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Telaprevir in HIV/HCV-coinfected patients: a new standard with a short half-life

Infectious Disease Medical Article: Telaprevir in HIV/HCV-coinfected patients: a new standard with a short half-life (Telaprevir in HIV/HCV-coinfected patients: a new standard with a short half-life: Future Virology
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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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Gilead Expands Generic Sovaldi Pact to Add Investigational Pill - Bloomberg

Gilead Expands Generic Sovaldi Pact to Add Investigational Pill - Bloomberg | Hepatitis C New Drugs Review | Scoop.it
Bidness ETC Gilead Expands Generic Sovaldi Pact to Add Investigational Pill Bloomberg The pill, which combines sofosbuvir, the chemical name for Sovaldi, with GS-5816, a compound in advanced clinical trials in the U.S., could treat six genotypes of...
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HCV New Drug Research : Current and Future HCV Therapy-Do We Still Need Other Anti-HCV Drugs?

HCV New Drug Research : Current and Future HCV Therapy-Do We Still Need Other Anti-HCV Drugs? | Hepatitis C New Drugs Review | Scoop.it
RT @HCVNEWDRUGS: Current and Future HCV Therapy-Do We Still Need Other Anti-HCV Drugs? http://t.co/VmV3lCxNXw
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All-Oral 12-Week Treatment With Daclatasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase 3 Study - Nelson - Hepatology - Wiley Online Library

All-Oral 12-Week Treatment With Daclatasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase 3 Study - Nelson - Hepatology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
"@MichaelNathanso: Latest news: 12 W of daclatasvir+sofos is highly effective for #HCV genotype 3: http://t.co/zqeSEttP4d #AASLDjournals

 

Abstract

Treatment options for patients with hepatitis C virus (HCV) genotype 3 infection are limited, with the currently approved all-oral regimens requiring 24-week treatment and the addition of ribavirin. This phase 3 study (ALLY-3; http://www.ClinicalTrials.gov NCT02032901) evaluated the 12-week regimen of daclatasvir (pangenotypic NS5A inhibitor) plus sofosbuvir (pangenotypic NS5B inhibitor) in patients infected with genotype 3. Patients were either treatment-naive (n=101) or treatment-experienced (n=51) and received daclatasvir 60mg plus sofosbuvir 400mg once daily for 12 weeks. Co-primary endpoints were the proportions of treatment-naive and treatment-experienced patients achieving a sustained virologic response at posttreatment Week 12 (SVR12). SVR12 rates were 90% (91/101) and 86% (44/51) in treatment-naive and treatment-experienced patients, respectively; no virologic breakthrough was observed, and ≥99% of patients had a virologic response at the end of treatment. SVR12 rates were higher in patients without cirrhosis (96% [105/109]) than in those with cirrhosis (63% [20/32]). Five of 7 patients who previously failed treatment with a sofosbuvir-containing regimen and 2 of 2 patients who previously failed treatment with an alisporivir-containing regimen achieved SVR12. Baseline characteristics, including gender, age, HCV RNA levels, and IL28B genotype, did not impact virologic outcome. Daclatasvir plus sofosbuvir was well tolerated; there were no adverse events leading to discontinuation and only 1 serious adverse event on-treatment, which was unrelated to study medications. The few treatment-emergent grade 3/4 laboratory abnormalities that were observed were transient. Conclusion: A 12-week regimen of daclatasvir plus sofosbuvir achieved SVR12in 96% of patients with genotype 3 infection without cirrhosis and was well tolerated. Additional evaluation to optimize efficacy in genotype 3-infected patients with cirrhosis is underway. 

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All-Oral 12-Week Treatment With Daclatasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase 3 StudyDavid R. Nelson1,*, James N. Cooper2,Jacob P. Lalezari3, Eric Lawitz4, Paul J. Pockros5, Norman Gitlin6, Bradley F. Freilich7, Ziad H. Younes8, William Harlan9, Reem Ghalib10, Godson Oguchi11, Paul J. Thuluvath12, Grisell Ortiz-Lasanta13,Mordechai Rabinovitz14, David Bernstein15,Michael Bennett16, Trevor Hawkins17,Natarajan Ravendhran18, Aasim M. Sheikh19, Peter Varunok20, Kris V. Kowdley21,†,Delphine Hennicken22, Fiona McPhee23,Khurram Rana24, Eric A. Hughes25 andon behalf of the ALLY-3 Study Team

DOI: 10.1002/hep.27726

© 2015 by the American Association for the Study of Liver Diseases

 
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UNITAID REVIEW OF DETECTION AND MONITORING TECHNOLOGIES FOR HEPATITIS C

Geneva – January 2014.   UNITAID’s review of testing technologies for hepatitis C (HCV) published today, finds that although current diagnosis and screening options for the disease remain too complex and expensive for widespread scale up, there are some emerging technologies which could change this situation.  The new report, Hepatitis C Diagnostics Technology Landscape [PDF, 4 MB], follows an initial scoping report released in 2013 that explored the many issues and challenges related to HCV treatment and diagnosis. The new landscape report identifies several simpler tests which will enable diagnosis and monitoring closer to the point-of-care with the patient.  Some of these are expected to reach the market later this year. 

