This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
Gilead Sciences isn't letting a few of its own generics interfere with advertising its pan-genotypic hep C drug Epclusa. The Big Biotech is turning to TV again to promote its hep C franchise, this time with a commercial that highlights Epclusa's versatility across different strains of the disease.
The TV commercial features multiple patients disclosing details about their individual hep C infections, such as whether the viral strain was rare or common, whether they are symptomatic, and whether they're newly diagnosed or long knew they had the disease.
HCV-treatment: cost, access and generic versions
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions implemented by private insurers/Medicaid/Medicare and the effectiveness, safety and availability of generic versions of hepatitis C medications.
Generic direct-acting antivirals (DAAs) are just as effective and safe as their branded equivalents for the treatment of chronic hepatitis C virus (HCV) infection, according to Egyptian research published in Liver International. Generics achieved...
Controversy and barriers over hepatitis C drugs
Link to news articles addressing barriers to hepatitis C treatment, for instance insurance restrictions of these therapies by private insurers Medicare or Medicaid. In addition review research articles on the effectiveness, safety and availability of generic versions of hepatitis C medications.
Drug pricing: still a barrier to elimination of HCV
On Sept 24, 2018, Gilead announced plans to introduce generic versions of two of their key treatment regimens for chronic hepatitis C virus (HCV) infection—the pangenotypic combination sofosbuvir/velpatasvir (marketed as Epclusa) and sofosbuvir/ledipasvir (Harvoni)—in the USA. The generic versions will be available from January, 2019, via a newly formed subsidiary, Aseguea Therapeutics, and will be listed at US$24 000 for a 12-week course of treatment. Coming at least 10 years before the patents for the originator formulations expire, the prices for the generics represent a substantial reduction in cost compared with launch prices for both originator direct-acting antiviral formulations—initially $74 760 per course for sofosbuvir/velpatasvir and $94 500 for sofosbuvir/ledipasvir. The announcement comes against a backdrop of declining market share, in part due to AbbVie's 2017 launch of the pangenotypic glecaprevir/pibrentasvir regimen at $24 600 for an 8-week course....
Welcome, thanks for stopping by! Check out this month's index of exceptional Hepatitis Newsletters, and well written blogs; many provided by patient–consumers who offer an insight into what it's really like dealing with hepatitis.
Weekly Review
Begin by catching up on what you missed this week, here's one of two weekly reviews:
HepCBC
HepCBC is a Canadian non-profit organization offering information about HCV awareness, testing, treatment and care.
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
Gilead Launches Generics for HCV Meds, First Human Case of Rat Hepatitis, and Eliminating hepatitis C in Washington.
Overview of Transmission and Prevention of Hepatitis C
Marijuana is not associated with the progression of hepatic fibrosis in liver disease: a systematic review and meta-analysis
Eight-week hepatitis C treatment with new direct-acting antivirals has a better safety profile while being effective in the treatment-naïve geriatric population without liver cirrhosis and hepatitis C virus-RNA < 6 Million IU/mL
BRIEFLY…..
Approaches, progress, and challenges to hepatitis C vaccine development
Australia on track to achieve WHO HCV elimination targets following rapid initial DAA treatment uptake: a modeling study WHAT’S UP!
HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.
World Hepatitis Alliance We run global campaigns, convene high-level policy events, build capacity and pioneer global movements, ensuring people living with viral hepatitis guide every aspect of our work.
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.
Hepatitis NSW provides information, support, referral and advocacy for people affected by viral hepatitis in NSW. We also provide workforce development and education services both to prevent the transmission of viral hepatitis and to improve services for those affected by it.Latest issue of The Champion
GI & Hepatology News Over 17,000 gastroenterologists and hepatologists rely on GI & Hepatology News every month to cover the world of medicine with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online.
View all updates here....
Hep-Your Guide to Hepatitis
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
Hepatitis Victoria Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
View the Latest Newsletter, or relax and listen to a short podcasts interviewing health experts and practioners on topics related to viral hepatitis - come have a listen!
