Showing posts with label HCV generics. Show all posts
Showing posts with label HCV generics. Show all posts

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

Wednesday, May 23, 2018

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions
May 23, 2018
Sydney Lupkin, Kaiser Health News

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”

https://khn.org/news/drugmakers-blamed-for-blocking-generics-have-milked-prices-and-cost-u-s-billions/

This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Wednesday, March 7, 2018

Generic Hepatitis C Drugs Begin to Emerge

Recommended Reading
J Viral Hepat. 2018 Jan 28. doi: 10.1111/jvh.12870. [Epub ahead of print]
Full Text - Download Article
Shared by @HenryEChang via Twitter.

Secialty Pharmacy Times
Generic Hepatitis C Drugs Begin to Emerge
Laurie Toich
Associate Editor Publish Date: Wednesday, March 07, 2018
The cost of hepatitis C virus (HCV) antivirals has been at the forefront of health care spending conversations for years. Although it has slowed, spending on the blockbuster drugs remains high. Despite the curative ability of the treatments, it is likely that a significant need for antiviral drugs will remain into the foreseeable future due the prevalence of undiagnosed HCV cases.
Continue Reading

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

Tuesday, January 30, 2018

Efficacy of Generic Oral Directly Acting Agents in Patients with Hepatitis C Virus Infection.

J Viral Hepat. 2018 Jan 28. doi: 10.1111/jvh.12870. [Epub ahead of print]

Efficacy of Generic Oral Directly Acting Agents in Patients with Hepatitis C Virus Infection.
Gupta S1, Rout G1, Patel AH2, Mahanta M1, Kalra N1, Sahu P1, Sethia R1, Agarwal A1, Ranjan G1, Kedia S1, Acharya SK1, Nayak B1, Shalimar1.


Full Text
shared by @HenryEChang via Twitter.
Download Article

Abstract
Novel direct-acting antivirals (DAAs) are now the standard of care for the management of Hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented. 490 patients (mean age: 38.9±12.7years) were treated with generic DAAs in the study time period. Their clinical presentations included chronic hepatitis (CHC) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases, and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n=372, 75.9%) followed by genotype 1 (n=97, 19.8%). Treatment naïve and treatment-experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%) respectively. Generic DAA treatment regimens included sofosbuvir in combination with ribavirin (n=175), daclatasvir alone (n=149), ribavirin and peginterferon (n=80), ledipasvir alone (n=43), daclatasvir and ribavirin (n=37), and ledipasvir and ribavirin (n=6). Overall SVR12 was 95.9% (470/490) for all treatment regimens. SVR12 for treatment-naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58) respectively, P=0.005. High SVR12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR12 with 12 weeks or 24 weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAAs are associated with high SVR rates in patients with HCV infection in a real life clinical scenario.

This article is protected by copyright. All rights reserved.
Continue to article: https://jumpshare.com/v/mKWNPYZU3hXMw3WB2Cb2

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Wednesday, November 29, 2017

Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt

Alimentary Pharmacology and Therapeutics - November 29, 2017

Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt
H. Omar, W. El Akel, T. Elbaz, M. El Kassas, K. Elsaeed, H. El Shazly, M. Said, M. Yousif, A. A. Gomaa, A. Nasr, M. AbdAllah, M. Korany, S. A. Ismail, M. K. Shaker, W. Doss, G. Esmat, I. Waked, Y. El Shazly


Abstract
Summary
Background
Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3. The national program in Egypt is using SOF-DCV combination for large scale treatment.

Aim
To assess the efficacy and safety of combined SOF-DCV in treating patients with HCV-G4 in a real-world setting.

Methods
Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the national hepatitis C treatment program in Egypt are presented. Treatment-naïve patients without cirrhosis were treated without RBV, and those who had cirrhosis or were treatment-experienced (interferon experienced or SOF experienced) received RBV. Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post-treatment week 12 (SVR12) were explored.

Results
During the first 2 months of the programme, 18 378 patients with HCV-G4 started treatment with SOF-DCV with or without RBV. Overall, 95.1% achieved SVR12 (95.4% among patients treated without RBV and 94.7% for patients treated with RBV, P = .32). Treatment was prematurely discontinued in only 1.5% of patients. The most common events leading to discontinuation were patient withdrawal (n = 76) and pregnancy (n = 5). Five deaths occurred within this group.

Conclusions
Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.