 

 

In the longer term, identification of infected patients is also important to help build the market intelligence that will be necessary to encourage new drug manufacturers to enter the market and enable treatment options to be made more affordable and accessible, especially for the newly developed highly effective medicines which can cure the disease.  UNITAID has already started investing to make some of these new medicines more affordable for those in need.

Krishan Maggon 's insight:

There are 130 to 150 million people infected globally with HCV, the vast majority of whom are unaware of their status because the initial stages of infection have no symptoms. It is the potential long-term effects that are the most damaging: cirrhosis, liver cancer and liver failure.  Screening and monitoring is vital to enable treatment, but can cost $300-1,400 per patient, out of reach for most middle-income countries which have 75% of those infected. Few individuals therefore currently access HCV testing and treatment, including only a small fraction of the estimated 4 to 5 million people who are co-infected with HIV and HCV.  

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Recent advances and future directions in the management of hepatitis C infections

Recent advances and future directions in the management of hepatitis C infections | Hepatitis C New Drugs Review | Scoop.it

Abstract

Current estimates indicate that the hepatitis C virus is the leading cause of death in the United States with infection rates steadily increasing. Successful treatment is made difficult by the presence of various host, virus, and treatment-related factors, warranting the development of new approaches to combat the silent epidemic. The addition of telaprevir and boceprevir to the pharmacotherapeutic arsenal drastically improved success rates in genotype 1 infected patients, but rapid development of resistance mechanisms, increases in adverse effects, and a low spectrum activity proved to be barriers to efficacious treatment. In late 2013, two new agents were approved – sofosbuvir and simeprevir – that have higher barriers to resistance, favorable safety profiles, and profoundly improved success rates; however higher costs associated with the new medications could limit their wider utilization. Further strategies to combat the virus are under development, ranging from interferon-free regimens as well as prophylactic and therapeutic vaccines to applications of nanotechnology, helping us get closer to improved treatment of patients infected with hepatitis C.

Krishan Maggon 's insight:

Pharmacology & Therapeutics

Volume 145, January 2015, Pages 92–102

Associate editor: F. Tarazi Recent advances and future directions in the management of hepatitis C infectionsVictoria Belousovaa, Ahmed A. Abd-Raboua, b, c, Shaker A. Mousaa, ,   doi:10.1016/j.pharmthera.2014.09.002

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How to optimize HCV treatment impact on life years saved in resource-constrained countries - Obach - Hepatology - Wiley Online Library

How to optimize HCV treatment impact on life years saved in resource-constrained countries - Obach - Hepatology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
How to optimize #HCV treatment impact on life years saved in resource-constrained countries→http://t.co/fmL0t5i5Il via @HEP_Journal #HepC

 

Abstract

In resource-constrained countries where the prevalence of HCV disease is usually high, it is important to know which population should be treated first in order to increase treatment effectiveness. The objective was to estimate the effectiveness of different HCV treatment eligibility scenarios in three different countries. Using a Markov model we estimated the number of life years saved (LYS) with different treatment eligibility scenarios according to fibrosis stage (F1-F4, or F3-4), compared to base-case (F2-F4), at a constant treatment rate, of patients aged between 18 and 60 years, at stages F0/F1 to F4, without liver complications or co-infections, chronically infected by HCV, and treated with pegylated interferon/ribavirin or more efficacious therapies (i.e. interferon-free). We conducted the analysis in Egypt (prevalence=14.7%, 45,000 patients treated/year), Thailand (prevalence=2.2%, 1,000 patients treated/year), and Côte d'Ivoire (prevalence=3%, 150 patients treated/year). In Egypt, treating F1 patients in addition to ≥F2 patients (SE1 vs. SE0) decreased LYS by 3.9%. Focusing treatment only on F3-F4 patients increased LYS by 6.7% (SE2 vs. SE0). In Thailand and Côte d'Ivoire, focusing treatment only on F3-F4 patients increased LYS by 15.3% and 11.0%, respectively, compared to treating patients ≥F2 (ST0 and SC0, respectively). Treatment only for patients at stages F3-F4 with interferon-free therapies would increase LYS by 16.7% vs. SE0 in Egypt, by 22.0% vs. ST0 in Thailand, and by 13.1% vs. SC0 in Côte d'Ivoire. In this study we did not take into account the yearly new infections and the impact of treatment on HCV transmission.

