Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

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Alan Franciscus

Editor-in-Chief

HCV Advocate



Monday, January 5, 2015

Business of Health: OMRF president celebrates FDA approval of hepatitis C treatment

Dr. Stephen Prescott: "Express Scripts made the newly approved treatment from AbbVie the exclusive option for patients who suffer from the most prevalent form of hepatitis C (known as genotype 1). Express Scripts has done what the U.S. government couldn’t: It has started a price war."

Price war
In the U.S., Medicare and Medicaid are legally forbidden from negotiating drug prices. If a treatment is approved by the FDA, the government has to pay the sticker price—and it cannot bar access to it. And, generally, whatever rate the federal government pays, private payers (like insurance companies and health plans) fall into line.

So Express Scripts has done what the U.S. government couldn’t: It has started a price war. The hope is that Gilead will respond by lowering Sovaldi’s price. That’s generally how markets work. In this case, it’s happening a bit belatedly, but it’s happening. And the special sauce that made it all work was competition.

Companies like Gilead and AbbVie have created products of real value in these new drugs. They’ve invested significant time and money in developing and bringing to market these life-changing therapies. They are certainly entitled to profit from their work, not only to recover their costs and reap the benefits of their innovation, but also to encourage others to follow suit in developing new therapies for other illnesses.

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Saturday, January 3, 2015

Pakistan: Infectious diseases: Capital hospitals witnessed surge in cases

ISLAMABAD: The surge in prevalence of infectious diseases warrants urgent measures from health authorities to control their spread.

The two federal capital hospitals registered 16,000 new cases of hepatitis B and C last year.

Despite the alarming situation the federal government has been unable to initiate any alternative programme to prevent spread of hepatitis after the devolution of the health ministry.

Read more...

Friday, January 2, 2015

MTP pattern predicted SVR in Egyptian patients with HCV genotype 4

Microsomal triglyceride transfer protein, or MTP, could be used as a predictor for measuring sustained virologic response from antiviral therapy in Egyptian patients with hepatitis C virus genotype 4 infection, according to study data.

“Till now, (there has been) no sufficient data about correlation of MTP variants with response to therapy in HCV,” the researchers wrote. “To justify this issue, the current study aimed to determine the pattern of MTP gene polymorphisms in naive HCV genotype 4 patients to then identify the impact of MTP polymorphism on the response to combined pegylated interferon-ribavirin therapy in chronic HCV genotype 4.”

One hundred treatment-naive patients with HCV genotype 4 were recruited to receive antiviral therapy with 180 mcg of PEG-IFN alfa-2a per week and weight-based ribavirin for 48 weeks. Forty controls also were included in the study, and all 140 patients underwent DNA and laboratory testing to determine any impact of MTP polymorphism. 

New: A Guide to Understanding Hepatitis C: 2015

Be sure to check out this new edition of our popular Guide to Understanding Hepatitis C, by Alan Franciscus.



Top News of 2014 —Alan Franciscus, Editor-in-Chief

Top News of 2014
—Alan Franciscus, Editor-in-Chief     

2014 was by far the most incredible year in hepatitis C (HCV) treatment advances, but there was a lot of bad news about treatment access.  However, first let’s concentrate on the good news – all oral therapies approved to treat hepatitis C.

We started the year with the combination of Sovaldi (sofosbuvir), pegylated interferon and ribavirin that had been approved in 2013 to treat genotypes 1 and 4.  The combination of Sovaldi (sofosbuvir) and ribavirin had also been approved to treat genotypes 2 and 3.  The combination of Sovaldi and Olysio (simeprevir) with and without ribavirin was used off-label and later in the year was approved by the Food and Drug Administration (FDA) to treat hepatitis C genotype 1. 

THE GOOD: On October 10, 2014 the FDA approved the first interferon- and ribavirin-free treatment for genotype 1—Harvoni (sofosbuvir/ledipasvir).  Harvoni combines both drugs into a pill taken once daily.  The majority of patients are treated for 12 weeks, patients with minimal disease are treated for 8 weeks, and patients with more severe disease can be treated for 24 weeks.  

On December 19, 2014 the FDA approved the second all oral HCV treatment—AbbVie’s 3D combination, now called VIEKIRA PAK, to treat HCV genotype 1.  In the “Pak” are three drugs: ombitasvir, paritaprevir, and dasabuvir. The “PAK” also includes another drug, ritonavir, that helps to increase the blood levels of paritaprevir.  VIEKIRA PAK is taken with and without ribavirin.  The treatment duration is 12 to 24 weeks.  The cost of VIEKIRA PAK is $83,319 for a 12-week course of treatment. 

These are truly miraculous drugs that in clinical trials have cured 90 – 100% of the patients treated.  The high cure rates in clinical trials are being replicated in ‘real world’ settings—that is, patients in regular practice are achieving similar cure rates.  The new all oral drugs work for people who have minimal disease, severe disease, pre- and post-transplant—in other words everyone with HCV.  This is truly spectacular!

