AHF to Gilead: Do Your Patriotic Duty and Lower Hep. C Drug Prices for Veterans

AHF to Gilead: Do Your Patriotic Duty and Lower Hep. C Drug Prices for Veterans

AIDS organization calls out Gilead Sciences for offering its Hepatitis C drugs Sovaldi and Harvoni to India and other countries for $900, yet charging the U.S. Department of Veteran Affairs nearly $50,000 per veteran. With rates of Hepatitis C nearly five-times higher among veterans than in the general population, Sovaldi and Harvoni are expected to cost the VA over $1.3 billion over the next two years.

WASHINGTON--(BUSINESS WIRE)--AIDS Healthcare Foundation (AHF), the world’s largest AIDS organization and an outspoken advocate against runaway drug pricing for lifesaving HIV/AIDS and other medications, today called on Gilead Sciences, Inc., the manufacturer of Sovaldi (and its combination form, Harvoni), a new treatment for Hepatitis C, to lower the price of this drug for the Department of Veterans Affairs (VA) to the $900 price per person for Sovaldi it charges India and other countries. Currently, the VA pays nearly $50,000 per person for Sovaldi. The price of Harvoni, a combo drug of which Sovaldi is the primary ingredient, is expected to cost the VA and other payers even more.

“Gilead’s rabid greed has now extended to extracting as much profit as possible from the care of America’s service men and women”

“Gilead’s rabid greed has now extended to extracting as much profit as possible from the care of America’s service men and women,” said Michael Weinstein, President of the AIDS Healthcare Foundation. “As a nation, we have promised the members of our armed forces – men and women who put their lives at risk protecting our freedoms – that when they come home, we will take care of them. By charging our VA system nearly $50,000 per person for the treatment of Hepatitis C, Gilead is driving up healthcare costs by billions of dollars which will ultimately lead to the rationing of care for our veterans. Even more galling, Gilead charges the VA $50,000 while it offers other countries the same treatment for approximately $900 per person per year. AHF is calling on Gilead CEO, John Martin to do his patriotic duty by offering the VA the same $900 price it charges India and other countries for Sovladi.”

Earlier this month, Senator Bernie Sanders (I-VT) raised the alarm on the impact of Hepatitis C drug pricing on the VA. In a statement, Sen. Sanders said, “My goal as chairman is to help VA provide the best quality care to our veterans. But when VA has to spend an enormous amount of money on prescription drugs – money that has not been budgeted for – other important services are put at risk. This is an issue that has to be explored because when we put money into the VA we want to make sure it goes toward making sure veterans get the best care possible, not to pad the profit margins of large pharmaceutical companies.”

According to the statement put out by Sen. Sanders’ office, the VA treats approximately 174,000 veterans with Hepatitis C, and the costly new treatment is projected to cost the Department of Veterans Affairs $1.3 billion over the next two years.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 354,000 individuals in 36 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare

Contacts

AIDS Healthcare Foundation
Washington:
Timothy Boyd
Director of Domestic Policy
+1.202.543.1083 (cell)
timothy.boyd@aidshealth.org
or
Los Angeles:
Ged Kenslea
Senior Director, Communications
+1.323.308.1833 (work)
+1.323.791.5526 (cell)
gedk@aidshealth.org

Multi-part series: Opioid Addiction Crisis Fuels Another: Hep C

Related:

Multi-part series on hepatitis C

Part 1At The Crossroads, Part 1: A Tale Of Two Epidemics

Opioid Addiction Crisis Fuels Another: Hep C

By KRISTIN GOURLAY

Unforeseen consequence
There's been a surge in new users of injection drugs, mainly heroin... Along with it, the CDC reports a surge of new cases of hepatitis C... I spoke with the head of the CDC's division of viral hepatitis, Dr. John Ward, who told me that epidemiologists are still trying to get a handle on this surge. But he called it a new epidemic:

“We have been concerned for several years about the rising number of reports of new cases or new infections with hepatitis C virus from an increasing number of states. And this was first reported in the state of Massachusetts around 2009 and then has progressively spread westward with an increasing number of states reporting rising rates of new infections with hepatitis C," said Ward.

Continue Reading......... 

