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Putting an end to global health's 'silent killer'
The most notable advances in the field of hepatitis are in the area of treatment. Recently developed medicines can cure most people with hepatitis C and can control hepatitis B infection. People who receive these medicines are much less likely to die from liver cancer and cirrhosis and much less likely to transmit the virus to others.
World Hepatitis Summit harnesses global momentum to eliminate viral hepatitis
Around 400 million people are currently living with viral hepatitis, and the disease claims an estimated 1.45 million lives each year, making it one of the world’s leading causes of death. Hepatitis B and C together cause approximately 80% of all liver cancer deaths, yet most people living with chronic viral hepatitis are unaware of their infection.
HCV Advocate September Newsletter
♦ HEPATITIS C in CHILDREN
♦ HEALTHWISE: Big Questions about Hepatitis C
♦ CONSUMER REPORTS BEST BUY DRUGS BOOKLET
HCV Advocate Eblast: September 1, 2015
Attention: There are many insurance companies that are denying coverage of HCV medications to only the sickest of patients. I am working on a brief …
What Controls Liver Size?
Most people know that liver can regenerate, but how does it know when to stop growing?
5 Key Things to Know About Data on Adverse Effects
An adverse event is not necessarily an adverse effect.
A side effect isn’t necessarily a bad thing. An unexpected side effect of taking aspirin, for example, turned out to be..
Ledipasvir-sofosbuvir plus ribavirin in advanced HCV does well
Key clinical point: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks achieved high SVR rates among patients with hepatitis C virus infection and advanced liver disease.
Meta-analysis- SVR and its Treatment Predictors in HCV Genotype 4 Compared to Genotypes 1, 2, and 3
Does treatment with pegylated interferon and ribavirin bring about sustained virological response in HCV genotype 4 as compared to genotypes 1, 2, and 3?
Hepatitis C screening push focuses on boomers, IV drug users
For example, Medicaid requires a patient to be diagnosed with late-stage cirrhosis or liver scarring. "I think it's a great push and I do think the primary care doctors should be testing, but the question is going to be are the state and the insurance ...
Costly Hepatitis C Drugs for Everyone?
New drugs to treat hepatitis C are tremendously effective - and tremendously costly - raising fears that the high prices might outstrip the ability of public and private insurers to pay.
Probiotics before liver transplantation reduces infections
Patients receiving prebiotics and probiotics before liver transplantation develop fewer infections than controls, reports September's issue of the Clinical Gastroenterology & Hepatology.
Articles in Press - Liver Toxicity Associated with Sofosbuvir, an NS5A Inhibitor and Ribavirin Use
Hepatitis C responsible for more liver damage than estimated
If you have been wondering about the recent spike in medications that can cure the silent killer, hepatitis C, you might find the answer in a recent study that was published in this month’s issue of The American Journal of Gastroenterology
Patients With Renal Disease: One of the Remaining Challenges in HCV Therapy
Nancy Reau MD - 8/25/2015
A recent patient discussion highlighted important questions about how to approach HCV infection in renal disease.
TGIF HCV Rewind: A Week In Review With A Spotlight On Don Crocock and Greg Jefferys
Here is a look back at this weeks HCV headlines, research and updates from around the web.
Health ministry approves new hepatitis C drug under insurance scheme
A health ministry panel has added a new highly effective, but expensive, hepatitis C virus drug to the national health insurance scheme, giving high hopes for patients who have had to endure painful interferon injections.
Cytokines influence impaired cognitive function in children with HCV
“Chronic HCV infection may cause many extrahepatic manifestations, one of which affects the central nervous system,” the researchers wrote.
A new virus in liver cancer
More than a cause of a simple infection, viruses are often involved in the development of serious diseases. Such is the case with liver cancer, which often develops in an organ that has been weakened by hepatitis B or C virus. Researchers at Inserm, the Paris Public Hospitals (AP-HP), Paris Descartes University, Paris 13 University (USPC), and Paris Diderot University have just identified the role of a new virus, hitherto unsuspected, in the occurrence of a rare type of liver cancer.
Seattle Children’s Bellevue clinic warns of potential infection risk
Hospital staff are sending out warnings to patients and their families and asking the patients to come in for blood tests for diseases, including hepatitis B and C and HIV.
