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

Wednesday, December 5, 2018

Appeal lodged against decision to uphold Gilead’s patent on hepatitis C drug

Video - The story of sofosbuvir illustrates how research and development for new prescription drugs really works: When Big Pharma plays for keeps, who wins and who loses?

Appeal lodged against decision to uphold Gilead’s patent on hepatitis C drug
Press Release
5 December 2018
Paris – Six organisations, including Médecins Sans Frontières (MSF), have just appealed the European Patent Office’s September decision to uphold US pharmaceutical corporation Gilead Science’s patent on the key hepatitis C drug sofosbuvir.

The appeal – filed by Médecins du Monde (MdM), MSF, AIDES (France), Access to Medicines Ireland, Praksis (Greece) and Salud por Derecho (Spain) – states that the European Patent Office (EPO) should revoke Gilead’s patent because it does not meet the requirements to be a patentable invention from a legal or scientific perspective.

The appeal comes exactly five years after sofosbuvir was first approved for use, in the US, where Gilead launched the drug at US$1,000 per pill, or $84,000 for a 12-week treatment course.

The corporation has made more than $58 billion from sales of the drug and its combinations in the last five years.

In March 2017, civil society organisations from 17 European countries filed a challenge against Gilead’s patent on the base compound of sofosbuvir, stating that Gilead’s patent claims were not legitimate, primarily because they lack inventiveness. 

Out-of-control drug prices 
Gilead’s monopoly on sofosbuvir in Europe has allowed the corporation to charge excessive prices for the drug.

In some European countries, Gilead charges as much as €43,000 for a 12-week treatment course, when generic versions of the same course can be purchased for less than €75 outside Europe.

"What is the point of medical innovation if people and health systems cannot afford the products coming out of it? Gaëlle Krikorian, head of policy at MSF’s Access Campaign"

These exorbitant prices have forced health systems to ration sofosbuvir, leaving thousands of people in Europe with hepatitis C without treatment.

Despite compelling arguments presented by the organisations opposing the patent, on 14 September 2018 the European Patent Office (EPO) decided to uphold Gilead’s patent, thereby making it impossible to produce or sell affordable generic versions of the drug in Europe.

“The EPO is being too lenient with pharmaceutical corporations, giving them a free pass,” said Olivier Maguet of MdM’s drug pricing campaign. “There needs to be much greater scrutiny in Europe when it comes to determining whether pharmaceutical corporations deserve patents or not; otherwise, unmerited monopolies will continue to result in out-of-control drug prices.”

The appeal aims to put an end to pharmaceutical corporations’ abuse of medicines patenting systems to increase their own profits – including in countries outside Europe, where patent offices often follow the EPO’s decisions when they decide whether to grant a patent to a pharmaceutical corporation or not.

As some new patented drugs – such as those to treat cancer – come to market with price tags reaching €400,000 per person, there is an urgent need to reform patent systems so that people have access to the medicines they need to stay alive and healthy.

“Unmerited patents in Europe are giving pharmaceutical corporations the monopoly power that allows them to charge exorbitant prices for many lifesaving drugs,” said Gaëlle Krikorian, head of policy at MSF’s Access Campaign.

The excessive prices Gilead is charging for sofosbuvir have kept this breakthrough medicine away from millions of people with hepatitis C in Europe and around the world. What is the point of medical innovation if people and health systems cannot afford the products coming out of it?”
https://www.msf.org/appeal-lodged-against-decision-uphold-gileads-patent-hepatitis-c-drug

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of current articles regarding the effectiveness and safety of generic hepatitis C medicines, as well as 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"

Tuesday, November 27, 2018

Wall Street - Curing diseases like Hepatitis C just doesn’t pay

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of current articles regarding the effectiveness and safety of generic hepatitis C medicines, 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"

In The News
Wall Street Wants the Best Patents, Not the Best Drugs
Curing diseases like Hepatitis C just doesn’t pay.
By
Joe Nocera
‎November‎ ‎27‎, ‎2018‎ ‎8‎:‎00‎ ‎AM‎ ‎EST 
It’s probably unfair to start a column about the new drugs that are curing Hepatitis C by referencing Jonas Salk and the discovery of the polio vaccine, but I’m going to do it anyway. It’s worth remembering what the world used to look like as we contemplate what it looks like now.

