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Ontario, British Columbia Covers Zepatier

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  • Merck’s Zepatier will be used for the treatment of hepatitis C/HCV beginning March 21st, 2017.
  • Zepatier is made up of elbasvir and grazoprevir and is taken once a day for 12 weeks.
  • Zepatier is used for HCV genotypes 1, 3 or 4, ribavirin is not required.
  • Ontario will allow hepatitis C patients that have fibrosis of 1 or zero are eligible for treatment who also have HIV or hepatitis B.
  • Government of Canada believes it will eliminate HBV and hepatitis C/HCV by 2030.

Bluegrass State Highest rate of Hepatitis C/HCV

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  • Only 30 counties in the state have started a needle exchange program.
  • Opponents of the needle exchange believe it could condone needle drug use.
  • Kentucky spends $50 million to treat hepatitis C/HCV patients a year.
  • HIV patient treatment costs $380,000 a year. Hepatitis C patient cost is about $85,000. Compare and contrast this to the cost of a clean syringe.

Fiona Stanley Hospital Liver Service

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  • Has helped over 400 hepatitis C patients get treatment and cured.
  • Australia has a vision of eliminating hepatitis C in the next 10 years.
  • Curing hepatitis C virus with generic Harvoni, Sovaldi, Epclusa and Daklinza has helped patients avoid liver disease and liver transplant.
  • Number one reason for liver transplant in Australia is hepatitis C/HCV.
  • Almost $250 million Australian dollars can be saved from treating hepatitis C a year. Liver damage and liver cancer are a result of hepatitis C and they can be avoided if detected early and treated.
  • A fiver percent risk of parent to child transmission with hepatitis C.

Herbals to Thwart Hepatitis C virus/HCV

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  • Cannabidiol (CBD) found in the herbal cannabis could be used to treat hepatitis C infections or HCV.
  • A very possible pharmaceutical product to help over 200 million hepatitis C patients around the world.
  • Cost factors associated with Harvoni, Sovaldi, Epclusa and Daklinza are astronomical compared to cannabis. Affordable treatment for the low and middle income countries.
  • CBD decreased hepatitis C replication by 86.4% at 10 micrometers. Cannabis/CBD did significant damage to the hepatitis C virus in vitro. Hepatitis B did not react to CBD.

Gov. Terry McAuliffe Allows Syringe Access in Virginia

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  • Stigma of needle exchange is finally going by the way side atleast according to Virginia’s governor.
  • Needle exchanges are very important in high risk groups of hepatitis C, HCV, hepatitis B, HIV and other blood borne infectious diseases.
  • Opiod addiction and overdose is on the super highway in Virginia. Focusing on education on prevention, screening, testing and treatment.
  • Generic Harvoni from http://www.sunnypharma.org was donated to several Virginians that could not afford treatment. We will continue to donate to those that are denied and require life saving treatment.
  • Virginia Dept of Health has more than 8000 cases of hepatitis C.

WHO: Viral Hepatitis Testing Guidelines

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  • WHO estimates more than 300 million people have hepc/hepatitis c/HCV.
  • Direct acting antivirals (DAA) cure 90%+ of all hepatitis C patients.
  • WHO guidelines recommend the use of rapid testing kits to increase outreach those with hepatitis B or C.
  • Injecting drug users should also be included in the program in terms of screening, testing, treatment and education.
  • Training is also highly recommended for volunteers and staff to remove the stigma of hepatitis C for the populations they serve.

Alcohol, Hepatitis C/HCV and Harvoni

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  • Effective treatment with Harvoni or generic Harvoni is greatly increased for those who do not consume alcohol.
  • Alcohol and Harvoni is not recommended due to the results of ineffective treatment.
  • Only 20% of heavy drinkers that stopped drinking before treatment cleared the virus.
  • More alcoholic drinks increase the viral load.
  • Five or more drinks a day will develop scar tissue on the liver and cirrhosis.
  • Twenty percent of all hepatitis C patients have a chance of developing fibrosis, developing to cirrhosis.
  • Heavy drinkers are 16 times more likely to develop cirrhosis than non drinkers.

Patients Vs. Big Pharma

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  • President Trump has stated that drug prices have been astronomical and need to come back to Earth.
  • Proposition 61 in California did not get approval that would allow drug companies not to set price caps on medication.
  • $325 billion dollars spent on medical drugs. 10% total of healthcare budget ($3.2 trillion) or National Health Expenditure.
  • Four percent of US GDP is spent on medical machinery, durable and non durable medical goods.
  • Firestorm due to the left protesting against the right in regards to $109 million spent to oppose the proposition 61 in California.
  • Drug prices may reduce a few percentage points but for long term they will continue to keep up with inflation.

10X Increase in Hepatitis C Drugs in Australia

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  • 30,000 Australians have been treated since the listing on PBX on March 2016.
  • Direct acting antivirals are the key component to the treatment of hepatitis C/HCV.
  • Generic Harvoni was the most popular treatment amongst hepatitis C positive population.
  • Generic Sovaldi and other agents were prescribed a 12 week course. One percent was treated for 24 weeks of generic Sovaldi treatment.
  • General Practitioners prescription increased from 4% to 19% just in 6 months.

Ukraine Signs Hepatitis C/HCV Treatment with Gilead

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  • Sovaldi costs $250 for 28 tablets. 84 tablets will cost $750 for a full course.
  • US price cost is $84,000 for 84 tablets.
  • Gilead filed a claim against Ukraine for $800 million but that case has been now dismissed due to the new agreement.
  • Ukraine had to force a generic version of Sovaldi and Harvoni to stop production due to the lawsuit filed by Gilead Sciences. Gilead in return have stated they will reduce discount prices for Harvoni, Sovaldi and Epclusa.

Ontario, Canada Puts Generic Epclusa on the List

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  • Ontario has 102,000 chronic hepatitis C patients.
  • A total of 250,000 of Canadians have hepatitis C and thousands adding to this list every year.
  • Genotype 1, 64% of Canadians represent this genotype.
  • Genotype 2 and 4, 14% of Canadians have this genotype.
  • Currently 44% of hepatitis C/HCV patients are not diagnosed.

British Columbia, Ministry of Health Treatment for All HepC Patients

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  • March 2018 will allow all hepatitis C patients to access hepatitis C treatments.
  • Currently only if you have a fibroscan of 2 or above you can be eligible for treatment in British Columbia.
  • BC’s Ministry of Health motto is “No One Left Behind”, planning to ensure that all those with hepatitis C/HCV will get treatment.

Liver Cancer after HepC Eradication?

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  • SNP or single nucleotide polymorphism at TLL1 gene is associated with hepatocellular carcinoma (HCC), from a Japanese study.
  • After a sustained virologic repsonse, 2% of patients develop HCC after 3 years, 8.8% develop HCC within five years.
  • The results are associated with a interferon based hepatitis C therapy. Direct acting antivirals like Sovaldi, Harvoni, Epclusa, Daklinza and others are not associated with hepatocellular carcinoma or HCC.

Priority Review Vouchers by Sarepta

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  • Introduced in 2007 to promote innovative treatment for tropical diseases.
  • In 2012; addition of childhood diseases and four months can be reduced for new drug development for limited commercial purposes.
  • Essentially, priority review vouchers are a fast forward button for pharmaceutical companies to get past the FDA and in to market.
  • Sarepta priority review vouchers bought for $125 million by Gilead Sciences.

