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Experimental drug cures 70 percent of patients with hepatitis C - Raw Story

Experimental drug cures 70 percent of patients with hepatitis C Raw Story An experimental drug combination cured 70 percent of patients with hepatitis C in early trials, offering hope of a simpler remedy for the chronic liver disease, US...
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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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New Hope for Patients with Hepatitis C

New Hope for Patients with Hepatitis C | Hepatitis C New Drugs Review | Scoop.it
New and forthcoming medicines can halt the progression of hepatitis C and, in many cases, provide a cure.
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PHRMA infographic about the impact of new HCV drugs. 

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EMA/EC approve Bristol-Myers Squibb Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis

 

The approval of Daklinza is supported by data from multiple studies, including an open-label, randomized study of Daklinza with sofosbuvir in genotypes 1, 2, and 3, including patients with no response to prior therapy with telaprevir or boceprevir and patients with fibrosis. Results showed that a regimen of Daklinza with sofosbuvir achieved SVR12 (sustained virologic response 12 weeks after the end of treatment; a functional cure) in 99% of treatment-naïve patients with HCV genotype 1, 100% of patients with genotype 1 who had failed treatment with either telaprevir or boceprevir, 96% of those with genotype 2 and 89% of those with genotype 3.

In addition, the regimen resulted in low rates of discontinuation (<1%) due to adverse events (AEs). The rate of serious adverse events (SAEs) was low (4.7%). The most common adverse events were fatigue, headache and nausea. Across clinical studies, Daklinza-based regimens have been generally well tolerated with low rates of discontinuation across a range of patients. Ongoing and completedDaklinza studies have included more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care.

The safety of Daklinza for the treatment of hepatitis C has been demonstrated in diverse patient populations that include elderly patients, patients with advanced liver disease, post-liver transplant recipients and patients co-infected with HIV. No unique safety concerns have been identified in patients who were treated withDaklinza across clinical studies and in the early access program. Several of these studies are ongoing.

Krishan Maggon 's insight:

Daklinza, when used in combination with sofosbuvir, is an all-oral, once daily regimen that yields cure rates of up to 100%


Daklinza + sofosbuvir offers potential cure for a broad range of EU HCV patients, including those with advanced liver disease, genotype 3 and protease inhibitor failures.

 

NDA filed with FDA, under priority review, PDUFA date 30 Nov. 2014

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Resistance to hepatitis C virus protease inhibitors

Resistance to hepatitis C virus protease inhibitors | Hepatitis C New Drugs Review | Scoop.it
Highlights

 

Baseline protease inhibitor resistance is rare, with the exception of Q80K.

Emergence of resistance is common in patients who do not achieve an SVR.

Resistance pathways are dependent on drug exposure and viral genotype.

Potency and genetic barrier of regimen play major roles in inhibiting resistance.

Resistant populations tend to be replaced by wild-type virus over time.

Krishan Maggon 's insight:
Resistance to hepatitis C virus protease inhibitors ☆Tara L Kieffer , Shelley George DOI: 10.1016/j.coviro.2014.04.008
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Impact of hepatitis C virus infection on the risk of death of alcohol-dependent patients - Fuster - 2014 - Journal of Viral Hepatitis - Wiley Online Library

Impact of hepatitis C virus infection on the risk of death of alcohol-dependent patients - Fuster - 2014 - Journal of Viral Hepatitis - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
What Is the impact of #hepatitis C virus infection on the risk of death of alcohol-dependent patients?→http://t.co/0tqeifDmRV #HepC #HCV

 

