China, Taiwan FDAs accept trial applications for IFN-free HCV regimen

The China and Taiwan Food and Drug Administrations have accepted clinical trial applications filed by Ascletis Innovation for its interferon-free regimen to treat chronic hepatitis C virus infection, according to a press release

Ascletis is the first Chinese company to file clinical trial applications in China for an IFN-free regimen, according to the release, and will initiate a phase 2 trial in Taiwan. The trial will include a combination regimen of Danoprevir (ASC08), a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir (ASC16), an NS5A inhibitor.

“All oral IFN-free regimens are breakthrough treatments of [chronic hepatitis C] marketed outside China at the end of 2014. To date, there are no DAAs approved in China,” Zhuang Hui, MD, academician of the Chinese Engineering Academy and the honorary Chairman of the Chinese society of Hepatology at Peking University Health Science Center, said in the release. “We're very pleased that Ascletis is developing the first IFN-free regimen by a domestic company for [chronic hepatitis C] in China. It shows that the domestic pharmaceutical companies are now catching up with the global development for [chronic hepatitis C].”

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Eliminating Hepatitis C Means Treating Prisoners

Barry Michaelson is one of several people with hepatitis C who have sued this year to get access to new and very expensive treatments for the virus. But Michaelson’s lawsuit, unlike most of the others, isn’t against his insurance company. He’s suing the Minnesota Department of Corrections.

In May, Michaelson and another inmate filed a class-action lawsuit on behalf of Minnesota prisoners to gain access to new, highly effective drugs for hepatitis C, a virus that’s now essentially curable but can cause cirrhosis, liver failure and cancer if left untreated. In the weeks since, similar lawsuits have been filed by inmates in Pennsylvania and Massachusetts.

It wasn’t until 1992 that we could even test for the hepatitis C virus (HCV). Now we effectively have a cure, but at about $84,000 a person, it’s one of the most expensive drugs to ever hit the market. Insurers, including Medicaid and Medicare, are paying for treatment only for people with advanced liver disease in most cases, causing experts to push the White House to expand treatment. But prisoners, though they are the only group in the U.S. with a constitutional right to health care, are even more limited in access to treatment.

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14 million EU citizens living with Hepatitis C; low figures for Malta

There are currently around 13.3 million Europeans living with hepatitis B and 14 million living with hepatitis C, MEP Miriam Dalli pointed out in a question posed to the European Parliament.

“Approximately 120,000 people in Europe every year die because of these diseases.”

In Malta, the number of cases did not seem high in 2013, with 3.3 people per 100,000 being reported as having been infected that year. The number in other states is considerably higher such as in the UK, where the number stood at 21.5 per 100,000 people (nearly 14,000 in total that year).

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Guest commentary: Perplexed by governor's veto of hepatitis C bill

The governor recently vetoed Senate Bill 661, which is a cost-saving measure intended to save lives by requiring doctors to offer adults born between 1945 and 1965 a one-time screening test for hepatitis C. As the chairman of the Senate Committee on Public Health, I am perplexed by the reasons given for governor's veto and his unwillingness to reach a compromise or an alternative, other than an outright veto.

One of the primary concerns the governor had was that this measure would change a doctor's standard of care with respect to these patients, but I disagree. The Medical Society, the Centers for Disease Control and every doctor who testified before the Senate Public Health Committee all agreed that doctors should be offering the one-time screening test; however, some doctors are not following their own guidelines. This bill would codify the medical community's current guidelines and recommendations.

I also disagree with the governor's assertion that this bill will cost the state more money. The offer to screen a patient does not cost a dime. Additionally, if a patient accepted a doctor's offer to be screened, the current cost of screening is covered by all forms of insurance, including Medicaid. The cost of the screening test is around $10-$20 per test.

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When US, UK doctors refuse to prescribe Indian drugs, it reeks of racism

Greg Jefferys, a 61-year-old historian and author from Australia, hit international headlines when he flew to Chennai to use generic sofosbuvir to successfully cure himself of Hepatitis C. He spent 1/100th — just about $1000 — the amount it would have cost him if he were to use the patented version. Jefferys has since helped hundreds of patients access the medicine cheaply from here. Talking to Rema Nagarajan, Jefferys strongly criticises big pharma and the patent regime that is putting life-saving medicines beyond the reach of patients and allowing companies to make 'obscene profits'

Did you have concerns regarding the safety and quality of the Indian Sofosbuvir?
I have no concerns about Indian generics generally. In all areas of the world, there are issues of quality control and there are good companies and not-so-good companies. India has some of the largest and best pharmaceutical manufacturers in the world. I actually get really angry when doctors in the UK or the US refuse to prescribe life-saving drugs because they are made in India. It reeks of racism or post-colonial arrogance! Did you know that I have had dozens of emails from people in the UK with hep C who have tried to get a prescription for Indian Sofosbuvir and not one doctor in all of the UK would write it for these people. But I have had two prescriptions for Indian Sofosbuvir from the UK. One was from a doctor who had hep C himself and the other was from a doctor whose best friend had hep C. None other than that! It astounds me. Tens of thousands of people in the UK are suffering and dying simply because their GPs refuse to write them a prescription for Indian generic medicines!