Academics Pure Servants of Power for Big Pharma

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  • Lakdawalla a professor at University of Southern California can be found shining shoes for Gilead Sciences at congressional health advisory investigations and testimony. Shoe shining is an honorable profession.
  • Precision Health Economics, 75% of all publiations have been funded by drug companies or have been in colloboration with them.
  • Dr. Scott Gottlieb also a formidable shoe shinner that is a assistant professor of NYU school of medicine, a candidate for commissioner for FDA is a academic affiliate of Precision Health Economics. Lakadawalla and Gottlieb will do quite well shining shoes of hepatitis C drug manufacturers.

Messi Promotes Egypt; Why not India?

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Messi is in love with India and wanted to promote generics within India but Egypt’s government paid  more for his high profile celebrity status.

Modi, India’s PM is most probably unaware of infectious diseases in India due to his poor background in education.  Its okay, the Indian people still love him.

Gilead Sciences has a huge stake in Indian pharmaceutical companies to manufactures of generic Harvoni, Sovaldi and Epclusa.  Generic Harvoni is $1495, Generic Sovaldi is $695, Generic Epclusa $2195 and Generic Daklinza is $695

India is the best source for any kind of tourism for hepatitis C treatment or any medical procedure due to affordability and quality care.


Merck Investment in Uprifosbuvir from Idenix Pharmaceuticals

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  • Merck purchased uprifosbuvir for $3.9 billion from Idenix pharmaceuticals.
  • Uprifosbuvir is still undergoing clinical trials and has been eclipsed by other player like Sovaldi, Harvoni, Epclusa, Daklinza and others.
  • Merck is valuing the uprifosbuvir at $240 million a loss.
  • Merck will write down $2.9 billion or $1.9 billion after taxes for the Idenix investment.

Interferon-Alfa Treatment and Patients; Depression

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  • Severe depression is a result of taking interferon-alfa for hepatitis C virus.
  • Taiwan study of the past 12 years of patients with hepatitis C virus, with no previous record of depression before treatment.
  • 156 patients diagnosed for depression and full remission from depression.
  • 21,452 did not become depressed with interferon-alpha treatment.
  • Study concludes, treating patients with antidepressants while undergoing interferon-alfa treatment did not reduce the risk of depression recurring.

Deleting a region 1 of Hepatitis C Virus to Reduce Spreading the Virus.

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  • HVR1 deletion Hepatitis C variants would make it easier to prevent virus spreading due to antibody being present.
  • AR5A doses of antibody were introduced to Huh7.5 cells and HCV genotype 1a infection.
  • 30 days after administration of AR5A infection of HCV genotype 1a was less than 1%.
  • 30 days of HCV infection introduced to Huh7.5 cells (untreated with AR5A) was more than 80% .
  • Results produced show that AR5A treated hepatitis C virus were 10,000 more resistant compared to the untreated hepatitis C virus.

Hepatitis C/HCV in China: Genotype and Subtypes

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  • HCV-1b-2a, 1b-2 k and 6d-6 k subtypes are the most prevalent in China.
  • 95% of all hepatitis C/HCV major subtypes: 1b, 2a, 3a, 3b, and 6a
  • Mobility of the Chinese population has changed the diversity of genotype subtypes regionally.
  • Most hepatitis C positive individuals are not intravenous drug users.  However, intravenous drug users should not be ignored but educated, screened and tested.
  • China has not allowed Gilead Sciences to enter their HCV market, however, their direct acting antivirals are in clinical studies.

 

Ledipasvir 90mg and sofosbuvir 400mg on Genotype 2 Hepc.

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  • Harvoni or generic Harvoni is not approved to treat genotype 2 of the hepatitis C virus.
  • Some hepc patients have had good sustained virologic response after 8 weeks of treatment. You should consult with your doctor if this path to treating your genotype 2 is correct for you.
  • This study states that this not an approved course of treatment, its merely in clinical trials.
  • 100% of patients received sustained virologic response after 12 weeks. Eight weeks of treatment produced a SVR12 of 74%.

FDA Approves an Assay to Detect Hepc Viral Load

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  • Hologic makes the assay quantitation tool.
  • Product name is called Aptima HCV Quant Dx assay.
  • May reduce the need to take long regimens to treat hepatitis C.
  • Give accurate results for the appropriate direct acting antiviral, DAAs to be administered for treatment.

Hep C and HIV Screenings in ER NYC

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  • About 5000 unknowing participants in a blood test for hepc and HIV.
  • 19% had both HIV and hepatitis C.
  • 5% of the entire sample tested positive for HCV.
  • 7.5% of the sample tested positive for HIV.
  • Center for Disease Control(CDC) states 50% of the hepatitis C population do not know they are infected.
  • CDC states 13% of the population do not know they have HIV.

Veterans Administration(VA) Urges to Screen for Hepatitis C.

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  • Baby boomers born in early 1940’s to mid sixties should be tested.
  • 1992 testing for hepatitis C began for the first time. Blood products, transplants and transfusions are at risk for HCV.
  • CDC now states hep C infected in the US has now increased to 3.5 million people.
  • Point zero one percent of the US population has hepatitis C.

American Hepatitis C Patients; Cirrhosis Increasing

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  • Over the past 10 years cirrhosis has increased those with hepatitis C.
  • Forty percent increase in number of cirrhosis cases.
  • Unsure why such a surge in the increase of cirrhosis, American Association for the Study of Liver Diseases (AASLD).
  • Results of liver damage include but not limited to the following: hepatic encephalopathy, jaundice, variceal hemmoraging (vein rupture) and ascites (abdominal fluid accumulation).
  • Patients that had increased chance of cirrhosis of the liver are those over 60 years of age.

Egypt is Offering a Tour and Cure for Hepatitis C

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  • WHO held a conference in Cairo to celebrate 8000 people that were cured from generic direct acting virals.
  • Egypt hopes to bring in tourists from all over the world with the help of the soccer great Messi.
  • As of now 15 million hepatitis C active infections in Egypt.
  • Take caution especially with road side foods due to poor hygiene while in Egypt.
  • A Facebook commentator on the article stated to just have the medicine delivered to you buy DHL or the United States postal service, the treatment gets to the patients in need.

Iowa Doctors and Health Officials want Broad Testing for HCV/Hepatitis C

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  • Iowans with hepatitis C quadrupled from 303 in 2009 to 2235 in 2015.
  • The counties most affected are Woodbury, Polk, Linn, Scott/Black Hawk counties.
  • Reason for sudden upswing is due to blood clotting problems before 1987, injecting non prescription drugs, receiving blood transfusion or organ transplant before July 1992
  • Other reasons include having liver disease or abnormal liver tests, long-term hemodialysis treatment or working in a healthcare facility exposure to needle stick/injury by sharp object.
  • HIV infection is another reason.
  • Most Iowans are not symptomatic to hepatitis C, left unchecked can be fatal.

New Pan-genotypic Drug for Hepatitis C from Cocrystal Pharma

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  • Hepatitis C kills 1000 people per day and they can be prevented says Cocrystal Pharma, CEO, Dr. Gary Wilcox.
  • The investigational treatment dubbed CC-31244, orally potent drug that works on the NS5B RNA polymerase on all 6 major genotypes of hepatitis C.
  • Patients and governments spent over $10 billion on antivirals fighting hepatitis C/HCV.
  • CC-31244 is considered to be safe and effective in the treatment for hepatitis C patients. The drug is still undergoing clinical studies.

