Showing posts with label Sofosbuvir/Cost. Show all posts
Showing posts with label Sofosbuvir/Cost. Show all posts

Wednesday, October 10, 2018

Pathways to ensure universal and affordable access to hepatitis C treatment

In Case You Missed It

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.


Abstract
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.

Continue to full-text article:
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1162-z

On This Blog

The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles addressing the high cost of HCV medications, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries, or through online "buyers clubs"

Wednesday, October 3, 2018

Impatient patients turn to online 'buyers club' for new drugs

Also Read:
Hepatitis C Patients Are Being Forced Into Underground Buyers’ Clubs
October 2, 2018 | Elizabeth Brico
These buyers’ clubs operate by taking advantage of personal importation laws, which vary by country. For the U.S. that means buyers must import less than a three-month supply, and they cannot sell or distribute the medication. An added provision that a medication must be unavailable domestically leaves the legality of these practices in somewhat of a gray area .

Oct 3, 2018
Impatient patients turn to online 'buyers club' for new drugs
Ben Hirschler
LONDON (Reuters) - Frustrated by delays in new medicines reaching their own country, a small but growing number of patients are turning to an online broker that bills itself as a legal version of the Dallas Buyers Club. 

While regulators warn of the risk of buying drugs online, the Amsterdam-based Social Medwork sees its network of trusted suppliers as filling a gap in the market for the latest drugs against diseases such as cancer, migraine and multiple sclerosis. 

Read the article:

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles addressing the high cost of HCV medications, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries, or through online "buyers clubs".

Thursday, September 27, 2018

Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C

Of Interest
Sep 27, 2018

Sept 26 2018
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.

Maria Carolina Marcello, Gram Slattery
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.

Thursday, September 20, 2018

Cost-effectiveness analysis of treatment timing considering the future entry of lower-cost generics for hepatitis C

-- List Price of Authorized Generics to Reflect Discounts in the System Today -- 

Cost-effectiveness analysis of treatment timing considering the future entry of lower-cost generics for hepatitis C
Authors Heath K 

Received 16 April 2018
Accepted for publication 27 May 2018
Published 20 September 2018 Volume 2018:10 Pages 539—550


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.

Wednesday, September 19, 2018

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment
September 18, 2018
The Louisiana Department of Health is currently developing a “subscription style” payment plan with pharmaceutical manufacturers to provide state residents with access to hepatitis C treatment.

HCV Next spoke with the department’s chief of staff, Pete Croughan, MD, about the landscape of HCV in the state and the novel payment model designed to expand treatment despite the expensive cost of direct-acting antivirals.

The department estimates that this plan could increase treatment from approximately 3% of people on Medicaid and in correctional facilities up to nearly 60%.

“We’ve actually had conversations with all three hepatitis C manufacturers — AbbVie, Gilead and Merck — and all three have expressed interest in potentially partnering with us,” he said. “The plan is to ultimately select a partner through a request for proposal process, but we’re willing to work with any company that gives us the best deal.”

Continue reading: 

Read the September/October issue of HCV available online here:
https://www.healio.com/hepatology/news/print/hcv-next

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles addressing the high cost of HCV medications, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries, or through online "buyers clubs".

Expand Screening for HCV infection in all adults living in the US?

MEDPAGE TODAY
Gastroenterology > Hepatitis 
Time to Expand Age Base for HCV Screening? 
Bargain price of $11,378 per QALY gained for one-time, universal testing
by Diana Swift, Contributing Writer September 15, 2018

Compared with currently recommended birth cohort screening, universal one-time screening for hepatitis C virus (HCV) for U.S. adults would be highly cost-effective, resulting in an expenditure of $11,378 per quality-adjusted life year (QALY) gained, researchers reported

The findings support broadening the current age cohort for one-time screening to all U.S. adults, concluded Mark H. Eckman, MD, of the University of Cincinnati, and colleagues. "A recommendation for HCV testing of all adults will support the national response to the epidemic of HCV infection among young persons in the United States."

Continue reading:

Primary Source
Clinical Gastroenterology and Hepatology

Wednesday, September 12, 2018

Greg Jefferys: Purchasing Hep C Generics

Update - In The News
Monday, September 24, 2018
-- 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.