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One in four patients with HCV denied initial request for treatment

A new study published in PLoS ONE showed that one in four patients with hepatitis C virus infection who apply for treatment of the infection is initially denied.

“Delay in access may further challenge our ability to cure hepatitis C in this country,” Joseph K. Lim, MD, associate professor of medicine and director of the Yale Viral Hepatitis Program at Yale University, said in a press release. “Some patients are told they must wait until they have advanced liver disease before they can undergo potentially curative treatment. We hope these data may help inform national policy discussions on promoting more rational, patient-centered approaches to HCV treatment access.”

“This is the first study to our knowledge assessing real-world access to interferon-free [direct-acting antiviral] regimens in established cohorts of patients with chronic HCV seeking antiviral therapy,” the researchers wrote. “These results contribute to the limited data available addressing proportion of patients successfully obtaining drug authorization through public and private insurance carriers, time to approval, and predictors for approval. … Further studies are warranted to investigate the impact of evolving drug authorization policies by Medicare/Medicaid and private payers on access to curative HCV therapies such as [sofosbuvir and ledipasvir].” – by Melinda Stevens.

Do A, et al. PLoS One. 2015;doi:10.1371/journal.pone.0135645.

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Children as young as 10 are getting tattoos illegally, without realising they risk catching HIV and hepatitis

Children as young as 10 are getting tattoos, shocking new figures have revealed.

A worrying number of youngsters are visiting illegal tattoo parlours, unaware it is against the law for them to be inked before they are 18.

And half admitted to being unaware of the risk of infection from HIV and hepatitis.

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Cambridge biotech gets funding for development of hepatitis C vaccine

As several biotechs focus on developing lucrative hepatitis C drugs, a Cambridge firm has received funding to help develop a hepatitis C vaccine.

VBI Vaccines (Nasdaq: VBIV) has secured $6.29 million from a variety of venture capital investors, including new investor RTW Investments, with participation from ARCH Venture Partners and Perceptive Advisors.

Under the terms, VBI sold 3 million shares of stock at approximately $2 a share, resulting in the raise.

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Health ministry approves new hepatitis C drug under insurance scheme

A health ministry panel has added a new highly effective, but expensive, hepatitis C virus drug to the national health insurance scheme, giving high hopes for patients who have had to endure painful interferon injections.

The tablet drug Harvoni, developed by U.S.-based Gilead Sciences Inc., is expected to revolutionize the treatment of patients with hepatitis C genotype 1, which accounts for about 70 percent of all hepatitis C patients in Japan.

A daily dose of one pill set at ¥80,171 will starting Monday be covered by the insurance, limiting the patient cost to about ¥20,000 a month. Read more.... Read our Hepatitis C Around the World on Japan: go here....

One in four hepatitis C patients denied initial approval for drug treatment

Nearly one in four patients with chronic hepatitis C (HCV) are denied initial approval for a drug therapy that treats the most common strain of the infection, according to a Yale School of Medicine study.

The finding, published Aug. 27 in PLOS ONE, identifies a new barrier to caring for patients with this severe condition.

Prior to the FDA approval of novel antiviral therapies for HCV in 2014, treatment options for patients were limited, requiring weekly injections of interferon-based therapy that caused severe side effects. The new regimens revolutionized treatment and offered patients an oral therapy with cure rates exceeding 90%. However, the high cost of care led insurers to impose new restrictions on drug authorization. Read more....

Should We Be Rationing Hepatitis Drugs? Obama Pressured to End Restrictions

Amid mounting evidence that federal and state authorities are rationing costly new wonder drugs for treating people with the potentially lethal hepatitis C virus, public health experts have begun pressing the White House to intervene to expand the use of Sovaldi and other new medications.

An estimated 3.2 million adults are chronically infected with hepatitis C while an estimated 20,000 people die from the serious liver ailment every year, including many military veterans.

The New York Times reported on Tuesday that a group of experts from the Public Health Service and President Obama’s Advisory Council on H.I.V./AIDS wrote a letter to the White House complaining that restrictions on the use of these drugs by many states are inconsistent with prudent and sound medical practices. Read more....

HCV infection associated with hardening of the coronary artery

"A higher HCV load was associated with more extensive plaque formation."

