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World Hepatitis Day- World Hepatitis Alliance

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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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Sovaldi (sofosbuvir, Gilead) to overtake Humira as the best selling human medicinal brand in 2014

Sovaldi (sofosbuvir, Gilead) to overtake Humira as the best selling human medicinal brand in 2014 | Hepatitis C New Drugs Review | Scoop.it

Gilead 2Q 2014 earnings press release., Sovaldi sales helped 2Q earnings increase to $ 6.4 billion in 2014 from $ 2.66 billion in 2Q2013, the increase coming from sofosbuvir sales.

 

Krishan Maggon 's insight:

With sales of $ 5.7 billion in the first half of 2014, Gilead hepatitis C drug is likely to emerge as the successor to Lipitor, unless government pressure forces company to reduce the price of 1000 dollar/pill. Projected sales in 2014 may reach $15 billion making it the best selling human medicine of all time.

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New Expensive Treatments for Hepatitis C Infection

Opinion from JAMA — New Expensive Treatments for Hepatitis C Infection (@Jama_current: The simple math is that #Sovaldi will add ~$300 to every insured person's premiums per yr over 5 yrs http://t.co/A4FLjYg9Sh)...
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The past, present and future of neutralizing antibodies for hepatitis C virus

The past, present and future of neutralizing antibodies for hepatitis C virus | Hepatitis C New Drugs Review | Scoop.it
Highlights

 

Recent studies have provided insight into the protective role of neutralizing antibodies in hepatitis C.

Neutralizing antibodies show broad reactivity for diverse HCV genotypes.

Recombinant HCV glycoproteins can elicit neutralizing antibodies.

The HCV E2 core structure can inform rational design of immunogens.

 

 

Krishan Maggon 's insight:
Antiviral Research

Volume 105, May 2014, Pages 100–111

Review The past, present and future of neutralizing antibodies for hepatitis C virusJonathan K. Balla, Alexander W. Tarra, Jane A. McKeatingb, ,  Show more DOI: 10.1016/j.antiviral.2014.02.013Open Access funded by Medical Research Council 
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Next-generation sequencing reveals large connected networks of intra-host HCV variants

Next-generation sequencing reveals large connected networks of intra-host HCV variants | Hepatitis C New Drugs Review | Scoop.it
Next-generation sequencing (NGS) allows for sampling numerous viral variants from infected patients. This provides a novel opportunity to represent and study the mutational landscape of Hepatitis C Virus (HCV) within a single host.

 

Conclusions

Most intra-host variants are organized into distinct single-mutation components that are: well separated from each other, represent genetic distances between viral variants, robust to sampling, reproducible and likely seeded during transmission events. Facilitated by NGS, large components offer a novel evolutionary framework for genetic analysis of intra-host viral populations and understanding transmission, immune escape and drug resistance.

 


Via Mel Melendrez-Vallard
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open access full text

 

Research

Next-generation sequencing reveals large connected networks of intra-host HCV variants

David S Campo1*, Zoya Dimitrova1, Lilian Yamasaki2, Pavel Skums1, Daryl TY Lau3,Gilberto Vaughan1, Joseph C Forbi1, Chong-Gee Teo1 and Yury Khudyakov1

*Corresponding author: David S Campo fyv6@cdc.gov

Author Affiliations

1Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

2Laboratory of Genomic Studies, Department of Biology, UNESP - São Paulo State University, Brazil

3Liver Center, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Massachusetts, USA

For all author emails, please log on.

BMC Genomics 2014, 15(Suppl 5):S4  doi:10.1186/1471-2164-15-S5-S4


The electronic version of this article is the complete one and can be found online at:http://www.biomedcentral.com/1471-2164/15/S5/S4


Published:14 July 2014

© 2014 Campo et al.; licensee BioMed Central Ltd. 

