Local patients in clinical trials cured of Hepatitis C

Local patients in clinical trials cured of Hepatitis C
April 25

More than 150 local patients with hepatitis C have participated in clinical trials that not only cured most of them of a liver-destroying disease but also led to a breakthrough treatment showing record-high cure rates.

Getting rid of hep C used to involve a year of injections with a raft of side effects, a treatment that didn't always keep the virus from coming back.

But local patients had a hand in testing drugs that started arriving on the market several months ago drugs with success rates well above 90 percent, clearing the virus in as little as eight weeks. The oral medications are also much easier on the body.

This new generation of hep C drugs is being described as a game changer in the battle against a disease that has become the leading cause of liver transplants and that kills more people annually in this country than HIV/AIDS.

But here's the rub: The antiviral drugs come at a high price, in some cases $1,000 for a single pill taken daily for three months.

Insurance companies are balking at the $60,000-to-$100,000 drug regimen, as they scramble to balance cost and cure.

Douglas Gray, executive director of the Virginia Association of Health Plans, said drugs such as the hep C treatment are going to be a challenge for both private and government insurers. At a time when the Affordable Care Act is emphasizing control of health care costs, there's an array of effective, but very expensive, drugs that could break the budget.

The hep C drugs have been grabbing headlines lately, with one health insurer, UnitedHealth Group Inc., reporting it spent $100 million on a version from Gilead Sciences Sovaldi, approved by the Food and Drug Administration in December in its first three months on the market.

The debate is likely to intensify because not everyone with hep C which is spread primarily through contact with the blood of an infected person will have serious health consequences. The disease ranges in severity from a mild illness to scarring of the liver that can lead to cirrhosis or liver cancer.

So, who are the best candidates for the drug? And do you provide it only to people with hep C symptoms? Or also to people without symptoms to prevent liver damage from occurring? Those in early stages of the disease have shown higher cure rates.

There's also concern about populations that don't have ready access to health care, such as the homeless, prisoners, the uninsured and poor people in developing countries.

Dr. Michael Ryan, of Digestive & Liver Disease Specialists in Norfolk, has enrolled about 100 local hep C patients during the past five years in clinical trials of companies that are in a race to produce these drugs.

Ryan, a professor of clinical internal medicine at Eastern Virginia Medical School, has been participating in drug trials for years, but the cocktail of drugs including sofosbuvir, which suppresses replication of the virus, has shown particular effectiveness.

He said cost is the biggest issue, and about half of the patients for whom he's prescribed the new medication regimen since it was approved by the FDA have been turned down.

Dr. Mitchell Shiffman, medical director of the Bon Secours Liver Institute of Virginia, also has enrolled local hep C patients in various trials that have led to a cure, at both the institute's offices in Newport News and in Richmond.

Shiffman said it's been an exciting time, moving from early years of research where interferon injection treatment had terrible side effects and a cure rate of less than 50 percent. He said some of his patients in the most recent trials had been through several rounds of unsuccessful treatment before receiving the most recent drugs that cured them.

"Grown men break down in tears."

He said insurance companies have had varying responses to coverage since FDA approval, and some of his patients have been turned down, leading them to file multiple appeals. Some insurance companies are covering it only for people whose livers are already scarred.

"How would you feel if you had a virus and someone said we won't treat you until you have more scarring on your liver?"

The Centers for Disease Control and Prevention estimates 3.2 million Americans have the chronic form of hep C. Because it's a slow-moving disease, many people live with it for years before being diagnosed.

The CDC recommends all baby boomers be tested for it, because more than three-quarters of the cases are in that demographic.

Dennis Wyand, 62, of Virginia Beach fell in that cohort. He never experienced symptoms of hep C, but bloodwork done for his diabetes in 2010 led to a liver biopsy and diagnosis.

He was referred to Ryan, who suggested he enter a clinical trial that included the antiviral drug sofosbuvir and interferon shots. He was a little nervous to be part of a clinical trial, and he ran the idea past several of his doctors before deciding to enroll in it in 2012.

Within three months, his body was clear of the hep C virus. "I was elated," he said.

The treatment combination he took has since been approved by the FDA.

Less fortunate are those people who weren't part of the trials of the most recent breakthrough drugs and whose insurance won't cover the treatment. A 61-year-old Virginia Beach woman with hep C is discovering it's all about timing when it comes to volunteering for clinical trials.

The woman, who didn't want to be identified because she wanted to keep her health condition private, was part of a clinical trial that Ryan was involved in with interferon shots in 2001. She described the shots, which produce flu-like symptoms, as "hell on wheels."

