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THE FDA MAKES HEPATITIS C A PRIORITY

6/17/2013

3 Comments

 
June 14, 2013
The FDA Makes Hepatitis C a Priority
by Benjamin Ryan                    
Recognizing that investigational
drugs from three pharmaceutical companies show advantages over existing
hepatitis C therapies, the FDA has sped up its development and review process
for the therapies.


With pharmaceutical companies clamoring to bring to market second-generation direct
acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV), the U.S.
Food and Drug Administration (FDA) has recently given a trio of companies a
significant leg up. Two promising investigational agents—Gilead Sciences’
nucleotide analogue inhibitor sofosbuvir and Janssen’s protease inhibitor
simeprevir—each received what is known as a priority review status from the FDA
over the past few weeks. And in early May, the FDA tapped AbbVie’s
interferon-free combination therapy, ABT-450/r, ABT-267 and ABT-333 (which has
been studied both with and
without ribavirin) as a “breakthrough therapy,” qualifying those drugs for an
expedited development and review process in preparation for FDA approval.


The FDA grants priority review to drugs in development that appear to
offer significant advantages over available therapies. As of now, there are two
FDA-approved DAAs to treat hep C: Incivek (telaprevir) and Victrelis
(boceprevir), each of which cures about 50 to 75 percent of those who undergo
therapy lasting between 24 and 48 weeks. Both must be taken with ribavirin and
also interferon, an injectable drug that often causes difficult, flu-like side
effects. So at this stage, the FDA’s imprimatur for the investigational
therapies, while not necessarily a promise of the final stamp of approval, marks
an official recognition that the research indicates these new drugs will likely
improve on the current crop of therapeutic options on various fronts.


Simeprevir, for one, has shown in clinical trials to have
somewhat higher cure rates than today’s DAAs, but its major advancements are in
its once-a-day dosing, its reduction of side effects and its shorter duration of
therapy. Sofosbuvir, meanwhile, has been a champion of sorts throughout the
clinical trials process, consistently boasting high cure rates when used in
combination with other drugs in development: either Bristol-Myers Squibb’s daclatasvir or Gilead’s
own ledipasvir (the company
has longer-range plans to develop sofosbuvir and ledipasvir as a fixed-dose
pill).

For practical purposes, the priority review is intended to cut
down the FDA’s review process, which begins 60 days after a new drug application
(NDA) is filed, from the standard 10 months to six. Companies that receive
priority review also get additional guidance from the FDA to expedite the
development and approval process. On March 28, Janssen filed its NDA for
simeprevir, to be taken with ribavirin and interferon for treatment of those
with genotype 1 of hep C; as such, the company expects an answer from the FDA in
late November. Gilead is just a couple
weeks behind in the same process; it’s seeking approval for sofosbuvir to be
administered as an all-oral therapy with ribavirin among those with genotype 2
or 3, and in combination with ribavirin and interferon for genotypes 1, 4, 5 and
6.

By comparison, Incivek and Victrelis each received priority review
designation in January 2011 and were approved in May that same year.


Achieving breakthrough therapy status, on the other hand, promises a more
dynamic range of benefits to AbbVie, which is the first company developing an
HCV therapy that has received the designation. Intended to expedite the
development and review of investigational drugs when clinical trial data shows
they promise at least one significant improvement over currently available
treatments, the designation means AbbVie receives, for starters, fast track
designation. This allows a pharmaceutical company to submit elements of its
marketing application before submitting its complete application for the drug.
Among other benefits, the breakthrough therapy designation also grants AbbVie
more FDA involvement in the combo therapy development—for example, by providing
increased access to the agency’s senior management, as well as giving practical
advice and helping design clinical trials that are as efficient as
possible.

Alan Franciscus, executive director of the Hepatitis C Support
Project in San Francisco, said that AbbVie’s breakthrough status was awarded
“clearly because of the less frequent dosing and pill burden, lower side effects
and high cure rates” when compared with Incivek and Victrelis.

“I
believe that this will greatly accelerate the approval process, especially if
the FDA has stated that they will provide guidance during the development and
approval process,” Franciscus says.

But even with all this extra help,
AbbVie’s combo is still running behind its competitors, not having submitted an
NDA. Furthermore, sofosbuvir and simeprevir have been researched as an interferon-free combination
therapy with one another: Taken with or without ribavirin, they were found in a
recent study to boast high cure rates among those with genotype 1 of hep C. If
both drugs receive FDA approval, clinicians are free to prescribe them together
off-label, providing yet another option outside the FDA-sanctioned uses for
people with hep C.

Daniel Fierer, MD, an assistant professor of medicine
in infectious diseases at Mount Sinai School of Medicine in New York City,
projects that “since simeprevir and sofosbuvir were already expected to hit the
market soonest, probably at the same time, the only thing I can see is that
maybe AbbVie moves up its timeline a little. But if it doesn’t move it up to
being out before [Janssen’s simeprevir and Gilead’s sofosbuvir] come to the
table, they will start eating without AbbVie, and then it’ll be leftovers for
lunch.”