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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Structure of the core ectodomain of the hepatitis C virus envelope glycoprotein 2

Structure of the core ectodomain of the hepatitis C virus envelope glycoprotein 2 | Hepatitis C New Drugs Review | Scoop.it

Hepatitis C virus (HCV) is a significant public health concern with approximately 160 million people infected worldwide1. HCV infection often results in chronic hepatitis, liver cirrhosis and hepatocellular carcinoma. No vaccine is available and current therapies are effective against some, but not all, genotypes. HCV is an enveloped virus with two surface glycoproteins (E1 and E2). E2 binds to the host cell through interactions with scavenger receptor class B type I (SR-BI) and CD81, and serves as a target for neutralizing antibodies2, 3, 4. Little is known about the molecular mechanism that mediates cell entry and membrane fusion, although E2 is predicted to be a class II viral fusion protein. Here we describe the structure of the E2 core domain in complex with an antigen-binding fragment (Fab) at 2.4 Å resolution. The E2 core has a compact, globular domain structure, consisting mostly of β-strands and random coil with two small α-helices. The strands are arranged in two, perpendicular sheets (A and B), which are held together by an extensive hydrophobic core and disulphide bonds. Sheet A has an IgG-like fold that is commonly found in viral and cellular proteins, whereas sheet B represents a novel fold. Solution-based studies demonstrate that the full-length E2 ectodomain has a similar globular architecture and does not undergo significant conformational or oligomeric rearrangements on exposure to low pH. Thus, the IgG-like fold is the only feature that E2 shares with class II membrane fusion proteins. These results provide unprecedented insights into HCV entry and will assist in developing an HCV vaccine and new inhibitors.

Krishan Maggon 's insight:

Structural determination of the HCV may provide us with additional targets for new class of antiviral drugs

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How Gilead Sciences Can Deliver A Double: Part Two

How Gilead Sciences Can Deliver A Double: Part Two | Hepatitis C New Drugs Review | Scoop.it
Last month, Eugene Groysman made the case that Gilead Sciences (NASDAQ:GILD) can double its stock price because of high demand for its new Hepatitis-C drug, Sovaldi, even though it costs $84,000 per treatment. Eugene has an exceptional long-term investment track record so when he tells me how a stock can double I pay attention, and then I verify. When I research stocks, the opinions I value most highly come from those who have taken a position in the stock and have made money on it. After all, if the person expressing an opinion about the stock does not have a strong enough conviction to make a trade on it, why should we? And, if they have made trades on the stock, but have not made any money, why should we follow their lead?

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About Gilead (Part Two)

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New Hepatitis C Therapies: The Toolbox, Strategies, and Challenges

Therapy for hepatitis C is undergoing a revolution. Several new drugs against the hepatitis C virus (HCV) have reached the market and many others, including direct-acting antivirals and host-targeted agents, are in phase II or III clinical development. All-oral, interferon-free combinations of drugs are expected to cure more than 90% of infections. A vast amount of data from clinical trials are presented regularly at international conferences or released to the press before peer-review, creating confusion in the viral hepatitis field. The goal of this review is to clarify the current stage of HCV therapy and drug development. This review describes the different classes of drugs and their mechanisms and properties, as well as treatment strategies in development, including those that are interferon-based and interferon-free. HCV treatment options that will be available in 2014–2015 are presented for each genotype. A number of unanswered questions and challenges remain, such as how to treat special populations, the role of ribavirin in interferon-free regimens, the role of HCV resistance in treatment failures, and how to best re-treat patients who failed on treatment. Strategic choices, cost issues, HCV screening, and improving access to care in resource-constrained areas also are discussed.

 KeywordsDirect-Acting Antivirals; Interferon-Free Regimens; Sofosbuvir; Simeprevir; DaclatasvirAbbreviations used in this paperDAA, direct-acting antiviral; HCV, hepatitis C virus; HIV, human immunodeficiency virus; HTA, host-targeted agent; IFN, interferon; RdRp, RNA–dependent RNA polymerase; SVR, sustained virologic 
Krishan Maggon 's insight:
Gastroenterology

Volume 146, Issue 5, May 2014, Pages 1176–1192

 