In the late 1940s and early 1950s, there was nothing that scared American parents more than polio, a disease that a) caused partial paralysis, b) was easily transmitted, and c) primarily affected children. Salk, who had worked on flu vaccines during World War II, joined the University of Pittsburgh in 1947 and soon began working on a possible polio vaccine. In 1953, he announced — on a national radio broadcast, no less — that he had developed a vaccine that prevented the disease; two years later, once its efficacy had been proven, the country undertook a national inoculation program, paid for by the federal government.
Read More:

Sunday, November 25, 2018

In a Critical State: Ongoing Barriers to Treatment for Hepatitis C Virus (HCV)

Editorial
In a Critical State: Ongoing Barriers to Treatment for Hepatitis C Virus (HCV)
Jorge Mera, MD, Brigg Reilley, MPH, Jessica Leston, David Stephens, RN

DOI: https://doi.org/10.1016/j.amjmed.2018.10.031

The American Journal of Medicine
Publication History
Published online: November 24, 2018

Abstract 
Recent advances in Hepatitis C Virus HCV treatment could be described as revolutionary: for uncomplicated patients, treatment is nearly 100% effective, oral-only, has a low pill burden, minimal side effects, and results in a cure.1 Comparisons we have heard from clinicians are that HCV is now easier to treat than either diabetes or hypertension. Unfortunately for many patients, their state of residence is the decisive factor for whether they will receive lifesaving treatment. As part of a tribal telehealth network for HCV, we support several rural clinics successfully treating HCV and see this dilemma all too frequently.

Consider a patient with chronic HCV infection who presents with a recent history of marijuana use and has been late picking up hypertension medication. The patient has cirrhosis and is at high risk of HCV related mortality. He is enrolled in state Medicaid and highly motivated for treatment. What is the treatment plan? It depends on the state. A resident of New Mexico can start treatment without delay. If instead the patient lives in Montana, a state that determines treatment eligibility based on advanced liver fibrosis, documented sobriety, and compliance with existing medications, the consultation is effectively moot; treatment will be denied. Montana is far from alone in its HCV treatment restrictions. Patients in South Dakota, Oregon, and several other states we serve face similar hurdles …

View Full-Text Article Online:
https://www.amjmed.com/action/showFullTextImages?pii=S0002-9343%2818%2931072-6

Download PDF:
https://www.amjmed.com/article/S0002-9343(18)31072-6/pdf

Current Issue
November 2018
Volume 131, Issue 11 

Saturday, November 24, 2018

In half of hepatitis C patients, DAA treatment can shortened to 6 weeks

Recommended 
Media
Hepatitis C treatment can be shortened in 50 percent of patients, study finds
Shorter treatment times could significantly reduce costs of the expensive therapy

Slides available online @ NATAP

AASLD The Liver Meeting 2018
Abstract

In half of hepatitis C patients, DAA treatment can shortened to 6 weeks
Last Updated: 2018-11-23
By Lorraine L. Janeczko

NEW YORK (Reuters Health) - In about half of patients with hepatitis C virus (HCV) infection, response-guided therapy with oral direct-acting antiviral agents (DAAs) can be reduced from the standard 12 weeks to as little as six weeks and still be effective, according to a new pilot study.

DAAs have revolutionized hepatitis C treatment, eliminating the virus and enabling a cure with minimal side effects in over 90% of patients treated. But the high cost, which can exceed $50,000 per patient, limits patient access and burdens the insurance industry, researchers write in a press release.

"Implementing response-guided therapy as standard of care may lead to significant cost savings on the expensive hepatitis C treatment," senior author Dr. Amir Shlomai of Beilinson Hospital in Petah-Tikva, Israel, told Reuters Health by email.

The team enrolled 22 HCV patients with compensated liver disease and genotypes 1 to 6, who were either treatment naive or interferon experienced. Participants were treated with one of four DAA regimens chosen by the investigators.

