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WHO | Hepatitis treatment debuts on WHO Model Essential Medicines List

Good news has emerged for the 150 million people worldwide who have hepatitis C – a lifelong condition that is transmitted through contact with the blood of an infected person and can lead to cirrhosis, liver cancer, and even death.
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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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Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis

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Pharmacokinetics and Pharmacodynamics of Setrobuvir, an Orally Administered Hepatitis C Virus Non-Nucleoside Analogue Inhibitor - Clinical Therapeutics

Pharmacokinetics and Pharmacodynamics of Setrobuvir, an Orally Administered Hepatitis C Virus Non-Nucleoside Analogue Inhibitor - Clinical Therapeutics | Hepatitis C New Drugs Review | Scoop.it
What do we know about the #pharmacokinetics and #pharmacodynamics of #setrobuvir? http://t.co/ZJgw7NQ9J9 #medcomms #pubplan #HepatitisC

 

Findings

After single doses of setrobuvir (400–3000 mg) to volunteers in a fasted state, peak Cmax and AUC0–∞ increased in a less than dose-proportional manner. The mean apparent t½z ranged from 22.0 to 31.3 hours and was not dose related. Cmax and AUC increased significantly (4.3- and 6.3-fold, respectively) in volunteers who received 2000 mg with a high-fat meal versus fasting. After multiple oral doses, steady state was achieved after 7 days of dosing (400 or 800 mg QD and 600 mg BID) and accumulation was dose-independent. Mean day 14 plasma exposure increased in a less than dose-proportional manner in volunteers who received 400 and 800 mg QD, but it was more than dose-proportional in volunteers receiving 600 mg BID. Dose did not affect the mean t½z (range, 24.1–26.6 hours), apparent oral clearance (0.254–0.516 L/h), or apparent volume of distribution (9.60–18.1 L). In patients with CHC, dose-related reductions in HCV RNA concentration were apparent within 24 hours of the start of treatment. Reductions from baseline to the end of treatment (day 3) in patients treated with setrobuvir 200, 400, and 800 mg BID were –2.1, –2.2, and –2.9 log10 IU/mL, respectively (vs ≤0.1 log10 IU/mL with placebo). Reductions in HCV RNA were greater in patients with genotype 1b (range, –2.7 to –3.1 log10 IU/mL) than in patients with genotype 1a (range, –1.3 to –2.7 log10 IU/mL). Setrobuvir was well tolerated, with no serious adverse events.

Implications

The steady state pharmacokinetics of setrobuvir appear to be dose proportional, and setrobuvir produces a mean reduction of 2.9 log10 IU/mL in HCV RNA over 3 days in patients with genotype 1 (a and b) treated with 800 mg BID. ClinicalTrials.gov identifier: NCT00782353

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The drug is in Phase II trials.

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Treatment of hcv with ABT-450/r–ombitasvir and dasabuvir with ribavirin

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Will AbbVie Undercut Gilead on Hepatitis C? - Barron's (blog)

Will AbbVie Undercut Gilead on Hepatitis C? - Barron's (blog) | Hepatitis C New Drugs Review | Scoop.it
Morgan Stanley’s David Risinger and team downgraded AbbVie (ABBV) to Equal Weight from Overweight today, citing the fact that “risk-reward appears more balanced” now that Street gets the Hepatitis-C and Humira stories.
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A Comprehensive Comparison Of Gilead's Harvoni And AbbVie's Triple HCV ... - Seeking Alpha

A Comprehensive Comparison Of Gilead's Harvoni And AbbVie's Triple HCV ... - Seeking Alpha | Hepatitis C New Drugs Review | Scoop.it
I have been asked by multiple followers to write this piece contrasting Gilead's (NASDAQ:GILD) Harvoni and AbbVie's (NYSE:ABBV) triple regimen which will soon be approved with a PDUFA date of 12/22/2014

 

Gilead's Harvoni will dominate AbbVie's HCV regimen in the market place because in all instances, Harvoni is the safer and more effective drug.Physicians’ primary concern is the well-being of their patients. AbbVie’s regimen requires ritonavir and ribavirin (most cases) which greatly increases side effects and risks of anemia. Harvoni is the best choice.As pricing decreases and regimens improve, more patients will be treated, but the sheer numbers will allow massive profits for at least a decade or more.Gilead shares have dropped 15% over AbbVie's regimen approval and loss of market share due to pricing. The time to buy Gilead is now. Assume 30%-50% upside in 2015.