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How to optimize HCV treatment impact on life years saved in resource-constrained countriesDorothée Obach1,*, Yazdan Yazdanpanah1,2, Gamal Esmat3, Anchalee Avihingsanon4,5, Sahar Dewedar6,Nicolas Durier7, Alain Attia8,9, Wagida A. Anwar6, Anthony Cousien1, Pisit Tangkijvanich10, Serge Paul Eholié11,12,13,Wahid Doss14, Aya Mostafa6, Arnaud Fontanet15,16, Mostafa K. Mohamed6,†andSylvie Deuffic-Burban1,17

DOI: 10.1002/hep.27691

© 2015 by the American Association for the Study of Liver Diseases

Issue

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

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Gilead’s India Patent Snag May Spur More Low-Cost Sovaldi Copies

Gilead’s India Patent Snag May Spur More Low-Cost Sovaldi Copies | Hepatitis C New Drugs Review | Scoop.it
The Indian patent office’s rejection of a
key patent for Gilead Sciences Inc. (GILD)’s Hepatitis C treatment
Sovaldi may pave the way for more low-cost copies in the
country, potentially aiding local companies including Natco
Pharma Ltd. (NTCPH)
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Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study - The Lancet

Triple antiviral therapy can potentially cure Hepatitis C in 6 weeks @TheLancet #HCV http://t.co/hvFP9uMR2X

 

Findings

Between Jan 11, 2013, and Dec 17, 2013, we enrolled 60 patients, and sequentially assigned them into three groups of 20. We noted an SVR12 in all 20 patients (100%, 95% CI 83–100) allocated to sofosbuvir and ledipasvir for 12 weeks; in 19 (95%, 75–100) of the 20 patients allocated to sofosbuvir, ledipasvir, and GS-9669 for 6 weeks (one patient relapsed 2 weeks after completion of treatment); and in 19 (95%, 75–100%) of the 20 patients allocated to sofosbuvir, ledipasvir, and GS-9451 for 6 weeks (one patient was lost to follow-up after reaching sustained viral response at 4 weeks). Most adverse events were mild and no patients discontinued treatment. Two serious adverse events occurred (pain after a post-treatment liver biopsy and vertigo), both unrelated to study drugs.

Interpretation

In this small proof-of-concept study, two different three-drug regimens that were given for 6 weeks resulted in high cure rates for HCV infection with excellent tolerability. Addition of a third potent direct-acting antiviral drug can reduce the duration of treatment required to achieve sustained viral response in patients with chronic HCV genotype 1 infection without cirrhosis.

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Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort studyAnita Kohli, MD, Anuoluwapo Osinusi, MD, Zayani Sims, BS, Amy Nelson, RN, Eric G Meissner, MD, Lisa L Barrett, MD, Dimitra Bon, MS, Miriam M Marti, BS, Rachel Silk, RN, Colleen Kotb, NP, Chloe Gross, RN,Tim A Jolley, RN, Sreetha Sidharthan, BS, Tess Petersen, BS, Kerry Townsend, BA, D'Andrea Egerson, RN,Rama Kapoor, MD, Emily Spurlin, BA, Michael Sneller, MD, Michael Proschan, PhD, Eva Herrmann, PhD,Richard Kwan, PAC, Gebeyehu Teferi, MD, Rohit Talwani, MD, Gabbie Diaz, RN, David E Kleiner, MD, Brad J Wood, MD, Jose Chavez, MD, Stephen Abbott, MD, William T Symonds, PharmD, G Mani Subramanian, MD, Phillip S Pang, MD, John McHutchison, MD, Michael A Polis, MD, Anthony S Fauci, MD, Henry Masur, MD, Dr Shyam Kottilil, MDPublished Online: 12 January 2015DOI: http://dx.doi.org/10.1016/S0140-6736(14)61228-9
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Debiopharm Regains Full Rights to Alisporivir Program after Novartis bailout.

Debiopharm Regains Full Rights to Alisporivir Program after Novartis bailout. | Hepatitis C New Drugs Review | Scoop.it

Debiopharm Group™ Regains Full Rights to Alisporivir Program MarketWatch Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical company, today announced that it has updated its arrangement with Novartis to regain full rights to Alisporivir (DEB025) currently completing two Phase 2 studies of interferon-free treatment in Hepatitis C.

Krishan Maggon 's insight:
Novartis returns Alisporivir (DEB025) to Debiopharm Group™ including all rights for HCV and other indications.

