News Of The Day
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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
Hello everyone, as mentioned in this month of updates the website and blog will not be updated for the next few weeks while I am away on vacation.
July Newsletters: 5 Things to Know About Hepatitis C, 2014 Drug Guide, and More...
Check out this months edition of Hepatitis Newsletters, a rewind of hot topics and a bit of July's relevant news.
Validation of the fatigue severity scale in chronic hepatitis C
Fatigue is a common symptom of chronic hepatitis C virus (cHCV) infection and a common side effect of interferon-based treatment for cHCV. This study provides confirmatory evidence of the reliability and validity of the Fatigue Severity Scale (FSS) to document fatigue in cHCV research and identifies values that indicate clinically important differences in FSS to aid in interpreting fatigue in cHCV clinical trials.
Low vitamin D levels increased risk for advanced liver fibrosis, decreased SVR rate among patients with HCV Risks for advanced liver fibrosis and odds for achieving sustained virologic response were affected by vitamin D levels in patients with hepatitis C virus who were taking pegylated interferon-alfa with ribavirin in a recent study.
Transmission of hepatitis C virus following antiviral treatment - Millions of people throughout the world are infected with hepatitis C virus (HCV). Left untreated, infection results in serious complications such as cirrhosis of the liver and cancer. Many HCV-infected patients respond well to anti-viral therapy and remain virus free. However, trace amounts of HCV RNA are sporadically detected in patients thought to have successfully responded to HCV treatment.
This study demonstrates that small amounts of HCV RNA in successfully treated patients can be infectious, but these transmission events may be hard to detect due to delayed onset of disease.....
The American Association for the Study of Liver Diseases announces the release of a new practice guideline on the Evaluation of the Pediatric Patient for Liver Transplantation.
The purpose of this new guideline is to provide an evidence-based set of recommendations for the evaluation of pediatric patients who are potentially candidates for liver transplantation.
FDA Scolds Gilead Over a Paid Search Link
Last month, the FDA took a much-anticipated step by issuing guidelines for drug makers that want to use social media, including examples of how to run paid search links on Google.
Long term changes in liver histology following treatment of chronic hepatitis C virus
Good morning folks, another fun packed research article awaits you, this time by liver specialist Mitchell L. Shiffman, MD., exploring improvements in inflammation as well as fibrosis regression following SVR.
Misclassified fibrosis stages common among patients with chronic HCV
Multiple serum biomarkers, measured by various methods, revealed high misclassification rates when determining fibrosis stage accuracy among patients with chronic hepatitis C virus, according to study results.
Hepatitis C - We all pay for $1,000 a pill drug
Japan Approves HCV Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.
Weekend Reading: HCV Case Study: HCV Therapy for a Prior Partial Responder with Genotype-1 HCV Infection
If you have the time for some Weekend Reading, check out this short activity which looks at treatment options for a 55 year old female, with HCV genotype 1a, partial responder, presented by Projects In Knowledge.
Alcoholic Liver Disease Information and Its Complications
This video, produced by Dr. Joseph Galati and Liver Specialists of Texas, reviewed basic information about the effects of alcohol on the liver, and all of the associated complications. These complications include alcoholic fatty liver, alcoholic hepatitis, and alcoholic cirrhosis. Other more severe complications include the development of ascites, hepatic encephalopathy, neurologic damage, neuropathy, heart damage, and liver cancer (hepatoma).
Dietary Supplements—A Poorly Regulated Danger
Study Begins To Define How Long HCV Patients May Need Treatment
“Our findings begin to define for how long patients may need to be treated in order to achieve viral eradication,” says Talal, professor of medicine in the Division of Gastroenterology, Hepatology and Nutrition.
Ending hepatitis C in the United States: The role of screening
A new article on the role of screening hepatitis C has been published in Hepatitic Medicine: Evidence and Research, co-authored by Andrew Reynolds, Project Inform’s Hepatitis C Education Manage..