Reviews and Perspectives New Hepatitis C Therapies: The Toolbox, Strategies, and Challenges Jean–Michel Pawlotsky,  Show more DOI: 10.1053/j.gastro.2014.03.003
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Studies on the role of NS3 and NS5A non-structural genes of hepatitis C virus genotype 3a local isolates in apoptosis

Studies on the role of NS3 and NS5A non-structural genes of hepatitis C virus genotype 3a local isolates in apoptosis | Hepatitis C New Drugs Review | Scoop.it
International Journal of Infectious Diseases, Volume null, Issue null, Pages null, null, Authors:Sabeen Sabri; Muhammad Idrees; Shazia Rafique; Amjad Ali; Muhammad Iqbal

 

SummaryBackground

Hepatitis C virus (HCV) is the causative agent of chronic liver diseases, which usually lead to liver fibrosis, liver cirrhosis, and hepatocellular carcinoma (HCC). Among the non-structural genes of HCV, NS3 and NS5A play important roles in apoptosis. The NS3 and NS5A genes of HCV interact with the p53 tumor suppressor gene differentially. The objective of this study was to analyze the interaction of NS3 and NS5A genes of HCV genotype 3a with the p53 gene, subgenomic HCV replicons harboring NS3 and NS5A genes.

Methods

Huh-7 cell lines stably expressing NS3 and NS5A genes were generated. The stable cell lines were confirmed by Western blot, reverse transcriptase PCR, and immunofluorescence assay. HCV NS3- and NS5A-expressing cell lines were transfected with p53-expressing clone.

Results

NS3 and NS5A both interact with p53 by down-regulating the expression of the p53 gene. In HCV subgenomic harboring cells, the interaction of NS3 and NS5A with p53 was observed consistently. The suppression of p53 gene expression by NS3 and NS5A was observed significantly as compared with NS3- and NS5A-negative control Huh-7 cells.

Conclusion

It is concluded that both of the non-structural genes, NS3 and NS5A, of HCV play important roles in the hepatocarcinogenesis of HCV by interacting directly or indirectly in different manners with the p53 gene.

 KeywordsHepatitis C virus; Liver cirrhoses; HCC; Non-structural proteins; Huh-7 cell lines; p53 gene 
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Studies on the role of NS3 and NS5A non-structural genes of hepatitis C virus genotype 3a local isolates in apoptosisSabeen Sabria, Muhammad Idreesb, , , Shazia Rafiquec, Amjad Alid, Muhammad Iqbalc Show more
International Journal of Infectious Diseases

Volume 25, August 2014, Pages 38–44

 DOI: 10.1016/j.ijid.2014.01.010
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Major Gaps in Hepatitis C Care Identified As New Drugs and Screening Efforts Emerge, Penn Study Finds

A new meta-analysis published online in PLOS ONE by infectious disease and epidemiology specialists from the Perelman School of Medicine at the University of Pennsylvania highlights significant gaps in hepatitis C care that will prove useful as the...
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EMA recommends approval of Daklinza (daclatasvir, BMS) in chronic hepatitis C

EMA recommends approval of Daklinza (daclatasvir, BMS) in chronic hepatitis C | Hepatitis C New Drugs Review | Scoop.it

First-in-class medicine to offer new treatment option for patients

The European Medicines Agency's Committee for Medicinal Products for Human Use(CHMP) has recommended granting a marketing authorisation for Daklinza (daclatasvir) in combination with other medicines for the treatment of chronic (long-term) hepatitis C virus (HCV) infection in adults.

HCV infection is a major European public-health challenge. It occurs in between 0.4% and 3.5% of the population in different European Union (EU) Member States and is the most common single cause of liver transplantation in the EU.

The treatment paradigm of hepatitis C is currently rapidly shifting with the development of several new classes of direct-acting antivirals. Among these is Daklinza, which is the first representative of a new class of antivirals that block the action of NS5A, a protein which is essential for HCV to replicate.

Until very recently, the standard of care for hepatitis C included a combination of the medicines pegylated interferon and ribavirin, with or without an inhibitor of the viral NS3/4A protease enzyme. However, interferon-based therapies are associated with potentially serious side effects, which are sometimes difficult to manage. One of the major benefits of the new antivirals is to provide an interferon-free treatment option for HCV infection.