 

Alisporivir is a non-immunosuppressive cyclophilin inhibitor that is currently in development as a host-targeting agent for the treatment of Hepatitis C. It has already been tested in over 2,000 patients and has demonstrated promising efficacy including in difficult-to-treat patients with an acceptable safety profile. Alisporivir has the potential to be used for the treatment of additional diseases such as other viral infections, certain muscular dystrophies, and myocardial infarction.

 

 

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The Black Secret in the AbbVie -Gilead Sciences Hepatitis C Drug War

The Black Secret in the AbbVie -Gilead Sciences Hepatitis C Drug War | Hepatitis C New Drugs Review | Scoop.it
Figuring out the revenue AbbVie and Gilead Sciences are going to make on their new hepatitis C drugs should not be that difficult.
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Concise review on the insight of hepatitis C

Concise review on the insight of hepatitis C | Hepatitis C New Drugs Review | Scoop.it

Abstract

Hepatitis C is the disease of liver caused by hepatitis C virus (HCV). Due to its widespread impact on human population, there is continued surge for new therapeutic agents to treat and reduce HCV. Hence, nowadays HCV is considered as global burden throughout the world. Advancements in therapeutic invention and clinical outcomes are dependent on HCV genome and diversity in nature, pathogenesis, dietary factors, social, economic and environmental factors. In this review we have focused mainly on HCV genome, its history and clinical outcomes from its discovery to present day research.

In this article the authors have reviewed the published data from year 1997–2014. The topics of main concerns were hepatitis C with diverse nature and recent advances in the treatment of chronic hepatitis C. The authors used MeSH terms “Hepatitis C Virus (HCV)”, recent advances in the treatment of “HCV″, “HCV and Immunity”, “vaccination”, or “Interferon therapy” to search the PubMed database. All relevant studies identified were included and are described according to the subheadings.

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Journal of Taibah University Medical Sciences

Available online 6 January 2015

In Press, Uncorrected Proof — Note to users

Open AccessReview Article Concise review on the insight of hepatitis CAllah Nawaz, MDa, Syed Faisal Zaidi, MD, PhDb, c, , , Khan Usmanghani, PhDd, Irshad Ahmad,PhDe  doi:10.1016/j.jtumed.2014.08.004 

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CVS to Cover Expensive Hepatitis C Drugs - TIME

CVS to Cover Expensive Hepatitis C Drugs - TIME | Hepatitis C New Drugs Review | Scoop.it

The prescription drug benefit arm of CVS said Monday that it will exclusively cover two costly hepatitis C drugs that were until recently the only oral treatments available for the disease, following moves by a competitor to cover an alternative drug.

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Gilead had to offer discount to CVs for coverage?

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Long‐term follow‐up of successful hepatitis C virus therapy: waning immune responses and disappearance of liver disease are consistent with cure - Hedenstierna - 2015 - Alimentary Pharmacology & Th...

Long‐term follow‐up of successful hepatitis C virus therapy: waning immune responses and disappearance of liver disease are consistent with cure - Hedenstierna - 2015 - Alimentary Pharmacology & Th... | Hepatitis C New Drugs Review | Scoop.it
Long-term successful HCV therapy: waning immune responses & disappearance of liver disease consistent with cure To determine clinical, histological, virological and immunological markers 5–20 years after SVR. Methods In 54 patients, liver biochemistry, histology and elastography were evaluated. Liver biopsies, plasma and peripheral blood mononuclear cells (PBMCs) were tested for minute amounts of HCV RNA. HCV-specific T-cell responses were monitored by ELISpot and pentamer staining, and humoral responses by measuring HCV nonstructural (NS)3-specific antibodies and virus neutralisation. Results Liver disease regressed significantly in all patients, and 51 were HCV RNA-negative in all tissues tested. There was an inverse association between liver disease, HCV-specific T-cell responses and HCV antibody levels with time from SVR, supporting that the virus had been cleared. The three patients, who all lacked signs of liver disease, had HCV RNA in PBMCs 5–9 years after SVR. All three had HCV-specific T cells and NS3 antibodies, but no cross-neutralising antibodies. Conclusions Our combined data confirm that a SVR corresponds to a long-term clinical cure. The waning immune responses support the disappearance of the antigenic stimulus. Transient HCV RNA traces may be detected in some patients up to 9 years after SVR, but no marker associates this with an increased risk for liver disease.
Krishan Maggon 's insight:
Alimentary Pharmacology & Therapeutics Early View Alimentary Pharmacology & Therapeutics Previous article in Early View: Cost-effectiveness of all-oral ledipasvir/sofosbuvir regimens in patients with chronic hepatitis C virus genotype 1 infection Next article in Early View: Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir Online Version of Record published before inclusion in an issue Original Scientific Paper Long-term follow-up of successful hepatitis C virus therapy: waning immune responses and disappearance of liver disease are consistent with cure Authors M. Hedenstierna, O. Weiland, A. Brass, D. Bankwitz, P. Behrendt, I. Uhnoo, S. Aleman, K. Cardell, A. Fryden, G. Norkrans, A. Eilard, H. Glaumann, T. Pietschmann, M. Sällberg, E. D. Brenndörfer First published: 28 January 2015Full publication history DOI: 10.1111/apt.13096View/save citation
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Molecular epidemiology of newly acquired hepatitis C infections in England 2008–2011: Genotype, phylogeny and mutation analysis