Summary

Hepatitis C virus (HCV) infection is frequent among patients with alcohol use disorders. We aimed to analyse the impact of HCV infection on survival of patients seeking treatment for alcohol use. This was a longitudinal study in a cohort of patients who abused alcohol recruited in two detoxification units. Socio-demographic and alcohol use characteristics, liver function tests for the assessment of alcohol-related liver disease and HCV and HIV infection serologies were obtained at admission. Patients were followed until December 2008; causes of death were ascertained through clinical records and death registry. Cox models were used to analyse predictors of death. A total of 675 patients (79.7% men) were admitted; age at admission was 43.5 years (IQR: 37.9–50.2 years), duration of alcohol abuse was 18 years (IQR: 11–24 years), and median alcohol consumption was 200 g/day (IQR: 120–275 g/day). Distribution of patients according to viral infections was as follows: 75.7% without HCV or HIV infection, 14.7% HCV infection alone and 8.1% HCV/HIV coinfection. Median follow-up was 3.1 years (IQR: 1.5–5.1 years) accounting for 2,345 person-years. At the end of study, 78 patients (11.4%) had died. In the multivariate analysis, age at admission (HR = 1.71, 95%CI: 1.05–2.80), alcohol-related liver disease (HR = 3.55, 95%CI: 1.93–6.53) and HCV/HIV co-infection (HR = 3.86 95%CI: 2.10–7.11) were predictors of death. Younger patients (≤43 years) with HCV infection were more likely to die than those without viral infections (HR = 3.1, 95%CI: 1.3–7.3; P = 0.007). Among patients with alcohol-related liver disease, mortality rate was high, irrespective of viral infections. These data show that HCV infection confers a worse prognosis in patients with alcohol use disorders.

Krishan Maggon 's insight:
Journal of Viral Hepatitis

Early View (Online Version of Record published before inclusion in an issue)

Impact of hepatitis C virus infection on the risk of death of alcohol-dependent patientsD. Fuster1,2,*, A. Sanvisens1, F. Bolao3, I. Serra4, I. Rivas5, J. Tor1 andR. Muga1

Article first published online: 18 AUG 2014

DOI: 10.1111/jvh.12290

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Market cap of Achillion Pharmaceuticals up by $100 million based on a small study?

Market cap of Achillion Pharmaceuticals up by $100 million based on a small study? | Hepatitis C New Drugs Review | Scoop.it
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're.
Krishan Maggon 's insight:

Positive news about 100%  cure in only 12 patients in 8 weeks added $ 100 million to the company market cap. This is crazy and highly speculative. The results were  obtained in combination with sofosbuvir. Several other antivirals in R&D are expected to deliver similar results. 

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Modeling the dynamics of Hepatitis C virus with combined antiviral drug therapy: Interferon and Ribavirin

Modeling the dynamics of Hepatitis C virus with combined antiviral drug therapy: Interferon and Ribavirin | Hepatitis C New Drugs Review | Scoop.it

Highlights• Figure 2 has been re-drawn to show that the phases are dose-dependent.• Some parts of the numerical section have been revised and figures adjusted.• Major proof-reading has been done; 35 grammatical errors have been eliminated.

 

Abstract

A mathematical modeling of hepatitis C virus (HCV) dynamics and antiviral therapy has been presented in this paper. The proposed model, which involves four coupled ordinary differential equations, describes the interaction of target cells (hepatocytes), infected cells, infectious virions and non-infectious virions. The model takes into consideration the addition of ribavirin to interferon therapy and explains the dynamics regarding a biphasic and triphasic decline of viral load in the model. A critical drug efficacy parameter has been defined and it is shown that for an efficacy above this critical value, HCV is eradicated whereas for efficacy lower this critical value, a new steady state for infectious virions is reached, which is lower than the previous steady state value.