There remains a public-health need to make such new treatment options available for patients where available interferon-free treatment regimens may have suboptimal effectiveness.

In November 2013, the CHMP gave an opinion on the conditions under which early access to daclatasvir, in combination with sofosbuvir, another direct-acting antiviral medicine, could be given in compassionate-use programmes.

The EMA is actively supporting the development of these new treatment options. The applicant for Daklinza, Bristol-Myers Squibb EEIG, received scientific advice from the CHMP during the development of this medicine. Daklinza was evaluated byaccelerated assessment, a regulatory tool to help speed up patient access to new medicines where there is an unmet medical need.

Convincing efficacy with a good safety profile

The positive opinion granted by the CHMP for the marketing authorisation of Daklinza is supported by a pivotal trial in which the medicine was evaluated in HCV genotype-1, -2 and -3 infected patients, in combination with sofosbuvir with or without ribavirin. This study included a treatment arm with patients that previously failed on therapy with an NS3/4A inhibitor in combination with pegylated interferon and ribavirin. All such patients in the study reached a sustained virologic response, which is the goal of antiviral therapy for HCV. This trial is supported by a study of Daklinza in combination with pegylated interferon and ribavirin in patients with genotype 4 infection, and by several phase IIb trials of Daklinza with other combinations including with pegylated interferon and ribavirin.

The medicine showed convincing efficacy, in particular in combination with sofosbuvir, with an overall good safety profile.

The opinion adopted by the CHMP at its June 2014 meeting is an intermediary step on Daklinza’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will then take place at the level of each Member State considering the potential role/use of Daklinza in the context of the national health system of that country.

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This will be BMS first approval for HCV. 

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Janssen calls on governments to tackle hepatitis C - PMLiVE

Janssen calls on governments to tackle hepatitis C - PMLiVE | Hepatitis C New Drugs Review | Scoop.it
DigitalJournal.com
Janssen calls on governments to tackle hepatitis C
PMLiVE
Financial support for the programme came from Janssen, one of the companies at the forefront of hepatitis C treatment.
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Boehringer Ingelheim Stops Hepatitis C drug development and to withdraw submitted Faldaprevir NDA/MAA

Boehringer Ingelheim Statement on Hepatitis C drug development

 

 20 June, 2014 - Boehringer Ingelheim has re-evaluated its strategy in hepatitis C (HCV), and as a result the company has decided not to move forward in this therapeutic area. The HCV treatment environment has significantly and rapidly evolved since the submission of the faldaprevir marketing applications to regulatory bodies around the world. There are now several new treatment options available for patients and additional all-oral options are expected to be approved in 2014. This decision was taken as there is no longer an unmet medical need for the faldaprevir interferon-based regimen that was the subject of the application.

Boehringer Ingelheim will withdraw all pending marketing applications for faldaprevir worldwide and is discontinuing further development.

Boehringer Ingelheim is committed to developing new treatments that provide high therapeutic value in areas where medical need exists. The company is focusing its efforts on numerous promising development projects in immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.

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Safety of direct-acting antivirals in the treatment of chronic hepatitis C, Expert Opinion on Drug Safety, Informa Healthcare

Safety of direct-acting antivirals in the treatment of chronic hepatitis C, Expert Opinion on Drug Safety, Informa Healthcare | Hepatitis C New Drugs Review | Scoop.it
How cost effective are protease inhibitors for hepatitisC? #Boceprevir #Telaprevir find out for FREE http://t.co/FJubvevOE5 #ThinkHepatitis

 

Introduction: Combination therapy with pegylated interferon, ribavirin and the two first-generation NS3/4A protease inhibitors (PIs), telaprevir (TVR) and boceprevir (BOC), is the new standard-of-care therapy for patients who are chronically infected with genotype 1 hepatitis C virus. These combinations significantly increase sustained virological response (SVR) rates, but they also increase the rates of adverse events (AEs). Appearance of significant AEs may necessitate dose reduction or discontinuation of treatment, and may impact on virological response.

