patients with hemoglobinopathies (eg,
thalassemia major, sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE
PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF
THERAPY. Women of childbearing potential and men must use two forms of
effective contraception during treatment and during the 6 months after
treatment has concluded. Routine monthly pregnancy tests must be performed
during this time. If pregnancy should occur during treatment or during 6
months post-therapy, the patient must be advised of the significant
teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and
patients are strongly encouraged to immediately report any pregnancy in a
patient or partner of a patient during treatment or during 6 months after
treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.
Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of
hepatic decompensation and death when treated with alpha interferons,
including PEGASYS. During treatment, patients' clinical status and hepatic
function should be closely monitored, and PEGASYS treatment should be
immediately discontinued if decompensation (Child-Pugh score greater than
or equal to 6) is observed. Ischemic and hemorrhagic cerebrovascular events
have been observed in patients treated with interferon alfa-based
therapies, including PEGASYS. Events occurred in patients with few or no
reported risk factors for stroke, including patients less than 45 years of
age. Because these are spontaneous reports, estimates of frequency cannot
be made and causal relationship between interferon alfa-based therapies and
these events is difficult to establish.
The most common adverse events reported for PEGASYS and COPEGUS
combination therapy observed in clinical trials were fatigue/asthenia
(65%), headache (43%), pyrexia (41%), myalgia (40%),
irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%),
neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%),
injection site reaction (23%), arthralgia (22%), depression (20%), pruritus
(19%) and dermatitis (16%). Serious adverse events in hepatitis C trials
included neuropsychiatric disorders (homicidal ideation, suicidal ideation,
suicide attempt, suicide, psychotic disorder and hallucinations), serious
and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia
and rarely, aplastic anemia), cardiovascular disorders (hypertension,
supraventricular arrhythmias and myocardial infarction), hypersensitivity
(including anaphylaxis), endocrine disorders (including thyroid disorders
and diabetes mellitus), autoimmune disorders (including idiopathic
thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis,
lupus, rheumatoid arthritis and interstitial nephritis), pulmonary
disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial
pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic
colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of
vision, retinopathy including macular edema and retinal
thrombosis/hemorrhages, optic neuritis and papilledema). Adverse reactions
reported during post-approval use of PEGASYS therapy, with and without
ribavirin, include hearing impairment, hearing loss, serious skin
reactions, including erythema multiforme major, and infections (bacterial,
viral and fungal).
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2007 Roche was named
Top Company of the Year by Med Ad News, one of the Top 20 Employers
(Science) and ranked the No. 1 Company to Sell For (Selling Power). In
previous years, Roche has been named as a Top Company for Older Workers
(AARP) and one of the Best Companies to Work For in America (Fortune). For
additional information about the U.S. pharmaceuticals business, visit our
website http://www.rocheusa.com. Product and treatment information for U.S.
healthcare professionals is available at http://www.RocheExchange.com.
About Digestive Disease Week
DDW is the largest international gathering of physicians, researchers
and academics in the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American Association for
the Study of Liver Diseases, the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal Endoscopy and
the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22,
2008, at the San Diego Convention Center, San Diego, CA. The meeting
showcases approximately 5,000 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. For more
information, visit http://www.ddw.org.
All trademarks used or mentioned in this release are protected by law.
Contacts: Linda Dyson
Roche
973-562-2231 (office)
973-986-5973 (mobile)
Linda.Dyson@roche.com
Catherine Falcetti
Manning Selvage & Lee
212-468-4337 (office)
646-246-1843 (mobile)
Catherine.Falcetti@mslpr.com
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Via: Healthcare
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