While the interferon shots have worked for some patients, they didn't for her. Three months after she finished the treatment, the hep C virus returned.

She's now on a waiting list for another trial, hoping she'll qualify for the newer generation of drugs rather than trying to get her insurance to pay for them. "They say it's $90,000 for three months, and that doesn't include doctors that's just the drugs."

Ryan and Shiffman said the number of clinical trials has gone down as the successful drugs have hit the market. But there are still ongoing trials of competing companies, and trials with various combinations of oral meds with different types of the disease. Tests to determine the smallest amount of time you can take the medications and still be cured also are under way.

Results of those trials are expected to bring new brands of drugs on the market that will likely reduce cost.

Source

Elizabeth Simpson, 757-222-5003, elizabeth.simpson@pilotonline.com

Posted to: Health News

(c)2014 The Virginian-Pilot (Norfolk, Va.)

Visit The Virginian-Pilot (Norfolk, Va.) at pilotonline.com

Distributed by MCT Information Services

Congress Presses the VA for Increased Attention to Hepatitis C

Congress Presses the VA for Increased Attention to Hepatitis C

By Lyle Dennis, Cavarocchi – Ruscio – Dennis Associates, Consultants to AASLD

One of the more interesting aspects of the relationship between AASLD and the federal government is the broad range of interests that hepatologists have through many different departments and agencies.
Within the National Institutes of Health, there are about a dozen separate institutes and centers that play a role in liver-related research.

The Centers for Disease Control and Prevention, based in Atlanta, has the Division of Viral Hepatitis, with whom we work very closely.

The Food and Drug Administration deals with the approval of new drugs and such controversial issues as acetaminophen toxicity.

The Department of Defense and the Department of Veterans Affairs operate enormous health care systems and conduct relevant research, as well.

The Centers for Medicare and Medicaid Services set payment rates for liver-related services, physician reimbursements, and medication.

The Health Resources and Services Administration, through its Division on Transplantation, governs organ donation programs.

The list goes on and on. Each year as Congress moves its appropriations bills to fund all of these agencies, they issue a report (known as a Committee Report) explaining their intent in setting the funding levels they do. Thus far, the only such report issued for the FY2015 budget year is the House Military Construction/Veterans Affairs report, which addresses Congress’s interest in the Veterans Health Administration, among many other things.

The Committee Report contains an unusually-lengthy section related to hepatitis C in the veteran population:

Hepatitis C virus — The Committee has previously encouraged the VA to increase hepatitis C (HCV) testing and work to implement the Center for Disease Control and Prevention’s (CDC) HCV testing recommendations within the VA system. In light of the growing burden of hepatitis C-related liver complications and mortality among Veterans and the recent introduction of more effective treatments for HCV, the Committee directs the VA to establish a plan for testing and treating veterans enrolled in the VHA system and considered to be at risk for hepatitis C, including Vietnam-era veterans in the baby boomer birth cohort. Additionally, the VA shall submit a report to the Committee, no later than six months after enactment of this Act, updating its 2010 report, The State of Care for Veterans with Chronic Hepatitis C, on the prevalence of hepatitis C among veterans and detailing the estimated impact its HCV treatment plan will have on preventing hepatitis C-related cirrhosis, hepatocellular carcinoma, and mortality among veterans.

This language states clearly Congress’s interest in ramping up the VA’s attention to hepatitis C. While it is true that Congress does not always put "its money where its mouth is," language like this and the reports it requests go a long way toward building the case for more research, more services, and more attention to liver disease throughout the federal government.

https://www.aasld.org/NEWS/042414/Pages/default.aspx

AbbVie Reports First-Quarter 2014 Financial Results-Expected 2014 U.S. launch of its HCV therapy

AbbVie Reports First-Quarter 2014 Financial Results
- Reports First-Quarter Adjusted EPS of $0.71, Up 4.4 Percent and Above Previous Guidance Range of $0.67 to $0.69 (Reports GAAP EPS of $0.61)

- Delivers First-Quarter Revenue of $4.563 Billion, an Increase of 5.4 Percent Over First-Quarter 2013 (Up 6.7 Percent On an Operational Basis)

- Revenue Growth Reflects 17.5 Percent Global Reported Sales Growth from HUMIRA (Up 18.4 Percent On an Operational Basis) and Double-Digit Growth from Other Key Products

- Delivers Significant Gross Margin Expansion and Strong Investment Spending in R&D and SG&A

- Recently Submitted U.S. Regulatory Application for Interferon-Free HCV Combination; Continues to Expect U.S. Approval in 2014; EU Submission Planned for Early May

- Pipeline Continues to Advance in 2014 With Numerous Data Milestones, Regulatory Submissions and Phase Transitions, Including Initiation of a Phase 3 Trial for Veliparib in Non-Small Cell Lung Cancer

- Confirms 2014 Adjusted EPS Guidance Range of $3.00 to $3.10 (GAAP EPS Range is $2.63 to $2.73)

NORTH CHICAGO, Ill., April 25, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced financial results for the first quarter ended March 31, 2014. 