Webinar: Ageing with Chronic Hepatitis C
Incidence and Management of Rash in Telaprevir-Treated Patients: Lessons for Simeprevir?
Telaprevir-induced rash is a common, therapy-limiting adverse drug event (ADE) for patients with hepatitis c virus (HCV) infection. Given the similarity between telaprevir and simeprevir, real-world management of rash during treatment with an NS3/4A protease inhibitor and its implications are important.
Canada's public drug plans ranked from best to worst
The institute looked at how long patients must wait for new drugs to be funded by Canada's public drug programs, using information from Health Canada, and IMS Brogan spanning from January 1, 2004 to December 1, 2013. Apparently, Quebec appeared to have the best access to new drugs, timely reimbursement, and best coverage rates.
Challenges to the development of vaccines to hepatitis C virus that elicit neutralizing antibodies
Despite 20 years of research, a vaccine to prevent hepatitis C virus (HCV) infection has not been developed. A vaccine to prevent HCV will need to induce broadly reactive immunity able to prevent infection by the 7 genetically and antigenically distinct genotypes circulating world-wide
Cannabis Not Used to Develop Hepatitis C Vaccine or Suppositories
It seems like there’s another over-the-top headline about cannabis every other day, from studies proclaiming it is, in fact, dangerous, to those that claim cannabis can cure just about everything....
Merck, Gilead Lead Race To Eradicate Hepatitis C
Even if you're not a biotech or pharma investor, you've probably caught an earful of news lately about the virus called hepatitis C.
Screening for Hepatitis B Virus Infection in Nonpregnant Adolescents and Adults:
U.S. Preventive Services Task Force Recommendation Statement Screening for Hepatitis B Virus Infection
Update of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for hepatitis B virus (HBV) infection
Australia New Zealand - TGA approves Gilead's Sovaldi®
Gilead Sciences, Australia New Zealand, today announced that the Therapeutic Goods Administration (TGA) has approved Sovaldi® (sofosbuvir), a new direct acting antiviral treatment, for the treatment of chronic hepatitis C (CHC) infection in adults as a component of a combination antiviral treatment regimen.
Less than 10 percent of People Infected with Hepatitis C are Cured
“There are many people who don’t know that they have the infection, don’t have access to hepatitis C care and medications, and who haven’t been treated. With this data, we can see these gaps more clearly. This information will be useful for ensuring better access to hepatitis c care and treatment in the coming years.”
Treating Hepatitis C in Patients With a Diagnosis of Schizophrenia
What special considerations should be taken into account in the treatment of patients with hepatitis C who also have been diagnosed with schizophrenia?
Anesthesia for Patients With Liver Disease
Despite the fact that anesthesia in chronic liver disease is a scary and pretty challenging condition for every anesthesiologist, this hazard could be diminished by meticulous attention on optimizing the patient’s condition preoperatively and choosing appropriate anesthetic regimen and drugs in this setting.
Safety and Efficacy of Telaprevir for Advanced HCV
Gut, July 3, 2014
In compensated patients with advanced fibrosis due to hepatitis C genotype 1, how effective is triple therapy with telaprevir?
Only 25 minutes of mindfulness meditation alleviates stress
PITTSBURGH—Mindfulness meditation has become an increasingly popular way for people to improve their mental and physical health, yet most research supporting its benefits has focused on lengthy, weeks-long training programs.
Liver Cancer Drug Fails to Live Up to Early Promise
Although it looked promising in early studies, the drug everolimus didn't improve survival for people with advanced liver cancer in its latest trial, a new study found.
Persistent Infection Causes Hepatitis in Lyme Disease,
A new study suggests that persistent infection may cause hepatitis (inflammation of the liver) in Lyme disease. The study was published in the online journal
Research Open Access.