Molecular epidemiology of newly acquired hepatitis C infections in England 2008–2011: Genotype, phylogeny and mutation analysis | Hepatitis C New Drugs Review | Scoop.it
Highlights

 

Molecular epidemiology of newly acquired hepatitis C infections in England.

Evidence for the transmission of NS3 mutations associated with antiviral resistance.

Most commonly observed genotypes were 1a (49%) and 3a (42%).

Injecting drug use (58%) was the most common risk factor.

Genotype distribution differed between PWIDs and those with other risk factors suggesting two possible epidemics.

Krishan Maggon 's insight:
Journal of Clinical Virology

Volume 64, March 2015, Pages 6–11

 Molecular epidemiology of newly acquired hepatitis C infections in England 2008–2011: Genotype, phylogeny and mutation analysisShoshanna Maya, 1, Siew Lin Nguia, 1, Sarah Collinsb, 1, Sam Lattimoreb, 1, Mary Ramsayb, 1, Richard S. Teddera, c, d, 1, Samreen Ijaza, , 1,  doi:10.1016/j.jcv.2014.12.014
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Systematic review: patient‐reported outcomes in chronic hepatitis C ‐ the impact of liver disease and new treatment regimens - Younossi - 2015 - Alimentary Pharmacology & Therapeutics - Wiley Onlin...

Systematic review: patient‐reported outcomes in chronic hepatitis C ‐ the impact of liver disease and new treatment regimens - Younossi - 2015 - Alimentary Pharmacology & Therapeutics - Wiley Onlin... | Hepatitis C New Drugs Review | Scoop.it
Review: patient-reported outcomes in chronic hepatitis C - the news is betting better http://t.co/vXp1bmuRL8 #HCV #heptatology

 

Results

From the literature, it is evident that CH-C patients have baseline PRO impairment. Furthermore, treatment with interferon with or without ribavirin and first generation DAAs causes additional PRO burden which can negatively impact treatment adherence and indirectly, treatment efficacy and work productivity. The new treatment regimens with interferon- and ribavirin-free regimens not only have very high efficacy, but also result in the improvement of PRO scores as early as 2 weeks into treatment as well as possibly better adherence to treatment regimens.

Conclusions

CH-C and its treatment have been associated with patient-reported outcome impairment. The new IF-free and RBV-free regimens are associated with high efficacy and substantial improvement of patient-reported outcomes in clinical trial setting. Although very encouraging, more data are needed to assess patient-reported outcomes, adherence and work productivity of CH-C patients in the real world setting of clinical practice.

Krishan Maggon 's insight:
Early ViewPrevious article in Early View: Successful anti-viral treatment improves survival of patients with advanced liver disease due to chronic hepatitis C

 

Online Version of Record published before inclusion in an issue

Systematic ReviewSystematic review: patient-reported outcomes in chronic hepatitis C - the impact of liver disease and new treatment regimensAuthorsZ. Younossi, L. Henry First published: 23 January 2015Full publication historyDOI: 10.1111/apt.13090View/save citation
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Successful anti‐viral treatment improves survival of patients with advanced liver disease due to chronic hepatitis C - Rutter - 2015 - Alimentary Pharmacology & Therapeutics - Wiley Online Library

Successful anti‐viral treatment improves survival of patients with advanced liver disease due to chronic hepatitis C - Rutter - 2015 - Alimentary Pharmacology & Therapeutics - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
RT @APandT: Successful anti-HCV therapy lowers mortality, HCC & liver failure in 714 patients with advanced fibrosis http://t.co/biJOekPir3

 

 

Results

 