.

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Harvoni seems to be safer and more effective than the cheaper AbbVie HCV therapy.

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HCV cirrhosis at the edge of decompensation: Will paritaprevir with ritonavir, ombitasvir, dasabuvir, and ribavirin solve the need for treatment? - Journal of Hepatology

HCV cirrhosis at the edge of decompensation: Will paritaprevir with ritonavir, ombitasvir, dasabuvir, and ribavirin solve the need for treatment? - Journal of Hepatology | Hepatitis C New Drugs Review | Scoop.it
HCV cirrhosis at the edge of decompensation: Will paritaprevir/r, ombitasvir, dasabuvir and R solve the need for tx http://t.co/dVfDKqs8Ji

 

Abstract. BACKGROUND: The interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r) and the NS5A inhibitor ombitasvir (also known as ABT-267) plus the nonnucleoside polymerase inhibitor dasabuvir (also known as ABT-333) and ribavirin has shown efficacy against the hepatitis C virus (HCV) in patients with HCV genotype 1 infection. In this phase 3 trial, we evaluated this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis.

METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial, we assigned previously untreated patients with HCV genotype 1 infection, in a 3:1 ratio, to an active regimen consisting of a single-tablet coformulation of ABT-450/r-ombitasvir (at a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir, and 25 mg of ombitasvir), and dasabuvir (250 mg twice daily) with ribavirin (in doses determined according to body weight) (group A) or matching placebos (group B). The patients received the study treatment during a 12-week double-blind period. The primary end point was sustained virologic response at 12 weeks after the end of treatment. The primary analysis compared the response rate in group A with the response rate (78%) in a historical control group of previously untreated patients without cirrhosis who received telaprevir with peginterferon and ribavirin. Adverse events occurring during the double-blind period were compared between group A and group B.

RESULTS: A total of 631 patients received at least one dose of the study drugs. The rate of sustained virologic response in group A was 96.2% (95% confidence interval, 94.5 to 97.9), which was superior to the historical control rate. Virologic failure during treatment and relapse after treatment occurred in 0.2% and 1.5%, respectively, of the patients in group A. The response rates in group A were 95.3% among patients with HCV genotype 1a infection and 98.0% among those with HCV genotype 1b infection. The rate of discontinuation due to adverse events was 0.6% in each study group. Nausea, pruritus, insomnia, diarrhea, and asthenia occurred in significantly more patients in group A than in group B (P<0.05 for all comparisons). Reductions in the hemoglobin level were all of grade 1 or 2; reductions of grade 1 and 2 occurred in 47.5% and 5.8%, respectively, of the patients in group A, whereas grade 1 reductions occurred in 2.5% of the patients in group B.

CONCLUSIONS: In previously untreated patients with HCV genotype 1 infection and no cirrhosis, a 12-week multitargeted regimen of ABT-450/r-ombitasvir and dasabuvir with ribavirin was highly effective and was associated with a low rate of treatment discontinuation. (Funded by AbbVie; SAPPHIRE-I ClinicalTrials.gov number, NCT01716585.).