Published on Sep 11, 2018

Hep C Home Page

Facebook Page
https://www.facebook.com/greg.jefferys

Greg is also a blogger at Hep Blogs
https://www.hepmag.com/blogger/greg-jefferys 

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" 

Hepatitis C - Generic sofosbuvir-based interferon-free direct acting antiviral agents: a real-world multicenter observational study

In The News
Monday, September 24, 2018
-- List Price of Authorized Generics to Reflect Discounts in the System Today -- 

Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study
Chen-Hua Liu, Yi-Jie Huang, Sien-Sing Yang, Chung-Hsin Chang, Sheng-Shun Yang, Hsin-Yun Sun, Chun-Jen Liu, Wen-Chun Liu, Tung-Hung Su, Hung-Chih Yang, Chun-Ming Hong, Tai-Chung Tseng, Pei-Jer Chen, Ding-Shinn Chen, Chien-Ching Hung & Jia-Horng Kao

Full-Text Article 
Scientific Reports volume 8, Article number: 13699 (2018)
Published: 12 September 2018 

Abstract
Real-world data regarding the effectiveness and safety of generic sofosbuvir (SOF)-based interferon-free direct acting antiviral agents (DAAs) for patients with chronic hepatitis C virus (HCV) infection remain limited. A total of 517 chronic HCV-infected patients receiving 12 or 24 weeks of SOF-based therapies were retrospectively enrolled in 4 academic centers in Taiwan. The rate of sustained virologic response at week 12 off-therapy (SVR12) and that of treatment completion were assessed. The baseline characteristics and on-treatment HCV viral kinetics to predict SVR12 were analyzed. By evaluable population (EP) analysis, the SVR12 rate was 95.4% (95% confidence interval [CI]: 93.2–96.9%). The SVR12 was achieved in 29 of 34 patients (85.3%, 95% CI: 69.6–93.6%), 130 of 139 patients (93.5%, 95% CI: 88.2–96.6%), 119 of 124 patients (96.0%, 95% CI: 90.9–98.3%) and 215 of 220 patients (97.7%, 95% CI: 94.8–99.0%) who received SOF in combination with ribavirin (RBV), ledipasvir (LDV), daclatasvir (DCV) and velpatasvir (VEL), respectively. Of 517 patients, 514 (99.4%) completed the scheduled treatment. All 15 patients with true virologic failures were relapsers. Two decompensated cirrhotic patients had on-treatment deaths which were not related to DAAs. All 7 patients who were lost to follow-up had undetectable HCV RNA level at the last visit. The SVR12 rates were comparable in terms of baseline patient characteristics and viral decline at week 4 of treatment. In conclusion, generic SOF-based regimens are well tolerated and provide high SVR12 rates in patients with chronic HCV infection.

Introduction
Hepatitis C virus (HCV) infection remains a challenging health problem in the world. It is estimated that approximately 71.1 million people, which account for 1.0% of the world’s population, are HCV carriers1. Among patients with chronic HCV infection, about 20% of them will evolve to cirrhosis over a period of 20–30 years. Once cirrhosis is established, the annual rates of developing hepatic decompensation and hepatocellular carcinoma (HCC) are 3–6% and 1–4%, respectively2,3. In addition to increasing the risks of liver-related morbidity and mortality, HCV infection is also associated with various extra-hepatic manifestations which further compromised the patients’ health outcome and quality of life4. On the other hand, the morbidity and mortality are significantly reduced once these patients achieve sustained virologic response (SVR) by anti-HCV agents5,6,7,8,9.

The use of interferon (IFN)-free direct acting antiviral agents (DAAs) has made a paradigm shift and become the standard of care for HCV infection. Sofosbuvir (SOF) is a pyrimidine nucleotide analogue that inhibits the HCV non-structural protein 5B (NS5B) ribonucleic acid (RNA)-dependent RNA polymerase, which is essential for viral replication. After intra-hepatic metabolism to active uridine triphosphate form, the GS-461203, it is incorporated to HCV RNA by NS5B polymerase and acts as the chain terminator10. Clinically, SOF is administered once-daily with pangenotypic potency, well tolerability, a high genetic barrier to drug resistance, and low rates of drug-drug interactions (DDIs). Furthermore, SOF can be used in combination with various kinds of NS3/4 A protease inhibitors (PIs), NS5A inhibitors, and/or ribavirin (RBV) to achieve high SVR rates11,12,13,14,15,16,17,18,19,20,21,22,23. Because of the excellent therapeutic profiles, treatment of HCV by SOF-based regimens is appealing to most health care providers.