Areas covered: In registration trials, IFN-related AEs were a dominant feature in both types of therapy. Some events were more frequent with PI-containing regimens, like anemia and dysgeusia with BOC and anemia, pruritus, rash and anorectal symptoms with TVR. This review addresses the early identification and management of AEs to improve tolerance, and to avoid reduction in SVR rates.

Expert opinion: Every patient will experience adverse effects to differing degrees; a systematic approach to their management can be very helpful. Early recognition and intervention can help clinicians ensure that patients are able to complete therapy where possible and achieve the goal of viral eradication. Treatment with the next generation of antivirals will improve safety and efficacy.

Keywords: adverse events, boceprevir, direct-acting antivirals, hepatitis C virus, pegylated interferon, ribavirin, safety, telaprevir 




Read More: http://informahealthcare.com/stoken/default+domain/HepRev/full/10.1517/14740338.2014.884068

Krishan Maggon 's insight:

Great review concerning ADR of HCV antiviral drugs.

 

Open access full text

 

Reviews

Safety of direct-acting antivirals in the treatment of chronic hepatitis C

 

March 2014, Vol. 13, No. 3 , Pages 307-319 (doi:10.1517/14740338.2014.884068)PDF (308 KB)PDF Plus (337 KB)ReprintsPermissionsEzequiel Ridruejo 1,2 MD1 Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno “CEMIC”, Department of Medicine, Hepatology Section, Avda. Las Heras 2939, (C1425ASG) Ciudad Autónoma de Buenos Aires, Argentina +54 11 5299 1221; +54 11 5299 0600 ext 5900;eridruejo@gmail.com2 Hospital Universitario Austral, Hepatology and Liver Transplant Unit, Pilar, Argentina




Read More: http://informahealthcare.com/stoken/default+domain/HepRev/full/10.1517/14740338.2014.884068

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Asunaprevir, a protease inhibitor for the treatment of hepatitis C inf

Peer reviewed article authored by (Gentile I, Buonomo AR, Zappulo E, Minei G, Morisco F, Borrelli F, Coppola N, Borgia G). Read article or submit your manuscript for publishing.
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Could Gilead's Sovaldi also treat Hep C in HIV patients?

Could Gilead's Sovaldi also treat Hep C in HIV patients? | Hepatitis C New Drugs Review | Scoop.it
The results of a new clinical trial were excellent news for Gilead, but women and patients with cirrhosis were underrepresented in the study. (.@GileadSciences' #Sovaldi is already the talk of the town.
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The original study was covered in previous scoop.

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Antiviral treatment of hepatitis C

Antiviral treatment of hepatitis C | Hepatitis C New Drugs Review | Scoop.it

Abstract

Hepatitis C virus (HCV) infection is a substantial health problem worldwide. Most patients infected with HCV remain chronically infected, with an increased risk of cirrhosis and hepatocellular carcinoma. Although they are associated with toxicities and low sustained viral response rates, interferon alfa and ribavirin have been the mainstay of treatment until recently. New direct acting antivirals, specifically designed to inhibit three viral proteins (the NS3/4A protease, the NS5A protein, and the NS5B RNA dependent RNA polymerase) are now becoming available. The NS3/4A inhibitor simeprevir and NS5B inhibitor sofosbuvir have recently been licensed and can reduce the length of antiviral treatment, improve response rates, and allow for interferon-free regimens for some HCV genotypes. Several other newer direct acting antivirals have shown promise in clinical studies and are likely to be licensed soon. These agents seem to facilitate the use of shortened courses of combination interferon-free therapy, which are associated with high (>95%) sustained response rates and relatively few toxicities. These regimens have also been successful in patients who were previously difficult to treat, including those with cirrhosis, HIV coinfection, and those who have undergone liver transplantation. The high cost of these agents may be the biggest challenge to their implementation worldwide.