"AbbVie delivered strong first-quarter results, with sales and earnings per share above our original guidance, significant margin expansion, and increased R&D and SG&A investment to support our existing portfolio and our promising pipeline opportunities," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie.  "As we look ahead to the remainder of 2014, we continue to expect a significant amount of progress from our pipeline.  This includes key data presentations, phase transitions, regulatory submissions, and U.S. approval of our interferon-free HCV combination in 2014." 

First-Quarter Results

• Worldwide sales were $4.563 billion in the first quarter, up 5.4 percent.  On an operational basis, sales increased 6.7 percent, excluding a 1.3 percent unfavorable impact from foreign exchange rate fluctuations.  Excluding sales from our lipid franchise due to the loss of exclusivity, sales increased 13.5 percent on an operational basis in the quarter.  
• First-quarter sales growth was driven primarily by the continued strength of HUMIRA.  Global HUMIRA sales increased 17.5 percent, or 18.4 percent on an operational basis, excluding the impact of foreign exchange rate fluctuations.  Total company sales growth was also driven by double-digit growth from key products including Synthroid, Creon and Duodopa.
• The adjusted gross margin ratio in the first quarter was 78.4 percent, up 220 basis points versus the prior year, excluding intangible asset amortization and other specified items.  The gross margin ratio under U.S. generally accepted accounting principles (GAAP) was 75.9 percent.  
• Adjusted selling, general and administrative (SG&A) expense was 27.6 percent of sales in the first quarter, up 4.6 percent versus the prior year, reflecting continued investment in our growth brands and the expected HCV launch.  On a GAAP basis, SG&A was 29.4 percent of sales.
• Adjusted research and development (R&D) was 16.9 percent of sales in the quarter, up 22.0 percent versus the prior year, reflecting funding actions in support of our emerging mid- and late-stage pipeline assets and the continued pursuit of additional HUMIRA indications.  On a GAAP basis, R&D was 16.9 percent of sales, up 21.8 percent.
• Net interest expense was $65 million, and the adjusted tax rate was 22.3 percent in the quarter.  On a GAAP basis, the first-quarter tax rate was 23.8 percent.
• First-quarter diluted earnings per share were $0.61 on a GAAP basis.  Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $0.71, up  4.4 percent from first-quarter 2013.  

Key Events from the First Quarter

• AbbVie recently submitted its U.S. regulatory application for its interferon-free combination for patients with genotype 1 hepatitis C virus (HCV).  AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May.  The company expects U.S. commercialization in 2014 and European approval in early 2015.
• AbbVie presented new data from its Phase 3 HCV program at the 2014 International Liver Congress in London, including detailed results from the SAPPHIRE-I, SAPPHIRE-II, PEARL-III, and TURQUOISE-II studies.  Data from TURQUOISE-II, a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's regimen with ribavirin (RBV) in adult patients with genotype 1 chronic HCV infection with compensated liver cirrhosis, was presented as a late-breaker.  Patients in the study achieved sustained virologic response rates 12 weeks post-treatment (SVR₁₂) of 91.8 percent and 95.9 percent in the 12-week and 24-week treatment arms, respectively.
• AbbVie announced the initiation of a global Phase 3 clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).  This randomized, placebo-controlled, double-blind, multi-center trial will recruit approximately 900 patients, and the primary efficacy outcome of the trial is overall survival.  Veliparib is a PARP inhibitor being evaluated in multiple tumor types. 
• At the recent Conference on Retroviruses and Opportunistic Infections (CROI), AbbVie presented data on its next-generation HCV assets, ABT-493 and ABT-530, showing balanced pan-genotypic coverage.  These next-generation assets are currently in Phase 2 development.  AbbVie also presented the first detailed results from the pivotal Phase 3 study, PEARL-III.  PEARL-III evaluated the efficacy and safety of 12 weeks of treatment with AbbVie's investigational therapy with or without RBV in non-cirrhotic, adult patients with chronic genotype 1b HCV infection who were new to treatment.
• AbbVie announced the initiation of a pivotal Phase 3 clinical trial that will evaluate the use of HUMIRA as a treatment for fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis, an area of unmet need.  Currently there are no approved treatments for fingernail psoriasis.  The 26-week clinical trial is a multinational, double-blind, placebo-controlled study that is expected to enroll 200 patients with moderate to severe chronic plaque psoriasis with fingernail psoriasis. It will be conducted at approximately 32 sites worldwide.
• AbbVie announced plans to establish operations in Singapore for small molecule and biologics active drug substance manufacturing.  When completed, the facility will provide manufacturing capacity for compounds within AbbVie's oncology and immunology pipeline to serve markets globally.  The investment will establish AbbVie's manufacturing presence in Asia.
• On February 20, the AbbVie board of directors increased the company's quarterly cash dividend by  5 percent from $0.40 per share to $0.42 per share.  The cash dividend is payable May 15, 2014 to stockholders of record at the close of business on April 15, 2014.