Chronic hepatitis C virus (HCV) infection is associated with an important early warning side of cardiovascular disease, investigators from the Multicenter AIDS Cohort Study (MACS) report in the online edition of the Journal of Infectious Diseases. Both HIV and HCV infections were independently associated with hardening of the coronary artery, but there was no evidence that HIV/HCV co-infection worsened atherosclerosis. After controlling for HIV infection and other factors associated with heart disease, a consistent relationship was present between chronic HCV infection and coronary artery plaque formation.

“This is the largest study to date to demonstrate that chronic HCV [CHC] infection is associated with subclinical coronary atherosclerosis, an important predictor of future cardiovascular disease [CVD],” write the authors. “The association of CHC with plaque remained significant after adjustment for…recognized CVD risk factors and was independent of HIV infection.”

“The elevated prevalence of subclinical coronary atherosclerosis among men with chronic HCV infection, especially men with the highest HCV RNA levels, provides further evidence supporting a link between chronic HCV infection and cardiovascular disease,” conclude the authors. “The presence of HCV infection may warrant vigilant cardiovascular risk assessment in these patients.”

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Cure Hep C and You May See Your Liver Health Improve

Among those coinfected with HIV, a cure for hepatitis C virus (HCV) is linked with improvements in liver stiffness, even if they have cirrhosis, aidsmap reports. Publishing their findings in the journal AIDS, researchers studied 98 HIV/HCV-coinfected individuals who had taken at least one dose of hep C therapy.

Fifty-three members of the cohort (54 percent) achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure).

The median follow-up time for the entire study group was 45 months.

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Op-Ed How to pay the bill for hepatitis C

"California...is helping to lead the way out of the hepatitis C conundrum with a sensible policy: Treat everyone who needs it, but not until treatment is necessary."

How long should you wait to treat a possibly fatal but curable disease?

That's a question with major implications for millions of patients and for insurers and government programs that have to pay for the treatment.

In the last year this question has focused on hepatitis C, a viral infection of the liver that, left untreated, can lead to cirrhosis, cancer, liver failure and death. Hepatitis C is the leading cause for liver transplants in the United States.

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Snapshots Alan Franciscus, Editor-in-Chief

Article: Hepatitis C in children in times of change—RD Baker et al.
  Source:  Curr Opin Pediatr. 2015 Jul 18. [Epub ahead of print]

Results and Conclusions
The main focus of the abstract was when to initiate treatment and when it is safe to wait for approval of the new highly effective direct-acting antiviral therapies to treat hepatitis C (HCV).

Pegylated interferon and ribavirin is the current standard of care to treat children with hepatitis C.  There are pediatric clinical trials of sofosbuvir/ledipasvir, ribavirin, and Vieikira Pak, with and without ribavirin. Approval of these drugs is expected in the near future.    

The authors make a good case for their recommendations:

• Wait: Children generally have a slow disease progression so in most cases it is safe to wait for the interferon- and ribavirin-free medications to be approved.
  
  
• Treat: In the case of children who do have serious disease progression treatment now is warranted.  Genotype information should be factored into the treatment decision process since genotype 2 and 3 cure rates are higher and treatment durations are shorter with pegylated interferon and ribavirin combination therapy.   

The Bottom Line
All children with HCV should be monitored on a regular basis.  Any treatment decisions for children should be evaluated on a case-by-case basis.

Editorial Comment
The general consensus is to wait (if possible) until the interferon- and ribavirin- free therapies are available. However, there is a small percentage of children with HCV who progress on to serious liver disease very quickly—this is why it is so important to identify and monitor children on a regular basis. 

It will be very interesting once the new therapies are approved to treat children with HCV.  Will insurance companies be as restrictive as they are with adults?  Hopefully not!  But if they are it just might be enough to raise the level of public ire to demand that they cover the medications for everyone.  It might also be enough that the public finally demand that the prices come down so that everyone affected by hepatitis C can afford the medications. 

Coming soon:  An Overview of HCV in Children

Article:  Prevalence of Cirrhosis in Hepatitis C Patients in the Chronic Hepatitis Cohort Study (CHeCS): A Retrospective and Prospective Observational Study—S C Gordon et. al
  Source:  Am J Gastroenterol. 2015 Jul 28. doi: 10.1038/ajg.2015.203. [Epub ahead of print]

Results and Conclusions
In the Chronic Hepatitis Cohort Study (CHeCS) there were 9,783 patients, 2,788 (28.5%) were cirrhotic by at least one method. Biopsy identified cirrhosis in only 661 (7%).  Other parameters, such as the International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) were not assigned to the biopsy proven cirrhosis results. 