Viral load was measured at baseline, at day 2, and at weeks 1, 2, and 4 after the start of treatment. The primary endpoint was the proportion of patients with sustained virologic response at 12 weeks (SVR12) post-treatment, with undetectable HCV RNA (<15 IU/mL).

The researchers presented the preliminary proof-of-concept results in a late-breaking abstract poster session on November 12 at The Liver Meeting 2018, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), in San Francisco.

Participants averaged roughly 50 years of age, 11 were female and 9% had METAVIR scores of F3-4. The most common genotypes were G1b (59%) G3 (27%), G1a (9%), and G2 (5%).

The drug combinations sofosbuvir/velpatasvir, elbasvir/grazoprevir, sofosbuvir/ledipasvir and glecaprevir/pibrentasvir were administered to 41%, 31%, 23% and 5% of participants, respectively.

Mathematical modeling of viral kinetics was performed during weeks 2-4 to project time to cure, and model projections were used to individualize each participant's treatment duration.

Modeling predicted that treatment duration could be shortened to 10 weeks in one patient (5%), eight weeks in eight (36%) and six weeks in two (9%).

Of the 19 participants who completed therapy, 100% had undetectable viral load at the end of treatment. Of those, 18 (95%) remained HCV-undetectable four weeks after treatment.

Of the 15 patients who reached post-treatment week 12, 14 (93%) achieved SVR12.

One treatment-naive G3 patient with F1 fibrosis who was treated with sofosbuvir/velpatasvir for six weeks relapsed. Virus sequencing did not detect resistance-associated substitutions at baseline or in response to treatment, and no significant side effects were found among the DAA-treated patients.

"A shorter treatment may lead to improved compliance to treatment, especially in special populations, including hepatitis C patients with limited health insurance benefits," Dr. Harel Dahari of Loyola University Chicago in Maywood, Illinois, who also worked on the study, told Reuters health by email.

Dr. Dahari estimates that the shorter treatment may potentially decrease the cost of HCV drugs by up to 20%.

Now that the proof-of-concept pilot study has shown that response-guided therapy can potentially reduce treatment times, a large multicenter trial to validate the results is underway in Israel, the authors say.

Clalit Health Services in Israel and the United States National Institutes of Health helped support the study. The authors state that they have no conflicts of interest.

http://www.chronicliverdisease.org/reuters/article.cfm?article=20181123Other134843869

SOURCE: LB-34 Response-Guided Therapy with Direct-Acting Antivirals Shortens Treatment Duration in 50% of HCV Treated Patients

AASLD The Liver Meeting 2018.

Thursday, November 22, 2018

Blogging About Liver Disease: Reasons To Be Grateful


Happy Thanksgiving! This year, and every year, I am grateful for a small group of talented bloggers who continue to keep us informed about all types of viral hepatitis.

In the spirit of the holiday, each blog has featured many reasons to be thankful this year; from curing HCV to improving the treatment of HIV.

Latest Articles 
Some of the following blogs are published by support organizations, healthcare professionals or physicians, while others are written from a patients perspective, offering us healthy tips about each stage of liver disease.

New @ HIV and ID Observations
Paul E. Sax, MD
As noted here before, I’m a big fan of Thanksgiving, a great excuse to get together with family and friends, and to eat a gargantuan amount of food.*

Hepatitis B Foundation
Holidays with Hepatitis B: How to Tell Your Family
hepbtalk
As the holidays approach, families are planning parties and dinners and preparing to spend time with their loved ones. In such a merry atmosphere, the idea of discussing hepatitis B – whether its a recent diagnosis or the first time that you are ready to disclose your status – may be intimidating. However, it doesn’t have to be! In honor of National Family Health History Day – which falls on Thanksgiving – we put together some tips to help you start the conversation.

Joseph Galati, M.D.
Tips for a Healthier Holiday
Ahh, the holidays. A time to celebrate all the good that has come our way during the previous year. First up: Thanksgiving. What better way to begin the year-end wrap-up than to sit down at a hearty meal with family and friends? But the holidays are arguably the toughest time of the year to eat..