In The News - How stigma is entrenched by 'disease prestige' British Liver Trust The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services.
The Hepatitis C Trust is run by patients with the goal of eliminating HCV in the United Kingdom. The Trust’s mission is to reverse the rapidly increasing death toll caused by hepatitis C in the UK until no-one dies from this preventable and treatable disease and, ultimately, it is all but eradicated in this country.
The UK Parliament’s Health and Social Care Committee has today published a report on ’Prison Health’, which calls for the Government to do more to improve health outcomes for people in prison. The report, which follows an inquiry conducted in the first half of 2018, notes that hepatitis C is more prevalent amongst people in prison compared to the general population, making it a significant prison health issue.
Life Beyond Hep C is where faith, medical resources and patient support meet, helping Hep C patients and their families navigate through the entire journey of Hep C.
We strive to improve prevention and the quality of life of those living with liver disease by advocating for better screening, access to treatment, and patient care.
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide.
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals.
Kevin Pho is a practicing physician and most known for his blog KevinMD. Thousands of authors contribute to his blog: primary care doctors, surgeons, specialist physicians, nurses, medical students, policy experts. And of course, patients, who need the medical profession to hear their voices.
The goal of our publications is to bring people around the world the most current health information that is authoritative, trustworthy, and accessible, drawing on the expertise of the 10,000+ faculty physicians at Harvard Medical School.
HepCure is an innovative set of tools for hepatitis C virus (HCV) treatment. Developed by a team of HCV experts at the Icahn School of Medicine at Mount Sinai in New York City in collaboration with the New York State Department of Health and community health centers across the state. HepCure aims to improve provider knowledge for chronic disease management and increase patient engagement in persons with HCV infection.
Listen to experts discuss important HCV related topics in the following easy to access webinar:
Gilead charged $1,100 a day for this drug. Now it will launch a generic at quarter the price By Ron Leuty – Reporter, San Francisco Business Times A generic version of Harvoni — one in a series of life-changing hepatitis C drugs Gilead Sciences Inc. introduced four years ago at a price of over $1,000 a pill — will hit the market early next year at a quarter the price of the branded drug.
But while lower-priced generics generally a problem for drug makers because they eat into revenue, Foster City-based Gilead (NASDAQ: GILD) is looking forward to the generic: It will keep control of the drug and expand its market.
The "authorized generics" of Harvoni and another Gilead hepatitis C drug, Epclusa, will be marketed under the flag of Asegua Therapeutics LLC, a new Gilead subsidiary.
On This Blog The controversy over expensive new drugs for hepatitis C Link to a collection of current research articles regarding the effectiveness and safety of generic hepatitis C medicines. Read news articles addressing the high cost, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"
Pathways to ensure universal and affordable access to hepatitis C treatment
Caitlin H. Douglass, Alisa Pedrana, Jeffrey V. Lazarus, Ellen F. M. ‘t Hoen, Radi Hammad, Ricardo Baptista Leite, Andrew Hill and Margaret Hellard
BMC Medicine201816:175 https://doi.org/10.1186/s12916-018-1162-z
Received: 27 February 2018Accepted: 29 August 2018Published: 9 October 2018
History records very few opportunities to eliminate a chronic infection. In the DAA era, eliminating hepatitis C as a public health threat is possible, yet it can only be achieved with affordable access to DAAs worldwide. Case studies of Australia, Portugal and Egypt demonstrate that comprehensive public health-based viral hepatitis plans facilitate negotiations with pharmaceutical companies. Shifting from individual-focused hepatitis C treatment to elimination requires strong political will and advocacy. If price negotiations with pharmaceutical companies do not produce reasonable prices for DAAs, governments can utilise flexibilities in patent law to ensure access to low-priced generic sources.
