EMA Validates Gilead’s Marketing Application for Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C

European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C

If Approved, SOF/VEL Would be the First All-Oral, Pan-Genotypic Single Tablet Regimen for Chronic HCV in Europe --

-- SOF/VEL Granted an Accelerated Assessment by the European Medicines Agency --
December 04, 2015 05:28 AM Eastern Standard Time

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Marketing Authorization Application (MAA) for an investigational, once-daily fixed-dose combination of the nucleotide analog 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, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on November 17, 2015, support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.

“If approved, SOF/VEL will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes.”Tweet this

“Despite advances in the treatment of HCV, there is a need for simple, highly effective pan-genotypic therapies, particularly for patients with genotype 3 HCV infection, who traditionally have been more difficult to cure,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “If approved, SOF/VEL will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes.”

The MAA for SOF/VEL is supported by four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Ninety-four percent of patients who received SOF/VEL plus RBV for 12 weeks achieved an SVR12, while 83 percent and 86 percent of patients who received SOF/VEL for 12 weeks and 24 weeks, respectively, achieved SVR12. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2015, and were also published in The New England Journal of Medicine.

Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared with placebo-treated patients in ASTRAL-1. The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea.

SOF/VEL is the third investigational medicinal product from Gilead for HCV infection to receive Accelerated Assessment by the EMA. This, however, does not assure a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. Review of the MAA will be conducted under the centralized licensing procedure, which, if authorized, provides marketing authorization in all 28 member states of the European Union, Norway and Iceland. If approved, SOF/VEL could be available for marketing in the European Union in 2016. Gilead has also submitted a regulatory application for SOF/VEL in the United States.

SOF/VEL is an investigational product and its safety and efficacy has not yet been established.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com or call Gilead Public Affairs at +44 (208) 587-2477.

HCV Most Common Infectious Cause of Death, Yet Still Underestimated

HCV Most Common Infectious Cause of Death, Yet Still Underestimated
Carly Szabo
Publish Date: Wednesday, December 02, 2015

Hepatitis C infection causes more deaths than HIV, hepatitis B, and tuberculosis combined.

Despite the advent of direct acting antivirals (DAAs) in the fight against hepatitis C virus (HCV) in recent years, deaths related to HCV infection continue to rise in the United States, according to data presented at IDWeek 2015 in San Diego, California.

Even though death certificate data indicates that hepatitis C is the most common infectious cause of death, even more so than HIV, hepatitis B and tuberculosis combined, HCV-related mortality is still likely underestimated.

According to the US Centers for Disease Control and Prevention, there are between 3 and 4 million people living with HCV in the United States. Many of those infected were born between the years of 1945 and 1965; however, new data shows a spike in infections among younger intravenous drug users.

HCV has the potential to advance to severe liver disease including cirrhosis, liver cancer and end-stage liver failure. The virus is also the leading cause of liver transplantation, according to aidsmap.com.

A new study that evaluated a national multiple-cause-of-death (MCOD) database from 2003 to 2013 and data from the Chronic Hepatitis Cohort Study (CHeCS), which showed deaths with hepatitis C recorded on death certificates increased from 11,051 in 2003 to nearly 20,000 in 2013.

Deaths associated with all 59 other notifiable infectious conditions decreased from nearly 25,000 in 2003 to just 18,002 in 2013. The study also analyzed “hidden” mortality rates among people believed to have access to evolving HCV care and curative treatments.

Among more than 12,000 people receiving care in the CHeCS, the mortality rate doubled from about 2.3 per 100 person-years to 5.5 per 100 person-years from 2007 to 2013, respectively.

Of 1600 CHeCS patients who died, only 19% had HCV listed as the cause of death on their certificates, even though more than 75% showed evidence of liver disease prior to death, according to aidsmap.com.

When taking this percentage and applying it to the general population, it can be estimated that 75,000 deaths in 2013 were attributable to HCV.

“Deaths in chronic HCV-infected persons, even when grossly under-enumerated on death certificates, far outstrip deaths from 60 other infectious conditions reportable to CDC,” the investigators concluded. “Control of the ‘chronic’ and the ‘acute’ outbreaks will require a multipronged approach, with interventions along a testing-to-cure continuum of care.”

