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Hepatitis C New Drugs Review
FDA approved Incivek(telaprevir, Vertex) on Monday 23 May by its PDUFA deadline.A paradigm shift in the treatment of Hepatitis C virus infection. http://knol.google.com/k/krishan-maggon/boceprevir-merck-telaprevir-vertex/3fy5eowy8suq3/151#
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Created public version #121 of the knol: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval"

Created public version #121 of the knol: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval" | Hepatitis C New Drugs Review | Scoop.it
Krishan Maggon published version 121 of a knol titled: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval"...
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HCV in 2015: New Medication Approvals and Innovative Studies...Including a One-Shot Cure?

David Wyles, M.D., of the UC San Diego AntiViral Research Center, presents "HCV in 2015: New Medication Approvals and Innovative Studies...Including a One-Shot Cure?

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New Pill-only Regimens Cure 90% Patients With Hardest-to-treat Hepatitis C Infection - Science 2.0

New Pill-only Regimens Cure 90% Patients With Hardest-to-treat Hepatitis C Infection - Science 2.0 | Hepatitis C New Drugs Review | Scoop.it
Science 2.0 New Pill-only Regimens Cure Patients With Hardest-to-treat Hepatitis C Infection Science 2.0 (Vienna, October 17, 2014) Two new pill-only regimens that rapidly cure most patients with genotype 1 hepatitis C (HCV) infection could soon be...
Krishan Maggon 's insight:

Oral interferon and ribavirin free combos show over 90% SVR in HCV genotype 1. There are over 180 million patients infected with HCV in the world.

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The Changing HCV Landscape: - Gastroenterology & Endoscopy News

The Changing HCV Landscape: - Gastroenterology & Endoscopy News | Hepatitis C New Drugs Review | Scoop.it
Gastroenterology & Endoscopy News The Changing HCV Landscape: Gastroenterology & Endoscopy News One emerging regimen is the combination of the PIs ABT-450/r boosted with low-dose ritonavir and ombitasvir (ABT-257, NS5A inhibitor), coformulated in a...
Krishan Maggon 's insight:
The Changing HCV Landscape:Update on Diagnosis and Treatment Sonal Kumar, MD, MPHAssistant Professor of Medicine Weill Medical College of Cornell University New York, New YorkIra M. Jacobson, MDChief of the Division of Gastroenterology and Hepatology
Vincent Astor Distinguished Professor of Medicine
Weill Medical College of Cornell University
New York, New York
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The Hepatitis C Escalation: Baby Boomer Ripple Effects | Absolutely Maybe, Scientific American Blog Network

The Hepatitis C Escalation: Baby Boomer Ripple Effects | Absolutely Maybe, Scientific American Blog Network | Hepatitis C New Drugs Review | Scoop.it
There's never been anything quite like this. The latest ripple effect of the 1945-65 baby boom will be a drug bill so high, that paying it

 

The CDC estimates that 3.2 million people in America are infected. CVS estimates that about half have been diagnosed and most have few or no symptoms. The CDC and the US Preventive Services Task Forcerecommend testing for those who are high risk for getting infected – and everyone born between 1945 and 1965.

 

Sofosbuvir and other drugs like simeprevir (Olysio) and daclatasvir (Daklenza – which isn’t available in the US) can make hepatitis C treatment interferon-free. They’re oral – although still used in combination with other drugs, including injections – and the course is half the time. Sofosbuvir combinations have fewer adverse effects and clear up to 90% of infection – even up to 80% in people with cirrhosis.

But the cost for the sofosbuvir alone is around $1,000 a pill – and $84,000 for the course: closer to $95,000 when you count in the drugs used alongside. Forbes reports that is the price set for Harvoni.

, ...


Via Pharma Guy
Krishan Maggon 's insight:

Image

 

The images of the hepatitis C virus and developing liver fibrosis are from Tarik Asseleh et al, Gene expression and hepatitis C virus infection, Gut 2009, 58(6):846-858.

