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Hepatitis C - New Therapies Are Coming Soon: The Case To Wait
Webcast presented in a trial and jury format, which examines the "Treat Now Or Wait" scenario in patients with HCV. Listen to the judge and expert witnesses discuss new HCV regimens under development with or without ribavirin in this light-hearted innovative presentation.
Bristol-Myers Squibb’s Daklinza (daclatasvir), Approved By European Commission - for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. 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
Marijuana use in hepatitis C infection does not affect liver biopsy histology or treatment outcomes.
Marijuana use was not associated with premature interruption of therapy for side effects, the likelihood of completing a full course of therapy or sustained virological response. CONCLUSION: Marijuana use did not influence biopsy histology or alter key hard outcomes of hepatitis C virus antiviral therapy
Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection
Chronic hepatitis C and liver fibrosis
Commentary: Public Health Initiatives Needed to Combat
Cost-effectiveness of noninvasive liver fibrosis tests for treatment decisions in patients with chronic hepatitis C....... "treat all"
Achillion Hits 52-Week High After Rumors Gilead Might Buy It Out
Clinical evidence and bioinformatics characterization of potential hepatitis C virus resistance pathways for Sofosbuvir
Data suggests that Sofosbuvir (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 hepatitis C virus (HCV) infection.
Diabetes independently linked with infection, ascites risk in CHC, cirrhosis
Diabetes was an independent prognostic factor for various liver-related outcomes, including development of bacterial infection and ascites, among patients with chronic hepatitis C virus and cirrhosis, according to new study data.
HCV Weekend Reading: Fatty Liver Disease
PBAC decisions – a mixed bag for Australians living with Hepatitis C
Hepatitis Australia today welcomed the recommendation to add simeprevir (Olysio) to the Pharmaceutical Benefits Scheme (PBS) for the treatment of genotype 1 chronic hepatitis C.
Responding to the PBAC decision to reject an application to subsidise the antiviral medication sofosbuvir (Sovaldi), Ms Tyrrell said “it’s a sad day when access to game-changing therapy is denied. This is a bad outcome for people living with hepatitis C”.
Keeping an Eye on Hepatitis C Virus Drug Approvals
As researchers at Zitter, we wanted to find out how these parties would react to the expected steady, almost rhythmic approval of hepatitis C agents expected between 2014 and 2018. In January of this year, we began by surveying 100 payer representatives about their attitudes and management expectations for the category. We also surveyed 150 specialist physicians and 50 primary care doctors to gather their attitudes and reactions to the new entrants and payer decisions. Finally, we conducted interviews with a handful of practice managers at infectious disease and gastroenterology practices to get the story behind how payer policies impact treatment decisions and day-to-day operations...
Patients First: Cost–Benefit Considerations in HCV Therapy
Hello folks, with all this controversy over the high price of Gilead's Sovaldi, it was refreshing, and informative to watch a video presentation where the focus is on the HCV patient, and not only on drug cost.
Hepatitis C: Some Good News for a Change
By Lucinda K. Porter, RN
A Few Facts about Fibrosis
AASLD/IDSA mentioned the following points about fibrosis progression
Paritaprevir (ABT-450)/ombitasvir/dasabuvir- List Of Upcoming and Recruiting Clinical Trials
Verified clinical trials using AbbVie's three direct-acting antiviral oral free regimen or "3-DAA combination" consisting of boosted protease inhibitor paritaprevir (also known as ABT-450/r ), NS5A inhibitor ombitasvir (ABT-267), non-nucleoside polymerase inhibitor dasabuvir (ABT-333) with and without ribavirin for the treatment of hepatitis C, and Type 1 (HIV-1) co-infection. Trial participants will represent different stages of disease and genotype. A bit of background information on AbbVie's 3-DAA combination is included as well.
James Raftery: Sofosbuvir for hepatitis C—moving to country specific prices
Pharmaceutical companies have tended to charge a single global price, but it is based on the US market, which accounts for over half of all branded pharmaceutical sales. This might be termed the Apple strategy, in that an iPhone costs more or less the same in all countries. While this can ensure enormous profits, its application to effective drugs is often seen as unethical.