Direct-acting antivirals (DAAs) have dramatically changed the landscape of hepatitis C treatment and prevention. The World Health Organization has called for the elimination of hepatitis C as a public health threat by 2030. However, the discrepancy in DAA prices across low-, middle- and high-income countries is considerable, ranging from less than US$ 100 to approximately US$ 40,000 per course, thus representing a major barrier for the scale-up of treatment and elimination. This article describes DAA pricing and pathways to accessing affordable treatment, providing case studies from Australia, Egypt and Portugal. Pathways to accessing DAAs include developing comprehensive viral hepatitis plans to facilitate price negotiations, voluntary and compulsory licenses, patent opposition, joint procurement, and personal importation schemes. While multiple factors influence the price of DAAs, a key driver is a country’s capacity and willingness to negotiate with pharmaceutical companies. If negotiations do not lead to a reasonable price, governments have the option to utilise flexibilities outlined in the Agreement on Trade-Related Aspects of Intellectual Property Rights. Affordable access to DAAs is underpinned by collaboration between government, civil society, global organisations and pharmaceutical companies to ensure that all patients can access treatment. Promoting these pathways is critical for influencing policy, improving access to affordable DAAs and achieving hepatitis C elimination.
The U.S. drug pricing system is a mess. It's an absolute disaster. Just about every entity involved, from drug companies to consumers to insurers to the government, agrees that offering discounts off the list price is a convoluted way to sell a life-saving product.
A Brazilian court has stripped the patent protection of a Gilead Sciences Inc big-selling hepatitis C treatment in Brazil, paving the way for cheaper generics, a presidential candidate who pushed for the move said on Monday....
Gilead Sciences to Sell Authorized Generics of Hepatitis C Drugs
Gilead Sciences will sell authorized generics of its blockbuster hepatitis C drugs Epclusa and Harvoni, Bloomberg reported. The brand-name versions sparked widespread debate about US pharmaceutical costs when they were introduced at a price of more than $1000 per pill. The less expensive versions will cost $24,000 for a course of treatment, which compares with a list price for Harvoni of $94,500. The company’s hepatitis C drugs remain among the best-selling pharmaceutical products in history, but they've also made Gilead the subject of congressional hearings and accusations of greed.
Gilead Press Release
United States Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C
-- List Price of Authorized Generics to Reflect Discounts in the System Today --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today plans to launch authorized generic versions of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg), Gilead's leading treatments for chronic hepatitis C virus (HCV), in the United States, through a newly created subsidiary, Asegua Therapeutics LLC. The authorized generics will launch at a list price of $24,000 for the most common course of therapy and will be available in January 2019.
Since the launch of Gilead's first HCV medication in 2013, the average price paid for each bottle of medicine in the United States has decreased by more than 60 percent off of the public list prices, across health insurers and government payers. Due to the complexity and structure of the U.S. healthcare system, however, these discounts provided by Gilead may not always translate into lower costs for patients. Further, existing contracts, together with laws associated with government pricing policies, make it challenging to quickly lower a product's list price once it is on the market.
The authorized generics are priced to more closely reflect the discounts that health insurers and government payers receive today. Insurers will have the choice of offering either the authorized generics or the branded medications for both Epclusa and Harvoni. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to our medications to beneficiaries who were previously denied coverage.
"Launching these authorized generics is the best solution available to us today to quickly introduce a lower-priced alternative to our HCV medications without significant disruption to the healthcare system and our business," said John F. Milligan, PhD, President and Chief Executive Officer, Gilead Sciences. "This launch also will hopefully help increase transparency by more closely aligning our medications' list prices with their cost. Our ultimate goal is to lower the list price of Epclusa - a medication we believe is of great importance given its clinical profile across genotypes - and Harvoni. We are committed to working with all of our partners in the healthcare system to help enable list price reductions of our HCV medications and find better solutions to reduce patients' out-of-pocket costs."
Beyond the company's efforts to reduce patient costs, Gilead is continuing to pursue innovative collaborations and long-term financing models, such as a potential subscription model, that could not only expand access, but aim to eliminate HCV in the United States and around the world.
About Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Background: Cost-benefit analyses are crucial to inform treatment policies, particularly when the cost of patented drugs is very high. The cost of patented drugs is the limiting factor in hepatitis C treatment. However, hepatitis C drug costs are expected to fall following patent expiration, due to generic drug introduction.