Via burkesquires
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Abstract

 

Mathematical Biosciences

Volume 245, Issue 2, October 2013, Pages 235–248

 Modeling the dynamics of Hepatitis C virus with combined antiviral drug therapy: Interferon and RibavirinSandip Banerjee, , Ram Keval , Sunita Gakkhar

DOI: 10.1016/j.mbs.2013.07.005

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Online Expert Advice for Clinicians Treating Hepatitis C - AIDS.gov blog (blog)

Online Expert Advice for Clinicians Treating Hepatitis C  - AIDS.gov blog (blog) | Hepatitis C New Drugs Review | Scoop.it
Online Expert Advice for Clinicians Treating Hepatitis C Now Includes Section

 

State-of-the-art guidance for the treatment of hepatitis C virus (HCV) infection was updated this week to help healthcare providers to determine when and in whom to start antiviral treatment to cure patients of their HCV infection.

 

Launched earlier this year by the American Association for the Study of Liver Diseases  (AASLD) and the Infectious Diseases Society of America  (IDSA), in collaboration with the International Antiviral Society-USA  (IAS-USA), the online guidance at HCVguidelines.org  provides recommendations for testing, managing, and treating HCV, based on the latest evidence and on the consensus of a panel of 27 liver disease and infectious diseases specialists and a patient advocate. The three organizations have committed to regularly updating the guidance to keep pace with improved diagnostic tools and new drugs as they become available. This week’s addition was the first such update.

 

The new guidance states that “the goal of treatment of HCV-infected persons is to reduce all-cause mortality and liver-related health adverse consequences” and that “treatment is recommended for patients with chronic HCV infection.” - See more at: http://blog.aids.gov/2014/08/online-expert-advice-for-clinicians-treating-hepatitis-c-now-includes-section-on-when-and-for-whom-to-initiate-hcv-therapy.html#sthash.IqGMP9Yl.dpuf

- See more at: http://blog.aids.gov/2014/08/online-expert-advice-for-clinicians-treating-hepatitis-c-now-includes-section-on-when-and-for-whom-to-initiate-hcv-therapy.html#sthash.IqGMP9Yl.dpuf

Krishan Maggon 's insight:

Updated HCV Guidelines available for download from CDC, AASLD, IDSA websites.

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Treatment of Hepatitis C

Treatment of Hepatitis C | Hepatitis C New Drugs Review | Scoop.it
Review from JAMA — Treatment of Hepatitis C — A Systematic Review (RT @BrendaWaning: .@JAMA “Treatment of Hepatitis C: A Systematic Review” #HCV #HepatitisC #globalhealth #sofosbuvir http://t.co/ZsVZyy6KrU)...

 

Patients infected with HCV genotype 1 represent 60% to 75% of HCV infections in the United States. Hepatitis C virus genotype 1 is more difficult to cure than genotype 2 or genotype 3. Patients with HCV genotype 1 should receive treatment with sofosbuvir + pegylated interferon + ribavirin because of the shorter duration of therapy and high rates of SVR (89%-90%). Simeprevir + pegylated interferon + ribavirin is an alternative for patients with HCV genotype 1 (SVR, 79%-86%). Patients with HCV genotypes 2 and 3, representing 20% to 29% of US HCV infections, should receive therapy with sofosbuvir + ribavirin alone (SVR for genotype 2, 12 weeks’ duration: 82%-93%; SVR for genotype 3, 24 weeks’ duration, 80%-95%). Patients with HIV-HCV coinfection and patients with compensated cirrhosis (ie, cirrhosis but preserved synthetic liver function) should receive the same treatment as HCV-monoinfected patients.

Krishan Maggon 's insight:

 

Review | August 13, 2014Treatment of Hepatitis CA Systematic ReviewAnita Kohli, MD, MS1,2; Ashton Shaffer, BA3; Amy Sherman, MD3; Shyam Kottilil, MD, PHD3[+] Author AffiliationsJAMA. 2014;312(6):631-640. doi:10.1001/jama.2014.7085.
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Sofosbuvir for the treatment of chronic hepatitis C: between current evidence and future perspectives | HMER