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OA

 

Journal of Hepatology

 

HCV cirrhosis at the edge of decompensation: Will paritaprevir with ritonavir, ombitasvir, dasabuvir, and ribavirin solve the need for treatment?Tarik Asselah, Savino Bruno, Antonio CraxiReceived: June 13, 2014; Received in revised form: August 6, 2014; Accepted: August 9, 2014; Published Online: August 19, 2014 DOI: http://dx.doi.org/10.1016/j.jhep.2014.08.018
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Mayo Clinic on Twitter

Mayo Clinic on Twitter | Hepatitis C New Drugs Review | Scoop.it
Viral liver disease, or Hepatitis C, is the most common reason for liver transplant. #MayoClinicRadio pic.twitter.com/vSVG6f8CNG
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Microbiome: The bacterial tightrope from liver disease to cancer : Nature : Nature Publishing Group

Microbiome: The bacterial tightrope from liver disease to cancer : Nature : Nature Publishing Group | Hepatitis C New Drugs Review | Scoop.it
Imbalances in gut bacteria have been implicated in the progression from liver disease to cancer. This insight opens the way to preventive treatments.
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Krishan Maggon 's curator insight, December 4, 3:59 AM

Liver cancer almost always develops in the wake of preceding problems, such as fatty liver disease (see page S8) or viral hepatitis (see page S12). But it is not clear why some people with such problems go on to develop cancer, whereas others do not — only about 3% of cases become malignant each year. Still, “liver cancer without liver disease is very rare”, says Robert Schwabe, a gastroenterologist and liver researcher at Columbia University in New York. Schwabe, Hara and others think that certain elements in the microbiome might tip the scales towards cancer. If they are right, it could be possible to stop liver disease from turning malignant by targeting microbes in the gut.

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Multivalent N-Acetylgalactosamine-Conjugated siRNA Localizes in Hepatocytes and Elicits Robust RNAi-Mediated Gene Silencing - Journal of the American Chemical Society (ACS Publications)

Multivalent N-Acetylgalactosamine-Conjugated siRNA Localizes in Hepatocytes and Elicits Robust RNAi-Mediated Gene Silencing - Journal of the American Chemical Society (ACS Publications) | Hepatitis C New Drugs Review | Scoop.it

Conjugation of small interfering RNA (siRNA) to an asialoglycoprotein receptor ligand derived from N-acetylgalactosamine (GalNAc) facilitates targeted delivery of the siRNA to hepatocytesin vitro and in vivo. The ligands derived from GalNAc are compatible with solid-phase oligonucleotide synthesis and deprotection conditions, with synthesis yields comparable to those of standard oligonucleotides. Subcutaneous (SC) administration of siRNA–GalNAc conjugates resulted in robust RNAi-mediated gene silencing in liver. Refinement of the siRNA chemistry achieved a 5-fold improvement in efficacy over the parent design in vivo with a median effective dose (ED50) of 1 mg/kg following a single dose. This enabled the SC administration of siRNA–GalNAc conjugates at therapeutically relevant doses and, importantly, at dose volumes of ≤1 mL. Chronic weekly dosing resulted in sustained dose-dependent gene silencing for over 9 months with no adverse effects in rodents. The optimally chemically modified siRNA–GalNAc conjugates are hepatotropic and long-acting and have the potential to treat a wide range of diseases involving liver-expressed genes.

Krishan Maggon 's insight:

J. Am. Chem. Soc., Article ASAPDOI: 10.1021/ja505986aPublication Date (Web): December 1, 2014Copyright © 2014 American Chemical Societyrajeevk@alnylam.com, mmanoharan@alnylam.com

 

GalNAc-siRNA conjugates are a clinically validated, proprietary Alnylam delivery platform and are designed to achieve targeted delivery of RNA therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor (ASGPR). This targeted delivery platform enables specific, potent and durable knockdown of hepatocyte-expressed disease genes with subcutaneous dosing and a wide therapeutic index. GalNAc-conjugates have emerged as a promising strategy for the delivery of RNA therapeutics in advanced pre-clinical and initial clinical studies.