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Pharma Guy's curator insight, October 14, 5:02 PM


Only 10% non adherence ... sounds reasonable considering, I'd like to know, however, more about thee patients, such as, income. I'm betting  early adopters of Sovaldi have the $ for the co-pay, whereas poorer patients may be waiting for cheaper alternatives to reach the market.

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Janssen new data NS3/4A protease inhibitor OLYSIO® (simeprevir)

Janssen new data NS3/4A protease inhibitor OLYSIO® (simeprevir) | Hepatitis C New Drugs Review | Scoop.it
FRANKFURT, Germany--(Business Wire)--Janssen R&D Ireland (Janssen) today announced the presentation of

 

 additional data for the NS3/4A protease inhibitor OLYSIO® (simeprevir) at the Viral Hepatitis Congress (VHC) in Frankfurt, Germany. The data includes new analysis of a European and Israeli Hepatitis C (HCV) patient subset within the previously presented ATTAIN Phase 3 study. Additional data presented investigates treatment considerations for a broad range of patient populations including the renal function of those treated with simeprevir as well as the prevalence of the polymorphism of Q80k in European genotype 1 (GT1) patients.

 

The new analysis of the Phase 3 ATTAIN study (n=763), showed sustained virological response at 12 weeks (SVR12) to be similar in European and Israeli patients compared to previous analysis of the overall patient population (GT1, null and prior responder patients).1 Importantly these results have shown that Week 4 response rates are a good predictor of SVR12, showing that the majority of patients treated with simeprevir and pegIFN/ RBV with HCV RNA <25 IU/ml at Week 4, were likely to achieve SVR by week 12.2

 

The aim of the study was to demonstrate the non-inferiority of simeprevir versus telaprevir with pegIFN and RBV in difficult to cure HCV genotype 1-infected patients who were null or partial responders to prior pegIFN and RBV therapy. Overall, simeprevir met its primary endpoint of non-inferiority to telaprevir in treatment-experienced HCV patients and also demonstrated an improved tolerability profile, with SVR12 rates within the European cohort reported at 58 percent for the simeprevir arm and 60 percent for the telaprevir arm (compared to 54% and 55% respectively in the total patient population).1,2

“The new ATTAIN data presented at the Viral Hepatitis Congress adds to the breadth of data that highlights the value of simeprevir, in combination with pegylated interferon and ribavirin, as well as helping to further define patients who can benefit from this therapy,” said PD Dr. med. Holger Hinrichsen, Centre for Gastroenterology and Hepatology, Kiel, Germany and investigator of the ATTAIN study. “While interferon-free regimens are a focus of industry clinical development programmes, these results demonstrate that interferon based therapies still have an important role to play within current standards of treatment.”

The most common adverse events during the first 12 weeks of treatment occurred at a consistently lower frequency in the simeprevir treatment arm compared to the telaprevir treatment arm. Adverse events included: pruritus (31 percent versus 43 percent); fatigue (32 percent versus 38 percent); headache (25 percent versus 29 percent) and anemia (13 percent versus 37 percent).

 

Anaemia-related blood transfusions were significantly lower in the simeprevir treatment arm (0.8%) versus the telaprevir treatment arm (9.1%). Only two percent of patients in the simeprevir arm versus eight percent of patients in the telaprevir arm discontinued treatment early due to an adverse event.2

Krishan Maggon 's insight:

Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Simeprevir efficacy has been established in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.6

 

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. Simeprevir was approved for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with PegIFN + RBV in genotype 1 infected adults with compensated liver disease, including cirrhosis in September 2013 in Japan, in November 2013 in Canada and the U.S., in March 2014 in Russia, and in July 2014 in Mexico and Australia. In May 2014 simeprevir was granted marketing authorization by the European Commission (EC) for the treatment of adult patients with genotype 1 or genotype 4 chronic HCV.