According to the analysis, the hepatitis C cascade of care shows that of the 3.2 million people living with HCV in the United States, 50% have had HCV antibody tests, 38% have received hepatitis C care, 23% have had HCV RNA tests, 11% have received treatment and only 6% have achieved sustained virological response, or what is considered to be cured.

Data from Gilead Sciences, producers of two of the curative treatments for HCV, Sovaldi (sofosbuvir) and Harvoni, shows that prescriptions for sofosbuvir-based regimens reached 470,000 in the second quarter of 2015.

Yet, while the number of people receiving HCV treatment rises, barriers still exist to achieving universal treatment. Some of these barriers include the expense of treatment, clinicians thinking hepatitis C is a benign chronic condition that doesn’t require treatment, and reluctance to help people who inject drugs.

As more competition enters the marketplace and people become more educated about the risk factors that accompany an HCV infection, the frequency of HCV-related deaths should go down over time.

See more at: http://www.specialtypharmacytimes.com/news/hcv-most-common-infectious-cause-of-death-yet-still-underestimated#sthash.TcwAzZqk.dpuf

AbbVie Announces FDA Acceptance of NDA for VIEKIRA PAK® to Treat Genotype 1 Chronic Hepatitis C Virus Infection

AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection

- If approved, this regimen will be the first all-oral, co-formulated three direct-acting antiviral treatment for adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection

- New formulation reflects AbbVie's ongoing commitment to scientific innovation for people living with HCV

- Decision from FDA on New Drug Application anticipated in second half of 2016

The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily with a meal, with or without twice-daily RBV, potentially offering another important treatment option for people living with GT1 HCV. The NDA filing is supported by data from two bioavailability studies. Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.

NORTH CHICAGO, Ill., Dec. 2, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the United States for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is not for people with decompensated cirrhosis.

The proposed dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets once daily with a meal, with or without twice-daily RBV, potentially offering another important treatment option for people living with GT1 HCV. The NDA filing is supported by data from two bioavailability studies. Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal.

"Nearly one year after the launch of VIEKIRA PAK, AbbVie is pleased to announce the acceptance of a New Drug Application for a once-daily formulation for the treatment of patients with chronic genotype 1 hepatitis C," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone further underscores AbbVie's commitment to offer people living with hepatitis C optimized treatment options."

The Centers for Disease Control and Prevention (CDC) estimates that in the United States, approximately 2.7 million people are chronically infected with HCV.i Genotype 1 is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases.ii Hepatitis C is inflammation of the liver caused by an infection with HCV. It is transmitted when an infected person's blood enters the bloodstream of an uninfected person. There are six major HCV genotypes (GT1-6). Presently, there is no vaccine for HCV infection.

About VIEKIRA PAK USE
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated).

VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking VIEKIRA PAK.

IMPORTANT SAFETY INFORMATION
When taking VIEKIRA PAK in combination with ribavirin, people should read the Medication Guide that comes with ribavirin, especially the important pregnancy information.

What is the most important information to know about VIEKIRA PAK?
VIEKIRA PAK may cause severe liver problems, especially in people with certain types of cirrhosis. These severe liver problems can lead to the need for a liver transplant, or can lead to death.
VIEKIRA PAK can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).
Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with VIEKIRA PAK. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA PAK, and for about 2 weeks after treatment with VIEKIRA PAK ends. A doctor can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
A doctor should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.

A doctor may tell people to stop taking VIEKIRA PAK if signs or symptoms of liver problems develop. A doctor must be notified right away if any of the following symptoms develop or if they worsen during treatment with VIEKIRA PAK: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, color changes in stools, confusion, or swelling of the stomach area.

VIEKIRA PAK must not be taken if people:
have certain liver problems take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) • colchicine (Colcrys®) • efavirenz (Sustiva®, Atripla®) • ergot containing medicines, including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines • gemfibrozil (Lopid®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • midazolam (when taken by mouth) • phenytoin (Dilantin®, Phenytek®) • phenobarbital (Luminal®) • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®), when taken for pulmonary artery hypertension (PAH) • simvastatin (Zocor®, Vytorin®, Simcor®) • St. John's wort (Hypericum perforatum) or a product that contains St. John's wort • triazolam (Halcion®) have had a severe skin rash after taking ritonavir (Norvir®)

What should people tell a doctor before taking VIEKIRA PAK?
If they have: liver problems other than hep C infection, HIV infection, or any other medical conditions.