One in Four Hepatitis C Patients Denied Initial Approval for Drug Treatment
Fatty Liver and Diabetes Increase Liver Fibrosis Risk
Wider Reach Is Sought for Costly New Hepatitis C Treatments
WASHINGTON — Federal and state Medicaid officials should widen access to prescription drugs that could cure tens of thousands of people with hepatitis C, including medications that can cost up to $1,000 a pill, health care experts have told the White House.
Hepatitis C treatment: Back to the warehouse
Like many physicians that specialize in hepatitis C virus (HCV) treatment, I have spent the last few years advising many of my patients with chronic HCV infection to defer treatment and wait for new therapies. For those without advanced fibrosis or an extraintestinal manifestation of HCV, this process of “warehousing” patients for future HCV treatment made perfect sense.
Interferon-free regimens for the treatment of hepatitis C virus in liver transplant candidates or recipients
The purpose of this review is to summarize the recent findings concerning the use of the new IFN-free regimens in LT candidates or recipients with CHC.
HCV Treatment: What Can I Do Now? What's Coming Next?
The development of direct-acting antivirals represents a significant improvement in HCV treatment. New combinations of drugs have led to improved response rates, even in patients with characteristics previously associated with having lower response rates: African American, high viral load, concomitant cirrhosis, infection with genotype 1a, and failed treatment with other anti-HCV drugs.
Surprising Updates to the HCV Guidelines
off-label recommendations for daclatasvir.
LT recipient characteristics predict worse outcomes after transplant
In a retrospective cohort study, researchers in Brazil found that liver transplant recipient characteristics have a greater impact on patient outcomes compared with donor characteristics, according to study data.
Researchers find survival increased over time for patients with cirrhosis admitted to ICU
In a retrospective study, researchers found that survival in patients with cirrhosis following admission to an intensive care unit increased over the last decade, and sequential organ failure assessment and chronic liver failure-sequential organ failure assessment scores were similar in predicting patient survival, according to published findings.
Hepatitis C finally given approval in United Kingdom after 'inexcusable wait'
It comes as wonderful news for untold thousands of Hepatitis C sufferers, albeit one that came after an "Inexcusable wait.
Cure Hep C and You May See Your Liver Health Improve
Among those coinfected with HIV, a cure for hepatitis C virus (HCV) is linked with improvements in liver stiffness, even if they have cirrhosis, aidsmap reports. Publishing their findings in the journal AIDS, researchers studied 98 HIV/HCV-coinfected individuals who had taken at least one dose of hep C therapy.
Potential Need For Repeat Hepatitis C Testing
AASLD/IDSA Update - HCV guidance for Cost, Reimbursement and Cost-Effectiveness Considerations
An update to the HCV guidance for Cost, Reimbursement and Cost-Effectiveness Considerations.
Drug which cures hepatitis C given the go-ahead by NHS
A cure for the deadly hepatitis C virus has finally been granted NHS funding after ‘an inexcusable wait’ that has seen patients with the disease fall ill unnecessarily, say campaigners.
Significant Rise in Organic Food Recalls Due to Bacterial Contamination
Recalls have been driven by bacterial contamination, like salmonella, listeria, hepatitis A
Coffee consumption reduces the risk of gallstone disease
The latest issue of the Alimentary Pharmacology & Therapeutics investigates the association and dose–response of coffee consumption with gallstone disease.
Landmark Developments in Pediatrics: 1995-2015
Which landmarks in pediatrics over the past 20 years made our list?
Medicine in India: Rampant Quackery, Baffling Drug LandscapeFirst of a two-part series
Health Canada approves DAKLINZA™ (daclatasvir) for the treatment of chronic Hepatitis C infection across multiple genotypes including genotype 3
MONTREAL, Aug. 20, 2015 /CNW/ - Health Canada has granted the Bristol-Myers Squibb Canada medication DAKLINZATM(daclatasvir) approval for the treatment of chronic hepatitis C (CHC) infection. The approval includes a Notice of Compliance (NOC) for the treatment of adult patients with hepatitis C genotypes 1 and 2 with compensated liver disease including cirrhosis and a Notice of Compliance with conditions (NOC/c) for the treatment of genotype 3 patients with compensated liver disease including cirrhosis, offering Canadian physicians a new option to cure* these patients. When left untreated, HCV infection, can lead to serious liver disease and failure.
