Medicare spending for hepatitis C cures surges

Medicare’s prescription drug program spent nearly $4.6 billion in the first half of this year on expensive new cures for the liver disease hepatitis C — almost as much as it paid for all of 2014.

Rebates from pharmaceutical companies — the amounts of which are confidential — will reduce Medicare’s final tab for the drugs, by up to half. Even so, the program’s spending will likely continue to rise, in part because of strong demand.

Medicare’s stunning outlays, spelled out in data requested from the government by ProPublica, raise troubling questions about how the taxpayer-funded program can afford not only these pricey medications but a slew of others coming on the market

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HCV Advocate Eblast: October 15, 2015

Check out what we have in store for you in the October Mid-Month Newsletter

 Hello,

You have probably noticed a lot of changes on the HCV Advocate Website in the last couple of months. We launched the newly designed and organized HCV Advocate website.  We will be fine tuning the website for the next few months as we continue to roll out all the services. We appreciate the feedback we have received and thank you for your patience.

In this month’s issue we have the follow articles:

• Dr. David Mazoff has retired from HCSP/HCVAdvocate—read about his accomplishments and why he will be missed.
• Disability Column Open Enrollment Final – this is a must-read for everyone who will be signing up for new insurance, Obamacare and Medicare.
• The Five Clinical Trials: What Patients Need to Know: Are you considering volunteering for a clinical trial? If so, this will help you sift through the information to make an informed choice.
• Snapshots: This issue features a study of the risk of hepatitis C and miscarriages and another study that comes closer to the real number of people chronically infected with hepatitis C.
• What’s New? We are including our tattoo fact sheets from www.hepatitistattoos.org on our www.hcvadvocate.org. The tattoo fact sheets will be housed under our Fact Sheet tab.

We would also like to welcome our new Webmaster—Judy Barlow—who officially joined us in August 2015 and who has been working with David to ensure a smooth transition.

Cheers,

Alan

Achillion Announces That Janssen Has Initiated a Phase 2a Study to Evaluate the Combination of AL-335, Odalasvir (ACH-3102), and Simeprevir for the Treatment of Genotype 1 Chronic HCV

Once Daily Triple Direct-Acting Antiviral Regimen Will be Evaluated for Treatment Durations of Four, Six or Eight Weeks

NEW HAVEN, Conn., Oct. 16, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has initiated treatment in a phase 2a clinical trial to evaluate the safety, pharmacokinetics and efficacy of AL-335, odalasvir (also known as ACH-3102), and simeprevir in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection.

This phase 2a study is a randomized, open-label, three-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor, and simeprevir, an HCV NS3/4A protease inhibitor. Patients will be randomized to one of three treatment arms and receive once daily treatment for a duration of four, six or eight weeks. The primary objective of the study is to establish the safety of the treatment regimen with secondary endpoints consisting of pharmacokinetics, the proportion of subjects achieving sustained viral response (SVR), and the effect on the viral resistance profile after treatment. The study is expected to enroll approximately 60 patients across the three treatment arms.

As previously announced on May 19, 2015, Achillion has granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir.

Further information about the study can be found at www.clinicaltrials.gov. Study identifier: NCT02569710.

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How insurance providers deny hepatitis C patients lifesaving drugs - Doctors say up to 80 percent of patients are denied expensive but effective drugs like Harvoni

Amber Rojas was almost eight months pregnant when she learned she had hepatitis C. After her daughter was born on Dec. 23, 2014, Rojas had hoped to start treatment with a newly approved, highly effective drug called Harvoni.

After filing for prior authorization and waiting for months, the 34-year old mother received an unwelcome letter on August 27, 2015 — her treatment request had been denied because her liver was still too healthy. Rojas said that even though she felt very sick with flu-like symptoms, her insurance provider deemed her “not sick enough to qualify.”

Rojas is one of an estimated 3.2 million Americans with hepatitis C, an infection that attacks the liver. In the United States, hepatitis C kills more people every year than HIV. Drugs like Harvoni promise to cure more than 90 percent of patients, yet many insurance providers authorize treatment only if a patient has extensive liver damage, or a fibrosis score of 3 or 4.

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Hepatitis C rates exploding among suburban N.J. heroin users, study finds

Researchers recently confirmed what many in the medical and drug treatment community had feared: Rates of Hepatitis C are skyrocketing among New Jersey's suburban heroin users, particularly among the young.

A study that tested 861 suburban heroin users admitted to Princeton House, an inpatient treatment center, found that 44 percent tested positive for Hepatitis C, a potentially fatal but treatable disease that affects the liver. Of those, nearly two-thirds were under the age of 35.

"It's crazy. I'm not sure I even expected to see the number that high," said Ronald Nahass, an infectious disease specialist with ID Care, who conducted the study with researchers from Princeton House. "On the other hand, I don't know that I'm terribly surprised. We've noticed this happening, and it really wasn't being recognized, which is really upsetting me, frankly."

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President coming to Charleston Wednesday

This is encouraging that the President is coming to West Virginia to talk about an outbreak of prescription drug use--hopefully it will lead to support for needle exchange and funding for support services.  Alan

CHARLESTON, W.Va. (WSAZ) -- Battling heroin addiction by giving addicts clean needles may sound counter-productive, but Charleston is now the second city in West Virginia working to authorize a needle-exchange program.

Just like the program that started last week in Huntington, it will allow people to exchange dirty needles for clean ones.

The bill was introduced at Tuesday night's city council meeting.

The goal is to help addicts get information on treatment and recovery as well as stopping the spread of diseases like hepatitis.

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Hepatitis C May Increase Risk of Heart Disease

Positive hepatitis C infection may increase risk for liver damage as well as future heart problems, according to findings published in The Journal of Infectious Diseases.  

Researchers from Johns Hopkins Medicine evaluated almost 1,000 men aged 40 to 70 years with or without human immunodeficiency virus (HIV), of which 87 also had hepatitis C in order to measure associations between hepatitis C with coronary atherosclerosis. About 750 men participating in the study also underwent CT angiography. The participants, who did not have overt existing heart disease, were recruited from the Multicenter AIDS Cohort Study, a larger study focused on men who have sex with men.

Prior research demonstrated that people with HIV already have an elevated risk for heart disease, but the researchers believe their findings here offer strong support for hepatitis C also contributing to cardiovascular damage independent of HIV status.

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