Hep Blogs
Finding Gratitude in Sickness, Health and Hepatitis 
By Lucinda K. Porter, RN
Some good news in the hepatitis C realm, plus a look at the practice of gratitude.

Mavyret versus Epclusa
By Greg Jefferys
Both Mavyret and Epclusa give cure rates above 97% for all genotypes of Hepatitis C except for G3 where both give a cure rate of around 95%.

The End Times
By Grace Campbell
Who gave cirrhosis such a catchy generic title? End stage liver disease. There’s a name sure to invoke confidence.

Liver Meeting 2018 Wrap-Up: Vaccines, Diet, and an Increasing Liver Menace 
By Lucinda K. Porter, RN
Ending the week with summaries of research from the 2018 Liver Meeting. I cover hepatitis B vaccination, diet and alcoholic liver disease.

HepatitisC.net
Options for Treatment with Liver Cancer
By Karen Hoyt
After my diagnosis of liver cancer, I had to find out what options for treatment were available.

ADRLF (Al D. Rodriguez Liver Foundation)
Who says a fantastically delicious Thanksgiving spread can’t be healthy? This year, make your Thanksgiving feast even more special with these liver-healthy options that won’t give you or your family that post-holiday guilt; nor will they keep you stuck in the kitchen for hours on end! Check out these appetizing recipes for a healthy, scrumptious, easy-to-prep (or time-saving) Thanksgiving meal!

Finding Hope in Affordable Hepatitis Screening
Screening remains to be the best defense against detecting the hepatitis virus in its earliest stages, and potentially developing life-threatening complications, later down the line. Dubbed as the “silent killer,” hepatitis doesn’t exhibit obvious symptoms in many people, who may live, comfortably, with the virus for years and only discover their condition at its advanced, acute stage. Noting the importance of the timeliness of testing, Texas-based Link2Labs is making affordable hepatitis C tests available to uninsured and underinsured people.

HCV News
Weekly Review
Catch up on what you missed this week, read HepCBC's - Weekly Bull.

FYI - Lettuce Recall 
“I believe it’s all related to a big increase in obesity and type 2 diabetes in this country,” lead study author Zobair M. Younossi, MD, MPH, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases. “Those two risk factors drive NAFLD and its progressive type, nonalcoholic steatohepatitis (NASH). That accounts for at least part of the increase in mortality related to liver disease.”

AGA Journals - Blog
Dr. Kristine Novak
Persistent drinking of very hot coffee can cause exfoliative esophagitis due to thermal injury, researchers report in the November issue of Clinical Gastroenterology and Hepatology. Florian Schertl et al describe the case of a 55-year-old woman with new retrosternal pain upon swallowing. She had been receiving continuous and successful proton pump inhibitor.

Fatty Liver Disease
Canadian Liver Foundation
It Happened To Me | My Fatty Liver Journey
Melanie was all too familiar with fatty liver disease, with her husband being diagnosed 5 years earlier. But, she never thought it would happen to her.

The Flu & You
Canadian Liver Foundation
What’s intended to help shouldn’t hurt
Before you head to the cabinet for medication, there are a few things you should know to ensure that what you take will help, not hurt.

One Medical blog
So you’ve come down with a nasty bug that’s been making the rounds.

This Blog
Flu Activity Updated Nov 10/News Articles Nov 16
Weekend Reading - Baby Boomers and the Flu

Recommended Blogs
Dr Paul Gow talks all things the liver and answers call-in questions on ABC Nightlife 


Source - Hepatitis Victoria

On Twitter
Shared by @HenryEChang 

Just Because
Matthew Kaskavitch
CU Anschutz Medical Campus experts share Thanksgiving health insights
Thanksgiving is almost here, and that means two things: 1) time spent with family and friends around the television watching football, and 2) eating turkey. Lots and lots of turkey. At this time of year, we often overindulge and loosen our belt and wonder how we fit all that stuffing and gravy into our stomach. Don’t worry. We asked leading health experts from the University of Colorado Anschutz Medical Campus a few of the Thanksgiving questions you’ve always wanted to know the answer to.