People are Coping with Medicine Price Increases; says 2016 Study

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  • 20 million patients saw increase of 2.5% for prescription medicine, mostly generics.
  • Spending on “traditional” drugs declined by 2.7% and 13.7% increase on specialty medicines.
  • Diabetes medicines increased 18% in 2016, top source of spending on non specialty drugs.
  • Autoimmune disorders and rheumatoid arthritis drugs costs increased considerably for the specialty drugs category.
  • Hepatitis C drugs like Sovaldi, Harvoni, Epclusa, Daklinza and others made this list.

Hep C Patients Treatments: Hepatitis C Clinical & Economic Impact for Medicaid

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  • American Journal of Managed Care did a study of HCV patients under Medicaid.
  • The treatment was ledipasvir 90mg and sofosbuvir 400mg with Medicaid. Average age being 43.
  • The subsidized treatment for Harvoni was $31,500 to $47,250 per patient.
  • Medicaid rebate was approximately 25% of the $83,108.18 to $124,662.26 was covered by the US government and tax payers. Gilead Sciences the maker of Harvoni and generic Harvoni in India rebates helped very little to Medicaid patients.
  • Only Medicaid patients with fibroscans of 3 could get the treatment. 4% of patients with fibroscan 2 could get treatment and those 7% with fibroscan 4 could get treatment.

Hepatitis C Advocates Seek Life Saving Generic Drugs

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  • Legal challenges to patents by non profits and non governmental organizations from India and Argentina.
  • Approximately 200 million people in the world have hepatitis C argues the non profits and the medicine should be subsidized by governments around the world.
  • Patents block generic manufacturing, except for in India where it is licensed by Gilead Sciences, the maker of sofosbuvir, ledipasvir, velpatasvir and other direct acting antivirals.
  • Doctors Without Borders a NGO is one of the organizations leading the fight against Hepatitis C drugs and associated patents.

Loftus Hep C Free After 30 Years

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  • Limerick Councillor took 12 weeks, 84 tablets of Harvoni.
  • Cork University verified the test results of the virus not detected in his blood tests.
  • Loftus was told by his doctors he would not reach the age of 50 because of hepatitis C.
  • Loftus said the side effects of Harvoni made him sleepy and didn’t allow him to focus on more than one task at a time.
  • Loftus was grateful to Cork University’s hepatology department for watching after his health due to hepatitis C for the last 15 years.

Huron County Hepatitis C Spike

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  • A few years ago no one would think our small county would have an increase as it had.
  • Most of the time hepatitis C is not resolved due to the lack of treatment available.
  • Now, there are options from Sovaldi, Epclusa to Harvoni.
  • Before, you were limited to peginterferon-alpha and ribavirin, which has SEVERE side effects. Its like going on chemotherapy for a year sometimes 2 years. Its really hard on the body.
  • Today with direct acting antivirals like Harvoni, Sovaldi, Epclusa, Daklinza and others the side effects are very less. Most don’t have side effects, while a very few do.
  • Problem to treatment, its too expensive starting from $85,000 to $95,000 for 12 week course, 84 pills. If your doctor recommends your treatment for 24 weeks, then its goes up to $170,000 to $190,000.
  • Definitely not affordable. Others look for treatment wherever they can. They travel to exotic locations like India to find treatment that cost about $1000.
  • The generics are exact identical licensed by Gilead Sciences but for the poor Indian people. That’s how drug pricing works.

Bradenton, Florida New Turning Points HCV Provides Treatment for Free

Free screening and hepatitis C treatments in Turning Points.

Gilead sponsored testing and available direct acting antivirals like Sovaldi, Harvoni and Epclusa will be available to patients.

Many volunteers are required to take part in help with the assessments, screening and treatments. Most volunteers will be medical students from Lake Erie College of Osteopathic Medicine.

Manatee County residents that do make over $12,984 can qualify and they must not have insurance. Outside of this category, officials suggest visiting non profit SoulofHealing.org and SunnyPharma.org for more information regarding generic treatments that are only $700 to $1500 for generic Sovaldi and generic Harvoni respectively.


Indian and Argentina Challenges Hepatitis C Patents

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  • Initiative for Medicines, Access & Knowledge (I-MAK) and Medcins Sans Frontieres (MSF) file patent suits in India.
  • Patents for daclatasvir from Bristol-Myers Squibb and sofosbuvir from Gilead Sciences are disputed.
  • Fundacion Grupo Efecto Positivo (FGEP) filed a patent against Gilead with soupport from I-MAK in Argentina.
  • The dispute is historical for patients with HIV, due to anti retro viral treatments. Patents limit access to treatment. Allowed prices to drop 99% for these life saving drugs.
  • Hepatitis C drugs like Harvoni, Sovaldi, Epclusa, Daklinza, Viekira Pak and other direct acting antivirals allow patients to seek treatment for $100 rather than $100,000.
  • Generics in India allow hepatitis C patients around the world have access to treatment for $600 to $2000, for the new generic versions of Epclusa.

Obamacare Subsidized Hepatitis C Treatment

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  • Upper class individual from a white collar family addicted to heroin and cocaine.
  • Sobered up at age 26 and found out I had hepatitis C from shooting up.
  • Doctor informed me that I need Harvoni that cost $95,000 for 84 pills that will save my life.
  • My body ached all the time and I didn’t have any energy, now a 28 year old.
  • Doctor stated chances of you getting treatment was nil. But I got approved and now I am free of hepatitis C.

Gilead Loses Lawsuit to US Patent for $2.5 Billion

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  • Merck subsidiary Idenix developed a patent for the delivery of drugs to the specific base of the hepatitis C virus.
  • Gilead patent loss is the biggest in US history.
  • Sovaldi and Harvoni are both approved by the FDA and were developed using this technology of drug delivery with an orally taken tablet.
  • Gilead used Idenix intellecutal property assett to develop Harvoni and Sovaldi.
  • Gilead plans to appeal the verdict.

Riga, Latvia Blood Donor Tainted with Hepatitis C

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  • Former Health Minister Belevics informed the Prime Minister that HCV infected blood has been distributed to the population.
  • Screening is to be setup up at several public hospitals and clinics throughout the country.
  • Riga public hospitals have begun an awareness and education program. Call center have been setup to reach out to all those received tainted blood.
  • Several thousand to 10,000 individuals could be infected from the tainted blood. Transmission from those infected is unknown to the general population.

Drug Importation is the Answer, from Forbes

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  • Currently it is legal to import drugs in the US from other countries if you have a prescription.
  • Only people that are in dire need of treatment import medicine.
  • If they’re not able to import the medicine they or their loved one will not live much longer.
  • Ample time and policy have been implemented and rescinded but they have not addressed the issue of affordable treatment.
  • 80% of all generics in the US are imported. 60% of all generic in Canada are imported. 50% of all generics are imported in the EU. Japan imports 30% of all generics.

Murray Bridge, South Australia Hepatitis C Treatment Project

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  • Raise awareness of hepatitis C in the community.
  • Entire community approach to promote hepatiti C treatments to those infected, not just the infected.
  • Approach is education about symptoms of hepatitis C and transmission of the disease.
  • Focus on prevention through treatment and transfer to non HCV infected individuals.
  • 80% of the community have been tested, only 20% have to be tested to know if or if not have a HCV infection.
  • Murray Bridge in South Australia is the poster child for a community approach to screening and testing for hepatitis C infections.