Sofosbuvir for the treatment of chronic hepatitis C: between current evidence and future perspectives Elisabetta Degasperi, Alessio AghemoDivision of Gastroenterology and Hepatology, AM and M Migliavacca Center, Fondazione IRCCS Ca' Granda Maggiore Hospital, University of Milan, Milan, ItalyAbstract: In recent years, clinical research in the field of new treatments for chronic hepatitis C (HCV) has been devoted to developing regimens based on direct-acting antivirals (DAAs), with the goal of increasing treatment efficacy and improving tolerability and safety. This can be achieved by Peginterferon (PegIFN)-free anti-HCV regimens, as PegIFN is responsible for many side effects and limits treatment access due to contraindications in some patient categories. Sofosbuvir (SOF) is the first compound to enter the market with IFN-free combination regimens; it belongs to the nucleotide inhibitors of viral polymerase NS5B and acts as a chain terminator during the HCV replication process, exhibiting pan-genotypic antiviral activity with a high barrier to resistance. Clinical trials in HCV genotype 2/3 patients have demonstrated optimal efficacy in HCV-2, where the combination SOF/ribavirin (Rbv) for 12 weeks resulted in >90% sustained virological response (SVR) rates, while HCV-3 patients with advanced liver fibrosis and previous failure to PegIFN plus Rbv therapy still require individualized and optimized treatment strategies. Historically difficult-to-treat genotypes HCV-1, -4–6 can benefit from reduced duration of PegIFN plus SOF and Rbv, while IFN-free regimens in these patients will be based on SOF in combination with other DAA classes. Due to an optimal tolerability and safety profile with no significant drug-to-drug interactions, SOF is currently undergoing clinical trials in the setting of pre- and post-liver transplantation and HIV-coinfected patients, with the objective to address the until now unmet need for safe and efficient treatment in these populations. This article provides an overview of SOF features and the main clinical trials, discussing key results and potential future developments.Keywords: sofosbuvir, hepatitis C, antiviral treatment
Krishan Maggon 's insight:

open access full text pdf

 

Authors Degasperi E, Aghemo A

Published Date April 2014 Volume 2014:6 Pages 25—33

DOI http://dx.doi.org/10.2147/HMER.S44375

Received 14 December 2013, Accepted 12 March 2014, Published 29 April 2014

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Debunking the Myths of Treating Hepatitis C | PhRMA

Debunking the Myths of Treating Hepatitis C | PhRMA | Hepatitis C New Drugs Review | Scoop.it
A national dialogue is needed around the value of new medicines and cures and the role they play in improving patient health and helping to manage long-term spending in the U.S. health care system. Unfortunately, the debate around hepatitis C has, for the most part, been twisted to the point that modern-day cures are seen as a nuisance rather than a monumental step forward in the battle against disease. (This post was updated on August 5, 2014.)
Krishan Maggon 's insight:

 Hepatitis C is the leading cause of cirrhosis, liver cancer and liver transplantation, and the medical costs associated with these very serious complications are no minor expense. End stage liver disease average annual treatment costs are estimated at $59,995 per patient and for those with liver cancer, costs are estimated at $112,537. Liver transplant costs range as high as $500,000 and require many years of costly follow up care. 


Present treatment only cured 50% of treated, new drugs cure rates are >95% . 

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Politicians Shouldn't Question Drug Costs But Rather Their Value. Lessons From Soliris and Sovaldi- Forbes

Politicians Shouldn't Question Drug Costs But Rather Their Value. Lessons From ...
Forbes
What about the drug that has gained Congressional interest, Sovaldi?
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Recent Trends in the Treatment of Chronic Hepatitis C | Page

Recent Trends in the Treatment of Chronic Hepatitis C | Page | Hepatitis C New Drugs Review | Scoop.it
This article is an early utilization review of newer, more effective, and more costly regimens for the treatment of hepatitis C.
Krishan Maggon 's insight:

good review of new drugs in the market.