Happy Thanksgiving!

Tuesday, November 20, 2018

Kansas Agrees To Cover Potentially Life-Saving Drugs For Patients With Chronic Hepatitis C

Kansas Agrees To Cover Potentially Life-Saving Drugs For Patients With Chronic Hepatitis C 
By Dan Margolies
Kansas has agreed to cover the cost of drugs to treat Medicaid patients with chronic hepatitis C without subjecting them to a lengthy list of requirements.

A legal settlement, which awaits final court approval, resolves a class action lawsuit alleging the state made it too difficult for hepatitis C patients to receive the potentially life-saving treatments.

The parties first notified the court in July that they had resolved the case after mediation. On Tuesday, the court set deadlines for approval of a final settlement.

“Essentially, the agreement is that all hep C patients who use Medicaid to get their drugs will be entitled to Mavyret or Harvoni, the two curative drugs, regardless of their fibrosis score,” said Lauren Bonds, legal director of the ACLU of Kansas, which along with the Shook Hardy & Bacon law firm, sued Kansas officials over the state's hep C treatment guidelines in February.

Fibrosis scores measure the health of the liver. Scores range from F0, referring to mild or no scarring of the liver, to F4, referring to significant liver damage or cirrhosis. Kansas’ privatized Medicaid program, known as KanCare, had limited coverage to patients with a fibrosis score of F3 or F4. 

On Twitter 
Shared by @HenryEChang

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of current articles regarding the effectiveness and safety of generic hepatitis C medicines, 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"

Monday, November 12, 2018

Hepatitis C treatment can be shortened in 50 percent of patients, study finds

Hepatitis C treatment can be shortened in 50 percent of patients, study finds
Shorter treatment times could significantly reduce costs of the expensive therapy

Loyola University Health System

MAYWOOD, IL - Hepatitis C drugs cure more than 90 percent of patients, but can cost more than $50,000 per patient.

Findings from a new study could lead to significant cost savings. Preliminary data from the study, co-led by a theoretical modeling researcher from Loyola University Chicago Stritch School of Medicine and Loyola Medicine, found that in 50 percent of patients, the standard 12-week treatment regimen could be shortened to as little as six weeks without compromising efficacy.

"There's a potential to save up to 20 percent of the costs of hepatitis C drugs," said Loyola researcher Harel Dahari, PhD, co-first author of the study along with Ohad Etzion, MD, of Soroka University Medical Center in Israel. Senior author is Amir Shlomai, MD, PhD, of Beilinson Hospital in Israel.

The study was presented November 12 during the annual meeting of the American Association for the Study of Liver Diseases in San Francisco.

Dr. Dahari is co-director of the Program for Experimental and Theoretical Modeling (PETM) in the division of hepatology of Loyola Medicine and Loyola University Chicago Stritch School of Medicine. Two other Loyola authors are Susan Uprichard, PhD, co-director of PETM and an associate professor in the department of microbiology and immunology and Scott Cotler, MD, head of Loyola Medicine's division of hepatology and a professor in the department of medicine of Loyola University Chicago Stritch School of Medicine.

Hepatitis C is an infection caused by a virus spread through contaminated blood. It can lead to liver damage, liver failure and liver cancer. An estimated 70 million people worldwide, including about three million in the United States, are chronically infected with hepatitis C.

A class of oral medications called direct acting anti-virals (DAA) has revolutionized the treatment of hepatitis C. In more than 90 percent of patients, the medications eliminate the virus and cure the patient, with minimal side effects. But the high cost limits access and is a substantial financial burden on Medicare, Medicaid and private insurers.

"Treatment currently is standardized to be given for a set period of time, usually 12 weeks, rather than being tailored to the individual patient," Dr. Cotler said.

In the new study, researchers used a personalized medicine technique called modeling-based response-guided therapy to reduce treatment times when possible. After patients had undergone treatment for a few weeks, researchers measured how much hepatitis C virus levels had decreased. They used mathematical modeling to estimate how long it would take to completely eliminate the virus.