Health Canada approves Daklinza for HCV
The approval includes a Notice of Compliance (NOC) for genotypes 1 and 2 with compensated liver disease and cirrhosis and a NOC with conditions (NOC/c) for genotype 3 with compensated liver disease and cirrhosis. The NOC/c was issued based on final ...
HCV: The Best Cure Possible or the Best Possible Cure?
Is a regimen combining interferon (IFN) with a highly effective direct-acting antiviral agents (DAA) still an acceptable choice in 2015? The ultimate goal for society as a whole is to obtain what is best for each individual, but in doing so, it should aim not towards the best possible cure, but the best cure possible.
Bad News for Hepatitis C Patients: Your Treatment Costs May Be Higher Than Expected
The scary news for hepatitis C patients is that the cost of their treatments could rise even further if a new study released from the Henry Ford Health System and CDC is correct.
Liver Biopsies Miss 75 % of Hep C-Related Cirrhosis Cases
Relying solely on a liver biopsy to diagnose cirrhosis among people with hepatitis C virus (HCV) likely misses three in four cases of the advanced stage of liver disease, Reuters reports.
“Cowboy Doctors” and Health Costs
WHO’S DRIVING UP U.S. healthcare costs? A recent study by Harvard professors and colleagues revealed that the culprits may be “cowboy doctors”—physicians who provide intensive, unnecessary, and often ineffective patient care, resulting in wasteful spending costing as much as 2 percent of the nation’s Gross Domestic Product—hundreds of billions of dollars annually.
Vital Therapies crashes after liver therapy fails trial
Hepatitis C sufferer imports life-saving drugs from India, takes on global pharmaceutical company
It is straight from the script of Hollywood movie Dallas Buyers Club — an Australian hepatitis C sufferer has taken on a global pharmaceutical company, accusing them of failing to provide a life-saving medication at an affordable cost.
How to pay the bill for hepatitis C
In July the California Department of Health Care Services ordered a new protocol that will mean many thousands of Medi-Cal patients will have to wait for treatment. But far from jeopardizing lives, the department is helping to lead the way out of the hepatitis C conundrum with a sensible policy: Treat everyone who needs it, but not until treatment is necessary...
Poll: Americans want government to bring down prescription drug prices
Overall, 72 percent said the cost of prescription medications is unreasonable. Large majorities support requiring pharmaceutical companies to disclose how they set prices (86 percent); allowing Medicare to negotiate drug prices on behalf of beneficiaries (83 percent); limiting what drug companies can charge for medications to treat serious illnesses (76 percent); and allowing consumers to get prescriptions filled by pharmacies in Canada (72 percent).
The epidemiology of cirrhosis in the USA
A team of doctors estimated the prevalence of cirrhosis in the general US population, as published in this month's Journal of the Clinical Gastroenterology.
Causes of death in people with liver cirrhosis
August's issue of the American Journal of Gastroenterology evaluates causes of death in people with liver cirrhosis in England compared with the general population.
Your Good Health: Hep C curable, but cirrhosis irreversible
Dear Dr. Roach: I am a 59-year-old woman who was recently diagnosed with hepatitis C and cirrhosis. I have never been a drinker. I was treated with Harvoni for ...
Latest News on Hepatitis C Cures
by Dr. Joe Galati
For tonight’s broadcast of Your Health First, Dr. Rashid Khan joins me to discuss the latest news on fatty liver disease, and the new therapies for hepatitis C, which results in a cure rate of over 95% of the cases. You can listed to the audio from the three segments here...
While Washington Tackles Opioid Abuse Epidemic, Hepatitis C Treatment Remains Unaffordable
If Washington wants to do something about the public health issues left behind by the opioid abuse epidemic, it might have to start doing something about prescription-drug costs.
Hepatitis C - Liver Damage Significantly Underestimated and Underreported
The number of hepatitis C patients suffering from advanced liver damage may be grossly underestimated and underdiagnosed, according to a study led by researchers at Henry Ford Health System and the U.S. Centers for Disease Control and Prevention.