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Minimum costs to produce Hepatitis C Direct Acting Antivirals - hepCoalition

Minimum costs to produce Hepatitis C Direct Acting Antivirals - hepCoalition | Hepatitis C New Drugs Review | Scoop.it
Minimum costs of treatment and diagnostics to cure hepatitis C virus (HCV) were estimated at US$177-354 per person without genotyping, and (...) (RT @hepCoalition: Minimum costs (177 $US) to produce #HCV Direct Acting Antivirals (#sofosbuvir + #daclastavir)...
Krishan Maggon 's insight:

Minimum costs of treatment and diagnostics to cure hepatitis C virus (HCV) were estimated at US$177 per person without genotyping, and US$267 per person with genotyping. 
These costs assume that large-scale treatment programmes can be established for Hepatitis C, similar to those implemented for HIV/AIDS. This low cost treatment package could make universal access to HCV treatment in lower resource settings a realistic goal.


If HCV drugs are produced in India under license with single digit 5-7% royalties for the originating company, these costs can come down.

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Clinical evidence and bioinformatics characterization of potential hepatitis C virus resistance pathways for Sofosbuvir - Donaldson - Hepatology - Wiley Online Library

Clinical evidence and bioinformatics characterization of potential hepatitis C virus resistance pathways for Sofosbuvir - Donaldson - Hepatology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Even #sofosbuvir may give #resistance to #hepatitisC #hepC http://t.co/rSrzIRndMC

 

ABSTRACT

Sofosbuvir (Sovaldi™, SOF) is a nucleotide analog prodrug that targets the hepatitis C virus (HCV) NS5B polymerase and inhibits viral replication. High sustained virologic response rates are achieved when SOF is used in combination with ribavirin with or without pegylated interferon in subjects with chronic HCV infection. Potential mechanisms of HCV resistance to SOF and other nucleos(t)ide analog NS5B polymerase inhibitors are not well understood. SOF was the first FDA-approved antiviral drug for which genotypic resistance analyses were based almost entirely on next generation sequencing (NGS), an emerging technology that lacks a standard data analysis pipeline. The FDA Division of Antiviral Products developed an NGS analysis pipeline and performed independent analyses of NGS data from 5 SOF clinical trials. Additionally, structural bioinformatics approaches were used to characterize potential resistance-associated substitutions. Using protocols we developed, independent analyses of the NGS data reproduced results that were comparable to those reported by Gilead Sciences, Inc. Low frequency treatment-emergent substitutions occurring at conserved NS5B amino acid positions in subjects who experienced virologic failure were also noted and further evaluated. The NS5B substitutions, L159F (sometimes in combination with L320F or C316N) and V321A, emerged in 2.2-4.4% of subjects who failed SOF treatment across clinical trials. Moreover, baseline polymorphisms at position 316 were potentially associated with reduced response rates in HCV genotype 1b subjects. Analyses of these variants modelled in NS5B crystal structures indicated that all 4 substitutions could feasibly impact SOF anti-HCV activity. Conclusion: SOF has a high barrier to resistance; however, low frequency NS5B substitutions associated with treatment failure were identified that may contribute to resistance of this important drug for chronic HCV infection. (Hepatology 2014;)

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Endocannabinoid CB1 antagonists inhibit hepatitis C virus production, providing a novel class of antiviral host targeting agents

Endocannabinoid CB1 antagonists inhibit hepatitis C virus production, providing a novel class of antiviral host targeting agents | Hepatitis C New Drugs Review | Scoop.it