The study has included 22 patients so far. Mathematical modeling predicted that treatment could be shortened to 10 weeks in one patient (five percent of the total patients), eight weeks in eight patients (36 percent) and six weeks in two patients (nine percent). The other 11 patients (50 percent) needed to be treated for the standard 12 weeks.

Twenty-one patients remained virus-free. The only patient who relapsed had the most difficult-to-treat form of the hepatitis C virus, known as genotype 3.

The proof-of-concept pilot study showed that using response-guided therapy to reduce treatment times is feasible. To validate the results, a large multicenter trial is underway in Israel.

Dr. Dahari said that in addition to cutting costs, shorter treatment regimens would make it easier to treat hepatitis C patients who have limited health insurance benefits.

###
The study was conducted with David Yardeni, MD, Anat Nevo-Shor, MD, Daniela Munteanu, MD, and Naim Abufreha, MD, of the Department of Gastroenterology and Liver Diseases, Soroka University Medical Center, Beesheba, Israel; Assaf Issachar, MD, Michal Cohen-Naftaly, MD, Orly Sneh Arbib, MD, and Marius Braun, MD, of the Liver Institute, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel; and Orna Mor, PhD, of the Central Virology Laboratory, Ministry of Health, Sheba Medical Center, Israel.

The study is titled, "Response-Guided Therapy with DAA Shortens Treatment Durations in 50 Percent of HCV-Treated Patients."

The study was supported in part by Clalit, a health service organizaton in Israel and the U.S. National Institutes of Health. 

Thursday, November 8, 2018

Drug pricing: still a barrier to elimination of HCV

The Lancet Gastroenterology & Hepatology
Published: December, 2018
DOI: https://doi.org/10.1016/S2468-1253(18)30354-6

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....

Abbvie has entered into legal action against NHS England over hepatitis C drug program


NHS England taken to court over 'largest ever medicines procurement' 
6 November 2018
NHS England taken to court over 'largest ever medicines procurement'

Pharmaceutical company takes NHS England to court 
Legal challenge over procurement for suppliers of hepatitis C treatment 
Procurement aimed to kick start drive to eliminate disease in England 

A global pharmaceutical company has taken the NHS to court over a procurement process aimed to help England become the first country to eliminate hepatitis C.

American firm Abbvie is claiming NHS England breached procurement rules during a process seeking suppliers for hepatitis C treatment.

The Illinois based company launched proceedings in London’s Technology and Construction Court this summer. NHS England has denied the allegation.

Read More: https://www.hsj.co.uk/service-design/nhs-england-taken-to-court-over-largest-ever-medicines-procurement/7023733.article

Saturday, November 3, 2018

Ohio Medicaid lifts restrictions on costly hepatitis C drugs

Ohio Medicaid lifts restrictions on costly hepatitis C drugs
By Kaitlin Schroeder, Cox Newspapers

DAYTON, Ohio -- As the opioid crisis led to a spike in new hepatitis C cases, a breakthrough prescription hit the market five years ago that could cure the viral liver disease -- but at an eyepopping price tag of $1,000 per pill.

Now, as costs are coming down and demands for compassion mount, Ohio Medicaid will let all patients get the potentially life-saving medication once diagnosed instead of providing them to only the sickest patients.

The expensive medications caused Medicaid and private insurers that manage Medicaid plans to consider whether to limit the treatment based on the patient's stage of liver damage, and many did.

But Ohio Medicaid announced this week that in an effort to mitigate the harm caused by the opioid epidemic, the department is changing policy starting Jan. 1 to begin treatment at the time of chronic hep C diagnosis.