Expression of a single gene lets scientists easily grow hepatitis C virus in the lab
In a study published in Nature on August 12, scientists led by The Rockefeller University's Charles M. Rice, Maurice R. and Corinne P. Greenberg Professor in Virology and head of the Laboratory of Virology and Infectious Disease, report that when they overexpressed a particular gene in human liver cancer cell lines, the virus could easily replicate. This discovery allows study of naturally occurring forms of hepatitis C virus (HCV) in the lab.
Can we Reduce Muscle Cramps in Patients with Cirrhosis?
L-carnitine appears to be safe and effective for reducing muscle cramps in patients with cirrhosis, researchers report in the August issue of Clinical Gastroenterology and Hepatology.
High Cost Of Diabetes Drugs Often Goes Overlooked
When it comes to treating chronic conditions, diabetes drugs aren't nearly as sexy as say, Sovaldi, last year's breakthrough hepatitis C drug that offers a cure for the chronic liver infection at a price approaching six figures.
Lack of health insurance limits the benefits of Hepatitis C virus screening
A study in this month's American Journal of Gastroenterology identifies barriers to access to hepatitis C virus (HCV) treatment among screen detected subjects.
FDA warns makers of superbug-prone devices over testing violations
Manufacturers of medical devices linked to recent superbug outbreaks at U.S. hospitals skirted a host of testing, manufacturing and reporting requirements, the U.S. Food and Drug Administration said in warning letters to the companies released on Monday.
HCV Weekend Reading
News and Views: Recent Approval Holds Promise for Genotype 3, but Hurdles Anticipated
Hi everyone, hope you are all enjoying the weekend! We have a few August updates from; Healio, HCV Advocate and a handful of wonderful bloggers, enjoy.
Hepatitis C patients in England denied lifesaving liver drug
Health experts concerned about decision not to extend Daklinza treatment to patients with genotype 3 strain of virus
HCV Advocate Mid-Month Newsletter
In this month’s column of HCV Drugs I discuss the exciting news about the Food and Drug Administration (FDA) approval of AbbVie’s and BMS’s HCV medications, the study results from AbbVie’s once-a-day combination to treat genotype 1b, and the acceptance by the FDA of Merck’s new drug application for grazoprevir and elbasvir and the decision date
Hepatitis C infection may fuel heart risk
People infected with the hepatitis C virus are at risk for liver damage, but the results of a new Johns Hopkins study now show the infection may also spell heart trouble.
Key Management Decisions in HCV - Case-based Video Presentation Led By Ira M. Jacobson, MD.
SVR leads to survival benefit among HCV patients
In a systematic review, researchers found that patients with hepatitis C virus infection who achieved a sustained virologic response after treatment had a survival benefit vs. patients who did not achieve a sustained virologic response, according to published findings.
Tx Options for HCV GT 1 or 4 Non-responders
New study shows that genotype 1- or 4-infected non-responders, including patients with cirrhosis, achieve high SVR12 rates on the 24 week, quad treatment regimen of daclatasvir plus asunaprevir and peginterferon/ribavirin. The combination was well tolerated and no additional safety and tolerability concerns were observed compared with peginterferon/ribavirin regimens. A combination of Direct Acting Antivirals (DAAs) and peginterferon/ribavirin may provide a viable treatment option for those patients who experience virologic failure on all-oral, DAA regimens.
A Study of Health-related Quality of Life - Interferon Plus Ribavirin to Interferon- and Ribavirin-free HCV Regimens
This is the largest analysis of Health-related Quality of Life (HRQL) in over 3400 CH-C patients who were treated with a variety of anti-HCV regimens in nine phase 3 clinical trials. In this study, we clearly demonstrated a significant improvement of HRQL scores with regimens which were free of IFN, and more recently, regimens which are also free of both IFN and RBV.
New breath test shows possible biomarker for early-stage liver disease diagnosis
In the UK liver disease has risen sharply over the past few decades and is the third biggest cause of premature mortality, with three quarters of liver deaths due to alcohol. Patients do not often present with symptoms until the disease is advanced
New HCV Drugs Cost-effective but Costly: Now What?