Indeed, there is much excitement over these drugs in the
pipeline, as well as over the larger wave of interferon-free regimens that
should arrive a bit further down the line. Franciscus acknowledges this but also
hopes that the hubbub doesn’t distract physicians from the hep C patients who
have urgent therapeutic needs.

“What really scares me is that people with
HCV and their medical providers are waiting for the interferon-free drug
approval, but there are definitely some people who should be treated now—it
could be dangerous to wait,” he says. “There is never a guarantee that the
interferon-free drugs will work for
everyone.”  






Search: Hepatitis C virus, HCV, hep C, priority review, fast track, breakthrough therapy, U.S. Food and Drug Administration, FDA, AbbVie, Gilead Sciences, Bristol-Myers Squibb, sofosbuvir, daclatasvir, ABT-450/r, ABT-267, ABT-333, ribavirin, interferon, Incivek, telaprevir, Victrelis, boceprevir, simeprevir, Alan Franciscus,  Daniel Fierer. 


3 Comments

BLOOD TESTS OK FOR FIBROSIS DX IN HEPATITIS C

6/11/2013

3 Comments

 
Blood Tests OK for Fibrosis Dx in Hep C
By Salynn  Boyles, Contributing Writer, MedPage
Today
Published: June 03,
2013
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman
School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA,
BSN, RN, Nurse Planner
Action Points


  • While liver biopsy remains the gold standard for predicting disease
    progression in people with HCV infection, it is no longer recommended as
    necessary in all patients before the initiation of antiviral therapy with newer
    medications.

  • This study suggests that blood tests can help to identify HCV-infected
    patients with clinically significant fibrosis, with somewhat greater accuracy
    for identifying cirrhosis than for less advanced
    fibrosis.


Blood testing can accurately identify clinically significant fibrosis and
cirrhosis in people with hepatitis C virus (HCV) infection and may be an
alternative to liver biopsy in some patients, a new study found.


The analysis of 172 studies comparing various blood tests to biopsy in HCV
patients revealed that some of the simplest, cheapest blood tests performed as
well as more expensive, complex tests, reported Roger Chou, MD, and Ngoc Wasson,
MPH, from the Evidence-Based Practice Center at Oregon Health and Science
University in Portland.


Six tests identified clinically meaningful fibrosis with a median positive
likelihood ratio of 5 to 10 at commonly used cutoffs and areas under the
receiver-operating characteristic curve (AUROCs) of 0.70 or greater (range 0.71
to 0.86), they wrote in the June 4 issue of the Annals of Internal
Medicine.



The tests were the platelet count, age-platelet index, aspartate
aminotransferase-platelet ratio index (APRI), FibroIndex, FibroTest, and Forns
index.


In addition, three of those tests, platelet count, age-platelet index, APRI,
plus Hepascore, all identified cirrhosis with median positive likelihood ratios
of 5 to 10 and AUROCs of 0.80 or greater (range 0.80 to 0.91).


"Our results suggest that blood tests can help to identify HCV-infected
patients with clinically significant fibrosis, with somewhat greater accuracy
for identifying cirrhosis than for less advanced fibrosis," the researchers
wrote.


Liver biopsy remains the gold standard for predicting disease progression in
people with HCV infection, but it is no longer recommended in all patients
before the initiation of antiviral therapy. Drawbacks of liver biopsy include
the potential for sampling error and risk for complications such as bleeding,
severe pain, and infection,


Blood tests have been proposed as a less invasive alternative to liver
biopsy, and more than two dozen tests have been studied for this purpose.


"We expect to see all-oral, interferon-free HCV treatment regimens in a few
years, and that means many more people are likely to begin antiviral therapies,"
they wrote. "Having blood tests to help identify patients who can benefit from
these treatments will be increasingly important."


Using MEDLINE, the Cochrane Library database, and other reference lists, the
authors identified studies that compared blood tests to liver biopsy for
diagnosing fibrosis or cirrhosis in HCV-infected people.


Most of the studies included in the analysis were conducted in the U.S.,
Europe, Asia and northern Africa, and 15 were rated as good quality studies,
while five were rated poor quality. The remainder were considered fair
quality.


Chou said one of the most surprising findings was that the simple APRI blood
test performed as well or better than more complex and expensive tests.


"This test provided useful information about the severity of underlying liver
disease," he told MedPage Today. "For patients trying to decide if they
should begin antiviral therapy, this and other blood tests may be an alternative
to biopsy."


In a subanalysis in which APRI was compared to FibroTest (known as FibroSure
in the U.S.), the predictive value of the two tests was very similar, Chou
said.


FibroTest is a patented, six blood serum test for liver damage marketed by
French company BioPredictive.


APRI was associated with a slightly lower AUROC than the FibroTest for
fibrosis (18 studies: median difference, -0.03; range, minus 0.10-0.07), but
there was no difference for cirrhosis (seven studies; median difference, 0.0;
range, minus 0.04 to 0.06).