If they have had a liver transplant. If they take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), a doctor should check blood levels and, if needed, may change the dose of these medicines or how often they are taken, both during and after treatment with 

VIEKIRA PAK.
If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA PAK will harm a person's unborn baby or pass into breast milk. A doctor should be consulted about the best way to feed a baby if taking VIEKIRA PAK. Pregnant females who have both hep C and HIV infection should talk with a doctor about enrolling in the antiretroviral pregnancy registry.

About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA PAK.
A new medicine must not be started without telling a doctor. A doctor will provide instruction on whether it is safe to take VIEKIRA PAK with other medicines.
When VIEKIRA PAK is finished, a doctor should be consulted on what to do if one of the usual medicines taken was stopped or if the dose changed during VIEKIRA PAK treatment.

What are the common side effects of VIEKIRA PAK?
For VIEKIRA PAK used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.
For VIEKIRA PAK used without ribavirin, side effects include nausea, itching, and sleep problems.

These are not all of the possible side effects of VIEKIRA PAK. A doctor should be notified if there is any side effect that is bothersome or that does not go away.

This is the most important information to know about VIEKIRA PAK. For more information, talk with a doctor.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information, including the Medication Guide.

If people cannot afford their medication, they should contact www.pparx.org for assistance.

VA can't afford drug for veterans suffering from hepatitis C

VA Doctor Invented Hepatitis C Cure, Sold It For $400 Million Profit

December 3, 2015 by Benjamin Krause

Apparently, Dr. Raymond Schinazi, a VA doctor since 1983, founded a company named Pharmasset and led the scientific team that discovered sofosbuvir while working at VA. That is the substances used in current hep C pill treatments.

So who really owns the hepatitis C cure? Taxpayers or the VA employee who invented it while a full-time VA employee? Dr. Schinazi claimed it was all his.

Continue reading...

VA can't afford drug for veterans suffering from hepatitis C
On Tuesday, a Senate report found Gilead Sciences, which makes a cure for a fatal form of hepatitis, is more interested in profits than patients. The cure was invented under the leadership of a celebrated doctor in the Department of Veterans Affairs, but at $1,000 a pill, even the VA can't afford to save the lives of veterans who need it.

Dr. Raymond Schinazi founded the company, Pharmasset, and led the scientific team that discovered sofosbuvir. He also works for the Department of Veterans Affairs and has since 1983.

He said he is only a 7/8th's government employee. So what he does with his remaining time is up to him.

He said he is spending less than 1/8th of his time on private companies.

"Well, even less than that. I'm very efficient," he said

Dr. Schinazi made more than $400 million when he sold his company for $11 billion to pharmaceutical giant Gilead in 2012.

Read more...

View More: Health News|Live News|More News Videos

Australians must be given access to this life-saving Hepatitis C treatment

Australians must be given access to this life-saving Hepatitis C treatment

OPINION
By Amanda Bresnan

There's been a major campaign undertaken by people living with Hepatitis C, the medical community, and the organisations who represent and advocate on behalf of people living with hepatitis C, to have these new drugs listed on the Pharmaceutical Benefits Scheme (PBS).

These Hepatitis C treatments have already been approved by the PBAC and the reason for the delay in providing them to patients is the ongoing negotiations with the product sponsors over price.

The federal Health Minister, Sussan Ley, previously made some positive statements which suggested the possibility of treatments being listed by December 2015; however, this listing is looking less and less likely to occur....

Continue reading...

Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug

Related:

VA Doctor Invented Hepatitis C Cure, Sold It For $400 Million Profit

December 3, 2015 by Benjamin Krause

Apparently, Dr. Raymond Schinazi, a VA doctor since 1983, founded a company named Pharmasset and led the scientific team that discovered sofosbuvir while working at VA. That is the substances used in current hep C pill treatments.