More HCV screening, better treatments should curb infection rate, researchers find

Model Predicts Sharp Decline in Hep C Burden

October Issue:Gastroenterology & Endoscopy News 
by Monica J. Smith

More screening, better treatments should curb infection rate, researchers find

by Monica J. Smith

The public health burden posed by chronic infection with the hepatitis C virus (HCV), which claimed more lives in 2007 than HIV and is associated with an annual cost in the United States of about $6.5 billion, may be greatly diminished by 2036, according to a recently published computer simulation study (Ann Intern Med 2014;161:170-180).

Significant changes have occurred since the release of prior predictive analyses that were limited to the scenario of treatment with peginterferon and ribavirin (PEG-RBV) in an HCV screening-free setting, or that evaluated only the cost-effectiveness of new drugs.

The launching of direct-acting antiviral medications in 2011, the increasing availability of oral drug therapies, the continuing development of new drugs that increase sustained virologic response rates with fewer adverse effects, and the Centers for Disease Control and Prevention (CDC) recommendation for a one-time HCV screening of all people born between 1945 and 1965 may have a profound effect on the burden of the infection in the United States.

“We anticipated that the HCV burden would go down, but we wanted to quantify how quickly that would drop,” said Jagpreet Chhatwal, PhD, assistant professor of health services research at the University of Texas MD Anderson Cancer Center, in Houston, who helped conduct the study.

To predict the effect these recent developments may have on chronic HCV infections and associated outcomes, including cirrhosis, hepatocellular carcinoma, the demand for liver transplants and liver-related mortality, Dr. Chhatwal and his colleagues at MD Anderson and the University of Pittsburgh developed an individual-level state transition model capable of simulating the HCV-infected population spanning a 50-year range, from 2001 to 2050.

The model simulated the current clinical practice: treatment with PEG-RBV or protease inhibitor–based triple therapy before 2014, then with sofosbuvir- and simiprevir-based therapies and new drugs as they develop. The model also acknowledged one-time birth-cohort screening starting in 2013.

The researchers validated their model using several sources: the National Health and Nutrition Examination Survey 2003-2010 report, data from the CDC, a multicenter follow-up study of individuals with advanced fibrosis and earlier studies. Their model predicted a decrease in the number of chronic HCV cases from 3.2 million in 2001 to 2.3 million in 2013 in the general population, noting that screening baby boomers should identify nearly 490,000 cases over the next decade. One-time universal screening, on the other hand, could identify nearly twice as many.

“We should not be limiting ourselves to screening baby boomers, but explore other screening policies,” Dr. Chhatwal said, adding that expanding screening would require an evaluation of the effects of broader screening and of its cost-effectiveness. “We could look at geography, if the disease burden seems more prevalent in some areas, or by other settings. For example, there is a high prevalence of HCV among prison inmates; screening that population could be a very efficient and cost-effective way to reduce disease burden.”

The model also predicted that the availability of the most recently approved therapies for HCV could prevent a substantial number of HCV-related outcomes, reducing the number of new cases of cirrhosis by 124,200, the number of cases of hepatocellular carcinoma by 78,000, the number of liver-related deaths by 126,500 and the number of liver transplants by 9,900.

Type 1 Strain Accounts For Nearly Half of Cases

Of HCV’s six genotypes, type 1 appears to be the most prevalent, affecting more than 83 million people worldwide, according to the findings of one of the largest prevalence studies to date (Hepatology 2014 July 28. [Epub ahead of print]).

To estimate trends in genotype prevalence, researchers in the United Kingdom reviewed 1,217 studies reporting HCV genotypes. The studies, published between 1989 and 2013, represented 117 countries and about 90% of the global population. The researchers also used prevalence estimates generated by the World Health Organization’s Global Burden of Disease project.

Their analysis showed that genotype 1 made up 46% of all HCV cases. Genotype 3 accounted for 30%, with genotypes 2, 4 and 6 making up 23%, and genotype 5 making up less than 1%.

The authors noted that although genotype 1 is the most common, non–genotype 1 HCV cases account for more than half of all cases and are generally less well served by advances in vaccination and drug treatment.—M.S.