Direct acting antivirals have significantly improved treatment outcomes in chronic hepatitis C (CHC), but side effects, drug resistance and cost mean that better treatments are still needed. Lipid metabolism is closely linked with hepatitis C virus (HCV) replication and endocannabinoids are major regulators of lipid homeostasis. The cannabinoid 1 (CB1) receptor mediates these effects in the liver. We have previously shown up-regulation of CB1 receptors in the livers of patients with CHC, and in a HCV cell culture model. Here we investigated whether CB1 blockade inhibits HCV replication. The antiviral effect of a CB1 antagonist, AM251 was examined in the JFH1 cell culture and subgenomic replicon models. The effects on the expression of genes involved in lipid metabolism were also measured. CB1 shRNA was used to confirm that the effects were specific for the cannabinoid receptor. Treatment with AM251 strongly inhibited HCV RNA (~70%), viral protein (~80%), the production of new virus particles (~70%), and virus infectivity (~90%). As expected, AM251 reduced the expression of pro-lipogenic genes (SREBP-1c, FASN, SCD1 and ACC1) and stimulated genes promoting lipid oxidation (CPT1 and PPARα). This effect was mediated by AMPK. Stable CB1 knockdown of cells infected with HCV showed reduced levels of HCV RNA, compared with controls. Reduced CB1 signalling inhibits HCV replication using either pharmacological inhibitors or CB1 shRNA. This may be due, at least in part, to reduced lipogenesis, mediated by AMPK activation. We suggest that CB1 antagonists may represent an entirely new class of drugs with activity against HCV.

Krishan Maggon 's insight:
Endocannabinoid CB1 antagonists inhibit hepatitis C virus production, providing a novel class of antiviral host targeting agentsMahsa Shahidi1, Enoch S.E Tay1, Scott A. Read1,Mehdi Ramezani-Moghadam1, Kazuaki Chayama2, Jacob George1 andMark W. Douglas1,3

+Author Affiliations

1 Storr Liver Unit, University of Sydney at Westmead Hospital, Australia;2 Department of Gastroenterology and Metabolism, Hiroshima University, Japan↵3 E-mail: mark.douglas@sydney.edu.auReceived 27 April 2014.Accepted 21 July 2014.Published online ahead of print July 22, 2014, doi:10.1099/vir.0.067231-0J Gen Virol July 2014vir.0.067231-0
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Achillion Pharmaceuticals, Inc. (ACHN): Big Potential and Attractive Covered ... - iStockAnalyst (press release)

Achillion Pharmaceuticals, Inc. (ACHN): Big Potential and Attractive Covered ... - iStockAnalyst (press release) | Hepatitis C New Drugs Review | Scoop.it
iStockAnalyst (press release)
Achillion Pharmaceuticals, Inc. (ACHN): Big Potential and Attractive Covered ...
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Gilead: NICE OK for Solvadi and patent win vs Roche

Gilead: NICE OK for Solvadi and patent win vs Roche | Hepatitis C New Drugs Review | Scoop.it
Gilead Sciences can't seem to do anything wrong. Not only has the biotech's hepatitis C treatment Sovaldi become a multibillion-dollar drug less than.
Krishan Maggon 's insight:

Gilead has already paid  back the cost of Pharmasset acquisition by reaping multibillion dollar sales of soforbuvir and increase in its market cap. NICE OK means it is available to HCV patients of NHS at 30% discount to the US price. Patent win vs Roche is a bonus

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Achillion Achieves 100 Percent Sustained Virologic Response Rate (SVR4) From an Eight Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV ("Proxy St...

Achillion Achieves 100 Percent Sustained Virologic Response Rate (SVR4) From an Eight Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV ("Proxy St... | Hepatitis C New Drugs Review | Scoop.it

NEW HAVEN, Conn., Aug. 15, 2014 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced interim results from an ongoing Phase 2 proxy study evaluating ACH-3102, Achillion's second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection. Of the 12 patients treated, 100 percent (n=12/12) remained HCV RNA undetectable four weeks after completing therapy (SVR4).


Based upon these results, 12 additional patients will begin treatment with six weeks of once daily ACH-3102 and sofosbuvir.