Gilead pricing for Sovaldi hepatitis C drug slammed by senators
By ED SILVERMAN

The drug maker was aware more patients could have been treated if Sovaldi were priced for less than $1,000 a pill, or $84,000 for a full course of treatment. Instead, it refused to lower the price or offer meaningful discounts in order to maximize and outmaneuver competition, the investigation found. And Gilead did the same thing with its Harvoni follow-up treatment...

US lawmakers allege Gilead used "revenue-driven" pricing model for hepatitis C drugs

(Ref: The United States Senate Committee on Finance, Bloomberg)
December 1st, 2015
By: Joe Barber

A report released Tuesday by US Senators Ron Wyden and Charles Grassley claims that Gilead Sciences priced the hepatitis C treatments Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) with the sole goal of maximising revenue. The report was based on an investigation of 20 000 pages of internal company documents, dozens of interviews with health care experts and data from Medicaid programmes in all 50 states and the District of Columbia.......

For Immediate Release
December 01, 2015

Wyden-Grassley Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug

18-Month Investigation Reveals a Pricing and Marketing Strategy Designed to Maximize Revenue with Little Concern for Access or Affordability

Report Includes Landmark Release of Medicaid Data: In 2014, More than $1 Billion Spent by Medicaid Programs on Sovaldi Treated Less than 2.4 Percent of Enrolled Patients with Hepatitis C

Medicare Spent More on Gilead Hepatitis C Drugs in the First Half of 2015 than in All of 2014 

WASHINGTON – Senate Finance Committee Ranking Member Ron Wyden, D-Ore., and senior committee member Chuck Grassley, R-Iowa, today released the results of an 18-month investigation into the pricing and marketing of Gilead Sciences’ Hepatitis C drug Sovaldi and its second-wave successor, Harvoni. Drawing from 20,000 pages of internal company documents, dozens of interviews with health care experts, and a trove of data from Medicaid programs in 50 states and the District of Columbia, the investigation found that the company pursued a marketing strategy and final wholesale price of Sovaldi – $1,000 per pill, or $84,000 for a single course of treatment – that it believed would maximize revenue. Building on that price, Harvoni was later introduced at $94,500. Fostering broad, affordable access was not a key consideration in the process of setting the wholesale prices.

In the 18 months following Sovaldi’s approval, Medicare spent nearly $8.2 billion before rebates on Sovaldi and Harvoni. Over that same span, Medicare’s monthly spending on Hepatitis C treatments increased more than six-fold. In 2014 alone, Medicare and Medicaid combined to spend more than $5 billion on Sovaldi and Harvoni before rebates. That total is projected to climb in 2015. Gilead’s recent financial statements show U.S. sales of Sovaldi and Harvoni, including through public programs and private payers, totaled $20.6 billion after rebates in the 21 months following Sovaldi’s introduction.

Senators Wyden and Grassley will hold a press conference today at 11:15 a.m. in the Senate Radio/TV Gallery, S-325, to discuss the investigation. Details are below, including a streaming feed for media unable to attend in person. Further resources are also online and additional findings from the investigation are below.

“Gilead pursued a calculated scheme for pricing and marketing its Hepatitis C drug based on one primary goal, maximizing revenue, regardless of the human consequences. There was no concrete evidence in emails, meeting minutes or presentations that basic financial matters such as R&D costs or the multi-billion dollar acquisition of Pharmasset, the drug’s first developer, factored into how Gilead set the price. Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead. If Gilead’s approach to pricing is the future of how blockbuster drugs are launched, it will cost billions and billions of dollars to treat just a fraction of patients,” Senator Wyden said. “America needs cures for cancer, Alzheimer’s, diabetes and HIV. If those cures are unaffordable and out of reach to millions who need them, Congress will not have met its responsibilities to the American people. I reject the idea that America has to choose between soaring, out-of-reach drug prices and one-size-fits-all government policies. Solving this challenge will take fresh, bipartisan thinking and political independence to bring people together.”