Source

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RG-101 - Decreased viral load in patients with various HCV genotypes

Commentary @ Healio

Oct 23

Potential drug decreased viral load in patients with various HCV genotypes
Interim results from an ongoing clinical trial revealed that a microRNA therapeutic was well-tolerated and safe for the treatment of hepatitis C virus infection, according to a company release from Regulus Therapeutics.

In the trial, currently taking place in the Netherlands, RG-101 (Regulus Therapeutics), a GalNac-conjugated anti-miR targeting microRNA-122, was dosed at 2 mg/kg and given to 14 patients with HCV and various genotypes. This treatment resulted in significant and sustained reductions in HCV RNA among the patients, including those with difficult to treat genotypes and experienced viral relapse after a prior interferon-based regimen, according to the release. 

Continue reading @ Healio

Investment Commentary
Regulus Gets Seat at Hep C Table With Today's Impressive Drug Results 

By Adam Feuerstein
Oct 22
But you're getting way ahead of the facts if you think Regulus has a game-changing hepatitis C therapy in its grasp already. There's a lot more questions to be answered.
Continue reading @ TheStreet.com

Press Release

A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment History

- Interim Results from Ongoing Study Demonstrate Human Proof-of-Concept and Underscore the Value of Regulus' microRNA Platform -
- Conference Call Today at 8:30 a.m. EDT to Discuss Results -

LA JOLLA, Calif., Oct. 22, 2014 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it has demonstrated human proof-of-concept with a microRNA therapeutic from an ongoing clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 ("miR-122"), for the treatment of hepatitis C virus infection ("HCV"). Interim results from the ongoing clinical study demonstrate that treatment with a single subcutaneous dose of 2 mg/kg of RG-101 as monotherapy resulted in significant and sustained reductions in HCV RNA in a varied group of patients, including difficult to treat genotypes and patients who experienced viral relapse after a prior IFN-containing regimen. Additionally, RG-101 was safe and well tolerated and has demonstrated a very favorable pharmacokinetic profile to date, which may allow for combination with oral direct-acting antiviral ("DAA") agents to treat HCV.

Interim results from the ongoing clinical study are summarized below:

In the first dose cohort of part IV of the ongoing study, 16 HCV patients were enrolled with multiple genotypes, 10 GT1s, 5 GT3s, and 1 GT4. 14 patients, 8 naïve and 6 patients who experienced viral relapse after a prior IFN-containing regimen, received a single subcutaneous dose of 2 mg/kg of RG-101 as monotherapy while 2 patients received placebo.

In the 14 HCV treated patients, there was a mean viral load reduction of 4.1 log10 at day 29 (range -5.8 log10 to -2.3 log10).

6 out of 14 patients had HCV RNA levels below the limit of quantification at day 29 and the 3 patients from this group who have reached day 57 still have HCV RNA levels below the limit of quantification.
Viral load reduction occurs within the first 96 hours and virologic response is not influenced by IL-28 genotype.
Due to the long-lasting and sustained virologic effect seen, the ongoing study protocol has been amended to follow patients for up to six months after dosing to evaluate the possibility for certain patients to achieve viral cure after a single dose of RG-101.

There were no drug-drug interactions from part III of the ongoing study in which RG-101 was combined with simeprevir (OLYSIO™), an approved oral DAA (protease inhibitor), and the combination had no effect on the pharmacokinetic profile of RG-101 or simeprevir (OLYSIO™).
RG-101 is safe and well tolerated with no serious adverse events reported to date.

"We are very excited to have demonstrated our first human proof-of-concept results with a microRNA therapeutic from the ongoing study of RG-101, which is a significant milestone in Regulus' history, and represents a key achievement under our 'Clinical Map Initiative'," said Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer of Regulus. "We believe these interim data are exceptional and provide strong evidence to support the rapid advancement of RG-101 into future clinical studies, while presenting a clear opportunity for a potentially disruptive therapy to the current HCV treatment paradigm."

"RG-101 is the first microRNA therapeutic in clinical development to combine the most advanced RNA technologies from three leading RNA therapeutics companies; chemistry 2.5 from Isis, GalNAc conjugate from Alnylam, and Regulus' unique and proprietary chemistry including the novel linker that facilitates the release of the parent oligonucleotide after hepatocyte uptake," said Neil W. Gibson, Ph.D., Chief Scientific Officer. "We believe the innovative design of RG-101 has led to achievement of our first human proof-of-concept results, and hope these findings will advance the growth of our microRNA therapeutics pipeline."