Although SOF-based IFN-free DAAs are highly efficacious and well tolerated, many HCV-infected individuals have limited governmental reimbursement or private insurance support for brand-name agents24,25,26. Allowing generic SOF-based DAAs through voluntary or compulsory licensing can scale up the HCV treatment to facilitate more efficient HCV control, particularly for patients in resource-constrained countries. Regarding the effectiveness and safety of generic SOF in combination with ledipasvir (LDV), daclatasvir (DCV), and/or RBV, several reports from China, India, Egypt and Argentina indicated that the SVR rates were >90% and most patients tolerated the treatment well27,28,29,30,31. On the basis of these encouraging results, we aimed to evaluate the performance of generic SOF-based DAAs for HCV and factors potentially affecting the treatment response in a multicenter cohort in Taiwan.

Open Access
Full-Text Article Available Online:

Tuesday, September 11, 2018

Groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access

MSF and groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access 
-Pharmaceutical company Gilead has a patent monopoly on hepatitis C drug sofosbuvir in Europe
--The patent results in exorbitant prices, meaning people are unable to afford treatment 
--MSF and other organisations are urging the European Patent Office to overturn the patent in a hearing this week. 

Munich/Paris– This week in Munich, the European Patent Office is hearing a legal challenge filed by groups in 17 countries in March 2017, against an unmerited patent that allows US pharmaceutical corporation Gilead Sciences to charge exorbitant prices in Europe for the key hepatitis C drug sofosbuvir. Médecins du Monde (MdM), Médecins Sans Frontières (MSF) and Just Treatment are among the patient and treatment provider organisations that challenged the validity of a Gilead patent on sofosbuvir, on the grounds that it does not fulfill the requirements to be a patentable invention from a legal or scientific perspective. The groups urged the European Patent Office (EPO), which will hold a public hearing on 13 and 14 September, to rethink its decision that gives Gilead this monopoly.

If the patent challenge is successful, a major step will have been taken toward allowing the production and importation of affordable generic versions of sofosbuvir in Europe. Generic versions would protect health systems across Europe from financial burden due to the excessive price of this drug. The extremely high prices in Europe of newer hepatitis C medicines—called direct-acting antivirals, or DAAs—has led civil society organisations to investigate and subsequently challenge the monopoly status and legitimacy of such patents. 

Medical Activities
Hepatitis C
Worldwide, an estimated 71 million people are infected with the hepatitis C virus, double the number living with HIV. While hepatitis C can be cured, few people have access to treatment.

Governments forced to ration treatment
“I have been through an extremely agonising wait for three years to get access to sofosbuvir”, said Clare Groves, Just Treatment patient leader who was treated and cured of hepatitis C through the National Health Service (NHS) in the United Kingdom. The NHS was forced to ration supply of the medicine due to its high price. “I was repeatedly told by my doctor that I am sick, but not sick enough to qualify for the treatment under the public health programme. I don’t want other people to be denied sofosbuvir because its price is exorbitant, so I will continue to fight for their access to this cure.”

The World Health Organization estimates that 15 million people in Europe—approximately one in 50 people—are chronically infected with hepatitis C, leading to approximately 112,500 deaths per year from related liver cancer and cirrhosis. The advent of DAA drugs, which offer a safer, shorter and more effective cure compared to older treatments, has marked a major breakthrough in the treatment of the disease, with cure rates higher than 90 percent, compared to around 50 percent previously. Sofosbuvir forms the backbone of most hepatitis C combination treatments, yet access to these newer treatments remains very limited globally because of high prices, with governments and treatment providers in many countries forced to ration treatment and limit access only to people with advanced forms of the disease.

Exorbitant prices in Europe, but affordable elsewhere
Gilead charges as much as €43,000 for one person’s 12-week treatment of sofosbuvir in Europe. Meanwhile, in countries where the drug is not patented, competition among generic producers has driven the price to just €52 for the same treatment course. Studies have shown that it costs about €0.50 per daily pill to manufacture the drug. “Financial barriers in access to medicines and healthcare have become a challenge for high-income countries in Europe”, said Olivier Maguet, of MdM’s drug pricing campaign. “Because unmerited patents are the key driver for these excessive prices, it’s time to challenge these patents in Europe.”