Full-Year 2014 Outlook

AbbVie is confirming its diluted earnings-per-share guidance for the full-year 2014 of $3.00 to $3.10 on an adjusted basis, or $2.63 to $2.73 on a GAAP basis.  The company's 2014 adjusted diluted earnings-per-share guidance excludes $0.37 per share of intangible asset amortization expense and other specified items primarily associated with certain separation-related costs and ongoing restructuring activities.  AbbVie continues to expect 2014 revenue of approximately $19 billion, excluding any potential revenue from the expected 2014 U.S. launch of its HCV therapy.

http://www.prnewswire.com/news-releases/abbvie-reports-first-quarter-2014-financial-results-256679441.html

Hepatitis C Case Study: Interferon-Free Therapy Genotype 1a W-Prior Null Response

Hello everyone, Projects in Knowledge launched a couple new learning activities which provide a look at two different hepatitis C patients, each case study is followed by Paul Y. Kwo, MD.  

The first presentation is a genotype1b treatment-naive patient with cirrhosis. The second is a null responder with stage two fibrosis, a highlight of both presentations is provided below. Like any site offering continuing medical education (CME), it requires a free quick registration.

In addition, Ira M. Jacobson, MD will be hosting a satellite symposium on May 03, 2014; Hepatitis C - Hepatitis C Treatment Goes Viral: Let's Talk About Oral Therapies – Satellite Symposium. This CME/CE activity is designed for hepatologists, gastroenterologists, infectious disease specialists, primary care physicians, nurses, and pharmacists involved in the screening and treatment of patients with HCV or those at risk of acquiring the infection.

P. Kwo, MD

Hepatitis C — HCV Case Study: HCV Therapy for a Treatment-Naive Patient with Genotype-1 HCV Infection and Compensated Cirrhosis – Case Study 

Recently approved direct-acting antiviral agents offer new choices for patients with chronic hepatitis C virus infection, including those with cirrhosis. Join Paul Y. Kwo, MD, for this case study in which he follows a cirrhotic treatment-naive patient with genotype-1b infection from assessment through treatment.

Case Presentation - Patient Assessment 

A 68-year-old Hispanic male presented to you for a discussion of HCV treatment options. He was recently diagnosed with chronic HCV when his physician ordered an HCV screening test in response to the 2012 recommendation by the Centers for Disease Control and Prevention that all individuals born between 1945 and 1965 be tested for HCV, regardless of other risk factors.10 He likely acquired the infection approximately 30 years ago from a blood transfusion while in the military. His past medical history includes arthritis, hyperlipidemia, and diabetes, treated with ibuprofen, atorvastatin, and metformin, respectively. He is currently retired but travels extensively with his wife to visit their grandchildren. Follow-up HCV testing showed genotype-1b infection and a viral load of 6.2 million copies/mL. An imaging study and ultrasound of his liver demonstrated a nodular liver with mild splenomegaly. Endoscopy demonstrated small esophageal varices. Blood work showed a hemoglobin level of 13.2 g/dL, a platelet count of 108,000/mm3, an aspartate aminotransferase of 94 IU/L, and an alanine aminotransferase of 79 IU/L. Physical examination was normal. His blood pressure was 128/70 mmHg, respirations 16. There was no hepatomegaly or splenomegaly. He had mild central obesity (94 kg), no muscle wasting, and no palmar erythema.

Published on April 23, 2014

P. Kwo, MD

Hepatitis C — HCV Case Study: Interferon-Free Oral Anti-HCV Therapy in an Infected Genotype 1a-Infected Patient with Prior Null Response to Peginterferon/Ribavirin Combination Therapy – Case Study

Phase II data from emerging all-oral direct-acting antiviral regimens show high rates of sustained virologic response (SVR), even in patients with prior null response to peginterferon-based therapy. Join Paul Y. Kwo, MD, for this case study in which he identifies a null responder who elects to enroll in a phase III trial of an interferon-free regimen that includes more than one drug class. In addition, Dr. Kwo provides preliminary SVR12 data for multiple emerging regimens in this hard-to-treat patient population.