"We are very pleased and encouraged with the interim results and believe these findings strongly support the rapid advancement of RG-101 into Phase II development," said Paul Grint, M.D., Regulus' Chief Medical Officer. "Currently, we plan to file an Investigational New Drug Application with the U.S. Food and Drug Administration in the first quarter of 2015 and plan to initiate a Phase II DAA combination study of RG-101 in HCV patients in the second quarter of 2015. In addition, we look forward to reporting additional data from the ongoing study in the first half of next year."

"The efficacy and sustained viral response seen with a single dose of RG-101 is very promising and it was encouraging to see response across a diversity of genotypes and treatment experience in this clinical trial. Additionally, all patients in the first cohort on active therapy demonstrated a viral response to RG-101, which is also very encouraging," said Dr. Eric Lawitz, M.D., Vice President, Scientific and Research Development, The Texas Liver Institute, and Clinical Professor of Medicine, University of Texas Health Science Center in San Antonio. "These findings suggest the clinical benefit of utilizing a unique mechanism of action to potentially treat difficult patient populations. There may be an opportunity to improve upon the current real world compliance issues with therapies such as RG-101 that may be administered subcutaneously by a clinician. I look forward to seeing RG-101 advance into future clinical trials."

Conference Call & Webcast Information

Regulus will host a conference call and webcast at 8:30 a.m. Eastern Daylight Time today to discuss its interim results from the ongoing clinical study of RG-101 for the treatment of HCV. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 24374685. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode ID 24374685. The webcast and telephone replay will be archived on the company's website for ninety days following the call.

About RG-101 for HCV

RG-101 is a wholly-owned, GalNAc-conjugated anti-miR targeting miR-122 for the treatment of HCV. Regulus is currently evaluating RG-101 in an ongoing study being conducted in the Netherlands. The study has the following four parts: (I) a single ascending-dose study in which healthy volunteer subjects receive a single subcutaneous dose of RG-101, 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4 mg/kg and 8 mg/kg or placebo; (II) a multiple-ascending dose study in which healthy volunteer subjects receive a monthly single subcutaneous dose for four months of RG-101 or placebo; (III) a single-dose drug-drug interaction study in which healthy volunteer subjects receive a single subcutaneous dose of RG-101 in combination with simeprevir, an approved DAA; and (IV) a single-dose study in which HCV patients receive either a single subcutaneous dose of RG-101 or placebo at two doses, 2 mg/kg of RG-101 (the first dose cohort) or 4 mg/kg of RG-101 (the second dose cohort), to assess the safety and viral load reduction. The primary objective is to evaluate safety and tolerability and the secondary objectives are to evaluate pharmacokinetics, viral load reduction and any impact an oral DAA, such as simeprevir, may have on the pharmacokinetics of RG-101. Up to 100 healthy volunteer subjects and HCV patients with multiple HCV genotypes and treatment history are planned to be enrolled.

Today, Regulus reported interim results from the above study and plans to report additional results from the ongoing study in 2015.

About microRNAs

The discovery of microRNAs in humans during the last decade is one of the most exciting scientific breakthroughs in recent history. microRNAs are small RNA molecules, typically 20 to 25 nucleotides in length, that do not encode proteins but instead regulate gene expression. More than 800 microRNAs have been identified in the human genome, and over two-thirds of all human genes are believed to be regulated by microRNAs. A single microRNA can regulate entire networks of genes. As such, these molecules are considered master regulators of the human genome. microRNA expression, or function, has been shown to be significantly altered or dysregulated in many disease states, including oncology, fibrosis, metabolic diseases, immune-inflammatory diseases and HCV. Targeting microRNAs with anti-miRs, chemically modified, single-stranded oligonucleotides, offers a unique approach to treating disease by modulating entire biological pathways and may become a new and major class of drugs with broad therapeutic application.