Methods: An existing mathematical model by Shih et al was extended to consider lower-cost future generics in health economic models of hepatitis C. The model compared the cost-effectiveness of treating patients now with patented drugs vs postponing treatment until after patent expiration.
Results: For ledipasvir-sofosbuvir, this study finds that it is almost always more cost effective to treat hepatitis C with high-cost patented drugs immediately rather than waiting for patent expiry. For ledipasvir-sofosbuvir, a generic would need to enter the market at <16.40% of the patented price for delayed treatment to be cost effective. The further that patent expiry is in the future, the more cost effective delayed treatment becomes; however, uncertainty about generic pricing and market entry times are also higher if patent expiry is in the distant future.
Conclusion: It is more cost effective to treat hepatitis C sooner rather than later, regardless of the stage of the disease, and despite the high cost of patented drugs. However, patented drugs are being produced globally for prices much lower than those seen in the UK. Therefore, negotiation of patented drug prices with pharmaceutical companies may be a crucial step in cost effective treatment of hepatitis C.
-- List Price of Authorized Generics to Reflect Discounts in the System Today --
Greg Jefferys: Purchasing Hep C Generics
Hepatitis C advocate Greg Jefferys launched a new video providing an overview on how to purchase affordable Hepatitis C medicines, such as Harvoni or Epclusa through "Affordable Medical Access International".
His Story
Hi, my name is Greg Jefferys and this website was originally created to record my experiences after I discovered I was infected with Hepatitis C back in August 2014 and what happened as I progressed through the shock of the initial Hep C diagnosis to trying to find an effective and affordable Hepatitis C treatment such as generic Harvoni or Epclusa.
In May 2015 I found myself in India where I purchased generic Sovaldi (Sofosbuvir 400 mg) and twelve weeks later I was cured. Because I was the first person who publicly traveled to India to buy generic Hep C medication my journey received quite a lot of media attention around the world and soon I was getting hundreds of emails every day from people who needed reliable information about buying generic Hepatitis C medicine and about Hepatitis C treatment options generally.
As a direct result of these requests for assistance I started a business called Affordable Medical Access International. Through this business I can supply you with these new Hepatitis C medicines, such as Harvoni or Epclusa. I can deliver to anyone in any country at a fair price with shipping insurance and guaranteed delivery.
On This Blog The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles regarding the effectiveness and safety of generic hepatitis C medicines. Read news articles addressing the high cost, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"
Welcome folks! Read the latest hep B or C news in this months collection of newsletters, published monthly by a small group of kind people devoted to educating us all about liver disease. In addition, access new blog posts with information about major issues surrounding viral hepatitis, as well as tips for maintaining a healthy liver, again, provided by a handful of inspirational writers who blog just for you. Finally read today's news updated as the day progresses, check back for updates.
GIS – 08 August 2018: The Ministry of Health and Quality of Life will organise a Conference on Hepatitis C in October 2018.
The Conference will involve the participation of experts from the United Kingdom, Australia, Egypt and South Africa so as to guide the health care professionals on treatment and elimination of hepatitis C in Mauritius.
Its main objectives will be to educate the local doctors in the new treatments of hepatitis C and to develop a large scale treatment strategy for those who have been diagnosed. The Conference also aims at sourcing affordable tests for hepatitis C and developing a strategy for eliminating hepatitis C in Mauritius by 2025.
Researchers have found that a group of viruses that cause severe stomach illness — including the one famous for widespread outbreaks on cruise ships — get transmitted to humans through membrane-cloaked “virus clusters” that exacerbate the spread and severity of disease.
