--- In lonestarheppers@yahoogroups.com, blackdiamond_36
<no_reply@y...> wrote:
> 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
> Internal Medicine.
>
> 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.