About Hepatitis C Virus Infection (HCV)

Hepatitis C is a result of a hepatocyte specific infection induced by the virus known as HCV. Chronic HCV may lead to significant liver disease, including chronic active hepatitis, cirrhosis, and hepatocellular carcinoma. Up to 170 million people are chronically infected with HCV worldwide, and more than 350,000 people die from HCV annually. The CDC estimates that there are currently approximately 3.2 million persons infected with HCV in the United States. HCV shows significant genetic variation in worldwide populations due to its frequent rates of mutation and rapid evolution. There are six genotypes of HCV, with several subtypes within each genotype, which vary in prevalence across the different regions of the world. The response to treatment varies from individual to individual underscoring the inadequacy of existing therapies and highlights the need for combination therapies that not only target the virus but endogenous host factors as well, such as microRNA-122.

Regulus believes that its' miR-122 antagonist, RG-101, may be a useful agent in emerging combination regimens to address difficult-to-treat genotypes and to potentially expand upon the current therapies available to clinicians treating HCV patients.

Update to the 'Clinical Map Initiative'

Launched in February 2014, Regulus' 'Clinical Map Initiative' outlines certain corporate goals to advance its microRNA therapeutics pipeline over the next several years. In October 2014, Regulus demonstrated human proof-of-concept with a microRNA therapeutic, RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 for the treatment of HCV. The company plans to rapidly advance RG-101 in clinical development and expects to initiate a Phase II DAA combination study in HCV patients in the second quarter of 2015. In addition, Regulus expects to initiate a Phase I clinical study of RG-012 for the treatment of Alport syndrome, nominate a third microRNA candidate for clinical development by the end of 2014, and maintain a strong financial position and end 2014 with at least $75.0 million in cash, cash equivalents and short-term investments.

About Regulus

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is uniquely positioned to leverage a mature therapeutic platform that harnesses the oligonucleotide drug discovery and development expertise of Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc., which founded the company. Regulus has a well-balanced microRNA therapeutics pipeline entering clinical development, an emerging microRNA biomarkers platform to support its therapeutic programs, and a rich intellectual property estate to retain its leadership in the microRNA field. Regulus intends to focus its proprietary efforts on developing microRNA therapeutics for oncology indications and orphan diseases and is currently advancing several programs toward clinical development in oncology, fibrosis and metabolic diseases. Specifically, Regulus is developing RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy, and RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection. Regulus' commitment to innovation and its leadership in the microRNA field have enabled the formation of strategic alliances with AstraZeneca and Sanofi and a research collaboration with Biogen Idec focused on microRNA biomarkers. In addition, the Company has established Regulus microMarkers™, a division focused on identifying microRNAs as biomarkers of human disease, which is designed to support its therapeutic pipeline, collaborators and strategic partners.

For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including the expected ability of Regulus to undertake certain activities and accomplish certain goals with respect to RG-101, the projected timeline of clinical development activities related to RG-101, and expectations regarding future therapeutic and commercial potential with respect to RG-101. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Regulus' are described in additional detail in Regulus filings with the Securities and Exchange Commission. All forward-looking statements contained in this presentation speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

OLYSIO™ is a registered trademark of Janssen Therapeutics.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/a-single-subcutaneous-dose-of-2mgkg-of-rg-101-regulus-wholly-owned-galnac-conjugated-anti-mir-targeting-microrna-122-demonstrates-41-log10-mean-viral-load-reduction-as-monotherapy-at-day-29-in-patients-with-varied-hcv-genoty-248366539.html

SOURCE Regulus Therapeutics Inc.

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ACG Abbvie 3D: Interferon-free HCV Regimens of ABT-450/Ritonavir/Ombitasvir and Dasabuvir

New @ NATAP
Reported by Jules Levin
ACG Annual Scientific Meeting
Philadelphia, PA, October 20, 2014

Abbvie 3D at ACG
ACG: MANAGEMENT OF HEMOGLOBIN DECREASE IN PATIENTS TREATED WITH ABT-450/RITONAVIR/OMBITASVIR AND DASABUVIR WITH OR WITHOUT RIBAVIRIN IN HCV GENOTYPE-1 INFECTED PATIENTS - (10/20/14)

ACG: NORMALIZATION OF LIVER-RELATED LABORATORY PARAMETERS IN HCV GENOTYPE 1-INFECTED PATIENTS WITH CIRRHOSIS AFTER TREATMENT WITH ABT-450/R/OMBITASVIR, DASABUVIR AND RIBAVIRIN - (10/20/14)