Tuesday, October 31, 2017

MSF secures generic hepatitis C treatment at $120 compared to $147,000 launch price tag

MSF secures generic hepatitis C treatment at $120 compared to $147,000 launch price tag
Report from Médecins Sans Frontières

Tuesday, October 31, 2017 — Dramatic price drops should allow countries to provide treatment for millions of people

Reading Material: Not Even Close: This issue brief provides information on currently available HCV diagnostics and treatments, including pricing and registration information from manufacturers of DAAs www.msfaccess.org/hep-c-not-even-close

Geneva/Sao Paolo, 31 October 2017—On the eve of the World Hepatitis Summit in Sao Paolo, the international medical humanitarian organization Médecins Sans Frontières (MSF) today announced that it had secured deals for generic hepatitis C medicines for as low as US$1.40 per day, or $120 per 12-week treatment course for the two key medicines sofosbuvir and daclatasvir.

In the US, pharmaceutical corporation Gilead launched sofosbuvir at $1,000 per pill in 2013, and Bristol-Myers Squibb (BMS) launched daclatasvir at $750 per pill in 2015, leading to the original price tag of $147,000 for a person’s 12-week combination treatment course. The corporations have also been charging exorbitant prices in many developing countries, paralyzing the launch of national treatment programs and causing treatment rationing in many countries around the world.

“What good is a breakthrough medicine that people cannot afford?” asked Jessica Burry, Pharmacist for MSF’s Access Campaign. “Pharmaceutical corporations price hepatitis C medicines far out of reach for people paying out of pocket around the world, and also for many governments struggling to provide treatment in the public sectors; but the prices for generic versions keep coming down. Governments must use every tool in their toolbox to fight for access to lower-priced generics so they can scale up treatment for the millions of people who need it; they should follow the lead of countries like Malaysia and issue compulsory licenses when patents block people’s access to this life-saving treatment.”

In 2015, MSF started procuring sofosbuvir and daclatasvir from Gilead and BMS through their ‘access programs’ at a price of $1,400 to $1,800 per 12-week treatment. Today, MSF pays a fraction of that, at $120, sourced from quality-assured generic manufacturers.

An estimated 71 million people have chronic hepatitis C infection worldwide, 72 per cent of whom live in low- and middle-income countries. Direct-acting antiviral medicines (DAAs) represent a treatment breakthrough for people with hepatitis C, with cure rates of up to 95%, and with far fewer side effects than previous treatments. Yet access to DAAs has remained limited because pharmaceutical corporations charge unaffordable prices, leading many countries to reserve treatment only for people with the most advanced stages of the disease. By the end of 2016, three years after sofosbuvir was launched, only an estimated 2.1 million people globally had been treated with the medicines, leaving 69 million people still without access.

These high prices have also put a major strain on health systems in wealthy countries, in particular those enacting universal health care. Treatment is being rationed in countries such as Australia, Canada, Italy and the US, in addition to developing countries, and is a stark reminder of the early days of HIV treatment.

“Almost two decades ago, MSF and others worked hard to get access to generics and bring down prices for HIV medicines,” said Mickael Le Paih of MSF in Cambodia, where MSF treats people living with hepatitis C. “History is repeating itself with hepatitis C—the medicines we need are again too expensive, but we are finding ways to make treatment affordable so that our patients can be cured.”

MSF treats people with hepatitis C in 11 countries. Since 2015, MSF has provided DAA treatment to nearly 5,000 people with hepatitis C. Of those who have completed treatment to date, the overall cure rate – measured by ‘sustained viral response’ – is 94.9 per cent.

Reading Material: Not Even Close: This issue brief provides information on currently available HCV diagnostics and treatments, including pricing and registration information from manufacturers of DAAs

Sunday, October 22, 2017

The Liver Meeting® - HCV direct acting antivirals: Generics shown to be bioequivalent to originator brands

On Twitter - Shared By Henry E. Chang

Follow "Henry E. Chang" on Twitter to review clinical research and updates from The Liver Meeting® 2017; online via an easy to view sharing platform.

Of Interest - Forging a Path to HCV Elimination

Bioequivalent pharmacokinetics for generic and originator HCV direct acting antivirals
Andrew M. Hill1, Loai Tahat2, Mohammed Khalil Mohammed3, Sanjay Nath4, Rabab Fayez Tayyem3, James A. Freeman5, Ismahane Benbitour7, Sherine Helmy

Conclusion 


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Saturday, October 14, 2017

NPR-Ed Silverman, Dr. William Carey Discuss: New Pan-genotypic HCV Drugs: Cost & Cure


Wellness Wednesday: Hepatitis C, Plastic Surgery Safety

Oct 11, 2017
Program available online at WOSU Radio, hosted by Ann Fisher.

