Metastatic cancer in the liver is far more common than primary liver cancer.
with long-standing hepatitis C who develop cirrhosis are at increased
risk of developing liver cancer. Those who do not develop cirrhosis
usually do not develop liver cancer. Among people with both hepatitis C
and cirrhosis living in the United States, about 1 to 4 percent per year
will develop liver cancer.
Liver cancer is becoming more common
as a late complication of chronic hepatitis C infection among patients
who have developed cirrhosis. Patients who are concerned about their
risk of cancer should discuss with their medical care providers how they
can protect themselves from it. Tests that take images of the liver
(e.g., ultrasound, CT, MRI scans), together with measurements of AFP
levels in the blood, can detect liver cancer early much of the time.
FOSTER CITY, Calif.–(BUSINESS WIRE)–Sep. 24, 2014–
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has
submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and
Medical Devices Agency (PMDA) for approval of an investigational
once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV)
90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF)
400 mg for the treatment of chronic genotype 1 hepatitis C virus (HCV)
infection in adults. The data submitted in the NDA, which include a
Japanese Phase 3 study showing 100 percent SVR12 rates, support the use
of LDV/SOF for 12 weeks in treatment-naïve and treatment-experienced
patients with chronic genotype 1 HCV infection, including those with
cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If
approved, LDV/SOF would simplify HCV treatment for genotype 1 patients
in Japan to one daily tablet, eliminating the need for interferon and
Primarily due to HCV, Japan has one of the highest rates of liver cancer
of any industrialized country. Of the more than one million people in
Japan chronically infected with HCV, 70-80 percent are infected with the
genotype 1 strain of the virus.
The NDA is based on data from a Phase 3 clinical trial conducted in
Japan (GS-US-337-0113) among 341 treatment-naïve and
treatment-experienced genotype 1 patients. In the study, 100 percent
(n=83/83) of treatment-naïve and 100 percent (n=88/88) of
treatment-experienced patients receiving 12 weeks of LDV/SOF without RBV
achieved SVR12. Adverse events observed with LDV/SOF without RBV were
generally mild and included nasopharyngitis (28 percent), headache (6
percent) and malaise (5 percent).
The NDA is also supported by SVR12 results from three Phase 3 studies
(ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of LDV/SOF
among genotype 1 HCV patients. Trial participants included patients from
the United States, Europe and Puerto Rico who were treatment-naïve or
who had failed previous treatment, including protease inhibitor-based
regimens, and also included patients with compensated cirrhosis. Trial
participants in the ribavirin-free arms (n=863) achieved SVR12 rates of
94 to 99 percent.
LDV/SOF is currently under regulatory review in the United States and
On June 27, 2014 Gilead submitted an NDA to Japan’s PMDA for SOF as a
single agent in combination with RBV for the treatment of genotype 2 HCV
infection. SOF as a single agent has been approved by regulatory
authorities in the United States, European Union, Australia and Canada
under the tradename Sovaldi®.
LDV/SOF and SOF are investigational products in Japan and their safety
and efficacy have not yet been established.
– See more at: http://www.gilead.com/news/press-releases/2014/9/gilead-submits-new-drug-application-to-japans-pharmaceutical-and-medical-devices-agency-for-fixeddose-combination-of-ledipasvirsofosbuvir-for-chronic-hepatitis-c-genotype-1-infection#sthash.PuHLt7Fd.dpufShare This Page
It wasn’t until William J. Riley, 54, got a new doctor last year that
a simple blood test revealed why he had been feeling crappy on and off
for so many years.
“He called me in and I went down there and that’s when he told me I
had hepatitis C,” Riley explained. “I said ‘Well, how long have I had
it?’ He said, ‘I’m assuming from the things you’ve told me, you’ve had
it 25 to 30 years.’”
“It just lay dormant and then all of a sudden it blossomed like a rose,” Riley, of Kenosha, said.
NICE’s appraisal consultation document (ACD) has recommended the drug
for the treatment of chronic hepatitis C genotype 1 infection, but did
not recommend it for use in combination with sofosbuvir for patients who
are unable to tolerate an interferon-based regimen with genotypes 1 or 4
Peter Barnes, medical director at
Janssen, said: “We are pleased that simeprevir has been recommended for
the treatment of patients with genotype 1 hepatitis C when used in
combination with peginterferon and ribavirin.
“However, we are
disappointed with the preliminary recommendations from NICE for genotype
4 patients and those who are intolerant to interferon and could
therefore benefit from the use of a treatment regime that does not
67, of Fairview, Erie County was cured of hepatitis C that she
contracted from a blood transfusion in 1976. Diagnosed in 2000, she was
cured last summer with a dual-drug combination that cost $144,000.
Barbara Walter has experienced the full medical odyssey of chronic
hepatitis C infection, having faced its every major challenge while
benefiting from all of the modern breakthrough treatments.
She is one of the lucky few. She is cured, with no detectable virus in her blood since July.
People living with HIV are infrequently screened for hepatitis C virus (HCV) infection,
according to US research published in the online edition of Clinical Infectious Diseases. The
retrospective study examined screening practices at seven primary care sites
between 2000 and 2011. The frequency of testing increased, but practice varied
considerably between sites, and in some instances individuals with high-risk
behaviours were infrequently tested for HCV.
incidence HCV is variable across sites and improvement in frequency of
screening is also variable, highlighting the a need for US-based guidelines to
inform HIV practice,” write the authors.
An editorial in
the same issue of the journal stresses the importance of prompt HCV diagnosis
in people living with HIV.
Twice a week for two hours at a time, an unassuming windowless white
van parks at the intersection of Fifth and Harrison streets in
Thirty-one-year-old Mike knows the van, and knows it well – it’s where he can find clean works.
the last seven years that van, the hub for the state’s needle exchange
program, has traveled to at-risk areas in Wilmington, serving as a clean
syringe clearinghouse for those living with a drug addiction.