More scrutiny of patents needed
While the high prices charged for medicines are a well-known problem in many parts of the world, the recent excessive pricing of DAAs has brought Europe’s attention for the first time on the impact that monopolies have both on health budgets and on people’s access to many other essential medicines. Legal challenges against patents on sofosbuvir and other DAAs have been filed in several countries, and key patents on sofosbuvir have already been rejected in Egypt, China and Ukraine. Decisions are pending in other countries, including Argentina, Brazil, India, Russia and Thailand.

 “Every day, MSF witnesses first-hand how monopolies on medicines restrict people’s access to life-saving medicines,” said Gaelle Krikorian, Head of Policy at MSF’s Access Campaign. “MSF was only able to start scaling up treatment for people with hepatitis C in countries like Cambodia and India once more affordable quality-assured generics became readily available.”

“It’s high time that the European Patent Office and patent offices around the world apply greater scrutiny when granting monopolies on medicines, recognising the negative impact that unmerited patents have on people’s health”, said Gaelle Krikorian. “Revoking Gilead’s patent would end the corporation’s monopoly in Europe, and allow countries to access sofosbuvir from multiple generic manufacturers at affordable prices. It would also send a strong signal to other countries to challenge unmerited patents when people’s health and survival are at stake.”
https://www.msf.org/msf-and-groups-call-end-gileads-hepatitis-c-drug-monopoly-europe-which-blocks-access

Wednesday, August 8, 2018

Hep C and B August Newsletters - Liver Wellness Tips & Generic Direct Acting Antivirals

News updated Aug 8, 2018

August Newsletters
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. 

Liver Wellness Tips
In honor of World Hepatitis Day, start with:10 TERRIFIC WAYS TO LOVE YOUR LIVER THIS SUMMER, a must read series covering everything from foods containing anti-inflammatory agents to liver-friendly yoga poses! Recently launched by Al D. Rodriguez Liver Foundation.

Today's News
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.

New PHE data shows a decrease in deaths from hepatitis C but diagnoses of advanced liver disease and related cancers remain stable.

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.

Seeking your help to end the HIV and hepatitis C epidemics and significantly reduce the incidence of STDs in California!
Aug 7, 2018
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.

"This is a lifesaver": Patients who accepted infected kidney transplants cured of hepatitis C
Some patients in desperate need of a kidney transplant participated in a bold experiment where they received organs infected with hepatitis C. The gamble paid off.

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.

Study: Alcohol Abuse Increases Risks in Patients with Hepatitis C
Aug 7, 2018
The interaction between alcohol abuse and hepatitis C virus (HCV) can ... The study noted that approximately 20% of patients with alcoholic hepatitis have HCV.

August 6
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.

Entecavir Associated With Later Virological Relapse Than Tenofovir
Aug 6, 2018
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.

Related: April 12, 2018
sofosbuvir/ravidasvir
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
New Articles Under: Other Conditions Related To HCV 
- 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 

New Articles Under: HCC during and after direct-acting antiviral therapy in patients with hepatitis C
- Direct Antiviral Therapy of Hep C May Not Boost Hepatocellular Carcinoma Risk

New Articles Under: HCV-Statins 
- Statins: old drugs as new therapy for liver diseases?

New Articles Under: HCV-Education
- 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.”

Disparities in Access to Direct Acting Antiviral Regimens for Hepatitis C Virus (HCV): The Impact of Race and Insurance Status 
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.