ACH-3102 - 017: Phase 2 pilot study evaluating eight week treatment in combination with sofosbuvir for genotype 1 treatment-naïve HCV

Achillion is conducting a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of ACH-3102 and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were enrolled, including six observational patients. Twelve patients completed eight weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Ten of the 12 patients receiving eight weeks of treatment had genotype 1a HCV with median HCV RNA at baseline of 7.22 log10 (range 5.5 - 7.8 log10). No on-treatment viral breakthrough or post-treatment viral relapse has been observed to date. ACH-3102 and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment.  

Following achievement of the pre-specified response rate of 100 percent, the six observational patients plus six additional patients will be enrolled and receive six weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily. Achillion anticipates that SVR4 results from the crossover cohort will be reported by the end of 2014.


Krishan Maggon 's insight:
 ACH-3102
HCV NS5A InhibitorPROGRAM OVERVIEW

In 2011, Achillion discovered and nominated the investigational compound, ACH-3102. ACH-3102 is a structurally distinct second-generation NS5A inhibitor which has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C (HCV). Achillion recently initiated a pilot Phase 2 study evaluating the combination of ACH-3102 and sofosbuvir in treatment-naïve, genotype 1 (GT1) HCV patients over treatment durations of 8 weeks or less, with an objective of optimizing the use of ACH-3102 in nucleotide-based regimens, and expediting the development of the combination of ACH-3102 with Achillion’s proprietary nucleotide NS5B polymerase inhibitor, ACH-3422. Further, Achillion recently announced plans to initiate a Phase 2, all-oral, interferon-free combination study with ACH-3102 and the potent second-generation NS3/4A protease inhibitor, ACH-2684, in GT1b HCV-infected patients over a treatment duration of 8 weeks in mid-2014 to enable further combination studies. Achillion retains worldwide commercial rights to ACH-3102.


POTENCY

ACH-3102 has picomolar potency and has displayed pan-genotypic activity against all subtypes of HCV in vitro.

ACH-3102 has demonstrated robust antiviral activity with a greater than 3.7 log10 mean maximal reduction of HCV RNA with a single dose in GT 1a patients, the harder to treat GT1 subtype.

 

http://www.achillion.com/ACH3102

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The Competition To Gilead's Hepatitis C Drug Sovaldi - Bidness Etc

The Competition To Gilead's Hepatitis C Drug Sovaldi - Bidness Etc | Hepatitis C New Drugs Review | Scoop.it
Bidness Etc
The Competition To Gilead's Hepatitis C Drug Sovaldi
Bidness Etc
The high cure rate of the drug has led Merck's MK-5172A to progress to the Phase III trials.
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Sovaldi forces Incivek off the hep C market as Vertex calls it quits - FiercePharma

Sovaldi forces Incivek off the hep C market as Vertex calls it quits
FiercePharma
Bye-bye, Incivek. Just three years after nabbing the "fastest drug launch ever" award, maker Vertex is discontinuing the hepatitis C med on withering demand.
Krishan Maggon 's insight:

Incivek (Telaprevir) had sales of over 1 billion dollar within the first year after FDA approval. Introduction of newer HCV antivirals like sofosbuvir with shorter duration and higher SVR has changed the market leaving the first 2 approved antivirals with low sales.

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ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection - Gastroe...

ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection - Gastroe... | Hepatitis C New Drugs Review | Scoop.it
ABT-450/r, Ombitasvir, and Dasabuvir: 97-100% SVR +/- RBV in Treat-Exper Pts With HCV Gen 1b - Gastroenterology http://t.co/3ZBeyg41dr
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These are equivalent to complete cure rates for HCV. 