Forty-eight patients died during follow-up, 15 with SVR and 33 without (P < 0.001). Five- and 10-year mortality rates were 1.8% (10/551) and 2.7% (15/551) in the SVR group and 8.6% (14/163) and 19.1% (31/163) in the non-SVR patients (P < 0.001). In 29 patients, decompensation of liver disease [SVR: 9 (1.6%) vs. non-SVR: 20 (12.3%); P < 0.001] occurred and in 29 patients, HCC developed during follow-up [SVR: 10 (1.8%) vs. non-SVR: 19 (11.7%); P < 0.001]. Non-SVR was an independent predictor for developing (i) HCC [HR: 2.36 (95% CI: 1.07–5.23; P = 0.034], (ii) liver-related complications [HR: 2.62; (95% CI: 1.18–5.81; P = 0.018] and (iii) mortality (HR: 3.46; 95% CI: 1.91–6.29; P < 0.001). For patients with early stages of fibrosis (F0–F2), a survival benefit of SVR patients could not be demonstrated.

 

Conclusions

 

Successful anti-viral therapy decreases mortality, incidence of hepatocellular carcinoma and liver failure in patients with advanced fibrosis. However, hepatocellular carcinoma development or liver failure are not prevented completely, and further follow-up of patients is advisable.

 

Krishan Maggon 's insight:
Early ViewPrevious article in Early View: Familial colorectal cancer risk by subsite of primary cancer: a population-based study in Utah

 

Next article in Early View: Systematic review: patient-reported outcomes in chronic hepatitis C - the impact of liver disease and new treatment regimens

 

Online Version of Record published before inclusion in an issue

Original ArticleSuccessful anti-viral treatment improves survival of patients with advanced liver disease due to chronic hepatitis CAuthorsK. Rutter, A. F. Stättermayer, S. Beinhardt, T.-M. Scherzer, P. Steindl-Munda, M. Trauner, P. Ferenci, H. Hofer First published: 23 January 2015Full publication historyDOI: 10.1111/apt.13085View/save citationCited by: 0 articles last updated 23 January 2015
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Control of HCV Replication With iMIRs, a Novel Anti-RNAi Agent

Control of HCV Replication With iMIRs, a Novel Anti-RNAi Agent | Hepatitis C New Drugs Review | Scoop.it

Molecular Therapy — Nucleic Acids 

 

Abstract

MicroRNAs (miRNAs) serve important roles in regulating various physiological activities through RNA interference (RNAi). miR-122 is an important mediator of RNAi that is known to control hepatitis C virus (HCV) replication and is being investigated in clinical trials as a target for anti-HCV therapy. In this study, we developed novel oligonucleotides containing non-nucleotide residues, termed iMIRs, and tested their abilities to inhibit miR-122 function. We compared the inhibitory effects of iMIRs and locked nucleic acids (LNAs) on HCV replication in OR6 cells, which contained full-length HCV (genotype 1b) and a luciferase reporter gene. We found that RNA-type iMIRs with bulge-type, imperfect complementarity with respect to miR-122 were 10-fold more effective than LNAs in inhibiting HCV replication and functioned in a dose-dependent manner. Moreover, iMIR treatment of OR6 cells reduced HCV replication without inducing interferon responses or cellular toxicity. Based on these results, we suggest that iMIRs can inhibit HCV replication more effectively than LNAs and are therefore promising as novel antiviral agents.

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Citation: Molecular Therapy Nucleic Acids (2015) 4, e219; doi:10.1038/mtna.2014.71
Published online 20 January 2015

Control of HCV Replication With iMIRs, a Novel Anti-RNAi Agent
OPEN

Saori Itami1, Yutaka Eguchi2, Takayuki Mizutani3, Eriko Aoki3, Tadaaki Ohgi3, Masahiko Kuroda4, Takahiro Ochiya5, Nobuyuki Kato6, Hiroshi I Suzuki7, Norifumi Kawada1 and Yoshiki Murakami1

1Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan2Department of Medical Genetics, Osaka University Graduate School of Medicine, Suita, Japan3BONAC Corporation, Kurume, Japan4Department of Molecular Pathology, Tokyo Medical University, Tokyo, Japan5National Cancer Center Research Institute, Tokyo, Japan6Department of Tumor Virology, Okayama University, Okayama, Japan7Sharp Laboratory Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA

Correspondence: Yoshiki Murakami, Department of Hepatology, Graduate School of Medicine, Osaka City University, 1-4-3, Asahimachi, Abeno-ku, Osaka 545–8585, Japan. E-mail: 2079633@med.osaka-cu.ac.jp

Received 10 July 2014; Accepted 21 November 2014

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European Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for the Treatment of Chronic Hepatitis C - Jan ...