Canadians Can’t Afford Medicine

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  • 8.3% of all Canadians over fifty five years can’t afford prescription medicine.
  • Doctor prescribed medicine will not be taken by this age group due to cost.
  • Fair PharmaCare program is a subsidized program to afford medicine based on income in British Columbia.
  • Canada’s prescription medicine would cost $8 billion for its citizens.

Medicare Part D Payments Surge Due to Hepatitis C Treatments like Harvoni and Sovaldi

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  • Eighty percent of drug costs are paid by Medicare.
  • Thirty three billion dollars were spent on treatment by the federal government payments.
  • Prison inmates have been barred from getting treatment of Harvoni and Sovaldi the most popular treatment for hepatitis C.
  • Only few prisoners have received treatment due to $95,000 price tag of Harvoni.
  • Generic versions of Harvoni can be purchased for $1500 from India. Sunnypharma.org.

Barre, Vermont Opens Needle Exchange

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  • Prevention of hepatitis C and HIV transmission is the ultimate goal of this needle exchange.
  • Vermont care has provided more than 1 million clean syringes since its opening.
  • 800 people are under the care of this program.
  • Ultimate goal is prevention of infectious diseases in the community.

Diseased Liver Transplant in Utah

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  • Salt Lake City man is receiving a hepatitis C liver transplant.
  • 20,000 people wait for a liver transplant in 2017.
  • Only seven thousand received a liver transplant in 2016.
  • One thousand five hundred die waiting for a liver transplant in 2017.
  • The patient, Lorenzo took hepatitis C treatment, like Harvoni for only 3 weeks to cure the disease.
  • The patient has a normal liver now after treatment, it was a diseased liver when the transplant occurred.
  • Another patient in Salt Lake City went through the same transplant is equally doing well.

Johnstown Offering Needle Exchange

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  • Addicts require clean needles so transmission of hepatitis C and HIV are not transmitted with injectable drugs.
  • Rosalie Danchanko will receive $40K from United Way for the Community Impact Investment through a grant.
  • Harm reduction programs in Pennsylvania have showed more than thirty percent of addicts were enrolled in programs to treat hepatitis C and HIV.
  • Most addicts began their addictions with opiod pills, about eighty percent. Heroin is cheaper unfortunately that led to the communicable disease through injection.

TaiGen Hepatitis C Drug Success

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  • 12 weeks treatment successful with 22 patients with SVR12.
  • Twenty patients with IL28 CC genotype faired well with 95% success and SVR24.
  • Furaprevir is the drug developed by TaiGen a Taiwanese pharmaceutical company.
  • Furaprevir is peginterferon free treatment.

Hepatitis B Cure funding by NIH

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  • St. Louis researchers receive $416K for HCB cure.
  • John Tavis, PHD lead researcher at Saint Louis University (SLU).
  • Research will be focused on anti-RNaseH drug discovery.
  • Second focus will be on RNaseH inhibitor with HBV treatment options.
  • Hepatitis B treatments costs from $400 to $600 per patient, many cannot afford it.
  • Co-principal investigator will be Marvin Meyers also of SLU and World Health and Medicine.

Needle Exchanges Don’t Increase Drug Use says CDC

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  • Hepatitis C/HCV in Kentucky is highest in the US.
  • Eighteen out of twenty six counties in Kentucky have working needle exchange programs.
  • Exchanges reduce drug abuse and the spread of hepatitis C. Another instance of prevention in both HIV and HCV.
  • Two hundred forty percent increase in acute hepatitis C in Kentucky between 2009 and 2013.
  • Comparatively on a national scale, hepatitis C increase was only twenty two percent.

Advance Liver Disease Therapy with DAAs

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  • Real world study has shown that hepatitis c can be treated successfully with direct acting antivirals/DAAs.
  • Effective treatment with DAAs for advanced liver disease has a high efficacy rate.
  • Decrease of mortality and hepatocellular carcinoma associated with successful treatment of hepatitis C.

DAAs Dangers Dismissed by Liver Specialist

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  • Dr. Dieterich director of Institute for Liver Medicine at Mount Sinai in New York City.
  • ISMP reported 524 cases of liver failure due to DAAs.
  • ISMP reported 1058 liver damage (severe) due to DAAs.
  • Dieterich cites only patients with severe decompensated liver disease took the DAAs in the study.
  • The fatality rate for DAAs like Harvoni, Sovaldi and Epclusa is 0.066%.
  • Dieterich states the data that is “out there” is not reliable or peer reviewed – so its not really valuable medical information.

Michele Tait HCV Treatment Program Manager

  • Early riser that is dedicated to making sure hepatitis C patients get counseling.
  • Only 30 million Euros to treat 30,000 hepatitis C patients get treatment.
  • Irish people pay 25k to 70k Euros per patient.
  • 1,300 patients are ward of the state and prioritized for treatment.
  • She maintains her rigorous work life with yoga.

Hepatitis C Positive Man Bites Woman

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  • Two counts of 2nd degree assault were charged against Washington County District in Maryland.
  • Conviction of these charges carries a fine of $2500 and 10 years prison sentence.
  • The man and the woman had known one another previously and wanted to discuss disagreements.
  • Both man and woman were hospitalized due to violent exchange between one another.
  • Tests confirmed the man did have hepatitis C and is waiting treatment.

Ben Franklin in London Needs HCV Treatment

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  • Ben was getting beat up by hepatitis C, his life deteriorated considerably.
  • He was not able to get in to the bath and be 100% independent, this has caused a rift with his wife.
  • He lives in London where the wait for the treatment through NHS is longer than other parts in the UK.
  • Ben decided to get his treatment from India, sunnypharma.org.

Zepatier is Approved in Scotland for HCV

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  • Scottish Medicines Consortium approved Elbasvir-grazoprevir also know as Zepatier.
  • Origin of Hepatitis C has been traced back to WWII hospitals in Scotland.
  • Hepatitis C was dispersed worldwide through both World Wars unknowingly through contaminated blood products.

Duchene Muscular Dystrophy costs $89,000 a Year

  • Five years and older can take this drug to treat this muscular dystrophy medicine, Exondys 51.
  • Copay is $20 but in the end it costs $54,000 a year per patient.
  • Outside of the US the drug costs $1000 a year.
  • 15,000 patients in the US with DMD.
  • A revenue of $810 million a year for the drug.

Hepatitis C Drugs Price Gouging?

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  • President Trump says the pharmaceutical industry is getting away with murder.
  • Oregon Health covers 25% of all residents and cannot cover the cost of hepatitis C treatments like Harvoni, Sovaldi, Epclusa, Daklinza and other direct acting antivirals.
  • Gone are the days for $13 or $14 for prescriptions and refills. Now you have to take a mortgage to treat your illness.
  • Pharmassett Inc invested $62.4 million on research and development for sofosbuvir, the active ingredient in Harvoni, Sovaldi and Epclusa.

Walk Like an Egyptian; HCV Test and Treatments

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  • 2.4% drug addiction rate in Egypt.
  • 10% drug abuse rate in the general population.
  • Long Live Egypt Fund is to treat 75,000 addict/patients in 2015.
  • 15 million Egyptians have hepatitis C and need treatment.
  • Egyptian government vows to eliminate HCV by 2021.

