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Hep C TV - November 2013
Published on Nov 22, 2013
A monthly round-up of all things hep C! Taking a look at recent developments in hep C treatments, a tribute to the legendary musician Lou Reed and the latest contributions from our community here at Hepatitis C News.
November Spotlight On Series
This week, in the second of our ‘Spotlight on…’ series, we profile American country singer Naomi Judd and her incredible work in the fight against hep C.
In this, the first in a regular series, we profile actress and model Pamela Anderson and her experience of living with the hep C virus.
****Watch "Hepatitis C News" YouTube Channel for a November Re-cap
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HepCBC’s MONTHLY NEWSLETTER
The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.
ARTICLES IN THIS ISSUE:
HCV in the News
Lou Reed
Andrew Cumming: My Story
And More!
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GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.
Hot Topics
The committee recommend the approval of simeprevir, in combination with pegylated interferon and ribavirin for the treatment of adult genotype 1 patients with compensated liver disease, including cirrhosis.
As for sofosbuvir, the panel voted unanimously in support of approving the drug in combination with just ribavirin for treating adult HCV genotypes 2/3 and in combination with pegylated interferon/ribavirin for genotype 1 and 4 treatment-naive patients. For detailed information please download the FDA review package for
sofosbuvir and
simeprevir.
The FDA does not have to follow the advice of its panels, but most often will. The U.S. health regulators are scheduled to decide whether to approve sofosbuvir by December 8, and simeprevir by November 27.
*Of Interest - sofosbuvir
First Interferon-Free HCV Regimen Gets Unanimously Positive Vote
Sofosbuvir-ledipasvir alone or with ribavirin
In the November issue of "
The Lancet" researchers suggest that the fixed-dose combination of
sofosbuvir-ledipasvir alone or with ribavirin has the potential to cure most patients with genotype-1 HCV including those with compensated cirrhosis or who have previously failed treatment with protease inhibitors.
by Paul E. Sax, MD
Imagine for a moment the ideal medical future … there’s a vaccine that prevents the common cold … colon cancer screening no longer requires that horrendous “prep” … electronic medical records are easily accessible, intuitive, secure, and all communicate effortlessly with one another … your doctor’s office has an actual person who answers the phone instead of a prerecorded list of “menu options” … and hepatitis C is cured with one pill a day taken for 8 weeks.
Not sure about the timeline for the first four, but based on this study of sofosbuvir and ledipasvir
just published in the Lancet, the hepatitis C outcome is right around the corner:
In cohort A, SVR12 [no detectable virus 12 weeks after stopping treatment] was achieved by 19 (95%) of 20 patients (95% CI 75–100) in group 1, by 21 (100%) of 21 patients (84–100) in group 2, and by 18 (95%) of 19 patients (74–100) in group 3. In cohort B, SVR12 was achieved by 18 (95%) of 19 patients (74–100) in group 4 and by all 21 (100%) of 21 patients (84–100) in group 5 … These findings suggest that the fixed-dose combination of sofosbuvir-ledipasvir alone or with ribavirin has the potential to cure most patients with genotype-1 HCV, irrespective of treatment history or the presence of compensated cirrhosis.
You’ll note that the “groups” were pretty small, and that only one of them — group 1 — actually got just the one-pill sofosbuvir/ledipasvir combination for 8 weeks, but regardless, these are pretty spectacular results.
Even the most “complex” treatment group in this study received sofosbuvir/ledipasvir plus ribavirin for only 12 weeks, which is light years from the complexity of our current interferon-based therapies. Light years better, of course.
And since sofosbuvir has already been reviewed by the FDA advisory panel, we should be getting at least this drug by December 2013 at the latest; the combination pill with ledipasvir could be available some time next year (according to this article in the New York Times), and several other investigational HCV drugs will likely be approved soon as well (simeprevir this year too). But calm down already.
Take a deep breath. It’s a small phase II study. Shouldn’t we be more cautious? Shouldn’t we avoid wildly overstating the importance of this particular treatment approach? Of course, that’s the prudent thing to do.
But can people with HCV and their treaters be ecstatic about these results anyway? You betcha.
