Highest Sustained Virologic Response in Treatment of Hepatitis
C Ever Reported in a Prospective Study
Source: Rush-Presbyterian-St. Luke's Medical Center, 04/18/2002
A combination treatment of Pegasys (peginterferon alfa-2a 40kd)
a pegylated interferon, with ribavirin, an orally active anti-viral
medication, has shown some of the most effective treatment rates
yet for individuals with hepatitis C. The combination treatment
yielded a 61 percent sustained virologic response (SVR), the
highest SVR ever reported in a prospective trial for a pegylated
interferon using an intent-to-treat (ITT) analysis, according to
Dr. Donald Jensen at Rush-Presbyterian-St. Luke's Medical
SVR refers to a patient's continued undetectable serum hepatitis
C (HCV) RNA levels six months after discontinuation of treatment.
Results of a recently completed phase III study of the
investigational hepatitis C therapy were presented today at the
European Association for the Study of Liver (EASL) annual meeting
in Madrid, Spain.
The study also revealed strong evidence that, to achieve optimal
results, treatment regimens should be based on hepatitis C virus
genotype, rather than on the traditional, weight-based
Hepatitis C is a blood-borne infectious disease of the liver and
a leading cause of cirrhosis and liver cancer. It is also the
primary reason for liver transplantation in the United States. An
estimated 2.7 million Americans are chronically infected with the
virus, with about 35,000 new infections reported each year.
"These results are unprecedented," explained Jensen, a U.S.
investigator in the trial and director of Hepatology at
Rush-Presbyterian St. Luke's Medical Center, Chicago. "Physicians
can confidently expect that when Pegasys is available they can
prescribe it for the most appropriate length and dose of
combination treatment based on a patient's genotype and achieve
optimal results." Rush-Presbyterian St. Luke's Medical Center was
one of 29 U.S. trial locations.
The study also found a 51 percent SVR, the highest ever
achieved, for patients with genotype 1, the most difficult to treat
and most prevalent genotype in North America. There are six
different strains, or genotypes of hepatitis C. About 70 percent of
American patients with hepatitis C exhibit genotype 1.
The study showed that patients with HCV genotype 1 require 48
weeks of Pegasys treatment with the standard dose (daily
1000mg/1200mg) of ribavirin in order to achieve the optimal
A 78 percent SVR, previously only achieved in genotype non -1
patients treated for 48 weeks, was achieved with only 24 weeks of
therapy and a low daily 800 mg dose of ribavirin.
"These data are very important because we know 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 spare some patients nearly six months of unnecessary
treatment," said Jensen.
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 micrograms (µg) weekly (qw) + ribavirin 800
milligrams (mg) daily (qd) for 24 weeks
PEGASYS 180 µg qw + ribavirin 1000-1200 mg qd for 24 weeks
PEGASYS 180 µg qw + ribavirin 800 mg qd for 48 weeks
PEGASYS 180 µg qw + ribavirin 1000-1200 mg qd for 48
In this study, the adverse events were similar to previous
reported trials and included flu-like symptoms, fatigue and
Pegasys is a new generation hepatitis C therapy manufactured by
Hoffmann-La Roche and is awaiting FDA approval. A polyethylene
glycol (PEG) strand attached to the interferon molecule keeps the
drug active in the bloodstream longer and at a more constant level
than standard interferons. Hepatitis C virus is transmitted through
body fluids, primarily blood or blood products, and by sharing
needles. In many patients, the mode of transmission is unknown.
Unfortunately, most people infected with hepatitis C are unaware of
it because it may take years for symptoms to develop. Hepatitis C
chronically infects an estimated 170 million people worldwide
(three percent of the world's population), with as many as 180,000
new cases occurring each year. It is estimated that less than 30
percent of all cases are diagnosed.
Home | What is HCV | Transmission |
| Lab |
Links | Transplant |