Hawkeye & Cyclone State Has Tripled in HCV Infections

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  • Iowans aged 18 to 30 quadrupled in HCV infections from 2009.
  • 55% of Iowans with HCV live in Pottawattamie, Woodbury, Polk, Linn, Scott or Black Hawk counties.
  • CDC is recommending anyone born between 1945 to 1965 needs to be screened for hepatitis C.
  • Testing for HCV should be done on a statewide scale.

New Hepatitis C Drugs and Fewer Cases

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  • Early treatment of HCV and HIV coinfected patients is a form of prevention in Holland due to zero restrictions on direct acting antivirals or DAAs.
  • In US 90% of all states have restrictions on use of DAAs.
  • 98% of all coinfected patients of HIV and HCV are now are hepatitis C free.
  • HCV has been in decline in the Holland due to zero restrictions on the use of DAAs.

Peginterferon Lambda, Ribavirin & Daclatasvir; HCV & HIV Coinfection

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  • Cohort A received peginterferon w/ Lambda/RBV/DCV 12 weeks treatment.
  • Cohort B received only Lambda/RBV for 12 weeks treatment.
  • Results cohort A, 85% had SVR12.
  • Results cohort B, 76% had SVR12.
  • Note approximately 3% to 6% stopped treatment in both cohorts due to serious adverse effects(AEs).

New Strategies to Combat HCV

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  • HCV deaths total AIDS, tuberculosis and malaria combined.
  • Direct Acting Antivirals have been a boon to the treatment of hepatitis C. Prior we relied on 48 weeks of peginterferon-alpha and ribavirin treatments.
  • Scientists goal is now to develop HCV vaccines to help prevent the spread of disease.
  • Collaboration can be leveraged to address this infectious disease that is problematic around the world.

Iceland has Rapid HCV and HIV Testing

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  • 20 minutes quick mouth swab test from OraSure for HIV and HCV.
  • About 1000 people are infected with hepatitis C in Iceland.
  • HIV and HCV coinfection can be high, transmission is high for both infectious diseases.
  • Most importantly is to eliminate Hepatitis C from Iceland in less than 10 years.

Colorado HCV Treatment for Inmates

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  • $57,000 for each of the 32 inmates with hepatitis C.
  • Total of 2,280 inmates infected with HCV.
  • Colorado Dept of Corrections asks for $2 million in funding for the hepatitis C treatment.
  • Only $700,000 is ear marked to treat 32 inmates a year for hepatitis C.
  • Reinfection has not occurred after the treatment with Sovaldi and Harvoni.

Harvoni Counterfeit Hepatitis C Treatment in Japan

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  • Nara Prefecture drugstore chains found fake Harvoni.
  • 500 bottles of fake Harvoni found in 3 chain outlets.
  • 76,000 people have taken original Harvoni in Japan.
  • One pill of Harvoni costs $487.52 in Japan.

Renal Disease & Hepatitis C Patients

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  • Burden of two diseases, renal and HCV, costs and outcomes were studied.
  • 26.5% had chronic kidney disease with HCV.
  • Comorbidity was higher due to negative health outcomes that were costly.

HIV and HCV Coinfection Eradication in France 2026

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  • Coinfection of both HIV and HCV about 8,000.
  • Eight risk groups, high risk MSM, low risk MSM, heterosexual and women, intravenous drug users and patients with other risk factors.
  • Annual coverage rate for treatment in France is 30%.
  • 2026 coinfection rates among high risk groups will decrease.
  • Behavioral risk reduction, HIV screening in all MSM risk groups.

Jamaicans are using cannabis to develop HCV Drugs

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  • Dr. Wayne McLaughlin and Dr. Toyang have used cannabidiol to combat HCV in vitro.
  • The doctors also tried to combat hepatitis B in vitro but was not effective.
  • The research is not complete but may go to clinical trials next year.

Viral Load Test gets Pre Market Approval from the FDA

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  • Aptima HCV Quant Dx assay approved by FDA.
  • The assay provides a reliable quantitation to determine sustained antiviral response across most major genotypes and lineage.
  • Overall this assay will help doctors to determine which treatment is most effective and improve patient care.
  • The assay is tested on the Panther system in the US market.

HCV Grant and Bexar County

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  • Million dollars to fight hepatitis C awarded to San Antonio University Health System.
  • Grant is used to screen baby boomers and educate patients.
  • Latin Americans have a higher risk for hepatitis C.
  • Ultimate goal is prevention and also reducing the chance of liver cancer.

When is a Generic not a Generic?

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  • Pharmacy benefit managers (PBM) dictate what is a generic and non generic.
  • Gilead provides rebates to PBM’s $35,000 for one treatment of Harvoni.
  • Essentially PBM’s can save employers money, which could turn the savings to their employers.
  • Costs can be drastically reduced for specialty drugs like Sovaldi, Harvoni, Epclusa and others.

Mastercard and Gilead Explore Digital Healthcare

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  • Android devices with EMV standard chip cards.
  • Field staff and service providers in low and middle income countries can maintain standards and data with android devices.
  • Tracking of implementation will be easy with this model.
  • All data will be analyzed offline to maintain security.
  • Service providers and field staff on occasion will power up their phones to download data and communication with the team.

Will President Trump Lower Drug Prices

  • Bach and Trusheim have analyzed Gilead acquisition by US government.
  • Gilead’s total valuation would be approximately $158 billion dollars.
  • If US President Trump approves the acquisition, the cost of treatment for hepatitis C would be only $15,700 approximately.
  • Saving the American tax payer lots of money.
  • Unfortunately US government doesn’t purchase pharmaceutical companies to offset costs of hepatitis C treatments.

CDC Recommends Testing for Hepatitis C/HCV

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  • Pennsylvania passed ACT 87 mandates all baby boomers to be tested for hepatitis C.
  • Baby boomers are born between 1945 to 1965.
  • Recommending anyone that had blood transfusions or transplants before 1992.
  • Hepatitis C virus was only discovered in 1989.
  • Pennsylvania Attorney General found that 70% of claims for hepatitis C treatments have been denied.

Malaysia Can’t Afford HCV Treatment

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  • Malaysia a relatively developed country.
  • Sovaldi cost $80,000.
  • Health Ministry is working with several Japanese and Korean non profits to implement experimental treatment for HCV patients.
  • Six hospitals nation wide are involved with the non profits and the investigative treatment options.

Knoxville Hepatitis C Rates Shocking

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  • Knox County finds 10% infection rate among 3,000 patients in 2016.
  • Appalachia has the highest rate of hepatitis C.
  • Health officials are setting up screening centers for HCV through out the county.

29 Year of HCV Infection cleared

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  • Michelle Tolley blood transfusion in 1990s.
  • Infection most probably occurred during this period.
  • Hepatitis C treatment lasted for 3 months
  • Michelle is waiting to take the test again 6 months after her treatment.
  • Michelle is urging anyone that is not able to petition the UK government to provide treatment.

Hepatitis B Test to Assess Patient Therapy

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  • Quest launches HBV test to response to therapy.
  • Hepatitis B antigens (HBsAg) can be quantified for better outcome and better treatment results for HBV infections.
  • Approximately 2.2 million persons in the US are infected with chronic hepatitis B.