The new generation of hepatitis C virus (HCV) drugs save lives. They are also enormously expensive, which leaves the healthcare system struggling with questions about who should get the drugs and who should pick up the hefty tab.
Once Disparaged, 'Me-Too' Drugs Crucial For Lower Costs Of Cholesterol, Hepatitis C And Cancer Drugs
While the high cost of new drugs is worrisome, those responsible for drug benefit plans in the U.S. are especially concerned. When a cure for a hepatitis C drug, Sovaldi, was launched by Gilead at a cost of $84,000 for a 12-week cost of therapy, payers were outraged.
Cirrhosis and decompensation are common among people with chronic hepatitis C
Hepatitis C is 'silent epidemic'
There are 43,500 registered patients with hepatitis C in Ukraine. However, the World Health Organization believes that the real number of infected people is much higher, and estimates that up to 8 percent of people could live with hepatitis C in the country.
Bing To Warn Searchers Of Fake Online Pharmacies
Bing promises to warn searchers of fake and potentially harmful online pharmacy websites by teaming up with the FDA.
Challenge to deliver curative treatment to all patients with hepatitis C
Coffee reduces the risk of hepatic fibrosis in Hep C
Coffee and caffeine are associated with decreased risk of advanced hepatic fibrosis among patients with Hepatitis C, reports the latest issue of the Clinical Gastroenterology & Hepatology.
Coffee or caffeine has been proposed to protect against hepatic fibrosis, but few data are available on their effects in patients with chronic hepatitis C virus (HCV) infection.
Dr Hashem El-Serag and colleagues from Texas, USA conducted a cross-sectional study of veterans with chronic HCV infection to evaluate the association between daily intake of caffeinated and decaffeinated coffee, tea, and soda, and level of hepatic fibrosis, based on the FibroSURE test.....
HOLKIRA PAK/Nova Scotia - ‘Second shot at life’: N.S. government to cover cost of new Hepatitis C drug
AbbVie drugs are also licensed in the U.S., where they are known as Viekira Pak.
Dasabuvir and ombitasvir/paritaprevir/ritonavir: Hint of added benefit in further patients
AASLD/IDSA Guidlines Updated: When and In Whom to Initiate Therapy
The When and In Whom to Initiate Therapy, Initial Treatment, Retreatment, Acute HCV Infection, and Unique Populations (HIV/HCV Coinfection, Decompensated Cirrhosis, and Renal Impairment) sections have been updated to reflect newly available data presented at the European Association for the Study of the Liver (EASL) International Liver Congress 2015.
HCV Guidance is available as an "Accepted Article" in HEPATOLOGY
Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus
Lifestyle modified weight loss reduces NASH
Liver stem cell identified in mice
Researchers have found a previously unknown population of cells in mice that function as liver stem cells. The finding could aid drug testing and increase understanding of liver biology and disease.
Early virological response may predict treatment response in sofosbuvir-based combination therapy of chronic hepatitis c in a multi-center “real-life” cohort
Endoscopes still contaminated after cleaning, study shows
Elsevier Health Sciences
Advances in Hepatitis C Treatment: At the Crossroads
Journal for Nurse Practitioners, August 5, 2015
Harvoni - Resident benefits from new drug that cures hepatitis C
But in recent years medications combating hepatitis C have proven more effective than ever, with Harvoni leading the way. Nancy Reau, an associate professor of medicine at the University of Chicago Medical Center who specializes in hepatitis C treatment, told the Chronicle she has prescribed the drug to many of her patients and estimated that she has seen a more than 90-percent success rate. Reau explained that its effectiveness stems from its ability to target the hepatitis C virus’ enzymes used to make more of itself, as opposed to previous drugs that focused on immune modulation.
In Case You Missed It
Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States
The aim of this study was to systematically evaluate state Medicaid policies for the treatment of hepatitis C virus (HCV) infection with sofosbuvir in the United States.
HCV Drug Wars - So doctors want Congress to force drug prices down? “What we’re fighting is the greed”
The psychological effects of hepatitis C: 'It was a dirty and uneasy feeling and it began to haunt me
'When I finally found out through that blood test that I had contracted hepatitis C through intravenous drug use I was angry, very angry, and I looked for someone else to blame.