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BIT225 Trial Results Show Effective Cure of Hepatitis C - Drug Discovery & Development

BIT225 Trial Results Show Effective Cure of Hepatitis C - Drug Discovery & Development | Hepatitis C New Drugs Review | Scoop.it
Australian drug development company Biotron Ltd. announced that all Hepatitis C virus (HCV) genotype 3 (G3) patients completing a key Phase 2 trial of its lead antiviral drug, BIT225, have undetectable levels of HCV 12 weeks after ceasing all treatment. The endpoint of HCV treatment is a sustained virologic response (SVR).  Sustained virologic response at week 12 (SVR12) is defined as an undetectable HCV RNA level 12 weeks after completion of treatment. It is considered to be a prediction of permanent clearance of the virus and, effectively, a cure.
Krishan Maggon 's insight:

Open label trial results based on only 8 patients treated in Thialand?

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FDA approves first combination pill Harvoni (ledipasvir+sofosbuvir, Gilead) to treat hepatitis C

FDA approves first combination pill Harvoni (ledipasvir+sofosbuvir, Gilead)  to treat hepatitis C | Hepatitis C New Drugs Review | Scoop.it
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

 

Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

 

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.

 

In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.

The most common side effects reported in clinical trial participants were fatigue and headache.

 

 

 

Krishan Maggon 's insight:

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

 

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

 

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval.  Harvoni was reviewed under the FDA’s priority review program.

 The cost of the first oral interferon and ribavirin combo will be higher than sofosbuvir alone and expected to be $95,000 per patient for 12 weeks. 

 

 

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Krishan Maggon 's curator insight, October 11, 1:56 AM

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

 

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

 

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval.  Harvoni was reviewed under the FDA’s priority review program.

 

 The cost of the first oral interferon and ribavirin combo will be higher than sofosbuvir alone and expected to be $95,000 per patient for 12 weeks. 

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Called Strike 3 For Bristol-Myers Squibb: What This Says For Gilead And Its ... - Seeking Alpha (registration)

Called Strike 3 For Bristol-Myers Squibb: What This Says For Gilead And Its ... - Seeking Alpha (registration) | Hepatitis C New Drugs Review | Scoop.it
Background:The hepatitis C landscape is an extremely competitive area for pharmaceuticals and biotechs. Years ago, the standard of care for HCV genotype 1 patients was Pegasys and Ribavirin for 48 weeks of treatment.
Krishan Maggon 's insight:

BMS accepts that Gilead HCV combo is superior and will lead the market

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Can hepatitis C be eradicated in the United States?

Can hepatitis C be eradicated in the United States? | Hepatitis C New Drugs Review | Scoop.it
 Eliminating hepatitis C from the United States is possible, but will require a sustained national commitment to reach, test, treat, cure, and prevent every case. With strong political leadership, societal commitment, and community support, hepatitis C can be eradicated in the United States. Highlights

 

Highly effective antiviral regimens will make it feasible to eradicate hepatitis C in the United States.

Surveillance, prevention, screening, care, policy, and research must be enhanced.

Advocacy will be needed to build and sustain support for these efforts.

Leadership by physicians, scientists, and the public health community will be needed.

If this is to happen in our lifetimes, the time for action is now.

Krishan Maggon 's insight:

open access

 

Antiviral Research

Volume 110, October 2014, Pages 79–93

Can hepatitis C be eradicated in the United States?Brian R. Edlina, b, , , Emily R. Winkelsteinb,   Show moreDOI: 10.1016/j.antiviral.2014.07.015
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Gilead Sciences' Other Important New Drug - NASDAQ

Gilead Sciences' Other Important New Drug - NASDAQ | Hepatitis C New Drugs Review | Scoop.it
Source: Gilead Sciences. On Oct. 10, the FDA is expected to make a decision on Harvoni, Gilead Sciences '  second-generation hepatitis C drug..
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If Gilead's Hepatitis C Treatment Grosses $10B+ Per Year, Arrowhead's ... - Seeking Alpha (registration)

If Gilead's Hepatitis C Treatment Grosses $10B+ Per Year, Arrowhead's ... - Seeking Alpha (registration) | Hepatitis C New Drugs Review | Scoop.it
In December of 2013, Gilead Sciences (NASDAQ:GILD) started marketing its Hepatitis C treatment Sovaldi in the US. GILD was able to sell $5.75B of Sovaldi in 1H 2014; and the sales were accelerating in Q2 2014.
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Sofosbuvir-Based Treatment Regimens for Chronic, Genotype 1 Hepatitis C Virus Infection in U.S. Incarcerated Populations: A Cost-Effectiveness AnalysisSofosbuvir-Based Treatment of Hepatitis C in U...