Case Presentation - Patient Assessment 

A 50-year-old male presents to your practice to discuss the potential of starting treatment for genotype-1a HCV infection. In 2009 he had a null response to peginterferon/ribavirin, with his viral load dropping only 1 log at 12 weeks, from 10 million IU/mL pretreatment to 1.2 million IU/mL. His baseline liver biopsy at that time showed stage 2 fibrosis. He reported missing no doses but found the therapy difficult to tolerate. He experienced fatigue and increasingly painful injection-site reactions. Most importantly, he found it difficult to concentrate at his full-time job as a contractor and had to turn over major projects to his partner. He feels reasonably well now, with only occasional right upper quadrant pain. He takes lisinopril 20 mg for hypertension and ibuprofen 800 mg on an as-needed basis. On physical exam he is a slightly overweight male, with a weight of 120 kg. His vitals are otherwise stable with blood pressure of 130/88 mmHg. Other than mild hepatomegaly, his exam is normal. Laboratory tests show: hemoglobin14 g/dL, platelet count of 169,000/mm3, aspartate aminotransferase 112 U/L, alanine aminotransferase 115 U/L, total bilirubin 1.2 mg/dL. His Fibroscan® demonstrates liver stiffness of 12 kPa. An ultrasound shows mild hepatomegaly and fatty infiltration, with mild splenomegaly.

Published on March 31, 2014 

I. Jacobson, MD

Hepatitis C — Hepatitis C Treatment Goes Viral: Let's Talk About Oral Therapies – Satellite Symposium 

Register today! Join us at this compelling satellite symposium for informative and interactive expert-guided presentations on the current state of oral therapies for chronic hepatitis C virus (HCV) infection, the implications of clinical trial results, and how the latest advances are affecting today’s real-world clinical practice.

This program is not affiliated with Digestive Disease Week^®. 

In Case You Missed It 

Advances in Chronic Hepatitis C Management and Treatment - EASL 1.5-hour Internet symposium 

ViralEd just released an 1.5-hour Internet symposium discussing key data presented at the 49th Annual Meeting of the European Association for the Study of the Liver (49th EASL) which took place this month in London, England.

Aetna CFO says spent $30 mln on Sovaldi in Q1, as expected

Aetna CFO says spent $30 mln on Sovaldi in Q1, as expected
April 24 Thu Apr 24, 2014 7:00pm IST

(Reuters) - Aetna Inc. spent about $30 million during the first quarter on Sovaldi, the pricey new hepatitis C treatment from Gilead Sciences Inc., Chief Financial Officer Shawn Guertin said on Thursday during a conference call with investors.

Guertin said the costs were in line with the company's expectations. Most of it was in its commercial business and in Medicare Part D, the government program in which private insurers manage drug benefits.

Medicaid-related Sovaldi costs accounted for the smallest portion of that $30 million, he said, as some states continue to develop policies on the drug and because some states where it operates do not use private insurance to pay for any pharmaceutical benefits. (Reporting by Caroline Humer; Editing by Chizu Nomiyama)

Source - Reuters

Sovaldi PBS Video :Report on Gilead's profits, coverage and costs

A new drug has a 90 to 100 percent chance of curing the Hepatitis-C virus, but costs tens of thousands of dollars for a course of treatment. The announcement by the manufacturer that it earned more than $2 billion in the year’s first quarter raises the question, who should pay when drugs are highly effective, but extremely expensive? Hari Sreenivasan reports on the profits, coverage and costs.