The price of Sovaldi and Harvoni has been a lightning rod in the news.  The price is one piece of the puzzle because if you looked at the historical pricing of HCV treatment, Harvoni is actually about 10K to 20K higher (the duration of therapy is shorter), but the side effects are minimal.  Why the uproar?  Because insurance companies and government payers believe that there are thousands of patients waiting for these therapies.  This is the reason, they think, that it will cripple Medicaid/Medicare. It has also been suggested that the price of the all oral therapies could increase insurance premiums for everyone including those without HCV.  

THE HOPE:  AbbVie’s recently approved combo is coming in lower than Gilead’s.  Express Scripts announced a deep discount deal with AbbVie that will bring the drugs to more patients.  More deals = more patients treated.  
 
Personally, the best news I’ve heard all year was from people who have told me that they had been approved for the treatment.  I heard it from people who had been approved by their insurance carrier.  Approved by Medicaid.  Approved by Medicare.  Approved by pharmaceutical compassionate care programs.  I also heard from many  people who were treated and cured.  I heard from people who had been waiting for these treatments for many years who were treated and cured.  But I also heard from people who had not been approved—they fought back, got the medications and were treated and cured. Of course there were many people who I heard from who were denied.  They had never heard of the patient assistance programs.  Some I heard back from and some I didn’t hear back from.  Some got approved, some gave up.  I just hope that the ones who fought back got approved.  The message: Fight back—you have nothing to lose!
 
THE BAD: Who loses in the battle between pharmaceuticals and insurers/government?  It is always the people with hepatitis C who can’t get treated with these life-saving drugs.   If there was a ‘Shame Award’ it would be awarded to these groups that are withholding these drugs from patients.
For those who are cured, and want to leave all memory of HCV behind, think about one last gift of advocacy: Help one person before you leave. 

HCV WORLDWIDE:  The interferon-free therapies are being approved in other countries around the world.  Gilead has made sofosbuvir available in Egypt for a much lower cost.  Gilead has also reached an agreement with India to produce it at a much lower cost.  Daklinza (daclatasvir) in combination with sofosbuvir, peginterferon, and ribavirin is approved by the Committee for Medicinal Products for Human Use (CHMP) in the European Union.  CHMP has recommended the approval of Harvoni and Viekirax (VIEKIRA PAK in the US).  Canada has approved both Harvoni and HOLKIRA PAK (VIEKIRA PAK in the US). Japan approved the dual therapy of Daklinza plus Sunpreva (asunaprevir) to treat genotype 1. Unfortunately, insurance companies and governments have been restricting access to the new medications around the world, not only in the U.S.      
In 2014, we launched a new series of fact sheets ‘HCV Around the World’ to shine light on the issues of hepatitis C in other countries.  We would love to hear from others around the world about their struggles and victories. 

THE IGNORED:  The HCV epidemic among people who inject drugs continues to spread throughout the United States especially among people in their 20’s.  There have been reports of outbreaks in Kentucky, Vermont, California, Minnesota, and Wisconsin.  This is occurring in rural, suburban and urban areas. However, make no mistake this is an issue all over the country, but it is not being tracked efficiently nor is it being addressed.    

THE DEPLORABLE:  There is always one large outbreak of HCV due to unsafe infection control practices.  This year the outbreak was in a very vulnerable population—the elderly—at a nursing home, Manor Care, in Minot, North Dakota.  So far, 51 cases have been identified.  The source of the infections is unknown.   

I would like to end the article on a good note, saying thanks to all of our readers for their kind words.  In spite of all the bad news I am optimistic that we will be able to cure everyone of hepatitis C, especially now that we have these amazing drugs; we just need to get these and the ones that are coming down the pipeline to everyone who needs and deserves them.  
So BA-BAM!!! We now have two all oral therapies to treat HCV.  What a year it was!  And we are well on our way.

On behalf of the staff of the Hepatitis C Support Project and HCV Advocate, I would like to wish you and your loved ones a happy and healthy 2015!        Alan


http://hcvadvocate.org/news/newsLetter/2015/advocate0115.html#1

Nevada justices side with patients in hepatitis outbreak

CARSON CITY — Patients who were exposed to unsafe injection practices at some health care facilities in Southern Nevada can make a claim for negligence even though they have so far tested negative for hepatitis C or other illnesses, the Nevada Supreme Court said Wednesday.

A three-justice panel of the court reversed a Clark County District judge who had ruled against Susan and Jack Sadler and others in similar circumstances.

The court said even in the absence of a present physical injury, those patients who have so far tested negative for hepatitis B, hepatitis C and HIV, or who have yet to be tested, may claim negligence based on the need to undergo medical monitoring.

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Canada: B.C. medical researchers offer treatment by prevention for hepatitis C

Innovation: While stressing there is still work to be done when it comes to fighting HIV/AIDS – other provinces have not seen the same progress as B.C., and rates remain high in some First Nations communities – Dr. Montaner said one area he is watching is treatment of hepatitis C.

“I think one of the most exciting developments that is happening is the emergence of new treatment – highly effective, very simple, extremely well tolerated, but unfortunately very expensive – for hepatitis C.” - Julio Montaner, director of the B.C. Centre for Excellence in HIV/AIDS

Mel Krajden, medical head of hepatitis – clinical prevention services at the B.C. Centre for Disease Control, said between 70,000 and 80,000 British Columbians have hepatitis C, a chronic liver disease.