How Much? A Battle Over The Cost Of The New Hepatitis C Drugs
According to an
article over at
Pharmalot, Wall Street has estimated the cost of sofosbuvir to reach $80,000 to $90,000 per patient in the US. The high cost will put these drugs out of reach for low and middle-income countries. Columnist Ed Silverman mentioned a presentation at this months liver meeting which suggests a much lower cost then predicted by investment analysts. Andrew Hill of Liverpool University and colleagues presented a new analysis of predicted minimum costs to produce four next generation HCV DAAs, currently in Phase 3 development. The
poster was also presented earlier this year at the
7th IAS Conference. Here is a quick rundown of predicted costs: $20-63 for a 12-week treatment of ribavirin, $10-30 for daclatasvir, $68-136 for sofosbuvir, $100-210 for faldaprevir and $130-270 for simeprevir (
view the full analysis here)
Just In - Nov 13
Costs for Hepatitis C Treatment Skyrocket
Miriam E. Tucker
November 13, 2013
WASHINGTON, DC — The expense of telaprevir-based triple therapy for
hepatitis C — including adverse event management — is $189,000 per
sustained viral response, report investigators.
"Our findings indicate that the benefit-cost ratio is lower than
projected, based on results of the registration trials," lead
investigator Andrea Branch, MD, from the Icahn School of Medicine at
Mount Sinai in New York City.
New data were presented at the meeting for both direct-acting antivirals and for some investigational agents used in combination regimens for patients with genotypes 1 to 4 hepatitis C. Several trials suggest the potential for interferon- and ribavirin-free all-oral regimens for genotypes 2 and 3 hepatitis C, and there is a variety of new combinations for the hard-to-treat genotype 1.
The New Paradigm of Hepatitis C Therapy - Integration of Oral Therapies Into Best Practices
Emerging data indicate that all-oral antiviral treatments for chronic hepatitis C virus (HCV) will become a reality in the near future. In replacing interferon-based therapies, all-oral regimens are expected to be more tolerable, more effective, shorter in duration and simpler to administer.
Liver Deaths Cut Once HCV Viral Load Suppressed
Patients who achieved an undetectable viral load of hepatitis C virus (HCV) had decreased hepatic morbidity and mortality long-term, researchers found.
Hepatitis C, stigma and cure
Recently, an article titled "Hepatitis C, stigma and cure" published in the October issue of World J Gastroenterol, looked at the social stigma attached to HCV, consequences of living with the chronic infection, and new drugs to treat the virus.
AASLD
Sofosbuvir
AASLD
- Interferon-Free HCV Tx Benefits Mentally Ill -
WASHINGTON -- Hepatitis C (HCV) patients with mental
comorbidities, such as depression or bipolar disorder, can be successfully
treated with an interferon-free drug regimen, a phase II trial showed. Note
that this uncontrolled trial demonstrated similar rates of virologic response
among patients with and without psychiatric comorbidities treated with
sofosbuvir and ribavirin....
AASLD 2013: Sofosbuvir + Ribavirin for 12 or 24 Weeks Cures Most Genotype 2-3 Hepatitis C Patients
A dual oral regimen of sofosbuvir plus ribavirin led to sustained response for 93% of genotype 2 hepatitis C patients treated for 12 weeks and 85% of genotype 3 patients treated for 24 weeks, researchers reported last week at the 64th AASLD Liver Meeting in Washington, DC. A related study found that adding ribavirin to this combination may be an option for harder-to-treat individuals.
AASLD-Gilead
Announces New Sustained Viral Response Data for Sofosbuvir-Based Regimens in
Genotype 3-Infected Hepatitis C Patients
Gilead Sciences, Inc.
(Nasdaq:GILD) today announced results from two studies, the Phase 3 VALENCE
study and the Phase 2 LONESTAR-2 study, evaluating the investigational
once-daily nucleotide analogue sofosbuvir for the treatment of chronic hepatitis
C virus (HCV) infection among patients infected with genotype 3 HCV. These data
will be presented this week at the 64th Annual Meeting of the American
Association for the Study of Liver Diseases (The Liver Meeting 2013) taking
place in Washington, D.C.
AASLD-Gilead
Announces Phase 3 Results for an All-Oral, Sofosbuvir-Based Regimen for the
Treatment of Hepatitis C in Patients Co-Infected With HIV
Gilead
Sciences, Inc. (Nasdaq:GILD) today announced results from a Phase 3 study,
PHOTON-1, evaluating the investigational once-daily nucleotide analogue
sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection among
patients co-infected with HIV. In the trial, 76 percent (n=87/114) of genotype 1
HCV treatment-naïve patients receiving 24 weeks of an all-oral, interferon-free
regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic
response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12
are considered cured of HCV infection. These data will be presented this week
during the 64th Annual Meeting of the American Association for the Study of
Liver Diseases (The Liver Meeting 2013) in Washington, D.C.