TRANSCRIPT

JUDY WOODRUFF: Now: Who should pay when drugs are very effective, but extremely expensive?
That’s an important question for the U.S. health care system as new treatments come along, and it’s a matter of real concern over a new drug that has a 90 percent to 100 percent chance of curing the hepatitis C virus. Its manufacturer announced record sales yesterday of more than $2 billion in just the first quarter of the year. Profits, coverage and costs are all at issue, as Hari Sreenivasan reports.
HARI SREENIVASAN: Kim Bossley knows how fragile life can be. In 2005, Bossley was diagnosed with hepatitis C, a blood-borne virus that can destroy the body’s liver.
KIM BOSSLEY: I went from stage one to stage four, decomposed liver, very quickly.
HARI SREENIVASAN: News of her rapidly declining health was devastating for the 46-year-old mother of two.
KIM BOSSLEY: You fall into a depression when you’re diagnosed with hep C. Your own mortality rate hits you.
DR. GREGORY T. EVERSON, University of Colorado Hospital: That’s a pretty good response.
HARI SREENIVASAN: This fall, after nine years of battling the virus, Kim Bossley was accepted into a treatment trial with a new drug called Sovaldi.
DR. GREGORY T. EVERSON: So, Kim, we will check your labs here.
HARI SREENIVASAN: Almost immediately after taking Sovaldi, the hepatitis C virus disappeared.
DR. GREGORY T. EVERSON: Not detected, not detected, not detected.
HARI SREENIVASAN: Bossley’s doctor, Gregory Everson, is an expert on the hepatitis C virus. He says results with Sovaldi are remarkable.
DR. GREGORY T. EVERSON: Do you feel like you can do what you want to do on this treatment?
KIM BOSSLEY: Yes.
DR. GREGORY T. EVERSON: Yes.
HARI SREENIVASAN: A hepatologist at the University of Colorado hospital, Everson has treated some 200 patients with the new drug.
DR. GREGORY T. EVERSON: Kim’s response is typical. Her viral load was in the millions — within a week or two, undetectable. That is what we’re seeing in almost all the patients we’re treating today. It’s really quite extraordinary.
HARI SREENIVASAN: In fact, across the United States, hepatitis C patients are experiencing the same dramatic results, so much so that Dr. Everson calls the new drug manufactured by Gilead Sciences a game-changer.
DR. GREGORY T. EVERSON: We’re not talking about chronic disease anymore. We’re talking about getting rid of the infection completely. We’re talking about a complete cure rate.
HARI SREENIVASAN: And that is welcome news for the three million Americans infected with the hepatitis virus, 25 percent of whom are projected to die from it.
Even better news, in December, the Food and Drug Administration approved Sovaldi. But as spectacular as Sovaldi appears to be, so too is its price tag. Each pill is $1,000. And at a typical treatment of 120 days, the drug’s extraordinary cost has raised concerns.
MATT SALO, National Association of Medical Directors: The new development is simultaneously very exciting in terms of its efficacy, but potentially very, very frightening in terms of its cost, because we’re talking about a nexus of a drug that is, on the face of it, very expensive.
HARI SREENIVASAN: Matt Salo heads the National Association of Medicaid Directors. He says states are scrambling to figure out how to pay for Sovaldi with government-funded insurance, particularly when existing drugs are 50 to 70 percent effective.
MATT SALO: Medicaid is actually kind of used to dealing with pharmaceutical treatments that are very expensive, but for small numbers of people. With hepatitis C, we know there are at least three million people and potentially as many as five million people in this country who have hepatitis C.
So when you multiply those two, you are really looking at a game-changer in terms of cost.
WOMAN: One a day of that one.
HARI SREENIVASAN: Kim Bossley’s treatments are free because she’s part of the study for those with advanced liver disease. And while she agrees the drug’s price tag is high, she says the combination of drugs she used before Sovaldi, interferon and ribavirin, were extremely rough.
KIM BOSSLEY: There is no comparison.
HARI SREENIVASAN: Her previous drug treatment, she says, caused exhaustion, depression and hair loss.
KIM BOSSLEY: It is a very harsh regimen. It’s very debilitating.
HARI SREENIVASAN: In fact, Dr. Everson said the existing drug treatments are so tough on his patients, many hepatitis C sufferers avoid them altogether.
DR. GREGORY T. EVERSON: Most patients didn’t even want the treatments because of the side effects. People wouldn’t even come for treatment. They wouldn’t get their hepatitis C addressed.
HARI SREENIVASAN: And beyond the physical costs, Everson says there is a price for in the curing the virus.
DR. GREGORY T. EVERSON: It’s one of the costliest diseases when you get to the end stages, where people start to have complications of cirrhosis.
HARI SREENIVASAN: That point is echoed by John McHutchison, executive vice president at Gilead Sciences.
JOHN MCHUTCHISON, Gilead Sciences, Inc.: The costs of caring for patients with hepatitis C are not all up front. So whilst it might be expensive to treat somebody up front now, by curing somebody, you are preventing the costs of care of that patient later on, so, as their disease progresses over time, the cost of liver transplant, the cost of caring for somebody with liver cancer.
So if you can treat more people, and spend those dollars up front to cure those people, in the long-term, and over the long-term horizon, you will save the costs to the health care system.
NARRATOR: If you are one of the millions of people with hepatitis C, you haven’t been forgotten.
HARI SREENIVASAN: But while Gilead calls Sovaldi a cure, it is not a vaccine. Hepatitis C, which is transmitted through blood, can be contracted more than once. The most common way to get the virus is through I.V. drug use.
MATT SALO: One of the things to keep in mind with Sovaldi is that this is not an immunization. This doesn’t make someone hepatitis-free forever. And if you got hepatitis C because of certain risky behaviors and you go and you get, in effect, cured, there is nothing to prevent from you getting it again if you relapse back into those same behaviors.
HARI SREENIVASAN: Kim Bossley contracted the virus from a blood transfusion at her birth. Bossley was the first baby born to a mother who had undergone a kidney transplant. She was featured in “Good Housekeeping” magazine as a miracle baby. During the birth, Kim’s mother received a transfusion of blood infected with hepatitis C.
But neither knew they had the virus until getting sick later in life. Bossley’s mother ended up dying from the condition, something that makes Kim’s own condition even tougher.
KIM BOSSLEY: Seeing my mom suffer through the latter part of her stages, it really took a lot out of me, to the point where I finally had to — you know, this is not how mom or I want to live. You know, I want to fight. I want to find a cure.
HARI SREENIVASAN: As new sophisticated drugs to treat all kinds of conditions enter the market, Matt Salo says the question of costs will likely arise again.
MATT SALO: It’s not a Sovaldi question, per se, because this really is the tip of the iceberg. There are so many other drugs that have the potential of bringing on one hand, you know, incredible improvements in human life and health and well-being, but on the other hand extraordinary costs.
HARI SREENIVASAN: Salo would like to see a national dialogue about what insurers should cover.
MATT SALO: I think it is critically important that we start having that conversation about, how do we value health, what price health, and what price pharmaceuticals? I think this is an important conversation we need to have.
HARI SREENIVASAN: For her part, Kim Bossley has started a foundation to hep offset drug costs for other hepatitis patients.
GWEN IFILL: Online, you can read about how free samples can influence what doctors prescribe to their patients. That’s on our health page.