The World and Everything in It: hospice for the homeless. Death with dignity - WORLD Radio Blog
At age 50, Linda is dying of Hepatitis C that she contracted from needles while she was a heroin addict. Now the disease is causing her liver to fail. She's in a lot … August 7
Express Scripts Holding Co. said it will drop 48 drugs next year from its closely watched lineup of covered therapies, including Gilead Sciences Inc.’s HIV treatment Atripla and AbbVie Inc.’s hot-selling Mavyret medicine for hepatitis C. Express Scripts said that next year it will cover Symfi, a new HIV combo pill from Mylan NV that the benefit manager said has a 40 percent lower list price than Atripla. Express Scripts will also cover Merck & Co.’s lower-cost hepatitis C medicine Zepatier. In July, Merck said that it was cutting its list price for the drug by 60 percent.
It is time for California to develop its own Ending the Epidemic plan! The California HIV/AIDS Policy Research Centers, together with viral hepatitis and STD organizations (including Project Inform), have launched a community-driven effort to inform development of a statewide plan to end the HIV and hepatitis C epidemics and significantly reduce the incidence of STDs.
7, 2018 (HealthDay News) -- Dialysis patients waiting for kidney transplants might safely accept an organ from a donor infected with hepatitis C virus (HCV), …
Publish date: August 7, 2018
By Mark S. Lesney ID Practitioner
Marked differences were seen in the composition of hepatitis C virus hypervariable region 1 (HVR1) when comparing HIV-coinfected (CIP) with HCV-monoinfected (MIP) individuals, according to the results of a genetic analysis of nearly 300 patients.
The interaction between alcohol abuse and hepatitis C virus (HCV) can ... The study noted that approximately 20% of patients with alcoholic hepatitis have HCV.
Healio - Aug 6, 2018
Patients with chronic hepatitis B virus infection died an average of 14 years ... evidence of diabetes (27.2%), a history of alcohol abuse (17.7%), hepatitis C or …
FDA gives drugmakers new ways to prove opioid disorder treatments work
By Steven Ross Johnson | August 6, 2018
Under the new draft guidance, drug developers can look beyond whether medication-assisted treatments reduce patients' opioid use. They can prove efficacy through drops in mortality, emergency department visits, or transmission of hepatitis C. Other measurable outcomes could include improvements in patients' ability to resume work or school, or by the share of patients with moderate to severe forms of opioid use disorder who go into remission while using the experimental MAT therapies.
A comparison of the nucleos(t)ide analogues tenofovir and entecavir revealed that virological relapse occurred much later for people with a chronic hepatitis B virus (HBV) infection who were e antigen negative after stopping entecavir, according to findings published in The Journal of Infectious Diseases.
Ascletis Pharma Inc. (1672.HK) announced today Ravidasvir is recommended by the World Health Organization (WHO) Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C Virus Infection (July 2018) as a future pan-genotypic direct-acting antivirals agent (DAA). Ascletis received the acceptance letter for Ravidasvir new drug application (NDA) from the China Food and Drug Administration (CFDA) on August 1.
The results indicate that the sofosbuvir/ravidasvir combination is comparable to the very best hepatitis C therapies available today, but it is priced affordably and could allow an alternative option in countries excluded from pharmaceutical company access programmes,” said Dr Bernard Pécoul, Executive Director, DNDi.
Integrating Treatments for Opioid Use Disorder and Infectious Diseases
Aug 6, 2018
All healthcare providers have a role in combating the opioid use disorder (OUD) epidemic and its infectious disease (ID) consequences, according to an article published in Annals of Internal Medicine
Britain plans for opt-out organ donation scheme to save lives
LONDON Britain plans to increase the number of organ donors by changing the rules of consent and presuming that people have agreed to transplants unless they have specifically opted out.
Read The Latest News
For a quick review of news, stroll over to the good people at HepCBC to read the latest issue of the Weekly Bull.