Sofosbuvir-Based Regimens Liver Transplant Patients
AASLD-Gilead
Announces Phase 2 Results for Sofosbuvir-Based Regimens in Hepatitis C Patients
Before and After Liver Transplantation
Gilead Sciences, Inc. (Nasdaq:
GILD) today announced results from two Phase 2 studies evaluating an all-oral
treatment regimen of the investigational once-daily nucleotide analogue
sofosbuvir plus ribavirin (RBV) for both the prevention and treatment of
recurrent chronic hepatitis C virus (HCV) infection among patients who undergo
liver transplantation. The findings will be presented this week at the 64th
Annual Meeting of the American Association for the Study of Liver Diseases (The
Liver Meeting 2013) in Washington, D.C.
First
Study of its Kind Shows that All-oral Treatment Regimen Prevents Hepatitis C
Recurrence in Liver Transplant Recipients
For the first time,
researchers have been able to prevent the recurrence of hepatitis C virus (HCV)
infection in a large proportion of patients (64 percent, n=25/39) who undergo
liver transplantation for cirrhosis complicated by hepatocellular carcinoma
(HCC). This success was achieved with an interferon-free treatment regimen
containing the oral antivirals sofosbuvir, an investigational agent, and
ribavirin.
Slides:
Pretransplant Sofosbuvir and
Ribavirin to Prevent Recurrence of HCV Infection After Liver Transplantation
Sofosbuvir and
Ledipasvir
A two-drug, single-pill HCV regimen with/without ribavirin -- led to viral cures in 97% of patients
In the so-called LONESTAR study, Lawitz and colleagues are testing the single-pill combination of sofosbuvir, a nucleotide polymerase inhibitor, and ledipasvir, which blocks the nonstructural NS5A protein
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced data from the interferon-free COSMOS study demonstrating safety and efficacy of the investigational protease inhibitor simeprevir (TMC435) in combination with the investigational nucleotide inhibitor sofosbuvir (GS-7977), with and without ribavirin, in genotype 1 chronic hepatitis C adult patients with compensated liver disease was presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, D.C. during the late-breaking oral session on Monday, November 4....
HCV Combo Promising in Difficult Patients
WASHINGTON -- The combination of two novel hepatitis C (HCV) drugs that are close to market yielded good efficacy in hard-to-treat patients, a researcher said.
Simeprevir
Simeprevir
SVR in Treatment-Naïve and Treatment-Experienced Geno 1 Chronic Hepatitis C
Patients
Beerse, Belgium (Nov. 11, 2013) Janssen R&D Ireland
(Janssen) today announced the presentation of new data for the new generation
protease inhibitor simeprevir (TMC435) in the treatment of genotype 1 chronic
hepatitis C (HCV) in treatment-naïve and treatment-experienced adult patients
with compensated liver disease. In analyses of the Phase 3 QUEST-1 and QUEST-2
studies in treatment-naïve patients and the Phase 3 PROMISE study in prior
relapse patients, the efficacy of simeprevir was observed in HCV patients
considered difficult to treat, including patients with the IL28B TT genotype and
METAVIR scores of F4.
Daclatasvir and
Asunaprevir
Daclatasvir plus Asunaprevir HCV Regimen: No Interferon, No Ribavirin, No Problem
WASHINGTON -- Patients who failed to respond to standard treatment for hepatitis C virus (HCV) infection achieved greater than 80% sustained virologic response at 24 weeks with an all-oral regimen that eschewed both interferon and ribavirin, researchers reported here.
AASLD-Phase
III all-oral hepatitis C regimen daclatasvir and asunaprevir
For the 24-week study, 222 patients were studied, and 85.6
percent of those patients had a sustained virologic response (SVR) by week 12.
According to Kazuaki Chayama, MD, PhD, "Only around 75 percent of patients
treated with peg-interferon /ribavirin/telaprevir had a SVR but that therapy was
associated with severe side effects and high cost. New oral-only drug therapy is
quite safe and the eradication rate is so high."
Bristol
seeks Japan approval of all-oral hepatitis C treatment
Patients in the trial were given a combination of
daclatasvir, from a promising new class of drugs called NS5A inhibitors, and the
protease inhibitor asunaprevir for 24 weeks. Those who had no detectable levels
of the virus in their blood 24 weeks after completing the therapy were deemed to
be cured, a measure known as SVR24, for sustained virologic response.
