Study Shows Highest Sustained Response Rates Ever Reported in Patients Infected with Hepatitis C
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Please note that this is a NEWS report, and as usual with most
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Study Shows Highest Sustained Response Rates Ever Reported in
Patients Infected with Hepatitis C
- Combination of Pegasys(R) and Copegus(R) Yields Response in
Over 60 Percent of Patients -
LA JOLLA, Calif., March 2 /PRNewswire/ -- A landmark study
examining the efficacy and safety of the drug combination
Pegasys(R) (peginterferon alfa-2a), a pegylated interferon, with
Copegus(R) (ribavirin), an antiviral medication, has found the most
significant response rates ever achieved in patients infected with
hepatitis C, according to Paul Pockros, M.D., at Scripps Clinic.
The combination treatment yielded a 61 percent sustained virologic
response (SVR), the highest SVR ever reported in a clinical trial
for a pegylated interferon.
SVR refers to a patient's continued undetectable serum hepatitis C
(HCV) RNA levels six months after discontinuation of treatment.
The results of the study were published in this week's Annals of
Hepatitis C is a blood-borne virus that attacks the liver, causing
cirrhosis (liver scarring) and liver cancer, and is the primary
reason many patients undergo liver transplants in the U.S. An
estimated 4 million Americans are infected with hepatitis C, with
2.7 million chronically infected.
"The outcome of this study provides critical insights for treating
the 35,000 people being diagnosed each year with hepatitis C,"
explained Pockros, a U.S. investigator in the trial and head of the
division of gastroenterology and hepatology at Scripps Clinic in La
Jolla, Calif. "Most notably, we can now say that the virus can be
cured in more than half of the patients treated."
The study also revealed clinical evidence that, to achieve optimal
results, treatment duration should be based on hepatitis C virus
genotype, rather than on the traditional, weight-based methodology.
Additionally, the study found a 51 percent SVR, the highest ever
achieved, for patients with genotype 1, the most difficult to treat
and most prevalent genotype. The study also confirms that these
patients require a year of treatment (48 weeks) with Pegasys and
the standard dose of ribavirin (daily 1000mg/1200mg) in order to
achieve the optimal outcome. The success rate was even higher for
genotype non-1 patients, with 78 percent achieving an SVR after
only 24 weeks of therapy and a low daily 800mg dose of ribavirin.
"This is the first study to confirm that for certain patients, we
can use a lower dose of therapy and cut the treatment duration by
half without sacrificing efficacy. Potentially, this can save some
patients nearly six months of unnecessary treatment," said Pockros.
In addition to Scripps Clinic, the randomized, multi-center study
had a total of 99 sites around the world and included 1,284
patients stratified by genotype into one of four treatment groups:
* PEGASYS 180 ug qw + ribavirin 800 mg qd for 24 weeks
* PEGASYS 180 ug qw + ribavirin 1000-1200 mg qd for 24 weeks
* PEGASYS 180 ug qw + ribavirin 800 mg qd for 48 weeks
* PEGASYS 180 ug qw + ribavirin 1000-1200 mg qd for 48 weeks
In this study, the adverse events were similar to previous reported
trials and included flu-like symptoms, fatigue and depression.
Founded in 1924, Scripps Clinic is a multi-specialty, outpatient
care facility caring for patients at multiple locations throughout
San Diego County. Scripps Clinic and its physicians are
world-renown for research- driven care and medical specialty
expertise and is an operating unit of Scripps Health, a
not-for-profit, community-based health care delivery network that
includes more than 2,600 affiliated physicians, five acute-care
hospitals, home health care and associated support services.
Scripps Health is one of the largest health care organizations in
San Diego County, drawing from the expertise of more than 10,000
health care professionals.
SOURCE Scripps Clinic
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