In case you missed it, last week on the morning edition of NPR News, Ed Silverman, senior writer and Pharmalot columnist, STAT News, and Dr. William Carey, senior hepatologist in the Department of Gastroenterology, Cleveland Clinic, sat down to discuss cost and cure rates of the newly approved drugs used to treat all HCV genotypes.

Topics
Estimated 180,000 people with HCV go untreated
Gilead, AbbVie and Merck - Cost, price competition, treatment duration, and HCV cure rates
Disease progression
HCV Generics

The interview is about 15 minutes long, starting point is at 15.35, or fifteen minutes into the program.

Link
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Of Interest - On This Blog
Hepatitis C Timeline
First recorded references to hepatitis epidemics, to the 1989 discovery of the hepatitis C virus, as well as HCV discontinued agents, ending with the FDA approved treatments used today.

Saturday, October 7, 2017

High sustained virological response rates using imported generic direct acting antiviral treatment for hepatitis C

On Twitter
The following full-text article is available in PDF, shared on Twitter by @HenryEChang

Journal of Virus Eradication 
High sustained virological response rates using imported generic direct acting antiviral treatment for hepatitis C
Andrew Hill, Giten Khwairakpam, James Wang, Sergey Golovin, Julia Dragunova, Rachel Smith, Vicky Houghton-Price, Roxanna Korologou-Linden, Sanjay Nath, Anna Savage, Greg Jefferys

Abstract
Background: High prices of direct acting antivirals (DAAs) for hepatitis C virus (HCV) can lead to restrictions on access to treatment in high- and middle-income countries. An increasing number of people in these regions are treating their HCV infection with generic drugs produced in India, China, Bangladesh or Egypt. This analysis assessed the efficacy of generic imported DAAs. Methods: Patients sourced generic versions of sofosbuvir (SOF), ledipasvir (LDV) and daclatasvir (DCV) from suppliers in India, Bangladesh, China and Egypt via three buyers’ clubs. The choice of DAAs and the length of treatment were determined on baseline RNA levels, HCV genotype and stage of fibrosis. Patient HCV RNA levels were evaluated pre-treatment, during treatment, at end of treatment (EOT) and then for sustained virological response (SVR) at 4, 12, and 24 weeks, normally by a treating clinician. Results: Overall 616 patients submitted results: 199 from an Australian buyers’ club, 205 from a South-east Asian buyers’ clubs, and 212 from an Eastern European buyers’ club. Of the 616 patients treated, 276 received SOF/LDV (35 with ribavirin [RBV]) and 340 received SOF/DCV (61 with RBV). At baseline, 61% were male, 52 % had HCV genotype 1 and 11% had liver cirrhosis. The mean age was 44.3 years and the mean baseline HCV RNA was 6.9 log10 IU/mL. A rapid virological response (RVR) was observed in 314/375 (84%) of the patients treated. Based on currently available data, the percentage of patients with HCV RNA below the lower limit of quantification (LLoQ) was 99% (234/237) at EOT, 99% (299/303) at SVR4 and 99% (247/250) at SVR12. Conclusions: In this analysis, treatment with imported generic DAAs achieved high rates of HCV RNA undetectability at the end of treatment, and SVR12 in 99% of patients evaluated to date. Mass treatment with generic DAAs is a feasible and economical alternative route of accessing curative DAAs, where the high prices for branded alternatives prevent access to treatment.

Journal of Virus Eradication
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On This Blog
The controversy over expensive new drugs for hepatitis C
Link to current 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"

Friday, September 22, 2017

TAG Applauds Malaysian Government's Decision to Make Generic form of Life-Saving Hep C Cure

TAG Applauds Malaysian Government's Decision to Make Generic form of Life-Saving Hep C Cure
September 20, 2017, New York, NY—The Government of Malaysia reaffirmed its commitment to affordable access to hepatitis C treatment by issuing a compulsory license on sofosbuvir (Sovaldi). TAG lauds this landmark decision for enabling the entry of generic competition, which will effectively reduce prices.