Sofosbuvir-Based Treatment Regimens for Chronic, Genotype 1 Hepatitis C Virus Infection in U.S. Incarcerated Populations: A Cost-Effectiveness AnalysisSofosbuvir-Based Treatment of Hepatitis C in U... | Hepatitis C New Drugs Review | Scoop.it
RT @pzettler: Study in Annals of Internal Med finds #Sovaldi to be cost-effective for prisoners: http://t.co/AbGbcndQv0

 

Intervention: No treatment, 2-drug therapy (pegylated interferon and ribavirin), or 3-drug therapy with either boceprevir or sofosbuvir. For inmates with short remaining sentences (<1.5 years), only no treatment or sofosbuvir 3-drug therapy was feasible; for those with long sentences (≥1.5 years; mean, 10 years), all strategies were considered. After release, eligible persons could receive sofosbuvir 3-drug therapy.

Outcome Measures: Discounted costs (in 2013 U.S. dollars), discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.

Results of Base-Case Analysis: The strategies yielded 13.12, 13.57, 14.43, and 15.18 QALYs, respectively, for persons with long sentences. Sofosbuvir produced the largest absolute reductions in decompensated cirrhosis (16%) and hepatocellular carcinoma (9%), resulting in 2.1 additional QALYs at an added cost exceeding $54 000 compared with no treatment. For persons with short sentences, sofosbuvir cost $25 700 per QALY gained compared with no treatment; for those with long sentences, it dominated other treatments, costing $28 800 per QALY gained compared with no treatment.

Results of Sensitivity Analysis: High reinfection rates in prison attenuated cost-effectiveness for persons with long sentences.

Limitations: Data on sofosbuvir's long-term effectiveness and price are limited. The analysis did not consider women, Hispanic persons, or patients co-infected with HIV or hepatitis B virus.

Conclusion: Sofosbuvir-based treatment is cost-effective for incarcerated persons, but affordability is an important consideration.

Primary Funding Source: National Institutes of Health.

Krishan Maggon 's insight:

The NIH funded study shows that the use of soforsbuvir in prisons is cost effective despite high price 

 

Sofosbuvir-Based Treatment Regimens for Chronic, Genotype 1 Hepatitis C Virus Infection in U.S. Incarcerated Populations: A Cost-Effectiveness AnalysisShan Liu, PhD; Daena Watcha, MD, MS; Mark Holodniy, MD; and Jeremy D. Goldhaber-Fiebert, PhD[+] Article and Author InformationAnn Intern Med. 2014;161(8):546-553. doi:10.7326/M14-0602
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What Johnson & Johnson Can Tell Us about Gilead Sciences, inc. Stock - NASDAQ

What Johnson & Johnson Can Tell Us about Gilead Sciences, inc. Stock - NASDAQ | Hepatitis C New Drugs Review | Scoop.it
Source: Johnson & Johnson Johnson & Johnson is one of the planet's biggest drugmakers. Its drugs are used for a variety of diseases,.
Krishan Maggon 's insight:

Projections  for 2014 Sales of Olysio and Sovaldi based on 1-2 Q 2014 sales.