Read More: 

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"

Thursday, November 1, 2018

Gauging Clinical, Cost Impact of All-Oral DAAs on Hepatitis C

Gauging Clinical, Cost Impact of All-Oral DAAs on Hepatitis C
NOVEMBER 01, 2018
Kenneth Bender, PharmD, MA
A new analysis gauges the impact of all-oral direct-acting antivirals (DAAs) on the clinical and economic outcomes of hepatitis C virus (HCV) in the 4 years since the first of these treatments was approved for marketing in the US.
Haesuk Park, PhD, Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL and colleagues determined that, in this short term, all-oral DAA treatment of HCV was associated with a decreased risk of developing hepatocellular carcinoma (HCC) and decompensated cirrhosis (DCC) and a reduction in healthcare costs.
Read the article: https://www.mdmag.com/medical-news/gauging-clinical-cost-impact-of-alloral-daas-on-hepatitis-c

In the journal Hepatology
Hepatology. 2018 Oct 5. doi: 10.1002/hep.30303. [Epub ahead of print]

Anti-virals cure up to 98% of hepatitis C patients since 2014
Oct 8, 2018
Paul Cullen 
Use of revolutionary drugs has led to ‘a triumph of science’, says hepatologist

Up to 98 per cent of patients with hepatitis C virus have been cured thanks to the use of revolutionary anti-viral drugs over the past four years, new figures show.

The figures from the national treatment registry for Irish hepatitis C patients represent “a triumph of science”, Dr Diarmuid Houlihan, a hepatologist at St Vincent’s University Hospital told a conference in Dublin on Monday.

Hepatitis C is a virus that infects and damages the liver. It can cause inflammation scarring of the liver, which in some people can progress to cause serious liver damage, such as cirrhosis. It is often referred to as a silent disease, as symptoms can take several years to develop and people do not realize they have the disease.


On This Blog
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" 

Monday, October 29, 2018

Gilead $1,100 a day drug. Now it will launch a generic at quarter the price

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.

Read more:

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"

Friday, October 19, 2018

HCV Drug Ravidasvir is on the List of Proposed Priority Review by the Chinese Food and Drug Administration

Ascletis’Ravidasvir NDA Proposed for Priority Review by the CFDA
Hangzhou and Shaoxing, China (Oct. 18, 2018) - Ascletis Pharma Inc. (1672.HK) announces today the New Drug Application (NDA) of Ravidasvir is on the List of Proposed Priority Review, according to the public notification by the China Food and Drug Administration (CFDA) on Oct 17th, 2018. Such Priority Review will accelerate Ravidasvir NDA approval process significantly. Ravidasvir is Ascletis’ second category 1 drug for Hepatitis C.

Ravidasvir is a next-generation, best-in-class and pan-genotypic HCV NS5A inhibitor with a high genetic barrier to resistance. Ravidasvir in combination with Ganovo® (RDV/DNV Regimen) is the first all-oral interferon-free HCV regimen developed by a domestic company in China. Phase II/III clinical trial conducted in China has shown that RDV/DNV Regimen demonstrated a cure rate of 99 % (SVR12) with a short treatment duration of 12 weeks in genotype 1 patients. In patients with baseline NS5A resistance mutations, RDV/DNV Regimen demonstrated a cure rate of 100% (SVR12). Ascletis received the acceptance letter from the CFDA for Ravidasvir NDA on Aug. 1, 2018.

”We launched our first breakthrough HCV regimen 3 months ago. Ganovo Regimen has been well recognized and accepted by the doctors and experts,” said Jinzi J. Wu, Ph.D., Ascletis’ founder, Chairman and CEO. ”The Priority Review for Ravidasvir NDA will accelerate the launch of Ascletis’ all-oral regimen. This will enable Ascletis to soon provide two breakthrough HCV treatment regimens for Chinese patients and further strengthen our leadership position as an integrated solution provider in HCV treatment in China.” 

Of Interest
April 12, 2018 An affordable hepatitis C combination treatment including the new drug candidate ravidasvir has been shown to be safe and effective, with extremely high cure rates for patients, including hard-to-treat cases, according to interim results from the Phase II/III STORM-C-1 trial presented by the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) at the International Liver Conference in Paris.  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….

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
October 29, 2018
Gilead $1,100 a day drug. Now it will launch a generic at quarter the price
Sep 27, 2018
An ‘unusual decision’: Gilead to launch hep C generics ten years early

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"