Among HBV/HCV coinfected people, about half have dominant hepatitis B
virus while half have dominant hepatitis C, and those with active HBV
replication are at higher risk of liver-related complications and death,
according to study findings presented at Digestive Disease Week this
month in Chicago.
Due to similar routes of transmission, many people are coinfected with
both hepatitis B virus (HBV) and hepatitis C virus (HCV). Previous
research has shown that the 2 viruses can interact with one another,
with HBV suppressing HCV replication and vice versa. Patterns of viral
dominance are unpredictable, however, and their effects on clinical
outcomes are unclear.
Robert Kruse from the Center for Innovations in Quality, Effectiveness
and Safety and colleagues conducted a retrospective cohort study of
hepatitis C patients who received care at through the U.S. Veterans
Administration health system between 1997 and 2005.
SYDNEY, May 29, 2014 /PRNewswire/ — RNAi-based therapeutics company,
Benitec Biopharma Limited (asx:BLT) is pleased to announce that it has
dosed the first patient in its ‘first in man’, Phase I/IIa clinical
trial for TT-034, a ddRNAi-based therapeutic, designed to treat and
potentially cure hepatitis C (HCV) with a single injection.
Benitec Biopharma’s CEO and Managing Director, Peter French said, “The
commencement of this clinical trial of TT-034 represents a landmark in
the Company’s history. The trial is the first time Benitec’s gene
silencing technology, ddRNAi, has been used systemically in patients.
The primary objective of this first trial is to demonstrate that TT-034
can be used safely in patients with HCV. Preclinical work in non-human
primates demonstrated very low toxicity results at therapeutically
relevant doses, and we’re hopeful that we will see the same favourable
tolerability in humans. In addition, we will be able to assess the
impact of TT-034 treatment on HCV viral load in these patients, and this
important efficacy marker constitutes one of the secondary endpoints of
The TT-034 Phase I/IIa clinical trial is an open label, dose escalation
study in a total of 14 patients chronically infected with HCV genotype
1. Initial patient cohorts will be treated with a sub-therapeutic dose
of TT-034 to ensure that there are no unexpected safety concerns, before
proceeding to higher, potentially therapeutic doses.
An expert medical panel, the Data Safety Monitoring Board (DSMB), which
is independent of Benitec, will carefully assess the data from each
patient, in particular the safety data. The DSMB assessment will occur
after the first patient in each cohort and between cohorts, and will
determine the timing of each subsequent dosing.
Additional detail on the clinical trial design and protocol is included at the bottom of this announcement.
CINCINNATI—Hepatitis C is a very sneaky
creature that coats itself in an envelope which changes every time the
body tries to mount an immune response, says Kenneth Sherman, MD, PhD, a
UC Health physician and professor in the University of Cincinnati (UC)
College of Medicine.
“It’s very similar to HIV in that regard,” says Sherman, director of
the internal medicine department’s division of digestive diseases.
There is no vaccine for hepatitis C, which is receiving renewed
attention as the public learns more about a heroin epidemic that is
affecting not just the Tristate but the nation. Hepatitis C is spread
largely through injection drugs and shared needles and is following the
After incorporating input we received from stakeholders to a draft version, we are finalizing our guidance to industry today
in order to provide a more detailed explanation of these programs and
help drug innovators determine whether their products are likely
These expedited programs include:
Fast track designation: Providing for more frequent
meetings and communications with FDA to discuss the drug’s development
plan and ensure collection of appropriate data needed to support drug
approval, including such things as the design of the proposed clinical
trials and use of biomarkers.
Accelerated Approval: Basing approval not on a clinical endpoint but on
an agreed upon surrogate marker, that is a measure such as blood test
or urine marker, that is believed to be indicative of a disease state
and treatment effect, but not demonstrative of a direct health gain to
Priority review: Acting on drug applications within 6 months instead of 10 months for standard review, and;
Breakthrough Therapy Designation: Providing all of
the benefits of Fast Track designation plus intensive guidance on an
efficient drug development program, beginning as early as Phase 1, and
the commitment from FDA’s review staff, including senior managers, to
work closely together throughout the drug development and review
The outcry continues over the $1,000-a-pill hepatitis C drug made by California-based Gilead Sciences.
While the drug is a significant advance over older treatments
for the viral liver disease, the price set by the company “represents an
abuse of market power,” said John Rother, president and CEO of the
National Coalition on Health Care, which includes businesses, unions,
insurers, consumers and some drugmakers, including Teva Pharmaceuticals
and the Generic Pharmaceutical Association.
On Wednesday, the group urged a “national dialogue” on
the cost, saying Sovaldi’s price tag threatens the budgets of
government run-health programs as well as the premiums for everyone who
has private insurance.
California lawmakers are
currently considering legislation that would promote awareness by
requiring primary care physicians to offer a hepatitis C test to
patients born between 1945 and 1965. These baby boomers are five times
more likely to be infected.
More than 500,000 Californians are infected with hepatitis C, yet the vast majority of those infected don’t realize it.
Even though hepatitis C is the leading cause of catastrophic liver
damage, cirrhosis and liver cancer, it’s estimated that up to 75 percent
of infected Americans do not even know they have the disease. Because
of this, the Centers for Disease Control and Prevention predicts that
deaths due to this blood-borne virus will double or even triple in the
next 20 years.
The significant gap between the disease’s progression and diagnosis
is largely due to the fact that people can live for years — even
decades — without feeling sick, while testing for the virus is not
nearly as common as it should be.
PeaceHealth Southwest Medical Center and Clark County Public Health are advising 936 patients to be tested for hepatitis C.
investigation revealed that the patients might have been exposed to the
hepatitis C virus through the actions of a former PeaceHealth Southwest
employee suspected of diverting drugs for personal use. In certified
letters mailed May 19, the patients are urged to receive hepatitis C
testing at the expense of PeaceHealth Southwest.
Temporary patient service centers have been set
up in three locations to make the testing as convenient as possible. If
they choose, patients can be tested by their healthcare provider at
another location. Patients with questions are encouraged to visit www.peacehealth.org/HepC, send an email to HepC@peacehealth.org or call the patient care support line at (360) 729-2000 between 7 a.m. and 7 p.m., seven days a week.
The liver is a remarkable, if underappreciated, organ. It turns the
nutrients in our diets to substances the body can use and converts
toxins into harmless substances or makes sure they are removed from the
When the liver is working well, our metabolism hums along in
equilibrium. But drugs and dietary supplements can sometimes wreak havoc
with that system, leading to dangerous liver problems. The Food and
Drug Administration (FDA) is working to prevent drug-induced liver
“Any drug may cause dangerous liver problems but,
fortunately, such problems only occur rarely,” says John R. Senior,
M.D., an FDA gastrointestinal medical reviewer and consultant in
hepatology, which includes study of the liver. “It is challenging to
predict how drugs will affect the liver because each patient is
different in how they respond to a given drug. Our goal is to prevent
the toxicity of drugs.”
Acute liver failure is a rapid
deterioration of the organ’s ability to function. Data suggest that
prescription and over-the-counter drugs (OTC) and dietary supplements
cause more acute liver failure cases than all other reasons combined.