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Costs of telaprevir-based triple therapy for hepatitis C: $189,000 per sustained virological response - Bichoupan - 2014 - Hepatology - Wiley Online Library

Costs of telaprevir-based triple therapy for hepatitis C: $189,000 per sustained virological response - Bichoupan - 2014 - Hepatology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Costs of telaprevir triple therapy for hepatitis C: $189,000 per SVR Bichoupan 2014 Hepatology Wiley Online http://t.co/7EZ1l9yXKd

 

In registration trials, triple therapy with telaprevir (TVR), pegylated interferon (Peg-IFN), and ribavirin (RBV) achieved sustained virological response (SVR) rates between 64% and 75%, but the clinical effectiveness and economic burdens of this treatment in real-world practice remain to be determined. Records of 147 patients who initiated TVR-based triple therapy at the Mount Sinai Medical Center (May-December 2011) were reviewed. Direct medical costs for pretreatment, on-treatment, and posttreatment care were calculated using data from Medicare reimbursement databases, RED Book, and the Healthcare Cost and Utilization Project database. Costs are presented in 2012 U.S. dollars. SVR (undetectable hepatitis C virus [HCV] RNA 24 weeks after the end of treatment) was determined on an intention-to-treat basis. Cost per SVR was calculated by dividing the median cost by the SVR rate. Median age of the 147 patients was 56 years (interquartile range [IQR] = 51-61), 68% were male, 19% were black, 11% had human immunodeficiency virus/HCV coinfection, 36% had advanced fibrosis/cirrhosis (FIB-4 scores ≥3.25), and 44% achieved an SVR. The total cost of care was $11.56 million. Median cost of care was $83,721 per patient (IQR = $66,652-$98,102). The median cost per SVR was $189,338 (IQR = $150,735-$221,860). Total costs were TVR (61%), IFN (24%), RBV (4%), adverse event management (8%), professional fees (2%), and laboratory tests (1%). Conclusions: TVR and Peg-IFN accounted for 85% of costs. Pharmaceutical prices and the low (44%) SVR rate, in this real-world study, were major contributors to the high cost per SVR. (Hepatology 2014;60:1187–1195)

Krishan Maggon 's insight:
Costs of telaprevir-based triple therapy for hepatitis C: $189,000 per sustained virological responseKian Bichoupan1,*, Valerie Martel-Laferriere1, David Sachs2, Michel Ng1, Emily A. Schonfeld1, Alexis Pappas1, James Crismale1, Alicia Stivala1, Viktoriya Khaitova1, Donald Gardenier1, Michael Linderman2, Ponni V. Perumalswami1,Thomas D. Schiano1, Joseph A. Odin1,Lawrence Liu1, Alan J. Moskowitz3,Douglas T. Dieterich1 andAndrea D. Branch1

Article first published online: 25 AUG 2014

DOI: 10.1002/hep.27340

© 2014 by the American Association for the Study of Liver Diseases

Issue

Hepatology

Volume 60, Issue 4, pages 1187–1195, October 2014

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Olysio drives J&J pharma sales - PMLiVE

Olysio drives J&J pharma sales - PMLiVE | Hepatitis C New Drugs Review | Scoop.it
Olysio drives J&J pharma sales
PMLiVE
Johnson & Johnson (J&J) has raised its earnings forecasts for the year based on surging pharma sales driven mainly by new hepatitis C drug Olysio.
Krishan Maggon 's insight:

Olysio to top $2 billion sales in 2014, emerges as J&J second best selling drug after Remicade. Main use as add on to Sofosbuvir from Gilead. A 28 day supply is priced at $22400 in the US. Approval of Harvoni and its lower ccost will shift sales away from Olysio.

 

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Is Specialty Pharma Pricing At A Tipping Point? - Forbes

Is Specialty Pharma Pricing At A Tipping Point? - Forbes | Hepatitis C New Drugs Review | Scoop.it
Gilead has been under fire from payers, employers and patient groups for the pricing of Sovaldi, its high-cost hepatitis C medication, and now Harvoni, which received FDA approval on Oct. 10.
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FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions - Regulatory Focus

FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions - Regulatory Focus | Hepatitis C New Drugs Review | Scoop.it
On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value.
Krishan Maggon 's insight:

Gilead and Eisai were the winners with approvals of Harvoni (ledipasvir+sofosbuvir, Gilead) for Hepatitis C and Akynzeo (netupitant + palonosetron, Eisai) for nausea and vomiting in patients undergoing cancer chemotherapy. Both companies will gain 2 additional years of effective market exclusivity.