Wayne Kuznar, for MDLinx
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.
Newsletter Highlights
August Issue
HealthWise – Hepatitis C and Sugar by Lucinda Porter, RN – Lucinda discusses effects of sugar on the body, hepatitis C, and fatty liver. 
(1) State Prisons Fail to Offer Cure to 144,000 Inmates with Deadly Hepatitis C
(2) What’s Being Done to Stop the Spread of Hepatitis A in the Midwest? 
SnapShots by Alan Franciscus: 
-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
Abstract:  Use of ribavirin in viruses other than hepatitis C. A review of the evidence,
Genotype from Punjab, India: Expanding classification of hepatitis C virus into 8 genotypes

The National Viral Hepatitis Roundtable
The National Viral Hepatitis Roundtable (NVHR) is national coalition working together to eliminate hepatitis B and C in the United States.
Save the date: Webinar August 8th on Engaging Drug Users to Fight Stigma and Access HCV
On Wednesday, August 8, 2018
National Viral Hepatitis Roundtable, the Urban Survivor's Union, the People’s Harm Reduction Alliance, and the Atlanta Harm Reduction Coalition will be hosting a webinar; Engaging Drug Users to Fight Stigma and Access HCV. These groups are working collaboratively on the "More than Tested, Empowered" project which addresses barriers to hepatitis C care faced by individuals who use drugs. The webinar will include findings from surveys delivered to healthcare providers and suggested educational messaging to improve access to hepatitis C care. In addition, each partner will discuss their methods for integrating participants into their work. After the presentation, there will be time for questions and discussion. 

Need To Talk To Someone?
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.
Learn more about Help-4-Hep
View all NVHR newsletters

The New York City Hepatitis C Task Force
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.
July 27, 2018 - NY Governor Announces First-In-Nation Task Force To Eliminate Hepatitis C 
View: Hep Free NYC Newsletters
Review all news updates.

HCV Action
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.
Aug 3, 2018
HCV Action e-update: July 2018

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.
View Recent Newsletters 
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.
View - all issues
Check out the talented people who blog at Hep.

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.
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
Topics
Loneliness Affects All Ages
Health Capsule - Preventing Shingles

Harvard Health
Ask the doctors

Inspirational Bloggers
Karen Hoyt is devoted to offering support and accurate information to people coping with the effects of hepatitis C.
Latest blog entry: Tired with Liver Disease: There’s a Nap for That

Lucinda K. Porter
Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C.
Latest blog entry: Wading Through Medicare

Hep 
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
Latest blog entry: A World Without Hepatitis Advocates
Healing Your Fatty Liver

Hepatitis NSW 
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?

CATIE Blog
A comprehensive website for HIV and hepatitis C information
Latest blog entry: Eliminating hepatitis C among Canadian immigrants and newcomers: how
CanHepC’s blueprint will impact my work.

Canadian Liver Foundation 
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.

HepatitisC.net
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.
Latest blog entry: Should I Be Screened for Liver Cancer?

HIV and ID Observations  
An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.
Latest blog entry: Really Rapid Review — International AIDS Conference 2018, Amsterdam

From The Archives 
SVR leads to significant improvement of liver fibrosis.
Research has shown people who are cured of their HCV infection experience a reduction in the rate of liver fibrosis progression, as well as improved liver function. For instance published in Antiviral Therapy/Aug 2017, evidence suggest HCV eradication or response to treatment (cure) is associated with regression of fibrosis and recovery of liver function which can be detected as early as end of treatment, check out the article: SVR in HCV leads to an early and significant improvement of liver fibrosis. In this more recent study presented at the 2018 Liver Congress researchers reported; Sustained & continued improvement in hepatic fibrosis beyond the first-year (& in the subsequent 3 years) following HCV treatment. Finally, published in Alimentary Pharmacology & Therapeutics/May 29, 2018 researchers reported: anti-viral therapy reduced liver fibrosis and steatosis in patients with chronic hepatitis C virus.

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

Diet Heavy in Meat Boosts NAFLD Risk
Large study shows 40% increased risk in overweight, elderly patients

Probiotic use is a link between brain fogginess, severe bloating
Medical College of Georgia at Augusta University
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.... 

August 6, 20184:58 AM ET
Heard on Morning Edition 
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.