Source - PBS

Vitamin D – should you take it?

Vitamin D – should you take it? 
By Lindsay Kobayashi
Posted: April 24, 2014

Egg yolks contain a small amount of vitamin D
iStockphoto.com

My hunch is that it depends. Vitamin D is a nutrient that helps our bodies regulate the metabolism of calcium and phosphate (1). Most vitamin D comes from sunlight, while it is also found in certain foods including fatty fish, mushrooms, egg yolks, vitamin-D fortified foods. For example, milk in many countries is always fortified with vitamin D, and some brands of breakfast cereals and orange juice are fortified as well (2).  Vitamin D can also be obtained through taking vitamin D supplements found at your local grocery or health food store. The classic health consequences of inadequate vitamin D are rickets in children, and low bone mineral density and osteoporosis in older adults (3). Low vitamin D has also been associated with increased risk for many other health conditions including breast, prostate, and colorectal cancer, multiple sclerosis, and cardiovascular disease (4-6). However, the quality of scientific evidence for these relationships varies because it is actually quite challenging methodologically to study the cause-effect relationship of vitamin D on health.

Because definitive high-quality evidence is lacking, the actual beneficial effect of vitamin D on health has been heavily debated in recent years. Like many other dietary or lifestyle factors that have been linked to health outcomes with scientific uncertainty (examples: coffee, alcohol, vitamin C, herbal supplements), the available information about whether to take vitamin D supplements can be very confusing. Here is where we stand right now:

In 2011, the American Institute of Medicine released an expert report on the dietary reference intakes for vitamin D (3). They stated that, for people aged 1 to 70 years old including pregnant and lactating women, the recommended dietary allowance (RDA) is 600 IU per day of vitamin D. For adults aged over 70 years the RDA is 800 IU per day. Intake should not exceed 4000 IU per day for people aged 9 years and over. The full RDA guidelines can be found here. Interestingly, their expert panel concluded that current scientific evidence is insufficient to conclude that vitamin D plays a causal role in non-bone-related health conditions (3). Now, this statement may or may not mean that vitamin D has no effect on health aside from bone conditions, simply that our current knowledge is insufficient.