Hep C treatment turned me around: Psychological & Behavioral Transformation Related to Hep C Treatment
Psychological and behavioral barriers prevent many HCV-infected individuals from initiating or engaging in HCV treatment. This study aimed to investigate the psychological and behavioral experiences of current and former substance users receiving HCV treatment within a combined methadone and primary care clinic in the United States
A Promising Alternative Therapy for Advanced Liver Cancer
August Newsletters: The Cure for Gilead, New drugs, Genotypes, Plus Hepatitis C and Nonalcoholic Fatty Liver Disease
Welcome to this months index of August Newsletters with a few updates from around the Web and today's news.
The Cure for Gilead
We begin with an in-depth article on the steep price of Gilead's Sofosbuvir, and the insurers who are denying coverage to patients in dire need of treatment, published online at "The Blog" over at HuffPost Business.
At the end of July the FDA approved two new drugs for hepatitis C, one for genotype 3 and the other for genotype 4. Provided in this post is the lowdown on both drugs with a few informational links and a video by Dr. Joseph Galati offering us a quick review of Daclatasvir.
Janssen starts a study to evaluate simeprevir and odalasvir on AL-335 pharmacokinetics
Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has started a phase I clinical trial to evaluate the potential effect of simeprevir and odalasvir (also known as ACH-3102), on the pharmacokinetics of AL-335 in healthy volunteers.
Increased risk of hepatocellular carcinoma in chronic HCV patients with new onset diabetes
31 July 2015
A study published ahead of print the Alimentary Pharmacology & Therapeutics reports an increased risk of hepatocellular carcinoma in chronic HCV patients with new onset diabetes.
Efficacy and Safety of Daclatasvir for Chronic HCV
Alimentary Pharmacology & Therapeutics, August 3, 2015
Where is last month's news?
HCV News Digest 2015
HCV News Digest
Hepatitis C Newsletters
These links will take you to the premier Hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences and more.
Email - firstname.lastname@example.org
Where Can I find a specialist to treat HCV?
Find a Specialist In Your Area
Testing, Diagnosis and Treatment
Are you struggling to afford the costs of Hepatitis C treatments? A new program through the HealthWell Foundation may be able to help.
Patient Assistance Programs
Financial support - updated to include Daklinza and TECHNIVIE
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.
Approved Treatments for Hepatitis C updated to include
Daklinza and TECHNIVIE
Daklinza (daclatasvir) in Combination with Sofosbuvir for HCV Genotype 3
Package Insert, patient information with news and updates
TECHNIVIE (ombitasvir, paritaprevir, ritonavir)
TECHNIVIE, a fixed-dose combination containing ombitasvir, paritaprevir, and ritonavir in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis.
Package Insert, patient information with news and updates
HCV Drug Interaction Charts
Provides a clinically useful, reliable, comprehensive, up-to-date, evidence-based drug-drug interaction resource, freely available to healthcare workers, patients and researchers.
U.S. FDA Approves Gileads Harvoni (Ledipasvir/Sofosbuvir)
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.
Mar 3 2015
Gilead's Harvoni gains NICE yes - but won't face funding delay - genotype 1, 4 , but not genotype 3
Gilead's next generation hepatitis C pill Harvoni is set to be backed by NICE - and this time NHS England won't be delaying its funding as it has done with the firm's other hep C drug Sovaldi.
Research and Updates
Gilead's Sovaldi (Sofosbuvir) FDA Approved
Sovaldi is approved in HCV genotypes 1 and 4, treatment-naïve adults in combination with PEG-IFN and ribavirin and the first approved interferon-free treatment regimen for people with HCV genotypes 2 and 3. Overall cure rates are at 80%, response rates and treatment duration varies, depending on genotype, viral and host factors.
Sovaldi (sofosbuvir) - Prescribing And Medication Guides
For detailed information please see Sovaldi (sofosbuvir) - Summary of the basis of approval and highlights from prescribing information and download sofosbuvir FDA review package.
OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C
Important Safety Information
FDA approves Olysio (simeprevir) in combination with Gilead Sciences' Sovaldi (sofosbuvir)
FDA Approves AbbVie Combo Hepatitis C Treatment
On December 19, 2014, FDA approved VIEKIRA Pak (ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets) for use with or without ribavirin for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis.