Journal Updates Managing Neurologic Complications of Chronic HCV Infection
Chronic hepatitis C virus (HCV) infection can cause a multitude of extrahepatic complications, including neurologic manifestations. These complications can lead to substantial neuropsychiatric deficits, such as fatigue, cognitive impairment, restless legs syndrome, Parkinson's disease, and peripheral neuropathy. In addition to detecting and managing these neurologic complications, pharmacists in community settings can promote HCV screening, improve medication access and adherence, and recommend preventive strategies patients can use to avoid transmission of this widespread infection. International Journal of Infectious Diseases
2 August 2018
Download: High Efficacy of Generic and Brand Direct Acting Antivirals in Treatment of Chronic Hepatitis C. August Updates On This Blog
- Hepatitis C-Diabetes associated w-advanced fibrosis and progression in HCV non-genotype 3 patients
- Symptom burden, medical comorbidities, and functional well-being of patients with chronic hepatitis C virus (HCV) initiating direct acting antiviral (DAA) therapy in real-world clinical settings
- Long–term effect of liver fibrosis after SVR in patients with HCV July News Spotlight on mortality trends in liver disease
One study looked at 10-year U.S. mortality trends related to chronic liver diseases, while another assessed mortality from cirrhosis and liver cancer in the U.S. from 1999 to 2016.
“It is clear that the introduction of oral, highly efficacious and well-tolerated antiviral agents has improved outcomes in patients with viral hepatitis,” they wrote. “However, future challenges with [alcoholic liver disease] and NAFLD will pose a different set of problems and will necessitate a multidisciplinary approach with a dedicated focus on minorities.”
Despite highly effective and well-tolerated regimens for treating hepatitis C virus (HCV), patients face barriers in accessing treatment. In addition to suboptimal HCV screening programs and lack of effective linkage-to-care, other barriers include strict requirements from some payers to cover treatment. This study reports insurance status and Hispanic ethnicity as predictors of not receiving treatment.
“Coordinated care has the potential to improve access to treatment for individuals with hepatitis C who are naive to direct-acting antivirals; however, having Medicaid could hamper access, according to a recent study published in PLoSONE.”
People born between 1945 and 1975 are the group of people who are most likely to suffer from chronic hepatitis C in Canada, and Greg Powell is a Canadian who is part of those people. Greg contacted the hepatitis C in the 1980s, but the diagnosis came ten years later. Greg was already suffering from hemophilia B which is a hereditary bleeding disorder, so he needed to benefit from a series of blood transfusions.
Nearly three fourths of patients who present with acetaminophen-induced acute liver injury (ALI) or failure (ALF) are women, according to findings from a North American registry. Women with acetaminophen overdose leading to ALI/ALF were more likely than men to present with high-grade hepatic encephalopathy and have critical care needs, and more likely to have psychiatric disease and to co-ingest sedating agents with acetaminophen.
Newsletters
HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
-Efficacy of sofosbuvir and velpatasvir, with and without ribavirin, in patients with HCV genotype 3 infection and cirrhosis
-Incidence and spontaneous clearance of hepatitis C (HCV) in PWID at the Stockholm needle exchange – importance for HCV elimination
-Microenvironment eradication of hepatitis C: A novel treatment paradigm
-All‐oral direct‐acting antiviral therapy against hepatitis C virus (HCV) in human immunodeficiency virus/HCV–coinfected subjects in real‐world practice: Madrid coinfection registry findings
If you need information and resources about finding financial help to pay for low cost testing, or finding a free or low cost clinic, or financial help with payment for treatments, please call us. We know how to find doctors and support groups. We know how to help you find resources where you live. We have experienced hepatitis C ourselves or have supported patients living with hep C. We are peer counselors. Help-4-Hep is a trusted source of information, support and referrals—all free of charge to you.
We run global campaigns, convene high-level policy events, build capacity and pioneer global movements, ensuring people living with viral hepatitis guide every aspect of our work.
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World Hepatitis Alliance (WHA) presents hepVoice, a monthly magazine with updates on the latest projects, news from WHA members and key developments in the field of hepatitis.
GI & Hepatology News Over 17,000 gastroenterologists and hepatologists rely on GI & Hepatology News every month to cover the world of medicine with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online.
Hot topics
Lin Chang, MD
Publish date: August 1, 2018 Hepatitis B virus reactivation, endoscopic bariatric therapy, and more.
View all updates here.... Hep-Your Guide to Hepatitis Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
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Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
Check out this new Liver Health app: 'Top app for liver health is LiverWELL' says influential U.S. health blogger.