Chou and Wasson noted several limitations to their analysis, including the
fact that only English-language studies were included and that most trials
failed to describe blinded interpretation of liver biopsy specimens. Many also
included inadequate descriptions of enrollment methods.


The added that the results may not apply to populations excluded from the
review, including patients coinfected with hepatitis B virus, HIV, and those
receiving hemodialysis.



The study was funded by a grant from the Agency for Healthcare Research and
Quality.







Primary source: Annals of Internal Medicine
             Source
reference:
Chou R, et al "Blood tests to diagnose fibrosis or cirrhosis in
patients with chronic hepatitis c virus infection" Ann Intern Med 2013;
158.



 
 
 
 


 
3 Comments

The Majority of Physicians that Treat Hepatitis C Virus (HCV) Have Begun "Warehousing" and Preparing Their HCV Patients for the Next Generation of HCV Treatments.

6/1/2013

3 Comments

 
Sixty Percent of Surveyed Physicians Agree That They
Are Beginning To Warehouse HCV Patients Until New Interferon-Free Regimens Are
Available, According to a Recently Published BioTrends Report
     By BioTrends Research Group

BioTrends Research Group     
 
Last
modified: 2013-05-23T14:10:59Z

Published:
Thursday, May. 23, 2013 -  7:10 am
    Copyright 2013 . All rights
reserved. This material may not be published, broadcast, rewritten or
redistributed.


EXTON, Pa., May 23, 2013 -- /PRNewswire/ --
BioTrends Research Group, one of the world's leading research and advisory firms
for specialized biopharmaceutical issues, finds that, unaided, one in five
surveyed gastroenterologists, hepatologists, and infectious disease specialists
reported that in the past six months, they have begun warehousing patients
(e.g., intentionally delaying treatment) in anticipation of the next generation
of HCV treatments—notably more physicians than six months ago, when only 6
percent reported that they had begun warehousing patients.


(Logo:  http://photos.prnewswire.com/prnh/20130103/MM36805LOGO 
 


Furthermore, only one in five physicians agrees that they are satisfied with
currently available treatment options, underscoring the high unmet need for
alternatives to treat chronic HCV infections. The trending analyses of
physician-reported anticipated prescribing in TreatmentTrends®:
Hepatitis C Virus (US), Wave 1
also finds
that, for the first time in a year, surveyed physicians are expecting to treat a
greater proportion of their genotype 1 (3 percent) and 2/3 (3 percent) patients
in the next six months with regimens that are not currently available. Unaided
responses from most physicians who expect to be using other treatments suggest
they are expecting products in development, potentially interferon-free
regimens, to be available for use in the next six months.


In aided physician responses, Gilead's sofosbuvir and Janssen/Medivir's
simeprevir garnered the highest degree of familiarity for use in HCV treatment,
followed closely by Bristol-Myers Squibb's daclatasvir and asunaprevir.
Additionally, 20 percent of the surveyed physicians believe that Gilead's
sofosbuvir is the most promising product in development, primarily due to its
favorable tolerability, oral dosing, pan-genotypic activity, and its possibility
to be utilized as an interferon-free regimen.


"The protease inhibitors, Vertex's Incivek and Merck's Victrelis, were very
important advances in the management of HCV infections," said BioTrends Research
Group Associate Director, Lynn Price. "However, there is still a clear unmet
need for alternative HCV therapies and the recent NDA filings for simeprevir and
sofosbuvir have physicians hopeful for new treatment options that are highly
efficacious and more tolerable than the currently available protease
inhibitors."


TreatmentTrends®:
Hepatitis C Virus (US), Wave 1
is a report
that covers the use of agents for the treatment of HCV infections. This
bi-annual study focuses on current and future use of leading HCV treatment
regimens, patient market share, perceived strengths and weaknesses of the key
brands, barriers to broader usage, sales force performance, and perceived value
of manufacturers' patient assistance programs. In addition, this report assesses
potential impact of regimens in development, including Abbott's ABT-267,
ABT-333, and ABT-450, Boehringer Ingelheim's BI-207127 and faldaprevir,
Bristol-Myers Squibb's asunaprevir and daclatasvir, Janssen's simeprevir, and
Gilead's sofosbuvir and ledipasvir. In the current wave of research, BioTrends
surveyed 101 U.S. gastroenterologists, hepatologists, and infectious disease
specialists in March 2013.


About BioTrends Research Group BioTrends Research Group provides
syndicated and custom primary market research to pharmaceutical manufacturers
competing in clinically evolving, specialty pharmaceutical markets. For
information on BioTrends publications and research capabilities, please contact
us at www.bio-trends.com.
BioTrends is a Decision Resources Group company.


About Decision Resources Group Decision Resources Group is a cohesive
portfolio of companies that offers best-in-class, high-value information and
insights on important sectors of the healthcare industry. Clients rely on this
analysis and data to make informed decisions. Please visit Decision Resources
Group at www.DecisionResourcesGroup.com.


 
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