Malaysian civil society organizations, including Third World Network, Malaysian AIDS Council, and Positive Malaysian Treatment Access and Advocacy Group, have tirelessly pushed for expanded access to direct-acting antivirals (DAAs) in the public health sector. Last month, Gilead announced Malaysia’s inclusion in a voluntary license (along with Belarus, Thailand, and Ukraine) to permit generic DAA imports from India. Civil society groups urged the government to move ahead with issuing a compulsory license to guarantee high quality generics from an Egyptian manufacturer, which did not fall under the voluntary license.

Compulsory licenses allow a generic company or government institution to manufacture a patented medicine for the “supply of the domestic market” without the consent of the patent holder. However, using these policy flexibilities, enshrined in the global TRIPS Agreement, comes at a risk. Countries, particularly in the global South, may face political pressure or trade repercussions from governments and companies for employing these policy tools. Malaysia’s compulsory license prevents a monopoly control on sofosbuvir, while also paying a royalty to remunerate Gilead. This move helps to reconcile an imbalance between the intellectual property system and protecting public health.

Around half a million people are living with HCV in Malaysia yet DAAs have been priced well out of reach for most patients—a 12-week course of treatment costs up to US$12,000 [MYR 50,000], or nearly half the average annual household income. Healthcare costs and medical bills amount to 35% of Malaysians’ income.

“There’s no justification for Gilead’s exorbitant pricing in a middle-income country like Malaysia: Sofosbuvir can be produced for less than US$100 per average treatment course at volume. Once again, Gilead treats this essential medicine as a luxury good, squeezing maximum revenue from the few who can afford it rather than pricing for universal access,” said Annette Gaudino of Treatment Action Group.

“Patients around the world can no longer be held hostage at Big Pharma’s drug prices. Malaysia has set an example for other countries to fully use policy flexibilities, such as compulsory licenses, when companies like Gilead obstruct expedient delivery of affordable life-saving medicines,” said Bryn Gay of Treatment Action Group. “This decision reinforces people’s fundamental rights to health, the benefits of scientific progress, and access to medicines.”

People living with HCV will now have more treatment options. Sofosbuvir is one of the most widely prescribed DAAs worldwide, and is over 90% effective in curing chronic HCV infection across all genotypes when combined with other antiviral medications. Clinical trials are underway in Malaysia—a collaborative partnership between the Ministry of Health, Drugs for Neglected Diseases initiative, and Pharco Pharmaceuticals—to investigate the potentially new pangenotypic combination, sofosbuvir and ravidasvir.

Thursday, July 27, 2017

Hepatitis drugs more affordable but disease still deadly: WHO

Hepatitis drugs more affordable but disease still deadly: WHO
GENEVA (Reuters) - Prices of drugs to cure hepatitis C and to treat hepatitis B are dropping dramatically, offering affordability and hope to 325 million people living with the viral liver disease that can be fatal, the World Health Organisation (WHO) said on Thursday. A generic antiviral drug for hepatitis C, which can be cured in three months, was placed this week on WHO's list of pre-qualified medicines.
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The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Wednesday, July 26, 2017

Hepatitis C - Mylan Receives WHO Prequalification for Generic Sovaldi®

Mylan Receives WHO Prequalification for Generic Sovaldi®

First Generic Prequalification for Sofosbuvir Tablets

HERTFORDSHIRE, England and PITTSBURGH, July 26, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of approval from the World Health Organization Prequalification of Medicines Program (WHO PQ) of its application for Sofosbuvir Tablets, 400 mg, a generic version of Gilead Sciences' Sovaldi®. Sofosbuvir, a directly acting antiretroviral, will be available in developing countries to treat hepatitis C.

Mylan's Sofosbuvir Tablets, 400 mg, which are produced under license from Gilead Sciences, are the first generic version to be approved under the WHO PQ Program. With WHO PQ approval, international donors and purchasers, such as UNITAID and U.N. agencies, will able to fund and procure the product, and other buyers can be assured of the product's quality, safety and efficacy.

"This marks another important step in Mylan's leadership to help fight infectious diseases around the world," commented Mylan President Rajiv Malik. "It also furthers our mission of increasing access to high quality, affordable medicines to patients, healthcare practitioners, governments and other stakeholders to help treat hepatitis C."

Worldwide, there are more than 70 million people living with chronic hepatitis C, which results in nearly 400,000 related deaths every year. (1) The WHO estimates that antiviral medication can cure more than 95% of chronic hepatitis C cases. (2)

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.