Berkeley County #1 for Hepatitis B and C in Virginia

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  • Officials have asked for $35,000 from county and $15,000 from the city to start the needle exchange.
  • Clean needles prevent the transfer of highly contagious diseases like hepatitis B, hepatitis C and HIV.
  • West Virginia ranked 1st in the nation for hepatitis B cases and 2 for HCV cases.
  • County health department is looking for a comprehensive program to reduce STD, hepatitis and HIV infections.

Virginia Passes Bill to Provide Needle Exchange

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  • Opiod epidemic is strong in Virginia
  • Hepatitis C and HIV are a result of needle sharing from heroin and other injectable substances.
  • From 2000 cases of HCV to 8000 in 5 years, 2015.
  • 1 out of 100 to 200 are infected with hepatitis C in Southwest Virginia.

New Glecaprevir/Pibrentasvir 8 Week HCV Treatment Shows High Cure Rate in Phase III Trials

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  • 8 Weeks treatment for hepatitis C patients that do not have cirrhosis.
  • AbbVie is seeking the approval from the FDA for the ribavirin free drug.
  • The new drug would be effective for hepatitis C patients genotypes 1 through 6.
  • Clinical trial results show 99% cure rate 105/106 patients with SVR12.
  • Most common adverse evens were inflammation of the throat, nasal passages and some itchiness.

Hepatitis C in Central Wisconsin Rise Rapidly

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  • Mostly due to injectable drug use.
  • Wisconsin loses 281 people in 2015 due to Heroin.
  • Methamphetamine joins heroin increasingly as youngster inject drugs.
  • 90,000 hepatitis C patients in Wisconsin are infected.
  • 75% of the HCV infected do not know they have hepatitis C.
  • Marathon County is offering a needle exchange which shows promise.

Genotype 1b in Japanese Treatment with Daclatasvir & Asunaprevir

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    Shows safety and efficacy as a dual oral therpy.
  • 24 week daclatasvir (DCV) and asunaprevir (ASV) for chronic hepatitis C infection, genotype 1b.
  • Total number of patients tested 651 HCV-1b in Toranomon Hosptial in Tokyo, Japan.
  • Sustained virologic response (SVR12) was 87%

Liver Cancer Less Likely to Cause cirrhosis

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  • Fibrosis is a result of repair to injured tissues.
  • Cirrhosis scarred due to hepatitis, alcoholism or liver problems.
  • HCC or hepatocellular carcinoma is the most prevalent liver cancer.
  • Only 4% of patients that have cirrhosis have liver cancer.
  • HCC incidence per 1,000 people is about 3.9.

Sofosbuvir is Effective for European Patients

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  • 6 countries in Europe, 249 participants, genotype 1 hepatitis C.
  • Daclatasvir 12 weeks, 84 tablets was the treatment.
  • 234 patients high SVR rates between 82% to 100% according to the clinics involved in the study.
  • Genotype 3 hepatitis C patients were not included in the study.

Wisconsin Sees Rise in Hepatitis C

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  • 90,000 people with hepatitis C infections in Wisconsin.
  • Clean needle exchange in Marathon County has helped reduce the spread of HCV infections.
  • Mostly 30 years of age and younger are diagnosed with hepatitis C and are at higher risk due to opiod abuse.
  • 20% of all who inject drugs are infected with hepatitis C virus.

100’s of Children Could Be Infected with Hepatitis C

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  • 2500 children could be at risk for HCV from Pukekohe Intermediate Dental Clinic.
  • Dental drill for extraction or suction malfunctioned and could have risked children to HIV, hepatitis B and hepatitis C infections.
  • Two clinics will be setup for screenings at Pukekohe Intermediate Dental Clinic and Pukekohe Hospital
  • Auckland Regional Dental Services equipment was checked and no faults found.

Hepatitis C Infected Man Melee with Police Officer

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  • Michael 50, with cocaine wrestles with police officer.
  • He informs police officer that he is positive for hepatitis C.
  • Michael chokes the police officer and attempts to scratch him to infect him with HCV.
  • Michael was arrested for drug charges and intentionally attempting to spread a deadly hepatitis C infection to a police officer.

Multiple Cancers Associated with Hepatitis C

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  • Increased risk of liver cancer and subtypes of non Hodgkin lymphoma.
  • Million elderly US residents have been associated with several groups of cancers.
  • Cancers outside of hepatocellular carcinoma.
  • Cancers associated with bile ducts, pancreas, anus, non melanoma non epithelial skin cancers, diffuse large B cell lymphoma and myelodysplstic syndrome.

Cirrhosis and Liver Decompensation Increase Among HCV Patients.

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  • Advanced liver disease like cirrhosis, liver damage, hepatocellular carcinoma and hepatic decompensation.
  • Successful treatment can slow or stop liver disease progression but not for patients who are treated too late.
  • Hepatocellular carcinoma,end stage liver disease, and cirrhosis are still at risk if they treatment is administered too late.
  • Patients aged 60 and over, black people and men had higher death rates overall.

Tennessee Governor Funds HCV Requests for Prisoners

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  • Half of HCV patients will receive funding for treatment.
  • Total of $3.6 million a year funding for Department of Corrections.
  • 3,669 inmates have hepatitis C, only 7 receiving treatment.
  • Drawing blood from prison inmates for testing is considered treatment.

HCV Testing Among Commercially Insured Population

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  • Test those ages 18 to 39 for at risk individuals for a 10 year study.
  • Tests conducted from 2005 to 2014
  • Large increase of HCV infections due to updated national testing recommendations.
  • Testing is very low among the commercially insured population. Needs improvement.

Counterfeit Harvoni gets in Japanese Pharmacies

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  • Japan’s law allows buying drugs from an unlicensed company.
  • Kansai Medico pharmaceutical chain was victim to fake Harvoni.
  • One bottle of Harvoni in Japan costs 1.53 million yen, that is $13,700 USD.

Travis County Hepatitis C Residents get Treatments

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    500 Travis County residents get treatment.
  • CommUnity Care provides several programs that cater to infectious diseases, HIV and HCV.
  • Medicaid waiver made it possible to afford Harvoni at $1000 dollars a pill.
  • Some residents have gone through SoulofHealing.org for patient assistance programs setup by pharmaceutical companies.

Algoma Districk 7.2% Increase in Hepatitis C

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  • Increased drug use amongst the youngsters aged 20 to 29.
  • Take precautions from sharing needles, straws, pipes and safe sex.
  • Sharing of nail clippers, toothbrushes, scissors and razors should be avoided.

HCV Treatment for Coinfection of HIV/HCV Reduces Chances of Diabetes and Kidney Failure

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  • Curing hepatitis C in HIV/HCV coinfection reduces chances of diabetes.
  • Curing hepatitis C in HIV/HCV coinfection reduces chances of renal disease and failure.
  • Curing hepatitis C in HIV/HCV coinfection does not reduce the chances of cardiovascular diseases.
  • Cardiovascular diseases in hepatitis C patients are highly reduced, just not in a HIV/HCV coinfection.
  • 1625 patients and average age 40 years.
  • 38.6% had bridging fibrosis, F3 or F4.

