On February 24, 2014, FDA approved an update to the Victrelis
(boceprevir) label to include a new virologic futility rule.
Specifically Section 2, Dosage and Administration, Table 1 was
revised to state: If a patient has HCV-RNA results greater than or equal
to 1000 IU/mL at treatment week 8, then discontinue three-medicine
This statement is also reflected in subsection 2.4 Discontinuation of Dosing Based on Treatment Futility: Discontinuation
of therapy is recommended in all patients with 1) HCV-RNA levels of
greater than or equal to 1000 IU per mL at TW8 (treatment week 8); or 2)
HCV-RNA levels of greater than or equal to 100 IU per mL at TW12
(treatment week 12); or 3) confirmed detectable HCV-RNA levels at TW24
(treatment week 24).
You can view the complete revised Victrelis label and Medication Guide at Drugs@FDA.
Richard Klein Office of Special Health Issues Food and Drug Administration
Kimberly Struble Division of Antiviral Drug Products Food and Drug Administration
Adults with hepatitis C had an increased risk for dying and for dying
prematurely compared with the general population, according to findings
from a study conducted in New York.
They were particularly likely to die of HCV-associated conditions,
such as HIV or drug use, researchers from the New York City Department
of Health and Mental Hygiene reported in Clinical Infectious Diseases.
grants Designation request for investigational daclatasvir
(DCV) and asunaprevir (ASV) combination therapy for treatment of
genotype 1b chronic hepatitis C (HCV) infection
Marks second Breakthrough Therapy Designation for a daclatasvir-based regimen; 3DAA regimen granted Designation in 2013
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers
Squibb Company (NYSE:BMY) today announced that the U.S. Food and
Drug Administration (FDA) has granted its investigational DCV Dual
Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation
for use as a combination therapy in the treatment of genotype 1b chronic
hepatitis C infection (HCV). The designation is based on data from the
company’s ongoing Phase III clinical trial program evaluating the
all-oral combination regimen of DCV, an investigational NS5A replication
complex inhibitor, and ASV, an investigational NS3 protease inhibitor,
According to the FDA, Breakthrough Therapy Designation is intended to
expedite the development and review of drugs for serious or
life-threatening conditions. The criteria for Breakthrough Therapy
Designation require preliminary clinical evidence that demonstrates the
drug may have substantial improvement on at least one clinically
significant endpoint over available therapy.
“The FDA’s decision to grant Breakthrough Therapy Designation for our
DCV Dual Regimen (daclatasvir and asunaprevir combination therapy) marks
the second time that the FDA has granted the Designation to a
daclatasvir-based regimen, further underscoring its potential to help
address the high unmet needs of the HCV patient population,” said Brian
Daniels, MD, senior vice president, Global Development and Medical
Affairs, Research and Development, Bristol-Myers Squibb. “This is an
important milestone for Bristol-Myers Squibb as we continue our
strategic focus on the development of innovative medicines to address
areas of high unmet medical need, where potential expedited review can
make a critical difference for patients.”
Approximately 170 million people worldwide are infected with hepatitis
C, with an estimated 2.7–3.9 million chronically infected in the U.S.
Many of these people have been living with HCV for decades, putting them
at heightened risk for developing serious, potentially life-threatening
New data from Bristol-Myers Squibb’s ongoing Phase III clinical program
studying the DCV Dual Regimen is anticipated to be presented at an
upcoming scientific forum. Data from a separate daclatasvir and
asunaprevir Phase III trial in Japanese patients with HCV genotype 1b
who were either interferon-ineligible/intolerant or non-responders (null
and partial) to interferon-based therapies served as the basis for a
regulatory filing in Japan in October 2013.
Bristol-Myers Squibb also recently announced that the European Medicines
Agency (EMA) validated the company’s marketing authorization application
(MAA) for the use of daclatasvir for the treatment of adults with HCV
with compensated liver disease, including genotypes 1, 2, 3, and 4. The
application seeks the approval of daclatasvir for use in combination
with other agents for the treatment of chronic hepatitis C and will be
reviewed under an accelerated regulatory review.
Despite a number of social/behavioral intervention and educational programs, the spread of hepatitis C
(HCV) in people who inject drugs (PWIDs) remains a chronic problem.
Now, researchers affiliated with New York University’s Center for Drug
Use and HIV Research (CDUHR) are focusing on intervention strategies
that highlight the lesser-known dangers of HCV transmission through the
sharing of other injection equipment such as cookers, filters,
drug-dilution water and water containers.
Their article, “The Staying Safe Intervention: Training People Who
Inject Drugs in Strategies to Avoid Injection-Related HCV and HIV
Infection,” published in the 2014 March-April issue of AIDS Education and Prevention, explores the feasibility and efficacy
of their “Staying Safe Intervention,” a strengths-based
social/behavioral intervention conducted with small groups of PWID,
designed to facilitate long-term prevention of HIV and HCV.
What are the Department’s expectations around compliance?
The Department has worked collaboratively since the law went into
effect to assist providers in complying with its terms. DOH expects all
facilities and providers covered by the law to implement the routine
offer of testing and other provisions of the law by the law’s effective
date, or that facilities and providers have made their specific
technical assistance needs known to the Department and are making
substantial progress toward full compliance. Several evaluation projects
will be undertaken to determine the extent to which the law has been
implemented in a variety of settings.
What are the key provisions of the law?
A hepatitis C screening test must be offered to every individual
born between 1945 and 1965 receiving health services as an inpatient or a
hospital, or receiving primary care services in the outpatient
department of hospital, or in a freestanding diagnostic and treatment
center or from a physician, physician assistant, or nurse practitioner
providing primary care.
If an individual accepts the offer of the hepatitis C screening
test and the screening test is reactive, the health care provider must
offer the individual follow-up health care or refer the individual to a
health care provider who can provide follow-up health care. The
follow-up health care must include a hepatitis C diagnostic test.
The offer of testing must be culturally and linguistically appropriate.
SOUTH BERWICK, Maine — At a recent South Berwick
Town Council meeting, Town Manager Perry Ellsworth expressed optimism
about efforts to mitigate a recently imposed state Department of Labor
fine against the town.
The $4,250 fine cites the town for failing to meet several personnel measures, said Ellsworth.
These include a lack of training in blood-borne
pathogens for town employees, documentation of staff inoculations
against Hepatitis B and C, and hazard safety assessments for specific
On Nov. 22, 2013, Henry Sanchez, left, and his father, Leon, went
through liver transplant surgery. Today they are both alive and well.
Today they are both alive and well, and look forward to returning to
Leon Sanchez will never forget the day 12 years ago when his son
Henry made a goal in his soccer tournament and won the final game. On
the sidelines, Leon was on his knees.
“He was the hero. I was so proud of him,” Leon recalls, while the two sit in the living room of their west Lodi home.