The Risky Business of Limiting Medicaid Access to Sovaldi The goal is to restrict Sovaldi to people who already have severe liver damage, which opponents argue is too late. Among the states limiting Sovaldi are California, Florida, Louisiana and Oregon, which typically have larger Medicaid populations and more patients with hepatitis C....
HIV and Hepatitis C Risk in Pregnancy and Newborns
There are questions prospective foster and adoptive parents must ask.
Published on August 19, 2014 by Ira J. Chasnoff, M.D. in Aristotle's Child
Although HIV screening is fairly common during pregnancy, there are many instances in which it is not performed. In addition, Hepatitis C rates are burgeoning in the drug and alcohol using populations, and it is relatively rare that the pregnant woman has been tested for this. Many adoption agencies with which I have had the opportunity to work are now testing all newborns under their supervision for both HIV and Hepatitis C. However, potential foster and adoptive families need to ask a lot of questions before they make a long-term commitment to a new baby.
Screening for Hepatocellular Carcinoma in Chronic Liver Disease: A Systematic Review Screening for Hepatocellular Carcinoma in Chronic Liver Disease
We conducted a systematic review of the published literature to better understand the incremental benefits and harms of routine HCC screening compared with clinical diagnosis.
Statin Use is Associated with a Reduced Risk of Fibrosis Progression in Chronic Hepatitis C
Treating HCV- Learning The Basics
Happy Tuesday folks, hope you all had a great weekend. Since a new week is just beginning why not try something new by using an online learning activity to gain additional knowledge about HCV?
Hepatitis C - 40% Surveyed Specialists Expect to Prescribe Gilead's Sofosbuvir/Ledipasvir Regimen
Decision Resources Group finds that, for the treatment of hepatitis C virus (HCV) infections, 40 percent of surveyed HCV treating specialists expect to prescribe Gilead's investigational fixed-dose combination of sofosbuvir/ledipasvir in the next six months to their genotype 1 patients.
Under the radar: the silent grip of Hepatitis C
Many people living with the disease often don’t know they have it until it damages their liver
How Do NS5A Inhibitors Prevent HCV Replication?
NS5A inhibitors are likely to become an important component of hepatitis C treatment regimens, yet their exact mechanism of action are unclear. NS5A has no known enzymatic activity and no cellular orthologs or viral homologs, other than NS5A proteins of other hepaciviruses. However, NS5A functions in multiple aspects of the HCV life cycle.
Hepatitis C investigation ongoing
The monthslong investigation into possible hepatitis C exposure at PeaceHealth Southwest Medical Center is still underway, and hospital officials say they don't have a timeline for its completion.
Getting Dental Work with Hepatitis C and Cirrhosis
Emergent HCV epidemic among young, non-urban people who inject drugs in the United States
Broader organ sharing won't harm liver transplant recipients
New research shows that broader sharing of deceased donor livers will not significantly increase cold ischemia time (CIT) - the time the liver is in a cooled state outside the donor suggesting that this is not a barrier to broader sharing of organs. However, findings published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, do indicate that broader sharing of organs will significantly increase the percentage of donor organs that are transported by flying rather than driving.
Who Gets First Dibs On Transplanted Liver? Rules May Change
Healthcare affordability: The US-led TPP comes with strings attached for Vietnam
Vietnam faces a huge epidemic of HIV and hepatitis C due to injecting drug use. A number of new drugs for hepatitis C are patented and are exceedingly expensive – up to $80,000 per treatment.
As early as 2005, the UN estimated 8.2 percent of deaths in Vietnam are cancer related, and there are 1.5 million new cases every year. However, only 3 percent of the pharmaceutical market account for cancer medicines according to Oxfam. What happens to the rest? How do they afford the treatment?
Truckers Rolling Against Hepatitis C Launches at GATS This Week
Updated - Debunking the Myths of Treating Hepatitis C
ABT-450/ritonavir/ombitasvir/dasabuvir with and without ribavirin
Interferon-free regimens yield 96%-100% SVRs
Their findings show that 12 weeks of combined oral ABT-450/ritonavir/ombitasvir/dasabuvir therapy without ribavirin is at least as effective as interferon-containing regimens, and it produces significantly fewer and less severe adverse effects, the investigators said
Liver Health, Coffee and Genotype 3
Welcome to this edition of weekend reading, today the topic is hepatitis C and liver health.