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Hepatitis C Quiz: Myths and Facts -- Who Can Get It, How It's Treated

Hepatitis C Quiz: Myths and Facts -- Who Can Get It, How It's Treated | Hepatitis C New Drugs Review | Scoop.it
Hepatitis C prevention, treatment, and symptoms. Take this WebMD quiz to find out what you know.
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Target HIV Medicines | Medicines Patent Pool

Target HIV Medicines | Medicines Patent Pool | Hepatitis C New Drugs Review | Scoop.it

The Medicines Patent Pool focuses on increasing access to HIV medicines. Target medicines include those that exist but are either too expensive because of a lack of competition or are not adapted to the specific needs of resource-limited settings (e.g. medicines for children). They also include those that exist, but for which fixed-dose combinations have not yet been developed, drugs that are not yet available on the market, or those that are still under development.

 

The HIV medicines currently targeted for inclusion in the Medicines Patent Pool are chosen based on ongoing consultation with a wide variety of HIV experts. A working paper explaining the rationale for choosing these medicines is available here. The working paper is a living document currently in its third edition. Comments are both welcome and encouraged.


The second edition was released in November 2012, and is available here [pdf]; the first edition was released September 2011 and is available here [pdf].

Work is constantly on-going to revise the list of priority products for inclusion in the Medicines Patent Pool, as the field for HIV medicines changes constantly and new products are being developed and as more information is gathered about what is patented and where. The priority list will be updated on the basis of the latest scientific knowledge.

Current target products and formulations:

The MPP decides on target medicines based on two criteria: the medicine’s clinical importance (determined with the aid of medical and public health experts) and the existence of market and/or patent barriers that might prevent access to it. Each drug gets a ranking within each criterion of high, medium, or low.

 

 

 

 

The table above is based on the MPP’s ARV Priority List [pdf]. Earlier proposed lists of priority essential medicines for HIV as developed by UNITAID and the WHO are listed in “The Selection and Use of Essential Medicines.” More information on the list of priority missing essential medicines for HIV developed by UNITAID and the WHO, please read “UNITAID and WHO Secretariat proposal: the priority missing essential medicines for HIV.”

 

The Medicines Patent Pool on 18 February 2011 submitted a joint document with UNITAID and the WHO HIV/AIDS Department to the WHO Expert Committee on the Selection and Use of Essential Medicines. This document, available here [pdf], revises the list of missing antiretroviral formulations needed to treat adults and children living with HIV. It was reviewed at the 21-25 March meeting of the Expert Committee, and the evidence was incorporated into the ARV Priority List released in September 2011.

Krishan Maggon 's insight:

The mission of the WHO Medicine Patent Pool should be extended to include Hepatitis C, Cancer and other life saving medicines.

 

The Medicines Patent Pool (MPP) is a United Nations-backed organisation that aims to improve access to appropriate, affordable HIV medicines and technologies for people living with HIV in developing countries. Working in partnership with a range of stakeholders, the MPP opens the door to generic low-cost production of key HIV therapies as well as fixed-dose combinations and paediatric formulations by creating a pool of relevant patents for sub-licensing and product development.

 

Founded with support from UNITAID in 2010, to date the MPP has signed agreements with Bristol Myers-Squibb, Gilead Sciences, F. Hoffmann-La Roche, the US National Institutes of Health and ViiV Healthcare for nine antiretrovirals (ARVs) and one medicine for an HIV opportunistic infection. Ten generic manufacturers have now licensed from the MPP and are actively distributing low-cost medicines in developing countries or pursuing development plans for future introduction.

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Nonstructural Protein 5A (NS5A) and Human Replication Protein A Increase the ... - Journal of Virology

Using a rolling-circle RNA template, we have reconstituted an in vitro HCV replication system that allows us to interrogate the role of viral and host proteins in HCV replication and delineate the molecular interactions. We showed that HCV NS5A(S25-C447) and cellular replication protein A (RPA) functionally cooperate as a processivity factor to stimulate HCV replication by HCV NS5BΔ21 polymerase and NS3 helicase. This system paves the way to test other proteins and may be used as an assay for discovery of HCV inhibitors.