MK-5172 with
MK-874
AASLD-High
cure rates seen with Merck oral hepatitis drugs -study
A combination of
two oral hepatitis C treatments developed by Merck & Co led to high cure
rates in previously untreated patients, indicating the company is a contender in
the race to find new treatments for the liver destroying virus.
MK-5172
- Oral HCV Combos Promising
WASHINGTON -- All-oral combinations of two
novel drugs for hepatitis C (HCV) demonstrated promising efficacy in a small
clinical trial, a researcher said here.
Merck's
'breakthrough' hep C combo plays catch-up
Now its combination of
MK-5172, an NS3/4A protease inhibitor, and the NS5A treatment MK-8742 produced
cure rates ranging from 96% to 100% among small groups of genotype 1a and 1b
patients. A total of 58 evaluable patients were included in the readout with the
combo provided both with and without ribavirin.
Slides -
MK-8742, an
HCV NS5A Inhibitor With a Broad Spectrum of HCV Genotypic Activity, Demonstrates
Potent Antiviral Activity in Genotype-1 and -3 HCV-Infected Patients
Resistance Analysis [and
activity] of Genotype-1 and -3 HCV-Infected Patients Receiving MK-8742, an HCV
NS5A Inhibitor With Potent Antiviral Activity, in a Ph1b Monotherapy Study
High Efficacy and Safety of
the All-Oral Combination Regimen, MK-5172 / MK-8742 ± RBV for 12 Weeks in HCV
Genotype 1 Infected Patients: The C-WORTHY Study
ABT-450/r,
and ABT-267
HCV RNA "Target Detected" After "Target Not Detected" During IFN-free Treatment: Time to Worry or Not?
AASLD-New
Data from from AbbVie's Study, ABT-450 Containing Regimen
Enanta
Pharmaceuticals, Inc., (NASDAQ: ENTA a research and development-focused
biotechnology company dedicated to creating small molecule drugs in the
infectious disease field, today announced that additional data from AbbVie's
M13-393 study, referred to as PEARL-I, will be presented in an oral presentation
at 5:15 p.m. ET today at The Liver Meeting, the 64th Annual Meeting of the
American Association for the Study of Liver Diseases (AASLD) in Washington, D.C.
AbbVie’s two-drug, interferon-free
combination cures genotype 1b hepatitis C infection in 95%
AbbVie
is already testing ABT-450, an HCV protease inhibitor boosted by ritonavir, and
ABT-267, an Ns5A inhibitor, in several phase III studies in combination with a
third drug, the non-nucleoside polymerase inhibitor ABT-333. These trials will
begin to report results by the end of 2013, and it is likely that AbbVie will
submit a licensing application in early 2014 for this three-drug,
interferon-free combination in order to achieve marketing approval in the second
half of 2014.....
HCV Drug Combo
Cures Most in Select Group
WASHINGTON -- An investigational two-drug
combination treatment for hepatitis C (HCV) -- using none of the standard
medications -- led to cures in 90% or more of a selected group of patients, a
researcher said
here.
In the PEARL-1
study, Lawitz and colleagues studied ABT-450/r, an HCV NS3/4A protease inhibitor
boosted with the protease inhibitor ritonavir (Norvir), and ABT-267, which
blocks the viral nonstructural protein NS5A.
Slides -
Safety of
Ribavirin-containing Regimens of ABT-450/r, ABT-333, and ABT-267 for the
Treatment of HCV Genotype 1 Infection and Efficacy in Subjects With Ribavirin
Dose Reductions
Low Relapse Rate Leads to
High Concordance of SVR4 and SVR12 With SVR24 After Treatment With ABT-450/r,
ABT-267, ABT-333 + Ribavirin in Patients With Chronic HCV Genotype 1 Infection
in the AVIATOR Study
VX-135
Of Interest -
Aug 27 2013
Vertex’s
VX-135 partial hold signals heightened FDA scrutiny toward HCV drugs
The FDA seems to be very sensitive about any compounds causing hepatotoxicity (liver damage) in HCV, said one expert, a US-based investigator. There is now a lot of focus on cardiac and hepatotoxicity due to Bristol-Myers Squibb’s (NYSE:BMY) failed purine nuc, he said.
Slides-Nov 7
VX-135, A Once-daily
Nucleotide HCV Polymerase Inhibitor, Was Well Tolerated And Demonstrated Potent
Antiviral Activity When Given With Ribavirin In Treatment-naïve Patients With
Genotype 1 HCV