Impact of Coffee on Liver Diseases A Systematic Review
This extensive new review examines the association of coffee consumption with liver diseases, such as cirrhosis, hepatitis, and fatty liver disease. What's the verdict?
UK Recommends Covering Sovaldi Hepatitis C Pill
After reviewing the data, though, NICE agrees that Sovaldi is an effective improvement over existing treatments. The Gilead drug, by the way, can cure nine of 10 patients. The decision was likely helped by the lower price tag in the U.K. Gilead is selling its drug for about $56,000, according to a NICE spokesman. “It’s a lot cheaper here,” he tells us.
Gilead says wins favorable ruling on hep C drug Sovaldi
Aug 15 (Reuters) - Gilead Sciences Inc said an arbitration panel has ruled in its favor, rejecting patent infringement claims from Roche Holding AG, related to Gilead's hepatitis C drug, Sovaldi.
Achillion's hepatitis C drug shows promise in trial
The mid-stage trial tested Achillion's drug, ACH-3102, in 12 patients in combination with Gilead Sciences Inc's Sovaldi, also known as sofosbuvir. Achievement of 100 percent cure rate confirms the competitive profile of NS5A, Wells Fargo Securities analyst Brian Abrahams wrote in a note.
August Hepatitis Newsletters;The good, the bad and the ugly of the new treatments for hepatitis C virus
PegLambda Discontinued by BMS
We have decided to discontinue the Lambda HCV development program and will no longer be seeking regulatory review of Lambda, globally. We would like to take this opportunity to reinforce that our late-stage HCV DAA development program remains unaffected.
Vertex to stop selling hepatitis C drug Incivek
Incivek was approved by US and European regulators in 2011 and enjoyed what, at the time, was one of the fastest drug launches ever. More than 100,000 people globally have taken it over the past three years. But new and better treatments for hepatitis C -- especially the hugely successful pill Sovaldi -- have virtually wiped out sales of Incivek. Vertex’s decision to stop selling Incivek in the United States as of Oct. 16 was conveyed in a Monday letter to health care providers written by Charles Johnson, the company’s vice president of global medical affairs.
Researchers Develop Model To Test New Hepatitis B Treatments
Next-generation sequencing sheds light on the natural history of hepatitis C infection in patients who fail treatment
AASLD/IDSA New Section: When and In Whom to Initiate Hepatitis C Therapy
Efficacy of Nitazoxanide in the Treatment of HCV Geno 4
Liver International, August 8, 2014
Video Weekend: Hepatitis C - Understanding The Liver, and Cirrhosis
Preventing Mortality in Patients With Cirrhosis and HCV Journal of Viral Hepatitis, July 31, 2014
High HCV Response Rates With Daclatasvir/Asunaprevir: Phase III Data
Ledipasvir-sofosbuvir (fixed dose)
"Hepatitis C Online" a free educational web site from the University of Washington, has published an update that addresses the fixed dose combination of ledipasvir (90mg)-sofosbuvir (400 mg) for the treatment of chronic hepatitis C.
View a slide presentation, clinical trial data, summary and references, begin here....
Solving Sovaldi: David Harlow Talks Value-Based Payment with Cyndy Nayer
Enanta Advances Into Combination Studies with Alisporivir (DEB025)
How Can We Tell if Patients are Still at Risk for HCC after HCV Therapy?
AbbVie begins 'first-of-its-kind' hep C charity pilot
New Hepatitis-C drug Sovaldi 99% cheaper in India
FDA - Faster, Easier Cures for Hepatitis C
U.S. hepatitis C burden may ease in coming decades: study
New FDA process speeds approval of high-priced breakthrough drugs
This Issue Of HCV Next -Treat Now or Wait, Millennials, Drugs and HCV
HALLMARK, COSMOS: New HCV regimens show high cure rates
15 hepatitis C patients die of drug’s side effects
Fifteen hepatitis C patients who were prescribed a drug manufactured by Mitsubishi Tanabe Pharma Corp. have died after developing serious side effects such as liver failure and whole-body dermatitis, according to the drug company and other sources.