Supplements can be a good source of vitamin D

iStockphoto.com

Fast forward to today, and it doesn’t seem like our evidence base has evolved much. An ‘umbrella’ review of evidence on the link between blood plasma concentrations of vitamin D and 137 unique health outcomes was published in the British Medical Journal earlier this month (7). The review was the largest synthesis of knowledge to date, and the authors unfortunately had to conclude that:

“Despite a few hundred systematic reviews and meta-analyses, highly convincing evidence of a clear role of vitamin D does not exist for any outcome, but associations with a selection of outcomes are probable”

The authors concluded that vitamin D supplementation is probably linked to decreased dental caries (cavities) in children, reduced parathyroid hormone concentrations in patients with chronic kidney disease requiring dialysis, and to an increase in maternal vitamin D concentrations at term, and an increase in birth weight (7). These are very specific conditions that apply only to children, pregnant mothers, and chronic kidney disease patients. The authors also concluded that the evidence is ‘suggestive’ for a correlation between higher blood vitamin D concentrations and a lower risk of several conditions including colorectal cancer, non-vertebral fractures, cardiovascular diseases, depression, high body mass index, and type 2 diabetes (7). However, a major point to note is that these are correlations, which means that although vitamin D has been associated with these health conditions, it may not cause them. Because of the limitations of current research, including the difficulty in measuring the actual vitamin D intake of people, and how much of this actually gets absorbed and has a biological effect, the timing between vitamin D intake and disease onset, and determining the actual dose of vitamin D that may protect against disease, we don’t have definitive answers right now.

So, what should we do about our own health? It is clearly too soon to make any strong recommendations about population-level vitamin D supplementation. Following the current RDA for vitamin D is good, and achieving this level for yourself may include supplementation if you don’t eat many foods containing vitamin D. Always talk to your family physician if you have any concerns about your own health or vitamin D intake. And finally, as always, keep yourself informed with high quality information to make decisions for your own health.

References
1)      National Health Service. Vitamins and minerals – vitamin D. http://www.nhs.uk/Conditions/vitamins-minerals/Pages/Vitamin-D.aspx (accessed 21 April 2014).
2)      National Institutes of Health. Vitamin D: Fact sheet for consumers. http://ods.od.nih.gov/factsheets/VitaminD-QuickFacts/#h3 (accessed 21 April 2014).
3)      Committee to Review Dietary References Intakes for Vitamin D and Calcium, Institute of Medicine: Dietary Reference Intakes for Calcium and Vitamin D. Edited by Ross AC, Taylor CL, Yaktine AL, Del Valle HB. Washington, DC: The National Academies Press; 2011.
4)      Holick MF. Vitamin D deficiency. N Engl J Med 2007;357:266-81.
5)      Munger KL, Zhang SM, O’Reilly E, Hernán MA, Olek MJ, Willett WC, et al. Vitamin D intake and incidence of multiple sclerosis. Neurology 2004;62(1):60-5.
6)      Wang TJ, Pencina MJ, Booth SL, Jacques PF, Ingelsson E, Lanier K, et al. Vitamin D deficiency and risk of cardiovascular disease. Circulation 2008;117:503-11.
7)      Theodoratou E, Tzoulaki I, Zgaga L, Ioannidis JPA. Vitamin D and multiple health outcomes: umbrella review of systematic reviews and meta-analyses of observational studies and randomised trials. BMJ2014;348:g2035

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Gilead’s Medicine Sovaldi Beats Estimates by $1 Billion

Gilead Revenue Soars on Hepatitis C Drug
By ANDREW POLLACK 
APRIL 22, 2014 

Record sales of a new hepatitis C drug pushed the first-quarter earnings of Gilead Sciences far beyond expectations, the company reported on Tuesday, but could also heighten concerns about the high cost of the drug, known as Sovaldi, and the ability of the health care system to pay for it.

“If cost were not a factor, we would want to treat the entire population,” said Dr. Rena Fox, a professor of medicine at the University of California, San Francisco. She said it was frustrating that “we finally get this great treatment and then we withhold it.”

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Gilead’s Medicine Sovaldi Beats Estimates by $1 Billion
By Drew Armstrong April 23, 2014

Gilead Sciences Inc. (GILD:US) overwhelmed sales estimates for its new blockbuster hepatitis C pill in what analysts called the biggest drug start ever, raising questions about insurers’ ability to slow the use of the costly therapy. The shares gained in early trading. 

Sovaldi, the company’s $1,000-a-pill medicine to treat hepatitis C, had sales of $2.27 billion in the first quarter, the company said in a statement. That beat an average of analyst estimates by more than $1 billion. The Foster City, California-based company also reported profit excluding certain items of $1.48 a share, beating by 56 cents the analysts’ average estimate (GILD:US).

The hepatitis C sales are “above even the high end of buy-side expectations,” Mark Schoenebaum, an analyst with ISI Group LLC in New York, said in a note to clients. He called it the best drug introduction in history. Gilead, the world’s biggest makers of HIV drugs, yesterday reported total first-quarter revenue of $5 billion.

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