Thanks for stopping by!
Tina

Friday, July 20, 2018

Merck To Steeply Cut Price of Hepatitis C Drug Zepatier

Merck To Steeply Cut Price of Hepatitis C Drug Zepatier
July 20, 2018
The company announced that it plans to reduce other drugs in its portfolio as well. Merck will drop the price of its Hepatitis C drug Zepatier by 60%, the company announced yesterday. In addition, it plans to cut the price of “several other” drugs by 10%. In doing so, Merck went further than two competitors—Pfizer and Novartis—who said that they would not increase drug prices for the rest of 2018.
Read more: https://www.managedcaremag.com/dailynews/20180720/merck-steeply-cut-price-hepatitis-c-drug-zepatier

Merck Is Lowering Drug Prices. There’s a Catch
July 19, 2018
The drugmaker Merck said Thursday that it would lower prices on several drugs by 10 percent or more, but its rollback affects minor products and would not lower the cost of its top-selling, expensive cancer and diabetes products.
Read more: https://www.nytimes.com/2018/07/19/health/merck-trump-drug-prices.html

Of Interest
Roche Hiked Cancer-Drug Prices Before Pledge to Keep Them Flat
Bloomberg
‎July‎ ‎20‎, ‎2018
For example, Fazeli said, Merck's hepatitis C treatment Zepatier was already facing competition from a cheaper, shorter-course treatment from AbbVie Inc. Merck said on Thursday it would cut Zepatier’s price by 60 percent as part of a commitment to responsible pricing. But the company probably would already have had to apply a hefty discount to the list price, Fazeli said.
Louisiana's New Approach To Treating Hepatitis C
Louisiana is working with Gilead Sciences and other companies on a deal that would change how the state pays for expensive hepatitis C drugs, with the goal of eliminating the disease in that state.
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. These barriers occur despite the fact that HCV is the most common indication for liver transplantation and cause of hepatocellular carcinoma in the U.S. Therefore, it is critical that policymakers bring all the stakeholders together and develop a national policy to eradicate HCV infection from the U.S.

July 9, 2018
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.

Tuesday, July 17, 2018

HCV Next: Physicians Diagnosing,Treating HCV Define New Role in Opioid Crisis


Check out the July/August issue of HCV Next, just released online at Healio

Table of Contents
Cover Story 
Physicians Diagnosing,Treating HCV Define New Role in Opioid Crisis
The opioid epidemic in the United States has affected millions, exposing them to health risks that include a range of infectious diseases.

Feature
Point-of-Care HCV Assays: A Turning Point for Decentralized Diagnosis
Compared with traditional hepatitis virological tests, the benefit of point-of-care diagnostics is their use in patient care sites such as outpatient clinics, intensive care units, emergency departments and medical laboratories. Additionally, certain low- and middle-income countries have made use of point-of-care tests in blood banks.

In the Journals Plus
Most iatrogenic HCV cases unidentified until symptom onset
Insurance denials for HCV therapy increase in US

Meeting News
HCV outcomes worse for patients with public insurance, Medicaid
Homeless veterans with HCV diagnosed, treated via PCP outreach

Trend Watch

Begin here.....

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.

Elsewhere
Efficacy of Generic Oral DAAs in Patients With HCV Infection
Journal of Viral Hepatitis, July 20, 2018

Tuesday, July 10, 2018

N.J. Expands hepatitis C treatments for all Medicaid enrollees

N.J. Expands Vital Hepatitis C Treatments for Medicaid Enrollees 

TRENTON – The New Jersey Department of Human Services announced expanded hepatitis C treatments for all Medicaid enrollees in the state, a policy facilitated by increased funding in the fiscal year 2019 budget.

The improvement comes amid ongoing concern about increased infections due to the opioid epidemic and a growing focus on identifying and treating hepatitis C infection among Baby Boomers.

New Jersey Human Services Commissioner Carole Johnson said that under the new policy, New Jersey Medicaid will cover hepatitis C curative drug treatment once someone is diagnosed with the virus. Previously, individuals in New Jersey were required to wait until their liver had already been damaged before accessing this treatment.

Sunday, July 1, 2018

Cost-effective universal screening for hepatitis C in France

Cost-effective universal screening for hepatitis C in France
It is currently recommended in Europe that screening for hepatitis C virus (HCV) should target people at high risk of infection. In France, public health data suggest that in 2014 approximately 75 000 people aged 18 to 80 were infected by HCV, but were unaware of their status. In at least one in ten cases, these people are at an advanced stage of the disease when diagnosed. Today's treatments of HCV infection are both highly effective and well tolerated, and cure the infection in a few weeks in over 95% of cases. In Professor Yazdan Yazdanpanah's Inserm research team, Sylvie Deuffic-Burban has developed a mathematical model that assesses the efficacy and cost-effectiveness of different screening strategies, including universal screening.