ACG: Sustained Virologic Response 12 Weeks Post-treatment With ABT-450/Ritonavir/Ombitasvir and Dasabuvir With Ribavirin (SAPPHIRE I and II) Is Independent of Patient Subgroups - (10/20/14)

ACG: Low Incidence of Hyperbilirubinaemia With Ombitasvir-ABT-450/r and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Patients - (10/20/14)

ACG: Results From the Phase 2 PEARL-I Study: Interferon-free Regimens of ABT-450/r + ABT-267 With or Without Ribavirin in Patients With HCV Genotype 4 Infection - (10/20/14)

ACG: Safety Comparison of 12- and 24-Week Treatments in HCV Genotype 1-Infected Patients With Cirrhosis: Results From TURQUOISE-II - (10/20/14)

Additional Coverage @
ACG Annual Scientific Meeting

Australia's rejection of costly new treatment sofosbuvir a 'death sentence for Hepatitis C sufferers'

Australia's rejection of costly new treatment sofosbuvir a 'death sentence for Hepatitis C sufferers'

By Deborah Cornwall

Audio: Listen to Deborah Cornwall's report (PM) 

Liver experts at a conference on the Gold Coast have been warned Australia is on the verge of a catastrophic death spiral from Hepatitis C.

Dr Miriam Levy, the director of gastroenterology at Sydney's Liverpool Hospital, told the conference the recent decision by the Pharmaceutical Benefits Advisory Committee (PBAC) to refuse subsidies for a breakthrough treatment for Hepatitis C had effectively delivered a death sentence to up to 50,000 Australians who would die from the disease in the next few years.

"I am seeing on the blood tests absolute flashing red lights that are telling me that this patient is going to do badly in the next year," Dr Levy said.

"They don't even know it yet. They still feel OK. Then over the year they will become jaundiced, go yellow, they will develop fluid in their belly, they may develop liver cancer. 

"It's terrible. Those people need to be rescued. They are clinging on to the edge."

Australia is the only developed country in the world that has not agreed to subsidise the new $70,000 treatment for Hepatitis C for the most seriously ill patients.

The PBAC argued the costs were too high to treat Australia's 250,000 Hepatitis C sufferers and promised to review the decision in a year, when drug companies came back with a better price.

But Dr Levy said while 80 per cent of Australia's sufferers can probably afford to wait a few years until cheaper treatments become available, those who were already heading towards liver failure need the treatment now.

Those people need to be rescued. They are clinging on to the edge.
Dr Miriam Levy

"They don't seem to get this is urgent. This is a health system that can afford to treat those people," Dr Levy said.

"When the liver fails, that's it. There's only 50 liver transplants a year so we can't rescue them all with liver transplants. And once they get liver cancer then they are really done for."

'For them it is the Dallas Buyers Club scenario'

Dr Levy said she finds the plight of many of her patients so distressing she has even contemplated setting up a Dallas Buyers Club-style black market smuggling chain that flourished at the height of the AIDs virus in the 80s when the United States Food and Drug Administration banned life-saving treatments for HIV sufferers in America.

"You know if I could, without going to jail, I would fill my suitcase and come home and give them to patients, because I know the patients cannot wait a year or two," she said.

"It's cruel to see them in the clinic and know that they are stuck. They are desperate. You know for them, it is the Dallas Buyers Club scenario."

Dr Levy said she had no doubt desperate patients are already going online to try and track down the new treatment called sofosbuvir, which was "the worst possible indictment of our health system".

"We are spending millions on health treatments to extend the lives of people with cancer, where they may just get a few more months to live, yet this new treatment prevents cancer in Hep C patients," she said.

"How can we put these patients in this position when their lives could be saved?"

Morag Goodinson is a nurse practitioner who only discovered she had the virus three years ago.

She said the prospect of not getting access to the new treatment for at least four years was excruciating.

The message, she said, is that the Government has deemed her life not worth the cost of the treatment.

"I would like to think I would live for another 30-odd years but no doubt if I don't get treatment I am very likely to develop liver disease and that's not a nice prospect at all," Ms Goodinson said.