(1, 2) http://www.who.int/mediacentre/factsheets/fs164/en/

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Friday, July 21, 2017

WHO prequalifies first generic hepatitis C medicine and first HIV self-test

In the lead-up to Paris AIDS conference, WHO prequalifies first generic hepatitis C medicine and first HIV self-test

Hepatitis C

WHO today prequalified the first generic version of sofosbuvir, a critical medicine for the treatment of hepatitis C. The development could expand access to treatment by increasing the number of quality-assured generic medicines on the market. Sofosbuvir, 400 mg tablet, is manufactured by Mylan Laboratories Ltd., India.

“This is a break-through medicine with a 95% cure,” said Dr Suzanne Hill, Director, Essential Medicines and Health Products at WHO. “The first WHO-prequalified generic of this product will give large procurers and countries the assurance of quality for an affordable product.”

WHO prequalification means the product can now be procured by the United Nations and financing agencies such as UNITAID, which has recently introduced hepatitis C in the portfolio of diseases it covers. Countries such as Indonesia, Vietnam, Cambodia, Myanmar, Mongolia, Nepal, Rwanda, Uganda, Kenya, Zambia, Ethiopia, Pakistan and Egypt are already procuring generic versions of sofosbuvir. The fact that WHO has prequalified one of those generics will give them extra guarantee of the product’s quality, safety and efficacy.

“Direct acting antiviral medicines such as sofosbuvir are highly effective for treating and curing chronic hepatitis C infection. But, at best, 1 out of 10 people in need had access to these medicines in 2015,” said Dr Gottfried Hirnschall, WHO’s Director of the HIV Department. “Prequalification of the hepatitis C medicine for the first-time is therefore exciting news, ahead of World Hepatitis Day next week.”

The average price of the required three-month treatment course of Mylan’s sofosbuvir is around US$ 260, a small fraction of the medicine’s market entry price in late 2013, and of the price set in the majority of high-income countries. The medicine remains highly expensive in many countries, but licensing agreements between Gilead Sciences, who developed sofosbuvir, and a number of generic manufacturers have made it possible for low-income and some middle-income countries to provide the medicine at more affordable prices.

HIV self-test
WHO today prequalified the first HIV self-test in a move to increase HIV diagnosis and treatment. The product, OraQuick ® HIV Self-Test (manufactured by OraSure Technologies Inc.) uses oral fluid as a specimen and provides results in as little as twenty minutes.

“The prequalification of this product means that countries with poor laboratory infrastructure will be able to safely increase testing capacity, thereby facilitating treatment of people living with HIV,” said Dr Suzanne Hill, Director, Essential Medicines and Health Products, WHO.

The move also marks a significant step in allowing countries to implement WHO guidelines, released in 2016, recommending HIV self-testing as a complementary approach to reach those who remain undiagnosed due to fear of stigma and discrimination.

“Over the past year, the number of countries incorporating HIV self-testing into their policies has increased from 16 to 40. This is impressive progress,” said Dr Gottfried Hirnschall, WHO’s Director of the HIV Department. “Having quality-assured self-tests is essential to enable countries to implement more rapidly. It is a positive step towards making innovative HIV self-testing accessible to all those who would benefit from it.”

In 2016, an estimated 30% of all people living with HIV remained unaware of their HIV status, many from higher risk populations who are either less likely to approach a health facility or are unable to do so.

“As the first HIV self-testing product to obtain WHO prequalification, this is a major step that will help give governments the confidence they need to adopt and scale up use of self-testing,” said Philippe Duneton, Deputy Executive Director of Unitaid.

There is currently great interest from the international community in deploying tests intended for HIV self-testing, with numerous countries having developed national guidelines and plans for implementation. Support for procurement and deployment of these tests has been pledged by most major international financing and procurement agencies, including a specific agreement on affordable pricing for 50 lower-middle income countries in Africa and Asia between the manufacturer and the Bill and Melinda Gates Foundation, a funder of WHO Prequalification.