View the Latest Newsletter, or relax and listen to a short podcasts interviewing health experts and practioners on topics related to viral hepatitis - come have a listen! British Liver Trust The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services.
News: Almost half of people with Hepatitis C in the UK are unaware
On Saturday 28th July, World Hepatitis Day, the British Liver Trust unites with organisations, health professionals and supporters across the world to push for urgent …
View Recent Newsletters, here. National Institutes of Health A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services August Newsletter
Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C.
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Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
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Healing Your Fatty Liver
We provide information, support, referral and advocacy for people affected by viral hepatitis in NSW. We also provide workforce development and education services both to prevent the transmission of viral hepatitis and to improve services for those affected by it.
Latest blog entry: Govt intervenes to keep hep C elimination on track
Life Beyond Hepatitis C Life Beyond Hep C is where faith, medical resources and patient support meet, helping Hep C patients and their families navigate through the entire journey of Hep C.
Latest blog entry: Newly Diagnosed with Hepatitis C, What Do I Do Next?
A comprehensive website for HIV and hepatitis C information
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CanHepC’s blueprint will impact my work.
We strive to improve prevention and the quality of life of those living with liver disease by advocating for better screening, access to treatment, and patient care.
Latest blog entry: Life After Hepatitis C: A New Chapter
Pacific Hepatitis C Network The Pacific Hepatitis C Network works with people living with hepatitis C, with community based organizations and with government to address concerns about hepatitis C prevention, care, treatment access and support.
Latest blog entry: A few words from PHCN’s President on World Hepatitis Day 2018
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide.
Latest blog entry: - Newly Diagnosed with Hepatitis B? How Did I Get this? Learning the HBV Transmission Basics.
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Latest blog entry: Should I Be Screened for Liver Cancer?
Healthy You Simple swaps to eat less salt
The top 10 sources of sodium in the American diet include processed foods that contain several high-sodium ingredients, such as cheese and cured meats
While probiotics can be beneficial in some scenarios, like helping a patient restore his gut bacteria after taking antibiotics, the investigators advised caution against its excessive and indiscriminate use.
"Probiotics should be treated as a drug, not as a food supplement," Rao says, noting that many individuals self-prescribe the live bacteria, which are considered good for digestion and overall health....
New research suggests the mix of microbes in our guts can either help — or hinder — weight-loss efforts.
Watch: Liver Function Tests
The ACG now suggests that "liver function tests" be referred to as "liver chemistries" or "liver tests.
The reasoning behind the name change is "Liver Function Tests" are not true measures of hepatic function. Listen to this 2017 short podcast hosted by Arefa Cassoobhoy, MD, MPH to learn more about test guidelines.
Recently, Lab Tests Online AU uploaded the following video explaining commonly used tests to check liver function such as; alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin, and bilirubin tests. The ALT and AST tests measure enzymes that your liver releases in response to damage or disease.
Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions May 23, 2018 Sydney Lupkin, Kaiser Health News
Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.
As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.
The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.
The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.
The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”
Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.
The remaining drugs do not appear in the Medicare and Medicaid data.
By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.
Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.
Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.
The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.
Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.
Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.
“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.
The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.
Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.
Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”
PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.
“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.
Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.
The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.
Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”
The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”
This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.
J Viral Hepat. 2018 Jan 28. doi: 10.1111/jvh.12870. [Epub ahead of print] Full Text - Download Article Shared by @HenryEChang via Twitter.
Secialty Pharmacy Times Generic Hepatitis C Drugs Begin to Emerge
Laurie Toich
Associate Editor Publish Date: Wednesday, March 07, 2018
The cost of hepatitis C virus (HCV) antivirals has been at the forefront of health care spending conversations for years. Although it has slowed, spending on the blockbuster drugs remains high. Despite the curative ability of the treatments, it is likely that a significant need for antiviral drugs will remain into the foreseeable future due the prevalence of undiagnosed HCV cases.
On This Blog The controversy over expensive new drugs for hepatitis C Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"