Ledipasvir/Sofosbuvir Combination for Genotype 1 HCV Effective

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  • 1597 patients highly effective sustained virologic response (SVR).
  • 44 patients relapsed.
  • Age range from 18 to 89, average age 60.
  • 30% of patients were cirrhotic
  • Ledipasvir 90mg and sofosbuvir 400mg, one pill a day for 84 days or 12 weeks was highly efficacious.
  • Direct Acting Antivirals show real life effectiveness for patients with hepatitis C.

Prisoners and HCV Reduction

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  • 200,000 to 300,000 prisoners in Iran are infected with hepatitis C.
  • One third of all prisoners have cirrhotic liver.
  • 300,000 prisoners were vaccinated against Hepatitis B.
  • Sovodak is antiviral biosimilar interferon medicine that has no side effects.

Veterans Urged by Veterans Affairs for Hepatitis C Screening

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  • Those born between 1945 to 1965 should be screened for hepatitis C.
  • 200 screenings resulted from Veterans Affairs outreach letter.
  • 442 HCV screening that resulted in 3% being positive.
  • Veterans urged to visit the outpatient lab in Wilmington, VA, Dover, Georgetown, Vineland, Northfield and Cape May.

US Pharmacopeial Convention/USP Releases New Medicare Model Guidelines

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  • Keeping pace with new FDA approved drugs for the last 3 years.
  • Accommodating new drugs and therapeutic uses resulted 3 new USP Classes.
  • Three new classes are for Pulmonary Fibrosis Agents, Anti Hepatitis C Direct Acting Agents and Anti Hepatitis C Agents.
  • This helps streamline the cost classifications of Harvoni, Sovaldi, Epclusa and Daklinza with direct acting antivirals or DAAs.

MicroRNA to Tackle Hepatitis C Virus

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  • DAAs’ work by targeting hepatitis C virus proteins.
  • Liver specific microRNA targets miiRNA-122 to block cellular cofactors in replication.
  • Injections of RG-102 had a sustained virologic response.
  • Eight of the 28 patients developed resistance to the treatment.

Mapping of Antigen T Cells for HCV Patients

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  • Study for hepatitis C patients who clear the virus with or without spontaneous viral clearance.
  • Early treatment is necessary for T cells to act on hepatitis C virus.
  • Specific T Cells for HCV require DAA or direct acting antivirals to clear the virus.

Computer Modeling and Hepatitis C Drugs

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  • Study to quantify direct acting antivirals or DAA’s
  • Hope to reduce the cost of clinical trials for hepatitis C treatments with DAAs.
  • Triple DAA treatments are better than double DAA treatments.
  • Multidrug strategies of triple DAA treatments will lower the cost of clinical trials.

Health Canada Hepatitis C Candidate Maybe Eligible for glecaprevir/pibrentasvir or G/P

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  • AbbVie is working with FDA to provide glecaprevir/pibrentasvir for severe kidney disease patient with hepatitis C.
  • G/P is an experimental drug that has high SVR for severe kidney patients on hemodialysis with HCV.
  • Glecaprevir 300mg blocks activity of viral enzymes.
  • Pibrentasvir 120mg blocks NS5A a protein that duplicates hepatitis C virus.
  • Glecaprevir 300mg/Pibrentasvir 120mg is to be taken 3 oral tablets once a day.

Broome County HCV Rise/Epidemic

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  • 186 cases of hepatitis C in Broome County, NY.
  • Nurse Marianne Yourdon should contact sunnypharma.org to get generic hepatitis C treatments to address her patients.
  • Survivors of HCV are not immune to contracting hepatitis C through needle sharing.
  • Opiod abuse is rampant and that is number one cause of hepatitis C epidemic in Broome County, New York.

Officals Vow to Eliminate Hepatitis C

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  • Charles King CEO of Housing Works at NY HCV Summit declares to eliminate hepatitis C.
  • Baby boomers 53 to 71 are likely to have hepatitis C.
  • Drug use aged 20 to 40 has become an epidemic due to heroin and opiod addiction.
  • New York spent $700 million for hepatitis C testing and associated medical services for Medicaid.

Oldham County Needle Exchange a Possiblity

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  • Big spike in HIV and hepatitis C
  • Oldham County is the healthiest county in Kentucky but has an epidemic of heroin and opiod use among the young population
  • 191 hospitalizations in 2015
  • Judge proposes alternative generic treatments from India through a non profit SoulofHealing.org. Partner Sunnypharma.org supplying generics of Harvoni, Sovaldi, Epclusa and Daklinza at a fraction of the costs.

Hepatitis C Genotype 1 Treatment Glecaprevir/pibrentasvir Effective

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  • 300mg glecraprevir and 120mg of pibrentasvir once daily regimen.
  • Japanese hepatitis C patients will benefit once this drug is approved by the FDA.
  • Adverse effects of 84% patients included headache, fatigue, nause and insomnia.
  • High SVR rates in non-cirrhotic patients. No virologic failure.
  • Study sponsored by AbbVie

Hepatitis C Drug Market in 2021 will be $27.63 Billion

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  • North America fastest growing HCV drug markets at 40% of total revenue generated in 2015.
  • US is the number 1 contributor to the total of all revenue for hepatitis C treatments.
  • Europe is the second largest market and contributor to revenue for hepatitis C treatments like generics of Harvoni, Sovaldi, Daklinza and Epclusa.
  • Asia, Africa and Latin America markets are also growing fast for hepatitis C treatments.

Lupus Patients Have a Higher Incidence of Hepatitis C

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  • Lupus is also known as System Lupus Erythematosus (SLE)
  • Hepatitis C three times likely amongst Lupus patients.
  • Lupus patients aged 40 to 59 higher chance of hepatitis C.
  • Higher socioeconomic status, smoking and alcohol abuse also associated with higher risk of hepatitis C.

Amsterdam PrEP Study: High HCV Prevelance

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  • HCV prevalence is typcial of HIV negative men, which was not the case before.
  • Increase screening of hepatitis C for gay men.
  • Harvoni, Sovaldi, Daklinza and Epclusa could rapidly reduce the prevalence of hepatitis C in the gay population.

First Ever Hepatitis C Summit in New York

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  • State of New York has over 200,000 infected hepatitis C patients and maybe even more.
  • Organizers say Hepatitis C kills more patients nationally than HIV.
  • Access to generic hepatitis C treatment, prevention and policy discussions will be done by the panel
  • Heroin and opiod epidemic is the major cause of hepatitis C infections in the state.

Erie County Need of Generic Hepatitis C Medicine Due to Increase of Infections

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    Dr. Gale Burstein Erie County Health Commissioner spike in HCV infections is due to needle sharing of intravenous drugs.
  • Under 30 years of age being infected the most.
  • HCV infections can cause liver cirrhosis, cancer and other damages.
  • New York’s Hepatitis C Summit will discuss prevention and options to deal with the growing epidemic.
  • Will look for alternative methods of treatment from the availability of licensed and affordable generics from India.

Conflicts of Interest in Management of HCV Guidelines

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    There was a total of 29 committee members involved in deciding the HCV guidelines. Of those:
  • 72% of members (21) had commercial COI
    62% of members (18) disclosed industry-sponsored research
    34% of members (10) served on advisory boards
    17% of members (5) served on data safety monitoring boards
    10% of members (3) were consultants
    10% of members (3) reported other honoraria
  • Out of the six guideline co-chairs:
  • 67% of co-chairs (4) had commercial COI and had additional COI in other publications which were not revealed in the disclosures
  • The researchers also discovered that another co-chair had a commercial COI.