Krishan Maggon 's insight:
Accepted manuscript posted online 15 October 2014, doi:10.1128/JVI.01677-14                                                                J. Virol. January 2015 vol. 89no. 1 165-180Nonstructural Protein 5A (NS5A) and Human Replication Protein A Increase the Processivity of Hepatitis C Virus NS5B Polymerase Activity In VitroNagraj Mania, Alexander Yuzhakova, Olga Yuzhakova, Joyce T. Collb, Jim Blackb,Kumkum Saxenab, John R. Fulghumb, Judith A. Lippkeb, B. Govinda Raoc*,Rene Rijnbranda and Ann D. Kwonga*
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Hepatitis C Linked to Accelerated Immune Cell Differentiation

Hepatitis C Linked to Accelerated Immune Cell Differentiation | Hepatitis C New Drugs Review | Scoop.it
Hepatitis C is linked to accelerated differentiation of CD4 and CD8 cells—major building blocks of the immune system—into specific phenotypes.

 

 HCV-positive had 25 percent fewer naive CD4 cells, 33 percent more EM cells, and 37 percent fewer central memory CD8 cells when compared with those who did not have HCV. The coinfected group, however, only had one such association: a higher percentage of EM CD4 cells when compared with those monofinfected with HIV.  This particular link was restricted to individuals with fewer than 500 CD4 cells per microliter, which likely indicates a diminished immune system resulting from more advanced (and untreated) HIV disease. Additionally, among the coinfected set, the only link between hep C and higher percentages of activated CD4s and Tregs was among those with 500 or fewer CD4s.

Thus, while hep C was linked with accelerated immune cell differentiation, coinfection with HIV made the various related links less clear-cut.

Krishan Maggon 's insight:
Association of Chronic Hepatitis C Infection With T-Cell Phenotypes in HIV-Negative and HIV-Positive Women

Kuniholm, Mark H. PhD*; Xie, Xianhong PhD*; Anastos, Kathryn MD*,†; Kaplan, Robert C. PhD*; Xue, Xiaonan PhD*; Kovacs, Andrea MD‡; Peters, Marion G. MD§; Seaberg, Eric C. PhD‖; French, Audrey L. MD¶; Young, Mary A. MD#; Augenbraun, Michael MD**; Martinson, Jeffrey A. BA††; Bush, Kristin A. MS††; Landay, Alan L. PhD††,‡‡; Strickler, Howard D. MD, MPH*

 

JAIDS Journal of Acquired Immune Deficiency Syndromes:1 November 2014 - Volume 67 - Issue 3 - p 295–303doi: 10.1097/QAI.0000000000000310Clinical Science
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CA panel: Gilead's Harvoni cost-effective at $95K, but only affordable at half ... - FiercePharma

CA panel: Gilead's Harvoni cost-effective at $95K, but only affordable at half ... - FiercePharma | Hepatitis C New Drugs Review | Scoop.it
A California cost-effectiveness panel is prepared to say this about Gilead Sciences' brand-new combination treatment for hepatitis C: It's cost-effective, even at an eye-popping price. But--and this is a big but--the state can't afford to pay it.
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Gilead AbbVie Are Set To Split The $15 Billion Hepatitis C Market

Gilead  AbbVie Are Set To Split The $15 Billion Hepatitis C Market | Hepatitis C New Drugs Review | Scoop.it
A recent report by Morgan Stanley predicts a greater than 40 percent growth in the Hepatitis C (HCV) market in 2015. Projections indicate that the HCV market could be worth $15 billion in upcoming years, ...
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WIPO Seminar: For Access To Hepatitis C Treatments, Look At HIV Lessons - Intellectual Property Watch

WIPO Seminar: For Access To Hepatitis C Treatments, Look At HIV Lessons - Intellectual Property Watch | Hepatitis C New Drugs Review | Scoop.it
A seminar on innovation and access to medicine last week examined the issue of access to hepatitis C treatment, looking at the HIV/AIDS path. Voluntary licences, such as the one entered by Gilead f...
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European Medicines Agency - Find medicine - Harvoni

European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
Krishan Maggon 's insight:

Harvone  EPAR, Product summary and Risk Management plan.