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Krishan Maggon 's curator insight, October 14, 1:35 AM

Gilead and Eisai were the winners with approvals of Harvoni (ledipasvir+sofosbuvir, Gilead) for Hepatitis C and Akynzeo (netupitant + palonosetron, Eisai) for nausea and vomiting in patients undergoing cancer chemotherapy. Both companies will gain 2 additional years of effective market exclusivity.

Joel Finkle's curator insight, October 17, 10:38 AM

New exclusivity rule as of 10/10/2014 permits 5-year exclusivity for combination therapies with at least one NME.

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Structure of Hepatitis C Virus Envelope Protein an Early Step Toward Vaccine, Therapies

Structure of Hepatitis C Virus Envelope Protein an Early Step Toward Vaccine, Therapies | Hepatitis C New Drugs Review | Scoop.it
A new study performed in part at the National Synchrotron Light Source, a U.S. Department of Energy (DOE) Office of Science user facility at the DOE’s Brookhaven National Laboratory, takes researchers a step closer to understanding the molecular-level activity that takes place when the hepatitis C virus infects a host cell. 

 

A new study performed in part at the National Synchrotron Light Source by scientists from Rutgers University and the Emory University School of Medicine takes researchers a step closer to this goal. They determined the molecular structure of a protein that is directly involved in how the virus penetrates the host cell membrane. The protein is a component of the outer portion of the virus particle. The outer layer, made of HCV proteins and lipids derived from the membrane of the host cell, helps the virus enter the host cell and evade its immune system.

 

On HCV, there are two envelope proteins known as E1 and E2 that have roles in the infection process. This study focused on E2, which binds to the host cell and is a target for the host's antibodies. Therefore, this interaction is a logical starting point for potential therapies. But first, scientists need to learn much more about the precise roles of E1 and E2.

 

The x-ray studies show that E2's ectodomain core has a compact globular shape, consisting mainly of “random coil,” a term used to describe an irregular arrangement of protein segments, long protein “beta strands,” with two small spiral-shaped protein “alpha helices.” The beta strands form two sheets, A and B, arranged perpendicular to each other. With the exception of a certain fold exhibited by sheet A, these features are not consistent with class II viral fusion proteins. 

Krishan Maggon 's insight:

We can expect more specific and highly potent HCV antivirals based on the new structure details.

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Prime Therapeutics responds to FDA approval of Gilead's latest Hepatitis C drug

ST. PAUL, Minn., Oct. 10, 2014 /PRNewswire/ -- Today's U.S. Food and Drug Administration (FDA) approval of...
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Full Report | Recommendations for Testing, Managing, and Treating Hepatitis C

Full Report | Recommendations for Testing, Managing, and Treating Hepatitis C | Hepatitis C New Drugs Review | Scoop.it

TOC

 

Full ReportINTRODUCTION Read more>>METHODS

The Guidance was developed by a panel of HCV experts in the fields of hepatology and infectious diseases, using an evidence-based review of information that is largely available to healthcare...

Read more>>Methods Table 1. Summary of the Process and Methods for the Guidance Development

 

Read more>>Methods Table 2. Grading System Used to Rate the Level of the Evidence and Strength of the Recommendation for Each Recommendation

Recommendations are based on scientific evidence and expert opinion.

Read more>>Methods Table 3. Commonly Used Abbreviations and Their Expansions...Read more>>HCV TESTING AND LINKAGE TO CARE

A summary of recommendations for Testing and Linkage to Care is found in the BOX.

