Roche announced that new
data from three studies indicate that chronic hepatitis C patients who
received PEGASYS(R) (peginterferon alfa-2a) plus ribavirin had a greater
chance of achieving a sustained virological response (SVR) than patients on
peginterferon alfa-2b. Results from the studies were presented this week at
the 43rd Annual Meeting of the European Association for the Study of the
Liver (EASL) in Milan, Italy, adding to the robust body of evidence
supporting PEGASYS as an effective treatment choice for treating patients
with hepatitis C.



Ascione, et al: A Prospective, Randomized, Investigator-Initiated
Head-to-Head Trial



Results of the Peginterferon Alpha-2a Plus Ribavirin Versus
Peginterferon Alpha-2b Plus Ribavirin in Naive Patients with Chronic
Hepatitis C Virus Infection Study: Results of a Prospective Randomized
Trial, an independently-conducted study, were presented by Professor
Antonio Ascione, Director of the Department of Gastroenterology Liver Unit
at Cardarelli Hospital in Naples, Italy, in the oral late-breaker session
at EASL. It is a prospective, randomized, investigator-initiated
head-to-head trial designed to directly compare PEGASYS with peginterferon
alfa-2b, each in combination with ribavirin. Enrolling 320 patients in
Italy, of all genotypes, the study randomized patients to receive either
PEGASYS 180 mcg/week or peginterferon alfa-2b 1.5 mcg/kg/week. Importantly,
patients received equivalent starting doses of ribavirin (either 1,000 or
1,200 mg ribavirin per day based on body weight), and the process for
ribavirin dose reduction was the same for all patients.



The results showed that overall 68.7 percent (110/186) of hepatitis C
patients who were treated with PEGASYS achieved SVR, defined by
undetectable hepatitis C virus (HCV) RNA in the blood 24 weeks after the
end of treatment, compared to 54.4 percent (87/134) of patients who
received peginterferon alfa-2b (p=0.008). Furthermore, in genotypes 1 and 4
-- the most difficult-to-treat patient group -- 51 patients (54.8 percent)
taking PEGASYS achieved SVR, compared to 37 patients (39.8 percent) in the
peginterferon alfa-2b group (p=0.04). In genotypes 2 and 3; 59 patients
(88.1 percent) taking PEGASYS achieved SVR, compared to 50 patients (74.6
percent) taking peginterferon alfa-2b (p=0.046). Side effects were similar,
although there were more withdrawals for side effects in the peginterferon
alfa-2b group. (Please see below for complete safety information about
PEGASYS and COPEGUS.)



T. Witthoeft, et al: Hepatitis C Treatment in Real-Life PRACTICE in
Germany



Another study presented at EASL, a retrospective analysis called The
PRACTICE Study, analyzed the response of 3,470 patients of all genotypes,
to hepatitis C treatment between 2000 and 2007 in 23 German treatment
centers with a high volume of patients. Patients were matched with regard
to key baseline characteristics, including viral load, prior treatment
history, body mass index, history of drug addiction, HIV co-infection as
well as those who received a similar cumulative ribavirin dose. Among these
matched pairs, significantly more patients treated with PEGASYS plus
ribavirin achieved SVR compared to those treated with peginterferon alfa-2b
and ribavirin (59.3 percent (N=848) vs. 53.0 percent (N=848) [p = 0.008]).



A. Craxi, et al: PROBE Compares The Pegylated Interferons



The PROBE study, an observational study, was designed to prospectively
evaluate the efficacy of the pegylated interferons in real-life practice.
The study enrolled 6,644 patients with genotype 1 virus at 167 treatment
centers in Italy. The analysis included 1,351 patients of whom 887 received
peginterferon alfa-2a and 464 received peginterferon alfa-2b. The study
reflected "real-life" clinical settings by including patients with
comorbidities, including obesity, diabetes, advanced age, psychiatric
disorders, methadone use, thyreopathy and autoimmunity. Again, the trial
found a greater chance of achieving SVR in patients treated with PEGASYS
combination therapy compared to those treated with peginterferon alfa-2b
combination therapy (SVR rates of 41 percent (360/887) vs. 34 percent
(156/464), respectively [p = 0.004]).



"The outcomes of the three studies presented at EASL, comparing PEGASYS
to peginterferon alfa-2b, contribute to a growing body of evidence that
PEGASYS provides a successful outcome for many patients with hepatitis C,"
said Steven C. Sembler, vice president of Commercial Operations, Roche. "We
are committed to further advancing the treatment of hepatitis C. Reflecting
Roche's leadership in this area, our comprehensive clinical trials program
aims to optimize treatment with PEGASYS and COPEGUS in the hope of bringing
treatment success to even more patients."



Roche Comments on Schering-Plough "IDEAL" Study



Roche reiterated its position on the design of the Schering-Plough
sponsored "IDEAL" study results, which were also presented at EASL. Clear
biases in the design of this study that may have favored patients receiving
peginterferon alfa-2b regimens prevent any direct comparison of the
pegylated interferons. These biases include:



-- different ribavirin starting doses,



-- a different ribavirin dose reduction protocol, and



-- open label dosing for the PEGASYS arm.



IDEAL is a peginterferon alfa-2b dose-finding study that cannot answer
which pegylated interferon is better.



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.



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.



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