Krishan Maggon 's insight:

State of the Art Review

 

Antiviral treatment of hepatitis C

 

BMJ 2014; 349 doi:

http://dx.doi.org/10.1136/bmj.g3308 
(Published 07 July 2014)
Cite this as: BMJ 2014;349:g3308

 Eoin R Feeney, clinical research fellow1, Raymond T Chung, director of Hepatology and Liver Center2Author affiliationsCorrespondence to: R T Chung RTCHUNG@partners.org

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Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: Updated criteria and genotype assignment web resource - Smith - 2013 - Hepatology - Wiley Online Library

Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: Updated criteria and genotype assignment web resource - Smith - 2013 - Hepatology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Abstract

The 2005 consensus proposal for the classification of hepatitis C virus (HCV) presented an agreed and uniform nomenclature for HCV variants and the criteria for their assignment into genotypes and subtypes. Since its publication, the available dataset of HCV sequences has vastly expanded through advancement in nucleotide sequencing technologies and an increasing focus on the role of HCV genetic variation in disease and treatment outcomes. The current study represents a major update to the previous consensus HCV classification, incorporating additional sequence information derived from over 1,300 (near-)complete genome sequences of HCV available on public databases in May 2013. Analysis resolved several nomenclature conflicts between genotype designations and using consensus criteria created a classification of HCV into seven confirmed genotypes and 67 subtypes. There are 21 additional complete coding region sequences of unassigned subtype. The study additionally describes the development of a Web resource hosted by the International Committee for Taxonomy of Viruses (ICTV) that maintains and regularly updates tables of reference isolates, accession numbers, and annotated alignments (http://talk.ictvonline.org/links/hcv/hcv-classification.htm). The Flaviviridae Study Group urges those who need to check or propose new genotypes or subtypes of HCV to contact the Study Group in advance of publication to avoid nomenclature conflicts appearing in the literature. While the criteria for assigning genotypes and subtypes remain unchanged from previous consensus proposals, changes are proposed in the assignment of provisional subtypes, subtype numbering beyond “w,” and the nomenclature of intergenotypic recombinant. Conclusion: This study represents an important reference point for the consensus classification of HCV variants that will be of value to researchers working in clinical and basic science fields. (Hepatology 2014;59:318-327)

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Increasing number of HCV genotypes makes it more complex for drug targeting. 

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1 Drug More Important to Gilead Than Sovaldi - Motley Fool

1 Drug More Important to Gilead Than Sovaldi - Motley Fool | Hepatitis C New Drugs Review | Scoop.it
1 Drug More Important to Gilead Than Sovaldi
Motley Fool
AbbVie is awaiting approval for a three-drug combination therapy that effectively cured 99% of genotype 1b patients during phase 3 trials.
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How Gilead Sciences Can Deliver A Double

How Gilead Sciences Can Deliver A Double | Hepatitis C New Drugs Review | Scoop.it
Gilead Sciences’ (NASDAQ:GILD) drug portfolio has 16 medications, and generates gross margins over 70% with net margins consistently over 30%. It’s newest drug, Sovaldi, is dramatically boosting revenues and earnings, and two of our Masters, Eugene Groysman and Mike Koza, have noticed. This week I talked to Eugene to find out why he thinks GILD, which is up 49% in the last year, can double from here. Eugene has a 12-year track record with Marketocracy with his average annual return of 18.3%. You can view Eugene‘s top five holdings, learn more about his strategy, and track his progress with monthly Performance Insights emailed directly to you at the end of each month by visiting our website.

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About Gilead (parte one)

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Beyond sofosbuvir: What opportunity exists for a better nucleoside/nucleotide to treat hepatitis C?

Highlights

 

Sofosbuvir is a potent uridine nucleotide prodrug approved for genotype 1, 2, 3 and 4 hepatitis C patients.

Sofosbuvir shows some differential genotype efficacy, particularly in genotype 3.

Patients with severe renal impairment or taking drugs that induce P-glycoprotein may be contraindicated.

New nucleos(t)ide polymerase inhibitors should enable shorter treatment and an orthogonal resistance profile.

Recent clinical entrants appear similar to sofosbuvir and therefore may not provide added patient benefit.