 

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Pharmacogenetics of hepatitis C: transition from interferon to direct-acting antiviral agents | HMER

Pharmacogenetics of hepatitis C: transition from interferon to direct-acting antiviral agents | HMER | Hepatitis C New Drugs Review | Scoop.it
Pharmacogenetics of hepatitis C: transition from interferon-based therapies to direct-acting antiviral agents Sanaa M Kamal1,21Department of Medicine, Division of Hepatology, Gastroenterology and Tropical Medicine, Ain Shams Faculty of Medicine, Cairo, Egypt, 2Department of Medicine, Salman Bin Abdul Aziz College of Medicine, Kingdom of Saudi ArabiaAbstract: Hepatitis C virus (HCV) has emerged as a major viral pandemic over the past two decades, infecting 170 million individuals, which equates to approximately 3% of the world's population. The prevalence of HCV varies according to geographic region, being highest in developing countries such as Egypt. HCV has a high tendency to induce chronic progressive liver damage in the form of hepatic fibrosis, cirrhosis, or liver cancer. To date, there is no vaccine against HCV infection. Combination therapy comprising PEGylated interferon-alpha and ribavirin has been the standard of care for patients with chronic hepatitis C for more than a decade. However, many patients still do not respond to therapy or develop adverse events. Recently, direct antiviral agents such as protease inhibitors, polymerase inhibitors, or NS5A inhibitors have been used to augment PEGylated interferon and ribavirin, resulting in better efficacy, better tolerance, and a shorter treatment duration. However, most clinical trials have focused on assessing the efficacy and safety of direct antiviral agents in patients with genotype 1, and the response of other HCV genotypes has not been elucidated. Moreover, the prohibitive costs of such triple therapies will limit their use in patients in developing countries where most of the HCV infection exists. Understanding the host and viral factors associated with viral clearance is necessary for individualizing therapy to maximize sustained virologic response rates, prevent progression to liver disease, and increase the overall benefits of therapy with respect to its costs. Genome wide studies have shown significant associations between a set of polymorphisms in the region of the interleukin-28B (IL28B) gene and natural clearance of HCV infection or after PEGylated interferon-alpha and ribavirin treatment with and without direct antiviral agents. This paper synthesizes the recent advances in the pharmacogenetics of HCV infection in the era of triple therapies.Keywords: hepatitis C virus, interleukin-28B polymorphisms, PEGylated interferon and ribavirin, direct-acting antiviral agents, pharmacogenetics, rational therapeutics
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open access full text pdf

 

Authors Kamal SM

Published Date June 2014 Volume 2014:6 Pages 61—77

DOI http://dx.doi.org/10.2147/HMER.S41127

Received 8 January 2014, Accepted 3 April 2014, Published 24 June 2014

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Gilead to market Sovaldi at 1% of the US price in India/Egypt

Gilead to market Sovaldi at 1% of the US price in India/Egypt | Hepatitis C New Drugs Review | Scoop.it

In developing countries, Gilead therapies are priced using a tiered system that takes account of ability to pay, as measured
by gross national income per capita, and disease burden.
For HIV and hepatitis B, more than 125 low- and lower middle-income countries are eligible for Gilead therapies at no-profit
or steeply discounted prices. Gilead has also partnered with manufacturers in India and South Africa that are licensed to
produce generic versions of the company’s HIV and hepatitis B medicines for low-income countries. Today, our generic
partners supply more than 98 percent of the Gilead medicines that 5.4 million patients are receiving in developing countries,
and have lowered prices by 80 percent in eight years.


Gilead has worked since 1992 with the World Health Organization (WHO) and other agencies to provide visceral leishmaniasis
treatment at reduced prices in countries where the disease is endemic. In addition, Gilead has donated medicines to WHO
to assist with meeting global targets for controlling leishmaniasis by 2020.

Krishan Maggon 's insight:

It is a good start as  down the line, the price will come down as more generic companies are licensed to manufacture the drug. 

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Critics Raise Concerns About Sovaldi

Critics Raise Concerns About Sovaldi | Hepatitis C New Drugs Review | Scoop.it
Critics have raised an outcry over Sovaldi, a hepatitis C drug heralded as a breakthrough but costing $84,000 for a typical person’s total treatment.
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A group has been formed to oppose high price of Gilead drug.

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Hepatitis C 7 HCV Therapy Infographics : World Hepatitis Day

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