Thursday, July 20, 2017

Towards supporting greater and lower cost access to direct acting antiviral treatment for hepatitis C for all patients

Saudi J Gastroenterol [serial online] 2017 [cited 2017 Jul 20];23:263-4. Available from: http://www.saudijgastro.com/text.asp?2017/23/4/263/210834

LETTER TO EDITOR
Towards supporting greater and lower cost access to direct acting antiviral treatment for hepatitis C for all patients

Said A Al-Busafi1, Heba Omar2

Sir,
It is with great interest that we read the Saudi Association for the Study of Liver diseases and Transplantation (SASLT) position statement [1] and guidelines [2] on direct-acting antiviral agents (DAAs) for the treatment of hepatitis C virus (HCV) infection. The position statement and the guidelines, which were clearly influenced by the limited availability of highly priced DAAs, recommend that HCV treatment should be prioritized to patients at higher risk for developing HCV-related complications.

The introduction of the curative DAAs to the global market caused worldwide celebration because it is expected to save millions of lives and control if not eliminate one of the major infectious disease worldwide.[3] Unfortunately, for the majority of HCV patients, these costly medications are not readily available, accessible, or affordable even for those in the developed countries.[3] This is likely going to affect many countries in their ability to minimize the burden of this disease.[4]

On the other hand, generic DAAs (sofosbuvir, ledipasvir, and daclatasvir) are being produced in India and other countries with permission of the concerned pharmaceutical agencies and priced less than 1% of their current actual price in USA and Europe. The evidence for the clinical safety and efficacy of these generics is compelling including the recent interim results from international REDEMPTION trial presented by Freeman et al.[5] The results of this trial, which was supported by the European Association for the Study of the Liver (EASL), are important in indicating that generic DAAs are highly effective and safe comparable to those reported in clinical trials of branded DAAs. Another abstract presented by Hill et al. at the same meeting showed that the active pharmaceutical ingredient for the combination of sofosbuvir and daclatasvir was approximately $200 for 12 weeks' course of treatment per patient.[6]

Oman, with an estimated HCV prevalence of 1%, is one such country where access to those important agents is also limited.[7] This has led many of our patients to self-import these drugs from India giving them hope instead of waiting for years to be treated from this debilitating disease.

At the Sultan Qaboos University Hospital, using the EASL 2016 guidelines,[8] we have treated 58 HCV patients [28% genotype 3, 26% cirrhotic with 40% of them decompensated, and 3% severe chronic kidney disease (CKD)] with generic DAAs including (sofosbuvir, ledipasvir, and daclatasvir). Sustained virological response was achieved in 57 patients (98%), the remaining one patient with severe CKD discontinued treatment due to worsening renal function. All patients with decompensated cirrhosis were delisted from transplantation.

Therefore, healthcare leaders and policy makers at the national and international level should adopt strategies to ensure that these DAAs are made available and are accessible and affordable for all in need.
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Financial support and sponsorship
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Conflicts of interest
There are no conflicts of interest.

   References

1.
Alghamdi AS, Alqutub A, Abaalkhail F, Sanai FM, Alghamdi H, Altraif I, et al. SASLT position statement on the direct-acting antiviral agents for the treatment of hepatitis C virus infection. Saudi J Gastroenterol 2015;21:60-3.
[PUBMED]  [Full text]  
2.
Alghamdi AS, Alghamdi M, Sanai FM, Alghamdi H, Aba-Alkhail F, Alswat K, et al. SASLT Guidelines: Update in Treatment of Hepatitis C Virus Infection. Saudi J Gastroenterol 2016;22(Suppl 2):S25-S57.
    
3.
Freeman JA, Hill A. The use of generic medications for hepatitis C. Liver Int 2016;36:929-32.
    
4.
Edwards DJ, Coppens DG, Prasad TL, Rook LA, Iyer JK. Access to hepatitis C medicine. Bull World Health Organ 2015;93:799-805.
    
5.
Freeman J, Sallie R, Kennedy A, Hieu PT, Jeffreys G, Hill AM. High sustained virological response rates using generic Direct Acting Antiviral treatment for Hepatitis C, imported into Australia. J Hepatol 2016;2:S209.
    
6.
Hill A, Gotham D, Fortunak J. Significant Reductions in Costs of Generic Production of Sofosbuvir and Daclatasvir for Hepatitis C Treatment in Low- and Middle-Income Countries. J Hepatol 2016;2:S209.
    
7.
Alnaqdy A, Alfahdi A, Alkobaisi M, Kaminski GZ. Prevalence of autoantibodies in patients with hepatitis C virus infection in Oman. Ann Saudi Med 2003;23:127-31.
    
8.
European Association of the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol 2017;66:153-94.