Read more>>Testing and Linkage to Care Box: Summary of Recommendations for Testing and Linkage to Care Read more>>Testing and Linkage to Care Table 1. FDA-approved, Commercially Available Anti-HCV Screening Assays...Read more>>Testing and Linkage to Care Table 2. Measures to Prevent Transmission of HCV...Read more>>Testing and Linkage to Care Table 3: Common Barriers to HCV Treatment and Potential Strategies...Read more>>Testing and Linkage to Care Figure 1. CDC Recommended Testing Sequence for Identifying Current HCV Infection

 

Read more>>WHEN AND IN WHOM TO INITIATE HCV THERAPY

Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure; virologic cure is expected to benefit chronically infected persons.

Read more>>When and in Whom to Initiate HCV Therapy Box. Summary of Recommendations for When and in Whom to Initiate HCV Therapy Read more>>INITIAL TREATMENT OF HCV INFECTION IN PATIENTS STARTING TREATMENT Read more>>Initial Treatment Box. Summary of Recommendations for Patients Who are Initiating Therapy for HCV Infection or Who Experienced Relapse after Prior PEG/RBV Therapy, by HCV Genotype Read more>>RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED

Changes made on this page on March 21, 2014.

Read more>>Retreatment Box. Summary of Recommendations for Patients in Whom Previous Treatment Has Failed Read more>>MONITORING PATIENTS WHO ARE STARTING HEPATITIS C TREATMENT, ARE ON TREATMENT, OR HAVE COMPLETED THERAPY

Expansions and notes for abbreviations used in this section can be found in Methods Table 3.

Read more>>Monitoring Box. Summary of the Recommendations for Monitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy Read more>>UNIQUE PATIENT POPULATIONS

The recommendations for patients with HIV/HCV coinfection; patients with cirrhosis; patients who develop recurrent HCV infection post-liver transplantation; patients with renal...

Read more>>Unique Patient Populations: HIV/HCV Coinfection Box. Summary of Recommendations for HIV/HCV Coinfected Patients Who are Being Treated for HCV, by Genotype Read more>>Unique Patient Populations: Cirrhosis Box. Summary of Recommendations for Patients with Cirrhosis Read more>>Unique Patient Populations: Post-Liver Transplantation Box. Summary of Recommendations for Patients Who Develop Recurrent HCV Infection Post-Liver Transplantation Read more>>Unique Patient Populations: Renal Impairment Table. Dose Adjustments Needed for Patients with Renal Impairment Read more>>Unique Patient Populations: Renal Impairment Box. Summary of Recommendations for Patients with Renal Impairment Including Severe Renal Impairment (CrCl <30 ML/min) or ESRD Requiring Hemodialysis or Peritoneal Dialysis Read more>>MANAGEMENT OF ACUTE HCV INFECTION

Expansions and notes for abbreviations used in this section can be found in Methods Table 3.

Read more>>Acute Box. Recommendations for Management of Acute HCV Infection Read more>>REFERENCES Read more>>
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AASLD HCV Guidelines  open access

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Merck New Clinical Trials Hepatitis C data Grazoprevir/Elbasvir (MK-5172/MK-8742) at the 65th American Association for the Study of Liver Diseases

Merck New Clinical Trials Hepatitis C data Grazoprevir/Elbasvir (MK-5172/MK-8742) at the 65th American Association for the Study of Liver Diseases | Hepatitis C New Drugs Review | Scoop.it

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-

 

-Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data from clinical studies of the company’s investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir (MK-5172/MK-8742) are scheduled to be presented at the 65th American Association for the Study of Liver Diseases (AASLD) Annual Meeting, also known as The Liver Meeting®. The meeting is scheduled to take place at the John B. Hynes Veterans Memorial Convention Center in Boston, Mass., from Nov. 7 – 11, 2014.