Predicting the outcome of hepatitis C virus treatment
Open Access - Full Text Available here
Millions of people throughout the world are infected with hepatitis C virus (HCV), which can lead to cirrhosis of the liver and cancer. Directly acting antiviral agents inhibit viral proteins and have been used to successfully treat HCV. Unfortunately, antiviral therapy fails in some patients, resulting in a relapse of HCV. A study published in the Journal of Clinical Investigation identifies a marker that can identify patients likely to have an HCV relapse after antiviral therapy.
Serum Carnitine Level and Its Associated Factors in Patients With Chronic Viral Hepatitis
Dual Antiviral Treatment:Treating HCV-Associated Cryoglobulinemic Vasculitis
Dual antiviral therapy seems more effective than standard immunosuppression or rituximab only at treating cryoglobulinemic vasculitis associated with hepatitis C virus (HCV) infection, researchers from Russia report.
HCV July News: Noninvasive tests used to measure liver fibrosis
Proper Diet Is Critical for Patients with Liver Disease
For patients struggling with liver disease, diet can become a matter of life and death. Dr. Juan Gallegos talks about how daily food choices can impact the diseased liver. He also gives some tips for improving diet and prolonging the lives of patients with liver disease.
Genotype 1 HCV–Infected Cirrhotic Patients: Still Hard to Treat?
After years of telling our patients that better HCV treatments are coming soon, we finally have access to potent, safe, oral direct-acting antivirals (DAAs) in our clinics and we expect more oral DAA regimens to be approved over the next 18 months. As clinicians, the ability to offer the opportunity for HCV cure to our patients with the greatest medical need—those with cirrhosis—is truly great news.
Common Herbal Supplement Can Cause Dangerous Interactions with Prescription Drugs
Researchers at Wake Forest Baptist Medical Center reported ‘natural’ treatments like St. John’s wort can interact with other medications reducing effectiveness and cause treatment failure.
As a side note, according to SOVALDI's packet insert St. John’s wort also has the potential to interact with our newly approved HCV drug SOVALDI.
Medscape Blog-"Chief Complaint" Inhaled Insulin for Diabetics
Be on the lookout in the ED for patients taking a new, rapidly-acting inhalable form of insulin powder. Known as Afrezza, it was approved by the FDA last week for treating types 1 and 2 diabetes. In those with Type 1 Diabetes, Afrezza is taken with meals and is used as a supplement to long-acting insulin. Afrezza comes in cartridges of 4 and 8 units.
HCV DAA Drugs' Discounts
Oral Diseases Associated With hepatitis C
Hepatitis C virus can be frequently associated with potentially malignant and malignant oral diseases and could be a triggering factor of some of those disorders or at least influence their outcome. The association is very robust for oral lichen planus, while for Sjogren’syndrome it is strongly suspected and in oral squamous cell carcinoma indicated by recent large epidemiological data
Future Therapies for HCV: The Importance of New Treatment Paradigms and Interferon-free Regimens
Watch a documentary "BAD BLOOD" exploring the high cost of HCV treatment in the UK, read a bit of news, or sit back and watch a two-part learning activity released last month by ViralEd.
New all-oral HCV therapies for genotype 1: A final good-bye to interferon
There are several other IFN-free regimens in the pipeline. The furthest along involves a combination of asunaprevir, daclatasvir, and BMS-791325 a nonnucleoside polymerase inhibitor. In a phase 2b trial of 166 treatment naive patients including 9% with cirrhosis, SVR rates were 92% and 92% in the groups that received low-dose or high-dose BMS-791325.....
EU smiles on a key cog in Bristol-Myers' hep C combo
(CHMP) has recommended granting a marketing authorisation for Daklinza (daclatasvir) in combination with other medicines for the treatment of chronic (long-term) hepatitis C virus (HCV) infection in adults
Hepatitis C-Gilead Submits NDA to Japan for Sofosbuvir
2014 Hepatitis Newsletters
HCV News Digest
2014: June - 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 - Solvadi (sofosbuvir)
Updated - July 11
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 Solvadi.
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