“The Finance Committee has tremendous responsibility in overseeing the federal programs paying for prescription drug coverage,” Senator Grassley said.  “With that responsibility, the committee should know how the costs to the public programs and private insurance companies of a single innovative drug entering the market without competition can have major effects on which patients get the new drug and when.  This report sheds light on one example of the pricing decisions made by one company with a new prescription medicine that entered the market without competition in high demand.  This might be an example that received the most attention in some time, but it won’t be the last.  I look forward to discussions with my colleagues and the public on the policy questions in the report.  I encourage everyone to read the report for the level of detail into pricing strategy that we don’t often see.” 

Additional major findings from the investigation include:

• Gilead justified Sovaldi’s high price point based on price-per-cure: Documents acquired during the course of investigation illustrate that Gilead was aware it was in a position to create clear savings for payers, but chose to pursue a “regimen neutral” price justified by “cost-per-cure” calculations that resulted in greater revenue per treatment than previous direct acting anti-virals [see page 42]. Given the increased clinical efficacy of Sovaldi, Gilead believed that it was more than justified in using the cost-per-cure pricing model [37, 46].

• Gilead set a high price for Sovaldi with an eye toward ensuring a future high price for Harvoni: The documentation reviewed shows that Gilead considered a number of factors in determining a price point for Sovaldi, including costs for the existing standard of care for Hepatitis C treatment and setting a high baseline for the next wave of drugs, such as Harvoni [32-58]. In documents obtained during the course of investigation, Gilead officials noted the “value capture opportunity is in Wave 1,” and “Wave 2 access will be enhanced with a high Wave 1 price.” It went on to say that “[a]t any price, access for Wave 2 improves as the price for Wave 1 is increased, suggesting that Wave 1 will set a price benchmark against which Wave 2 will ultimately be evaluated.” By elevating the price for the new standard of care set by Sovaldi, Gilead intended to raise the price floor for all future Hepatitis C treatments, including its follow-on drugs and those of its competitors [44].

• Gilead underestimated the degree of access restrictions that it expected would result from its pricing decision: Gilead set a price as high as it thought the market would bear before significant access restrictions would be imposed [30]. Gilead’s analyses were ultimately incorrect on this point as many payers adopted substantial access restrictions at the final price of $84,000 [81-88, 96-98].

• Despite significant access restrictions, Gilead refused to significantly lower the net price: When confronted with the widespread initiation of access restrictions [99-106], Gilead refused to offer substantial discounts and did not significantly modify its contracting strategy to improve patient access. For example, Gilead offered Medicaid programs supplemental rebates of up to 10 percent; however, its offer came with the precondition that states had to drop some or all of their access restrictions [106]. For states already facing a steep financial burden, accepting that precondition in most cases would have increased the budgetary impact rather than easing it [107]. Only five state Medicaid programs reached agreements with Gilead to receive supplemental rebates in 2014 [138].

• The burdens on Medicare, Medicaid, and the Bureau of Prisons were significant: The price of Sovaldi constituted a large burden—notably among state Medicaid programs, Medicare, and the BOP—and triggered access restrictions across public and private payers, thus limiting the number of Hepatitis C-infected patients who could access the new treatment options [81-88, 96-98]. For example, state Medicaid programs nationwide spent $1.3 billion before rebates on the drug in 2014. Even with that expenditure, less than 2.4 percent of the roughly 700,000 Medicaid enrollees with Hepatitis C were treated with Sovaldi [82-87]

• Competition entered the market, prices responded, but there are still significant concerns: Three days following Viekira Pak’s approval on December 19, 2014, Express Scripts Holding Co., the nation’s largest pharmacy benefit manager, announced that it would make Viekira Pak its preferred treatment for Hepatitis C genotype 1 and would no longer cover Sovaldi and Harvoni for these patients [112]. Gilead responded in January and February 2015 by entering into discounting agreements for Harvoni and Sovaldi with CVS, Anthem, Humana, Aetna, and UnitedHealth Group. Cigna struck agreements with Gilead for Harvoni only [113]. Even as competition lowered prices for therapies, this report documents that concerns remain, particularly in the public payer community, about high costs for treating millions of people in the U.S. infected with Hepatitis C, as well as the budgetary effects of a future single source innovator that might not face competition as quickly [114-122].