This study applied data from a 2004 InVS seroprevalence survey to 18- to 80-year-olds in France, excluding people with diagnosed chronic HCV infection. The researchers developed their analytical model using a combination of these seroprevalence data and findings from studies of the characteristics of people infected (age, sex, stage of the disease at diagnosis, alcohol intake, etc.), the natural progression of the disease, the efficacy of treatments, the quality of life of the patients treated, and the cost of treatment of infection. The screening strategies assessed targeted the following groups: the at-risk population only, all men aged between 18 and 59, all people aged between 40 and 59, all people aged between 40 and 80, and everyone aged between 18 and 80, ie, universal screening.

The modeling results show that universal screening is associated with better life expectancy adjusted for quality of life than other strategies. Universal screening is cost-effective if the patients tested for HCV infection are treated rapidly after diagnosis. Sylvie Deuffic-Burban points out that "Screening, on an individual basis, enables rapid treatment, which avoids the development of serious complications. In time, collective screening helps eliminate hepatitis C from a population that has been screened without restrictions." The results of this ANRS-funded study therefore argue in favor of universal screening for HCV in France, followed by immediate treatment of those diagnosed with HCV infection. Sylvie Deuffic-Burban concludes that "Although our model is unable to test the idea, the epidemiological similarities of HCV, HIV, and HBV suggest that universal and combined screening for these three viruses could be of particular interest."

Sources: Research Article
Assessing the cost-effectiveness of hepatitis C screening strategies in France
Sylvie Deuffic-Burban, Alexandre Huneau, Adeline Verleene, Cécile Brouard, Josiane Pillonel, Yann Le Strat, Sabrina Cossais, Françoise Roudot-Thoraval, Valérie Canva, Philippe Mathurin, Daniel Dhumeaux, Yazdan Yazdanpanah
DOI: https://doi.org/10.1016/j.jhep.2018.05.027
Publication stage: In Press Corrected Proof
Published online: July 1, 2018

Article Source

Tuesday, June 19, 2018

Increasing success and evolving barriers in the hepatitis C cascade of care

PLoS ONE 13(6): e0199174

Increasing success and evolving barriers in the hepatitis C cascade of care during the direct acting antiviral era 
Autumn Zuckerman, Andrew Douglas, Sam Nwosu, Leena Choi, Cody Chastain
Published: June 18, 2018
https://doi.org/10.1371/journal.pone.0199174 

With DAA therapy as the new standard of care, the HCV cascade of care (CoC) has transformed, still plagued by challenges in linkage to care yet substantially improved with regards to treatment outcomes. Interventions to emphasize screening, linkage to care, and access to treatment may address some of these challenges. Though DAA agents remain expensive for all groups, efforts to enhance and improve access across payer groups should be pursued. Integration of pharmacy services demonstrated high rates of medication access compared to previous studies, even in those with Medicaid. With new medications and modern tools, HCV treatment can be well-tolerated, effective, and result in high rates of completion.
Full Article

Abstract
Barriers remain in the hepatitis C virus (HCV) cascade of care (CoC), limiting the overall impact of direct acting antivirals. This study examines movement between the stages of the HCV CoC and identifies reasons why patients and specific patient populations fail to advance through care in a real world population. We performed a single-center, ambispective cohort study of patients receiving care in an outpatient infectious diseases clinic between October 2015 and September 2016. Patients were followed from treatment referral through sustained virologic response. Univariate and multivariate analyses were performed to identify factors related to completion of each step of the CoC. Of 187 patients meeting inclusion criteria, 120 (64%) completed an evaluation for HCV treatment, 119 (64%) were prescribed treatment, 114 (61%) were approved for treatment, 113 (60%) initiated treatment, 107 (57%) completed treatment, and 100 (53%) achieved a sustained virologic response. In univariate and multivariate analyses, patients with Medicaid insurance were less likely to complete an evaluation and were less likely to be approved for treatment. Treatment completion and SVR rates are much improved from historical CoC reports. However, linkage to care following referral continues to be a formidable challenge for the HCV CoC in the DAA era. Ongoing efforts should focus on linkage to care to capitalize on DAA treatment advances and improving access for patients with Medicaid insurance.