Gilead's Sovaldi prescribed more than all other hepatitis C drugs combined
Hepatitis C Could Become Rare Disease in 20 Years: Study
Podcast August 2014: Evolution of Hepatitis C Virus Treatment
An editorial in the August issue of CGH discusses changing treatment methods for Hepatitis C Virus infection over the last several years.
What Will the new Hepatitis C Medicines do to Medicare Part D?
HCV Advocate's own Alan Franciscus will host a; Hepatitis C Training Workshop in Cleveland, OH on September 25, 2014.
FREE WEBINAR: Scaling Up Risk Based Hepatitis C Screening in the US
Project Inform will host the upcoming webinar: Scaling Up Risk Based Hepatitis C Screening in the US, presented by Andrew Reynolds, Hepatitis C Education Manager for Project Inform. Wednesday July 23, 2014 10:00–11:00am EDT
Simeprevir, Sofosbuvir, and the Limitations of the COSMOS
These are exciting times for hepatitis C treatment, as the approval of simeprevir and sofosbuvir in late 2013 have made curing this disease a whole lot easier.
2014 Hepatitis Newsletters
HCV News Digest
2014: July - January
2013 : HCV News Digest
HCV Advocate's own Alan Franciscus will host a; Hepatitis C Training Workshop in Cleveland, OH on September 25, 2014.
Cost - Sovaldi (sofosbuvir)
Updated - Aug 23
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to current information and controversy over the high price of Sovaldi.
Bristol-Myers Squibb’s Daklinza (daclatasvir), Approved By European Commission
June 13 2014
U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C
The AbbVie investigational regimen consists of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without RBV. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.
April 7 2014
Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination
U.S. Food and Drug Administration (FDA) has granted priority review to the company's New Drug Application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014. Feb/Gilead Files for U.S. Approval:Ledipasvir/Sofosbuvir Fixed-Dose Combo For Genotype 1 Hepatitis C
European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir
Advances in the Treatment of Hepatitis C
Sofosbuvir/Ledipasvir based regimens
Sofosbuvir-ledipasvir alone or with ribavirin
December 2013; Gilead Announces SVR12 Rates From Three Phase 3 Studies Evaluating a Once-Daily Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients
2013 - Two New Oral Drugs To Treat Hepatitis C Approved
The U.S. Food and Drug Administration approved two new oral drugs in 2013 to treat the hepatitis C virus. Johnson & Johnson's protease inhibitor Simeprevir is approved for the treatment of genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin. The second drug is Solvadi (sofosbuvir) a polymerase inhibitor approved for people with genotypes 1 and 4, in combination with interferon and ribavirin and for people with genotypes 2 and 3 with ribavirin alone, making it the first interferon free combination approved to treat HCV. Overall cure rates are at 80%, response rates and treatment duration varies, depending on genotype, viral and host factors.
April 2014 - Watch-Recent FDA approval of sofosbuvir and simeprevir- Implications for current HCV treatment
Will Sofosbuvir and/or Simeprevir Replace the Previous Generation of Antiviral Agents?
Preparing for the uncertain yet inevitable: Off-label combinations of antiviral agents in hepatitis C virus
This article will address anticipated issues regarding off-label use of HCV medications, including the role of the U.S. Food and Drug Administration (FDA), consumer pressure, medical society guidelines, and third-party payers.
Prescribing information, financial assistance, research articles and important updates
Prescribing and patient information, research and news
Chronic hepatitis C: Treat or wait?
A collection of news articles and research weighing the risks and benefits of treating HCV now vs waiting for future therapies.
Clinical Trial Updates
ClinicalTrials.gov:updated in the last 30 days
To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
Everything You Need To Know Before Starting Treatment
Lucinda K. Porter, RN the author of "Free from Hepatitis C"
new book "Hepatitis C Treatment One Step at a Time" is now available on Amazon
Need To Talk To Someone ?
Help is available, recently "Project Inform" announced the launch of a new national helpline, 877-HELP-4-HEP (877-435-7443), run by and for people affected by hepatitis C.
The helpline operates Monday through Friday 9am to 7pm EST. To learn more, visit www.help4hep.org