Krishan Maggon 's insight:
Antiviral Research

Volume 107, July 2014, Pages 119–124

 

Beyond sofosbuvir: What opportunity exists for a better nucleoside/nucleotide to treat hepatitis C?Michael J. Sofia  Show more DOI: 10.1016/j.antiviral.2014.04.008
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Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen | BMS Newsroom

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. 


The Daklinza+Sunvepra Dual Regimen

The indications for Daklinza and Sunvepra in Japan are for the improvement of viraemia in either of the following patients with chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1 with compensated cirrhosis: (1) patients who are ineligible or intolerant to interferon-based therapy, and (2) patients who have failed to respond to interferon-based therapy.

The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR24 (sustained virologic response 24 weeks after the end of treatment; a functional cure) among 84.7% of Japanese HCV patients with genotype 1b. Among patients 65 years of age or older who were either interferon-ineligible or intolerant, 91.9% achieved SVR24. Further, patients with compensated cirrhosis present at baseline had overall SVR24 rates of 90.9%.

The regimen used in the Phase III study resulted in low rates of discontinuation (5%) due to adverse events (AEs). In addition, the rate of serious adverse events (SAEs) was low (5.9%) and few SAEs were experienced by more than one patient. Nasopharyngitis was the most common AE in the study (30.2%).

Results from the HALLMARK-Dual study, the Phase III multinational clinical trial investigating the Daklinza+Sunvepra Dual Regimen among genotype 1b HCV patients, demonstrated similar results to the Japan registration study and support filings in countries that have a high prevalence of genotype 1b, such as Korea and Taiwan.

- See more at: http://news.bms.com/press-release/japan-approves-first-all-oral-interferon-and-ribavirin-free-hepatitis-c-treatment-dakl&t=635403202514919778#sthash.2oD1IhZ0.dpuf

Krishan Maggon 's insight:

BMS Hepatitis C R&D pipeline

 

Daclatasvir, a potent pan-genotypic NS5A complex inhibitor (in vitro), which continues to be investigated in multiple treatment regimens and in people with co-morbidities, and is undergoing regulatory review in the U.S. and Europe.

 

Daclatasvir is being studied in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program.

 

In 2014 FDA granted Daclatasvir+Asunaprevir Dual Regimen Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection.

 

In 2013, investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation in the U.S., which helped to expedite the start of the ongoing Phase III UNITY Program. 

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New Drug Combination Highly Effective For Hepatitis C

New Drug Combination Highly Effective For Hepatitis C | Hepatitis C New Drugs Review | Scoop.it
Hepatitis C, a bloodborne liver disease, primarily acquired via unscreened blood products or blood transfusions, IV drug use, or inadequate sterilization of medical equipment in the healthcare setting, can potentially result in a condition known as...
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Closer Look at Gilead's Slowing Hep C Prescriptions - TheStreet.com

Closer Look at Gilead's Slowing Hep C Prescriptions - TheStreet.com | Hepatitis C New Drugs Review | Scoop.it
TheStreet.com Closer Look at Gilead's Slowing Hep C Prescriptions TheStreet.com NEW YORK (TheStreet) -- The number of prescriptions written for Gilead Sciences' (GILD) hepatitis C drug Sovaldi are showing signs of slowing growth, even a marginal...
Krishan Maggon 's insight:

Slowing prescriptions indicate price backlash against Gilead $1000 a pill price and may negatively impact $10 billion analysts sales projections for 2014.

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The 25th Anniversary of the Discovery of the Hepatitis C Virus

Dr. Phoebe Thorpe and Dr. John Ward discuss the latest curative breakthroughs in treating chronic Hepatitis C infection. •These new developments are making history in medicine •The "baby...
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Bristol-Myers Squibb: Pipeline Asset Update for Daclatasvir (DCV; BMS-790052)

Bristol-Myers Squibb: Pipeline Asset Update for Daclatasvir (DCV; BMS-790052) | Hepatitis C New Drugs Review | Scoop.it
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
Krishan Maggon 's insight:

daclatasvir, also known as BMS-790052 or DCV, is the first NS5A replication complex inhibitor to be investigated in hepatitis C clinical trials.

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