The report in full is available here.

An executive summary is available here.

A timeline of events pertaining to Gilead, Sovaldi and Harvoni is available here.

A glossary of terms pertaining to the investigation is available here.

Letters from state Medicaid programs are available here. 

Information on today’s press conference and a link to streaming video is below:

Who: Senator Ron Wyden, D-Ore.Senator Chuck Grassley, R-Iowa 

What: Press conference on the findings of an 18-month, bipartisan investigation into the pricing of Gilead Sciences’ Hepatitis C drugs Sovaldi and Harvoni 
Where: Senate Radio/TV Gallery (S-325)U.S. Capitol Building Washington, DC 20510
When: December 1, 2015 11:15 a.m.
Streaming Feed:
https://www.youtube.com/watch?v=rxd_PTFoouo

Enhanced treatment for hepatitis C could cut prevalence by 80%

Enhanced treatment for hepatitis C could cut prevalence by 80%
By Ziba Kashef

Novel antiviral therapies for hepatitis C could reduce the prevalence of the blood-borne infection by more than 80%, according to an analysis by Yale researchers. The finding raises the possibility of greatly reducing, and even eliminating, hepatitis C in the United States if enhanced screening and treatment efforts target high-risk populations.

The study published online Dec. 1 in Clinical Infectious Diseases.

Recently approved direct-acting antiviral medications have transformed treatment for individuals with hepatitis C virus (HCV), and are effective in over 90% of cases. The antivirals have the potential to significantly reduce or eliminate HCV in two ways: through treatment to prevent HCV-related complications and deaths, and by preventing further transmission among injection-drug users.

To study the effects of the new treatments on the U.S. population, the Yale team developed a transmission model to predict the effect of treatment with direct-acting antivirals over time. They also quantified the impact of use of the antivirals at current and at enhanced screening and treatment rates. Their analysis included outcomes such as cirrhosis, liver transplants, and mortality.

“The key finding is that a four-fold increase to the number of patients treated each year could virtually eliminate HCV from the non-injecting population within a decade,” said Jeffrey Townsend, associate professor of public health and senior author of the study. More modest increases in screening and treatment would also markedly reduce new infections and mortality, Townsend and co-authors determined.

The researchers also noted that expanded screening and treatment alone would not be sufficient to reduce HCV among individuals most at risk — injection-drug users. “In order to completely eliminate HCV, efforts to access that community are extremely important,” said David Durham, lead author of the study. Such efforts might include enhanced screening and treatment with the new therapies in combination with targeted behavioral interventions such as needle-exchange programs or opioid substitution therapy.

“We should be very optimistic about the prospect of eliminating HCV as a disease within the U.S. using these direct acting antivirals, especially if they are combined with targeted behavioral interventions to reduce transmission,” said Townsend. However, he added, “due to the currently high cost of these treatments, as a society we need to think carefully about how to make that happen.”

Other Yale authors include David P. Durham, Laura A. Skrip, Dr. R. Douglas Bruce, Dr. Silvia Vilarinho, and Alison P. Galvani. Elamin H. Elbasha is a co-author.

The research was funded by the Notsew Orm Sands Foundation and Merck.

Real life Dallas Buyers Club operation helps hepatitis C patients with free drugs

Real life Dallas Buyers Club operation helps hepatitis C patients with free drugs

Richard Woolveridge

Since the FixHepC Buyers Club was started by father-and-son team Dr John and Dr James Freeman, tens of thousands of people in more than 100 countries have made several million visits to the fixhepc.com website.

"At least 50 patients a week have signed up to get the drugs they need with the help of the club," Dr Freeman said.

"There's tremendous community spirit in Australia and we're getting patients saying, 'Look I'm not wealthy but I can afford to help out someone else with hep C. Let me donate the price of a course of pills for someone who can't pay'. "

Read more: http://www.smh.com.au/nsw/real-life-dallas-buyers-club-operation-helps-hepatitis-c-patients-with-free-drugs-20151128-glamtm.html#ixzz3sydVSafU
Follow us: @smh on Twitter | sydneymorningherald on Facebook

Of Interest - November Updates
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.