Thursday, June 7, 2018

Half of hepatitis C patients with private insurance denied life-saving drugs


Open Forum Infectious Diseases
Infectious Diseases Society of America
Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study
Charitha Gowda Stephen Lott Matthew Grigorian Dena M Carbonari M Elle Saine Stacey Trooskin Jason A Roy Jay R Kostman Paul Urick Vincent Lo Re, III
Open Forum Infectious Diseases, Volume 5, Issue 6, 1 June 2018, ofy076, https://doi.org/10.1093/ofid/ofy076
Despite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.
Link - Full Text Online
Download PDF

Half of hepatitis C patients with private insurance denied life-saving drugs

PHILADELPHIA - The number of insurance denials for life-saving hepatitis C drugs among patients with both private and public insurers remains high across the United States, researchers from the Perelman School of Medicine at the University of Pennsylvania reported in a new study published in the journal Open Forum Infectious Diseases. Private insurers had the highest denial rates, with 52.4 percent of patients denied coverage, while Medicaid denied 34.5 percent of patients and Medicare denied 14.7 percent.

The data was revealed through a prospective analysis of over 9,000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.

Direct-acting antiviral drugs (DAAs) - once-a-day pills that first became available in the United States in 2014 - are highly effective, with a 95 percent cure rate and few side effects for patients with chronic hepatitis C, but expensive. Because they can cost between $40,000 and $100,000, both private and public insurers have restricted access to the medications, approving the drugs only for patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit drug use, for example.

More recently, some of those restrictions had been relaxed because of vocal stakeholders and leaders, class action lawsuits, and greater drug price competition that experts believed would help increase the overall approvals by insurers. However, analysis of the data suggests otherwise.

"Despite the availability of these newer drugs and changes in restrictions in some areas, insurers continue to deny coverage at alarmingly high rates, particularly in the private sector," said study senior author Vincent Lo Re III, MD, MSCE, an associate professor of Infectious Disease and Epidemiology. "It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states."

The reason for the higher than expected denial rate is unclear, the authors said, but may be due to the varying restrictions on reimbursements that exist among the states. It's likely there were more attempts to treat patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist, they wrote.

The team analyzed prescriptions from 9,025 patients between January 2016 and April 2017 submitted to Diplomat Pharmacy Inc. throughout 45 states. Among those patients, 4,702 were covered by Medicaid; 1,821 by Medicare; and 2,502 by commercial insurance. In all, 3,200 (35.5 percent) were denied treatment.

The denial rates appear to be increasing, as well. The overall incidence of denials across all insurance types increased during the study period from 27.7 percent in the first quarter to 43.8 percent in the final quarter. In addition, a Penn study from 2015 found that just five percent who had Medicare received a denial, while 10 percent who had private insurance did.

That same study also found that 46 percent of Medicaid patients were denied coverage, compared to the current study's 35.7 percent. A statement from the Centers for Disease Control and Prevention in 2015 indicating that restrictions violated federal law prompted class action suits and legal action against Medicaid, which likely contributed to the public insurer easing its criteria across some states and improved approval rates, the authors said. Still, Medicaid denials increased over the study period.

"From a clinical standpoint, patients with chronic hepatitis C who are denied therapy can have continued progression of their liver fibrosis and remain at risk for the development of liver complications, like cirrhosis, hepatic decompensation, and liver cancer," Lo Re said. "In addition, chronic hepatitis C promotes not only liver inflammation, but systematic inflammation, which can lead to adverse consequences on organ systems outside of the liver, such as bone, cardiovascular, and kidney disease. Further, untreated patients can continue to transmit infection to others."

A recent report from the National Academies of Science, Engineering, and Medicine determined that at least 260,000 chronic hepatitis-infected patients must be treated yearly to achieve elimination of the virus in the United States by 2030. To reach that goal, they recommended that public and private insurers remove restrictions to the hepatitis C drugs that are not medically indicated and offer treatment to all chronic hepatitis C-infected patients. Those recommendations are also consistent with guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America.

"Eliminating hepatitis C in the U.S. is a feasible goal," Lo Re said, "but that's going to be hard to achieve if payers are not reimbursing for the treatment."

Today's News
Judge gives early OK to deal to expand Medicaid hep C relief
DETROIT (AP) - A judge has given preliminary approval to a deal that would expand access to hepatitis C treatments for Michigan residents on Medicaid.

On This Blog
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"