 Image  CDC PHIL  8153 transmission electron micrograph (TEM) revealed numerous hepatitis virions, of an unknown strain of the organism.  
Krishan Maggon 's insight:

Interim results of C-SWIFT, a Phase 2 study evaluating ultra-short treatment durations of grazoprevir/elbasvir (MK-5172/MK-8742) plus sofosbuvir, to be presented


Results from the C-WORTHy study, a Phase 2 clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742) across multiple patient populations, including difficult-to-cure, to be presented

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BMS Withdraws its FDA NDA for dual regimen of daclatasvir and asunaprevir

BMS Withdraws its FDA NDA for dual regimen of daclatasvir and asunaprevir | Hepatitis C New Drugs Review | Scoop.it

PRINCETON, N.J.--(BUSINESS WIRE)--

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb (NYSE:BMY) has decided that it will not pursue U.S. Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

Bristol-Myers Squibb’s HCV strategy has always been to focus on the unique unmet medical need of each local market. For example, in Japan we were pleased to receive regulatory approval for the dual regimen of daclatasvir and asunaprevir in July, bringing Japanese patients with HCV the first all-oral, interferon- and ribavirin-free treatment regimen.

The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world.

We plan to submit additional data for daclatasvir to the FDA from our ongoing clinical trial program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV. Next month at the annual meeting of The American Association for the Study of Liver Diseases (AASLD), we will present new data from several daclatasvir-based regimens. We look forward to bringing daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible.

Krishan Maggon 's insight:

The dual regimen is approved in Japan. The BMS dual therapy for HCV cures 85% after 24 weeks in genotype 1b which has lower prevalence in the US.

 

Rival 2-3 drug ribavirin and peg interferon free regimen from Gilead, AbbVie and Merck cure over 90-95% patients in 12 weeks and even shorter durations.

 

The withdrawal is obvious under the market conditions.

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Johnson & Johnson Takes Aim at Gilead Sciences, inc. - Motley Fool

Johnson & Johnson Takes Aim at Gilead Sciences, inc. - Motley Fool | Hepatitis C New Drugs Review | Scoop.it
Johnson & Johnson's acquisition of Alios could pose a threat to Gilead Sciences' Hovaldi, but not for years. - Todd Campbell - Health Care
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AbbVie R&D Hepatitis C Data from Clinical Program Presented at The Liver Meeting® - Oct 1, 2014

AbbVie R&D Hepatitis C Data from Clinical Program  Presented at The Liver Meeting® - Oct 1, 2014 | Hepatitis C New Drugs Review | Scoop.it

AbbVie (NYSE: ABBV) announced that data from its ongoing Phase 1 through Phase 3 hepatitis C clinical development programs will be presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014.

Abstracts will be presented highlighting results from AbbVie's investigational treatment combining three direct-acting antivirals (ABT-450/ritonavir, ombitasvir and dasabuvir) with or without ribavirin (RBV) in patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. These abstracts include a Phase 2/3 study in patients co-infected with human immunodeficiency virus type 1 (HIV-1) (TURQUOISE-I) and a Phase 2 study in liver transplant recipients without cirrhosis (CORAL-I). 

Additionally, Phase 2 data will be presented from investigational studies evaluating the combination of ABT-450/ritonavir and ombitasvir with or without RBV in genotype 4 (GT4) patients (PEARL-I). AbbVie will also be presenting data from its two additional pipeline HCV compounds, ABT-493 and ABT-530.

Krishan Maggon 's insight:
DATA FROM 25 ACCEPTED ABSTRACTS INCLUDE RESULTS FROM:-- ABBVIE'S INVESTIGATIONAL TREATMENT IN LIVER TRANSPLANT RECIPIENTS WITH RECURRENT GENOTYPE 1 (GT1) CHRONIC HEPATITIS C VIRUS (HCV) INFECTION AND IN GT1 HCV PATIENTS WITH HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 CO-INFECTION-- ABSTRACTS EVALUATING ABBVIE'S INVESTIGATIONAL TREATMENT COMBINING TWO DIRECT-ACTING ANTIVIRALS WITH OR WITHOUT RIBAVIRIN (RBV) IN PATIENTS WITH GENOTYPE 4 CHRONIC HCV INFECTION-- TRIALS OF OTHER PIPELINE COMPOUNDS ABT-493 AND ABT-530 IN GT1 CHRONIC HCV INFECTION
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