European Commission Grants Marketing Authorizations for AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for the Treatment of Chronic Hepatitis C - Jan ... | Hepatitis C New Drugs Review | Scoop.it

NORTH CHICAGO, Ill., Jan. 16, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of VIEKIRAX®(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets).1,2 The treatment has been approved with or without ribavirin (RBV) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.1,2Additionally, VIEKIRAX has been approved for use with RBV in genotype 4 (GT4) chronic hepatitis C patients.1

 

The approvals follow a review under accelerated assessment by the European Medicines Agency, designated to new medicines of major public health interest. Approximately nine million people in Europe are infected with chronic hepatitis C, a major cause of liver cancer and liver transplantation.4 Genotype 1 is the most prevalent form of hepatitis C in Europe, accounting for 60 percent of cases worldwide.5 In Europe, the most prevalent sub-genotype is 1b (47 percent).6 Genotype 4, most common in the Middle East, sub-Saharan Africa and Egypt, is becoming increasingly prevalent in several European countries, including Italy, France, Greece and Spain.7 AbbVie's treatment is now licensed for use in all 28 member countries of the European Union, as well as in the U.S., Canada, Switzerland, Iceland, Liechtenstein and Norway.


The approval of VIEKIRAX + EXVIERA is supported by a robust clinical development program designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries.1,2 The program consisted of six pivotal Phase 3 studies, which demonstrated that VIEKIRAX + EXVIERA cured 95-100 percent of hepatitis C patients with GT1 HCV infection who received the recommended regimen, with less than 2 percent of patients experiencing virologic failure.1,2 Additionally, more than 98 percent (n=2,011/2,053) of patients in clinical trials completed a full course of therapy.3 Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.1,2

The approval of VIEKIRAX + EXVIERA is also based on the results from Phase 2 clinical trials in GT1 chronic HCV infected patients, which showed that VIEKIRAX + EXVIERA cured 97 percent (n=33/34) of liver transplant recipients, 92 percent (n=58/63) of patients co-infected with HIV-1 and 97 percent (n=37/38) of patients on opioid substitution therapy.1,2Patients who achieve a sustained virologic response (SVR12) are considered cured of hepatitis C.

Approval of VIEKIRAX in GT4 chronic hepatitis C was based on a Phase 2 study in which patients treated with VIEKIRAX with RBV achieved 100 percent SVR12.1


Krishan Maggon 's insight:
EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATIONS FOR ABBVIE'S VIEKIRAX® (OMBITASVIR/PARITAPREVIR/RITONAVIR TABLETS) + EXVIERA® (DASABUVIR TABLETS) FOR THE TREATMENT OF CHRONIC HEPATITIS C- IN PHASE 3 CLINICAL TRIALS, VIEKIRAX + EXVIERA CURED 95-100 PERCENT OF GENOTYPE 1 CHRONIC HEPATITIS C PATIENTS, WITH LESS THAN 2 PERCENT OF PATIENTS EXPERIENCING VIROLOGIC FAILURE[1],[2]- TOLERABILITY PROFILE SHOWS MORE THAN 98 PERCENT OF PATIENTS COMPLETED A FULL COURSE OF THERAPY[3]- ALL-ORAL, INTERFERON-FREE REGIMEN ALSO APPROVED FOR HCV/HIV-1 CO-INFECTION, PATIENTS ON OPIOID SUBSTITUTION THERAPY AND PATIENTS WHO HAVE UNDERGONE A LIVER TRANSPLANT[1],[2]- VIEKIRAX + EXVIERA ARE THE FIRST PRODUCTS TO BE APPROVED AS A COMBINATION TREATMENT OF THREE DIRECT-ACTING ANTIVIRALS WITH DISTINCT MECHANISMS OF ACTION TARGETING HEPATITIS C AT MULTIPLE STEPS IN THE VIRAL LIFECYCLE[1],[2]
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Hepatitis C drug delayed by NHS due to high cost

Hepatitis C drug delayed by NHS due to high cost | Hepatitis C New Drugs Review | Scoop.it
NHS England balks at bill for dispensing sofosbuvir: £1bn for every 20,000 people treated
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Gilead Sciences, Inc. Is No Longer Just an HIV Company - Motley Fool

Gilead Sciences, Inc. Is No Longer Just an HIV Company - Motley Fool | Hepatitis C New Drugs Review | Scoop.it
HIV drugs now make up less than half of Gilead Sciences' revenue. - Brian Orelli - Health Care
Krishan Maggon 's insight:

Gilead has changed from a one leg to two leg company domination  of the HIV and HCV market.