 


Hepatitis C Treatment Options for Renal Impairment

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    Patients undergoing hemodialysis also have hepatitis C, HCV, infection.
  • Interferon based therapy is the standard for hemodialysis patients with HCV, but the prognosis is very poor.
  • Trials of direct acting antivirals or DAA show significant improvements in SVR.
  • Grazoprevir and elbasvir combination therpay with renal impairment is safe and effective.
  • Sofosbuvir is effective but not fully conclusive for genotype 1 patients with hemodialysis with hepatitis C infection.

 


DAA(Direct Acting Antivirals) for Hepatitis C Associated Diseases

  • DAA’s work for hepatitis C and no longer inteferon based treatment is necessary.
  • Hepatitis C treatment is only 12 weeks to 24 weeks, short and effective.
  • Extrahepatic diseases caused by hepatitis C like rheumatic, hematologic and cardiovascular diseases can be minimized with treatments like generic Harvoni, Sovaldi, Daklinza and Epclusa.
  • Sofosbuvir in combination with simeprevir, ledipasvir and daclatasvir.

Genotype 4 Combination Therapy for Hepatitis C

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  • Belgian researchers are saying its safe and effective.
  • The combination of sofosbuvir in combination with simeprevir with or without ribavirin was effective.
  • 87 patient/participants: 41% had severe fibrosis, 59% had cirrhosis. 2 patients received 12 weeks of treatment and the other 85 received 24 weeks of treatment.

FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

 

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“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus.
Knowing the genotype helps inform treatment recommendations and the duration of treatment. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small numbers of patients are infected with genotypes 4, 5 or 6. According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.The safety and efficacy of Epclusa for 12 weeks was evaluated in three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95–99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured. The safety and efficacy of Epclusa was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis (moderate to severe cirrhosis), of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.The most common side effects of Epclusa include headache and fatigue. Epclusa and ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.Epclusa carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Epclusa is not recommended.
Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood which could lead to reduced efficacy of Epclusa.Epclusa was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.Epclusa is manufactured and marketed by Gilead Sciences, Inc., of Foster City, California.The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


France to provide universal access to hepatitis C treatment

France will provide access to hepatitis C treatment with direct-acting antivirals to everyone diagnosed with hepatitis C from September 2016, and will begin to provide treatment to everyone with stage 2 fibrosis immediately, health minister Marisol Touraine announced last week.

Treatment will also be made available immediately for anyone with hepatitis C waiting for a liver transplant or experiencing a recurrence of hepatitis C infection after a liver transplant, regardless of the stage of post-transplant fibrosis.

 

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Immediate access to hepatitis C treatment will also be granted to groups at high risk of transmitting hepatitis C: prisoners, migrants, pregnant women and people who inject drugs. The French Society for Hepatology has criticised the lack of immediate access for people who acquired hepatitis C through transfusion or contaminated blood products prior to the introduction of screening in 1992.

Until now, treatment for hepatitis C using direct-acting antivirals has been restricted to people with stages F3 (advanced liver damage) or F4 fibrosis (cirrhosis). Approximately 30,000 people in France have received treatment with interferon-free combinations, of whom around 90% have been cured of hepatitis C.

Guidance on how to provide treatment for people with stages F0 and F1 fibrosis will be drawn up by the French national authority for health (Haute Autorité de Santé, or HAS) by September 2016.

Up to 230,000 people in France with hepatitis C could be treated for hepatitis C under the new rules, the French health ministry has said, but Marisol Touraine said that the prices paid by the French health system for direct-acting antivirals must be renegotiated. The current cost of treatment is around 41,000 euros, and the budget for hepatitis C treatment had been capped at 700 million euros, with Gilead required to pay an unspecified rebate on the cost of sofosbuvir if expenditure rose above this level.

The financial arrangements that will permit universal access are still unclear: the announcement comes ahead of any firm agreement on price reduction.The announcement on universal access will place pressure on companies with already-licensed products to cut deals with the government ahead of the European marketing approval of Merck’s Zepatier later this year.

“The time has come for France to renegotiate the price,” Marisol Touraine said in a press statement. She pointed out that the extension of indications for prescribing of drugs has expanded, increasing the size of the market, and competitor products are becoming available. “It is high time that the sense of responsibility prevails. In their own interest, laboratories must play the game.”

The Comité économique des produits de santé (CEPS) will now pursue a price renegotiation, taking into account recent price agreements in other countries.

The French health minister noted that other European countries had been able to use the French price negotiations to achieve favourable deals for high-volume prescribing. In Spain and Portugal prices of 13,000 euros are believed to have been achieved in confidential deals, in which governments pay nothing for patients who are not cured and the cost of treatment is the same regardless of duration. Funding will also be made available to assist associations and voluntary organisations in providing rapid testing for hepatitis C.

 


Gilead’s Epclusa Receives Positive CHMP Opinion for Treatment of All Genotypes of Chronic HCV – Let’s wait and see

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Epclusa®, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection. The data included in the application support the use of Epclusa (SOF/VEL) in adults with all genotypes (GT1-6) of HCV infection.

 

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The CHMP positive opinion was adopted following an accelerated review procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.The MAA for Epclusa is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of Epclusa.
The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of Epclusa with or without ribavirin (RBV) or 24 weeks of Epclusa. The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy (SVR12).Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to those who received Epclusa for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively). The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®. The fixed-dose combination of sofosbuvir and ledipasvir received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®.Gilead has also submitted a regulatory application for SOF/VEL in the United States. Gilead filed the NDA for SOF/VEL on October 28, 2015, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.


 Sunny Pharma acquires Dr. Sue Rodgers Clinic and Pharmacy

Sunny Pharma, a small boutique Indian pharmaceutical company launched in 1985, started manufacturing antibiotics and malarial medicine to budget strapped African nations.  The relationship with these governments led to the manufacturing of HIV medicines.

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Today, Sunny Pharma is focused on hepatitis C tourism and cancer treatments in India.  All Dr. Sue Rodgers Clinic and Pharmacy relationships with Manipal hospital, Wockhardt hosptial and Fortis Healthcare will be transitioned to Sunny Pharma over the next several weeks.  Sunny Pharma will continue to provide access to affordable hepatitis C treatment and medical care.  Sunny Pharma will be subcontracting the manufacture of generic Harvoni and generic Sovaldi in West Africa in the coming year.


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Abbott Labs: False Claims at $1.5 Billion.

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Pfizer: Off Label Promotion and Kickbacks  $2.3 Billion fine

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GlaxoSmithKline mischief unveiled

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Criminal: Off-label promotion, failure to disclose safety data.  Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.  Read more here.


$515 Million Criminal Fine Is Largest Individual Corporate Criminal Fine in History; Civil Settlement up to $800 Million for Eli Lily

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Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa.  Read more about the fraud here at Justice.gov our government website.


Sneaky Johnson and Johnson: 2.2 Billion fine.

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“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth.  Please read more here.


VA expands hepatitis C treatment to all patients with the virus

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We almost gave up!  Our soldiers serve our country and get denied by the VA to have access to Harvoni and Sovaldi.  Today is probably one of the greatest days in the debate of overpriced medication, our soldiers won the battle.   Thank you God!  Please read story here.


NY insurers lift restrictions on coverage of costly hepatitis C drugs

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Price of Cancer Drugs Has Skyrocketed Since 2000

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