I've nursed people with Hepatitis that have gone on to die from it.
Morag Goodinson

"It's unfathomable why we would do this in Australia. I've seen it. I've nursed people with Hepatitis that have gone on to die from it."

Ms Goodinson believes much of the resistance to making the new treatments available sooner is that there is no real outrage in the community - largely because Hepatitis C is still widely perceived as a drug addicts' disease.

"Clearly the people who are sick need to get the treatment first. Nobody would dispute that. However those of us are waiting how long do we have to wait?" she said.

"I don't have fibrosis (liver scarring) yet. But you know if I wait long enough I will have."

Source

More on this story:

• Hep C patients push for PBS listing of new drug
• Researchers claim breakthrough in tackling HIV
• Australia urged to subsidise 'revolutionary' new hepatitis C drugs
• New PBS listings offer hope to hep C patients

Reform Update: Medicaid programs crafting limits on Harvoni usage

Reform Update: Medicaid programs crafting limits on Harvoni usage

By Virgil Dickson

Posted: October 21, 2014 - 4:15 pm ET

Tags: Access, Government, Healthcare Reform, Medicaid, Pharmaceuticals, Suppliers

Which Medicaid beneficiaries will have access to Gilead Sciences' newest high-cost hepatitis C treatment, Harvoni, and when they'll get that access, now depends on prior-authorization criteria being hammered out by various state agencies.

Most will likely limit Harvoni use to patients dealing with liver failure, as 35 states now do for Gilead's Sovaldi. Some may adopt restrictions such as banning those dealing with drug and alcohol addiction from getting the specialty drug, or limiting who may prescribe it to only board-certified gastroenterologists, hepatologists or infectious disease physicians. Another option is implementing the so-called “once in a lifetime” rule, which allows Medicaid patients only one chance at treatment.

Continue reading... 

Harvoni will keep Gilead atop Hepatitis C virus treatment landscape, says GlobalData Analyst

Source -  European  Pharmaceutical Review

Harvoni will keep Gilead atop Hepatitis C virus treatment landscape, says GlobalData Analyst

The recent US Food and Drug Administration (FDA) approval of Harvoni (ledipasvir/sofosbuvir), Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus (HCV) genotype 1 (GT1) infection in adults, will enable the company to maintain its dominance in an increasingly competitive market, says an analyst with research and consulting firm GlobalData.

Christopher J. Pace, Ph.D., GlobalData’s Senior Analyst covering Infectious Diseases, expects Harvoni to quickly usurp other Sovaldi-based regimens as the preferred treatment option for GT1 patients, who comprise over 70% of all US adults with HCV. This is due to the drug’s stellar clinical profile and reduced pill burden relative to approved and off-label options.

Furthermore, by attributing the bulk of Harvoni’s wholesale acquisition cost (WAC) to Sovaldi, Gilead will also discourage the off-label use of more expensive Sovaldi-based, direct-acting antiviral (DAA) regimens, strengthening its position against competitors Bristol-Myers Squibb, Johnson & Johnson, AbbVie, and Merck.

Pace comments: “Gilead’s shrewd pricing strategy for the fixed-dose combination pill, with an anticipated WAC of $94,500 for a 12-week course, will help to facilitate its rapid uptake, particularly in the US.

“This approach will easily position Harvoni as the more cost-effective option for most GT1 patients, compared with the interferon-sparing Sovaldi regimens, which have an estimated WAC of $94,726 for a 12-week course of Sovaldi combined with Pegasys [peginterferon alfa-2a] and ribavirin. This pricing strategy will be especially effective for patients who can be cured with an eight-week course of Harvoni, which carries an expected WAC of $63,000.”

However, the analyst notes that while Gilead has a clear lead over competitors in the US, its position in other major markets is less tenable.

Pace explains: “Compared to the US, Gilead has faced a delayed uptake of Sovaldi-based regimens in the five European countries of Germany, Italy, Spain, France and the UK due to cost-effectiveness concerns, particularly in the latter two countries.

“Nevertheless, Harvoni’s convenient once-daily, single-tablet dosing will be hard for clinicians and eligible patients to ignore when it launches in these and the Japanese markets, especially if Gilead emulates its US pricing strategy.”