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Bristol-Myers Squibb Foundation awards nine grants to support care for high-risk patients with hepatitis B and C in China and India

Bristol-Myers Squibb Foundation awards nine grants to support care for high-risk patients with hepatitis B and C in China and India | Hepatitis C New Drugs Review | Scoop.it
World Pharma News - one of the world's leading web-based pharmaceutical news publications - is committed to providing and disseminating the most prominent pharmaceutical news and achievements.
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Mean annual cost of patients hospitalized for chronic hepatitis C in France: the HEPC-LONE study

Mean annual cost of patients hospitalized for chronic hepatitis C in France: the HEPC-LONE study | Hepatitis C New Drugs Review | Scoop.it
OBJECTIVE: To assess the mean annual cost of patients hospitalized for Chronic Hepatitis C, stratified by liver disease stage. METHOD: Hospital stays with ICD-10 code of chronic viral hepatitis C (B18.2) as principal, related or significantly
Krishan Maggon 's insight:

The mean annual cost was 1100 Euro per patient in France. It was before the introduction of newer HCV antivirals combo therapies with 95-99% cure rates.

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Liver Cancer Sex differences: Luck of the chromosomes : Nature : Nature Publishing Group

Liver Cancer Sex differences: Luck of the chromosomes : Nature : Nature Publishing Group | Hepatitis C New Drugs Review | Scoop.it

A multitude of well-studied factors influence a person's susceptibility to cancer — genetic background, chemical exposure, diet and behaviour all contribute. But one factor that seems to play a major part in malignancy has received surprisingly short shrift from scientists: whether someone is male or female.

 

 

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Krishan Maggon 's curator insight, December 4, 4:06 AM

Liver cancer strikes many more men than women — finding out why could lead to new ways of preventing the disease.

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Vaccines: Taking a shot at protection Hepatitis B : Nature

Vaccines: Taking a shot at protection Hepatitis B : Nature | Hepatitis C New Drugs Review | Scoop.it

More than 240 million people worldwide are chronically infected with HBV, according to the World Health Organization, and the virus is responsible for just over half of the world's cases of liver cancer and about 30% of all cases of cirrhosis (scarring of the liver)1. Public-health officials are trying to protect future generations by vaccinating as many children as possible; they have made considerable progress, but the virus is proving to be a tricky target. Not all children are getting vaccinated, and those who are still sometimes get infected. Until those gaps can be closed, and until decades have passed and immunized children grow into adulthood, HBV will remain a major threat to public health.

 

Early vaccination is crucial in the fight against HBV, which is generally transmitted during childbirth or through dirty needles or sex. More than 90% of adults exposed to the virus clear the infection within six months, most with few or no symptoms. But the younger that someone is exposed, the greater the odds of a chronic infection.

 

The World Health Organization has recommended universal infant vaccinations against HBV since 1992. As of 2012, 183 nations routinely vaccinate infants, and 79% of children worldwide are protected.

Krishan Maggon 's insight:

A vaccine to prevent hepatitis B, the most common cause of liver cancer, has promise — and limitations.