AbbVie Viekira Pak Homepage
AbbVie Viekira Pak - News, Research and financial support
ABBVIE 'VIEKIRA PAK' - HIGHLIGHTS OF PRESCRIBING INFORMATION
* This is not a complete list, click on labels located on the sidebar of our Blog for all topics, drugs and updates.
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.
ClinicalTrials.gov: updated in the last 30 days
Hepatitis C Clinical Trials - FDA Approved And Investigational Drugs
News, Research And Clinical Trials
See **Clinical Trials @ HCV Advocate For Enrollment Information
News and Research
Technivie (ombitasvir, paritaprevir, ritonavir)
Viekira Pak - (ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets)
Viekira Pak Prescribing Information
Before FDA Approval
ABT-450/ritonavir/ombitasvir/dasabuvir with or without ribavirin,
r = ritonavir
**Clinical Trials @ HCV Advocate-AbbVie
News and Research
**Clinical Trials @ HCV Advocate-Achillion
News and Research
In January 2014 Boehringer Ingelheim announced the development of deleobuvir would not be continued since recent findings from phase III trials did not suggest sufficient efficacy.
Faldaprevir - On June 20 2014 Boehringer Ingelheim announced it will withdraw all regulatory filings for faldaprevir, which had been granted accelerated assessment by the European Medicines Agency, and will discontinue further development of the protease inhibitor.
**Clinical Trials @ HCV Advocate-Boehringer Ingelheim
News and Research
DAKLINZA(DACLATASVIR) WITH SOFOSBUVIR
**Bristol-Myers withdraws FDA NDA for asunaprevir
**Clinical Trials @ HCV Advocate-Bristol-Myers Squibb (BMS)
News and Research
(Sofosbuvir) now Sovaldi
Before FDA Approval
GS-7977 sofosbuvir /GS-5885 ledipasvir,
GS-0938 and Sofosbuvir
Sofosbuvir/Ledipasvir plus GS-9451
Sofosbuvir/Ledipasvir plus GS-9669
GS-7977 now Sofosbuvir and simeprevir (TMC435)
**Clinical Trials @ HCV Advocate-Gilead
News and Research
**Clinical Trials @ HCV Advocate-Idenix
News and Research
August 2015 - Janssen starts a study to evaluate simeprevir and odalasvir on AL-335 pharmacokinetics
Simeprevir now Olysio
Before FDA Approval
Simeprevir - 2015
Simeprevir now Olysio and Daclatasvir
New - OLYSIO™ (Simeprevir) and Sovaldi (Sofosbuvir)
GS-7977 now Sofosbuvir and simeprevir (TMC435)
(TMC435) Simeprevir -2013 archives
**Clinical Trials @ HCV Advocate-Tibotec / Janssen
News and Research
July 2015 - FDA Acceptance of NDA for Merck's Grazoprevir/Elbasvir Treatment of Hepatitis C Genotypes 1, 4 and 6 Infection
On Jan 20,2015 The Food and Drug Administration (FDA) is informing that Victrelis (boceprevir; Merck) 200mg capsules will be discontinued.
Grazoprevir/Elbasvir (MK-5172/MK-8742) plus sofosbuvir,
FDA Approved - Victrelis (Boceprevir)
**Clinical Trials @ HCV Advocate-Merck
News and Research
**ClinicalTrials.gov - Danoprevir
News and Research
**ClinicalTrials.gov - Miravirsen
News and Research
**Vertex to stop selling hepatitis C drug Incivek
..Vertex said it will license an experimental hepatitis C drug called VX-135 to Alios BioPharma..As a reminder (VX-135) is still on partial clinical hold by the FDA in the U.S.
**Clinical Trials @ HCV Advocate-Vertex
To view all FDA approved treatments for hepatitis C, 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 ?
Patient Advocate Foundation Offers New CareLine for Hepatitis C Patients
Hepatitis C CareLine, providing individualized, sustained assistance to patients diagnosed with Hepatitis C. The CareLine will provide help to patients across the country to resolve healthcare access and insurance issues, at no charge to the patient.