REPOST: INFO: Treatment With PEGASYS(R)/COPEGUS(TM) Provides Hope For Hepatitis C Patients Whose Infection Did Not Initially Respond To Peg-Intron(R)/Ribavirin

[Guest guest]

This

study doesn’t apply to relapsers or non-responders to the old treatment.

Only non-responders to Peg-Intron.

November 4th, 2007

Treatment With PEGASYS®/COPEGUS Provides

Hope For Hepatitis C Patients Whose Infection Did Not Initially Respond To

Peg-Intron®/Ribavirin

http://www.medicalnewstoday.com

Roche announced final results from the REPEAT study,

which demonstrated that treatment with once-weekly PEGASYS® (peginterferon

alfa-2a) and daily COPEGUS (ribavirin) for 72 weeks is a promising

treatment option for patients whose infection did not respond to previous

treatment with another pegylated interferon (Peg- Intron®, peginterferon

alfa-2b) and ribavirin. Further, the results showed that response at 12 weeks was

a powerful predictor of the eventual outcome: the majority of patients with

undetectable virus at 12 weeks went on to achieve a sustained virological

response (SVR) after 72 weeks of treatment, while few patients with detectable

virus at 12 weeks achieved SVR. These data were presented in an oral session at

the 58th Annual Meeting of the American Association for the Study of Liver

Diseases (AASLD), being held in Boston, Nov. 2-6.

" One of the greatest areas of need in hepatitis C

today is to find solutions for patients who have not seen treatment success

with an initial course of therapy.

REPEAT is an important study which adds significantly

to our knowledge about how to manage these patients, demonstrating that

extending treatment with PEGASYS and COPEGUS is a promising option, " said

Jensen, M.D., Professor of Medicine and Director of the Center for Liver

Diseases at the University of Chicago Hospital in Chicago, and lead

investigator in REPEAT. " A significant finding from REPEAT is confirmation

of the reliability of using a patient's response at 12 weeks as a predictor of

treatment success, even in patients with cirrhosis. This means that patients

who achieve undetectable virus at 12 weeks can continue treatment with a good

likelihood of success. It also means that clinicians can confidently

discontinue treatment in patients who do not achieve an early response. "

More About the REPEAT Study

Enrolling 950 patients from Europe,

North America and Latin America, REPEAT (REtreatment with PEgasys in pATients

Not Responding to Peg-Intron Therapy) was designed to explore whether

intensified treatment with a higher fixed-dose induction of PEGASYS in

combination with COPEGUS and/or longer treatment duration may increase

treatment success rates in patients who didn't respond to at least twelve weeks

of Peg-Intron/ribavirin combination therapy. Patients were randomized

2:1:1:2 to one of four regimens:

Patients in arms A (n=318) and B (n=158) received

PEGASYS 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further

60 or 36 weeks, respectively

Patients in arms C (n=158) and D (n=316) received

PEGASYS 180 mcg/week for 72 or 48 weeks, respectively

All patients received COPEGUS (1,000/1,200

mg/day) in combination with PEGASYS

Results showed:

The primary endpoint was met: SVR, defined by

undetectable hepatitis C virus RNA in the blood six months after the end

of treatment, was significantly higher for arm A (16 percent) compared to

arm D (nine percent)

A pooled analysis of the 72-week arms vs. the 48-week

arms showed that 72 weeks of treatment had the biggest impact on success

of treatment, with a doubling of SVR rate compared to 48 weeks (16 percent

vs. eight percent). A pooled analysis of the induction dose arms vs.

standard dose arms showed that treatment with higher fixed-dose induction

for this difficult-to-treat patient population did not provide

significant additional benefit

Response at 12 weeks was a strong predictor of

successful treatment

Of patients whose virus was undetectable after 12

weeks of therapy, 57 percent in the 72-week arms went on to achieve

treatment success (by comparison, among patients who still had detectable

virus after 12 weeks, only four percent achieved treatment success)

The proportion of patients with undetectable virus

at 12 weeks was 17 percent

" REPEAT exclusively enrolled patients who had not

previously responded to pegylated interferon combination therapy, in this case

Peg-Intron and ribavirin, " continued Dr. Jensen. " These patients are

a more difficult-to- treat group than relapsers and those who did not respond

at all to treatment with non-pegylated interferons, either alone or with

ribavirin. For this reason, results from REPEAT cannot be meaningfully compared

to results from trials with a large proportion of patients who were relapsers

or who did not respond to treatment with older interferons. "

The incidence and types of adverse events and serious

adverse events were generally consistent across all the arms, and the frequency

of moderate to severe hematologic effects were broadly similar across all arms.

Discontinuations for adverse events and lab abnormalities were higher for

extended treatment. Patients with cirrhosis had a somewhat higher incidence of

adverse events, premature withdrawals and dose modifications.

http://www.hcvadvocate.org/news/newsRev/2007/NewsRev-230.html#_Treatment_With_PEGASYS®/COPEGUS(T