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Sofosbuvir, a novel nucleotide analogue inhibitor for hepatitis C virus - Summers - 2014 - Journal of Pharmacy and Pharmacology - Wiley Online Library

Sofosbuvir, a novel nucleotide analogue inhibitor for hepatitis C virus - Summers - 2014 - Journal of Pharmacy and Pharmacology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Free Review Article: #Sofosbuvir, a novel nucleotide analogue inhibitor used for the treatment of #hepatitis C virus http://t.co/B68c4GsAuq

 

Sofosbuvir is a novel nucleotide analogue inhibitor of hepatitis C virus (HCV) NS5B polymerase that has recently been approved by the Federal Drug Administration for the treatment of HCV genotypes 1, 2, 3 or 4 in a variety of patients. The emergence of such a novel treatment provides benefit to previously untreated genotypes and patient populations, with little chance of promoting significant viral resistance. Excellent sustained virologic response rates 12 weeks after the end of treatment (SVR12) were seen in phase II and III clinical trials when sofosbuvir was used with ribavirin. Even more promising are the results from phase II and III clinical trials that evaluated sofosbuvir in combination with other oral direct acting antivirals (DAAs). Data with sofosbuvir in the hepatitis C virus (HCV)/HIV coinfected and in the pre- and post-transplantation populations are still emerging. The drug was very well tolerated in clinical studies, with the most common adverse events of headache, nausea and fatigue.

Summary

Overall, sofosbuvir presents a new and effective treatment option for HCV-infected patients.

Krishan Maggon 's insight:

REVIEW


Next article in issue: Small-scale twin-screw extrusion – evaluation of continuous split feeding

 

Volume 66, Issue 12
December 2014 
Pages 1653–1666


Sofosbuvir, a novel nucleotide analogue inhibitor used for the treatment of hepatitis C virusAuthorsBryant B. Summers, Joshua W. F. Beavers, Olga M. Klibanov First published: 31 August 2014Full publication historyDOI: 10.1111/jphp.12294View/save citation
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WHO | World AIDS Day 2014: Closing the gap in HIV prevention and treatment

WHO | World AIDS Day 2014: Closing the gap in HIV prevention and treatment | Hepatitis C New Drugs Review | Scoop.it
The theme for World AIDS Day 2014 - Closing the gap in HIV prevention and treatment

 

Key factsHIV continues to be a major global public health issue, having claimed more than 39 million lives so far. In 2013, 1.5 [1.4–1.7] million people died from HIV-related causes globally.There were approximately 35.0 [33.2–37.2] million people living with HIV at the end of 2013 with 2.1 [1.9–2.4] million people becoming newly infected with HIV in 2013 globally.Sub-Saharan Africa is the most affected region, with 24.7 [23.5–26.1] million people living with HIV in 2013. Also sub-Saharan Africa accounts for almost 70% of the global total of new HIV infections.HIV infection is usually diagnosed through blood tests detecting the presence or absence of HIV antibodies.There is no cure for HIV infection. However, effective treatment with antiretroviral (ARV) drugs can control the virus so that people with HIV can enjoy healthy and productive lives.In 2013, 12.9 million people living with HIV were receiving antiretroviral therapy (ART) globally, of which 11.7 million were receiving ART in low- and middle-income countries. The 11.7 million people on ART represent 36% [34–38%] of the 32.6 [30.8–34.7] million people living with HIV in low- and middle-income countries.Paediatric coverage is still lagging in low- and middle-income countries. In 2013 less than 1 in 4 children living with HIV had access to ART, compared to over 1 in 3 adults.
Krishan Maggon 's insight:
World AIDS Day - December 1 - AIDS.govwww.aids.gov › News and Events › Awareness Days AIDS.gov The 2014 theme for World AIDS Day is 'Focus, Partner, Achieve: An AIDS-free Generation.'
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FDA rejects BMS Daclatasvir NDA for Hepatitis C, issues CRL

FDA rejects BMS Daclatasvir NDA for Hepatitis C, issues CRL | Hepatitis C New Drugs Review | Scoop.it
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C (HCV).

 

The initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor. Given the withdrawal of asunaprevir by Bristol-Myers Squibb in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. Bristol-Myers Squibb is in discussions with the FDA about the scope of these data.

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Patricia Autonell's curator insight, November 30, 9:31 AM

Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area