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Hepatitis C Drugs Show Patients Benefit Most From Treatment Choices - Science 2.0

Hepatitis C Drugs Show Patients Benefit Most From Treatment Choices - Science 2.0 | Hepatitis C New Drugs Review | Scoop.it
Hepatitis C Drugs Show Patients Benefit Most From Treatment Choices Science 2.0 In spite of the precedent and the application of prodigious money and manpower, it was not until 2011 that the first two specific antiviral HCV treatments—Victrelis...
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CDC DVH - Know More Hepatitis - Timeline of Hepatitis C

CDC DVH - Know More Hepatitis - Timeline of Hepatitis C | Hepatitis C New Drugs Review | Scoop.it
RT @cdchep: 1989: #HCV was identified by scientists at CDC & @NIHforHealth. Learn more http://t.co/H6hbmADs2A #HepC25th #HepC http://t.co/S&hellip;
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Merck speeds up drug-submission plans for Hep C, lung cancer -WSJ - Reuters

Merck speeds up drug-submission plans for Hep C, lung cancer -WSJ - Reuters | Hepatitis C New Drugs Review | Scoop.it
Jan 12 (Reuters) - Merck & Co has put on fast trackits plans to submit new drugs for hepatitis C and lung cancerfor regulatory approval, in an attempt to close the gap withcompetitors in two lucrative...
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OnCore BioPharma licenses Cytos VLP Immunogenic Platform for Hepatitis B

OnCore BioPharma licenses Cytos VLP Immunogenic Platform for Hepatitis B | Hepatitis C New Drugs Review | Scoop.it

Schlieren (Zurich), Switzerland, January 6, 2015 – Cytos Biotechnology Ltd. (SIX:CYTN) ("Cytos") announced today that it executed an exclusive license agreement granting OnCore Biopharma, Inc. (“OnCore”) access to Cytos’ clinically validated virus like particle (VLP) platform for the use in the treatment and prevention of hepatitis B viral infections. Cytos also granted an option for the treatment of additional viral diseases other than influenza. The agreement will become effective with the achievement of certain closing conditions, including a successful debt restructuring of Cytos.


For the first product in each of six possible product categories in the field of Hepatitis B that may be developed under the agreement, Cytos may receive up to USD 67 million in development milestones, or a maximum of USD 402 million if one product in each product category is developed. In addition, Cytos is eligible to receive commercial milestone payments of up to USD 120 million upon achievement of certain sales levels, and up to double-digit royalties on net sales from any successfully
developed product.

Krishan Maggon 's insight:

Versatile, defined and robust vaccine platform based on bacteriophage Q beta-derived virus-like particles (Qb VLPs). 

Cytos’ VLP platform builds on the repetitive and highly ordered protein array formed by the Qb VLP.  GMP grade Qb VLPs are produced efficiently at large scale in E.coli. Desired antigens are produced separately and can, using chemical linkers, be directionally conjugated to the VLP surface and presented in a highly ordered fashion to B-cells. As a result B-cell receptors are efficiently cross-linked, a key feature to induce a potent immune response. In addition, Qb coat proteins contain strong T helper-cell epitopes providing efficient T-help to B-cells. Cytos and its partners have tested a wide array of antigens ranging from chemical entities, to peptides, to large multimeric proteins. Vaccine candidates based on Cytos’ Qb VLP platform have been tested in  various preclinical and clinical studies and were found to be safe, generally well tolerated and highly immunogenic. The vaccine platform is modular, robust and scalable.

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Unique Features of HIV-1 Spread through T Cell Virological Synapses

Unique Features of HIV-1 Spread through T Cell Virological Synapses | Hepatitis C New Drugs Review | Scoop.it

The spread of viral infections can be initiated by the release of cell-free virus particles that infect at a distance or via cell-associated virus, which can promote the direct transmission of viruses between adjacent cells. In the case of human immunodeficiency virus type 1 (HIV-1), cell–cell contact has been found to enhance infection through specialized structures called virological synapses (VS). Cell–cell interactions between virus scavenging dendritic cells and T cells or between infected and uninfected T cells are two major cell interactions that enhance HIV infection. Here we review the features of VS formed between infected and uninfected T cells and focus on how these differ from infection by cell-free virus. While virus particle production is a shared characteristic of both cell-free and cell–cell HIV transmission, cell–cell infection displays several unique features that contribute to the enhanced efficiency of this mode of transmission. Five distinguishing features of HIV spread through T cell virological synapses are discussed below.

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Unique Features of HIV-1 Spread through T Cell Virological SynapsesRaymond A. Alvarez,  Maria Ines Barría,  Benjamin K. Chen mail Published: December 18, 2014DOI: 10.1371/journal.ppat.1004513Featured in PLOS Collections

 

Citation: Alvarez RA, Barría MI, Chen BK (2014) Unique Features of HIV-1 Spread through T Cell Virological Synapses. PLoS Pathog 10(12): e1004513. doi:10.1371/journal.ppat.1004513

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