The Bottom Line
The authors noted that the since the ICD-9 codes may not be the best codes to indicate the prevalence of cirrhosis and that there may be a ‘fourfold’ higher prevalence of cirrhosis in studies previously reported. 

Editorial Comment
This is an important study.  We need to understand the true prevalence of cirrhosis in this country.  It will help to push for better funding and making sure that people are treated sooner rather than waiting until people become sick. 

Article:  Chronic Hepatitis C Virus Infection Is Associated with Subclinical Coronary Atherosclerosis in the Multicenter AIDS Cohort Study (MACS): a Cross-Sectional Study—RA McKibben
  Source: J Infect Dis. 2015 Jul 27. pii: jiv396. [Epub ahead of print]

 

Results and Conclusions
Eighty-seven men with chronic hepatitis C were evaluated for the risk of cardiovascular disease (CVD).

Note: the study also looked at HIV and HIV/HCV coinfected men but did not find an association. 

The men were assessed for coronary plaque using non-contrast coronary CT and CT angiography and evaluated the associations of CHC with measures of plaque (substances that lead to hardening of the veins/arteries), prevalence, extent, and stenosis (narrowing of the veins). It was found that all types of plaques were significantly higher in men with chronic hepatitis C.

Bottom Line
This is not the first study that has shown that there are cardiovascular problems associated with hepatitis C.  But it is important to remember that this is a small study.  It also needs to be replicated in a larger patient population and in women with HCV. 

Editorial Comment:
As we come to understand more and more about hepatitis C it becomes clear how much damage hepatitis C causes to many organs outside of the liver.  Everyone with hepatitis C needs to be monitored on a regular basis.  In this case men and women need to be monitored for cardiovascular disease.  This is another reason why people with hepatitis C should be treated before these types of health issues are allowed to begin.

http://hcvadvocate.org/news/newsLetter/2015/advocate0815_mid.html#4

Local Health Officials Worried Over Spike in Hepatitis C Cases

 "The Green Bay area is following a national trend."

Health officials fear a public health concern they predicted a few years ago is now happening.

When heroin use began surging locally, they warned a jump in Hepatitis C cases would follow.

Now, that’s exactly what’s happening.

Read more....

Expression of a single gene lets scientists easily grow hepatitis C virus in the lab

 "What prevents non-mutated HCV from replicating in laboratory-grown cell lines?"

In a study published in Nature on August 12, scientists led by The Rockefeller University’s Charles M. Rice, Maurice R. and Corinne P. Greenberg Professor in Virology and head of the Laboratory of Virology and Infectious Disease, report that when they overexpressed a particular gene in human liver cancer cell lines, the virus could easily replicate. This discovery allows study of naturally occurring forms of hepatitis C virus (HCV) in the lab.

“Being able to easily culture HCV in the lab has many important implications for basic science research,” says Rice. “There is still much we don’t understand about how the virus operates, and how it interacts with liver cells and the immune system.”

Scientists have long attempted to understand what makes HCV tick, and in 1999 a group of German scientists succeeded in coaxing modified forms of the virus to replicate in cells in the laboratory. However, it was soon discovered that these forms of the virus were able to replicate because they had acquired certain “adaptive” mutations.

Read more...

The Five: HCV Myth Busters —Alan Franciscus, Editor-in-Chief

Ever since I’ve been working in hepatitis C there have been many, many myths about hepatitis C.  Thankfully, some of the myths have disappeared, but unfortunately, many still linger.  I have included the most common myths I still hear, but these are by no means all of the myths circulating out there! 

 

1. Myth: Hepatitis C is a death sentence! 
Fact: When someone is newly diagnosed with hepatitis C, one of the first questions he or she asks themselves is this question.  Yes, too many people die from hepatitis C but it is not necessarily hepatitis C that is killing people—the lack of diagnosis, medical care and treatment are responsible for all the deaths.  No one should die from hepatitis C!  If everyone with hepatitis C was diagnosed early on, received regular monitoring and was treated with HCV medications we would not see these many deaths that we see.   But of course, that is not reality so people are needlessly dying. 

2. Myth:  Genotype 1 is the ‘worst’ genotype!
Fact: Wrong!  As it turns out genotype 3 turns out to be the genotype that has the lower treatment response, and that seems to increase the chances of developing fatty liver. While the direct link between genotype 3 and fatty liver is not completely understood, it is known that when people with genotype 3 are cured the fatty liver is reduced and sometimes completely resolved.  It is well-known that fatty liver increases the rate of HCV disease progression that can lead to cirrhosis.  People with genotype 3 also have faster rates of disease progression. 

There may also be a link between genotype 3, insulin resistance and viral load, but more studies are needed. 

People with genotype 3 and cirrhosis have a much lower response rate with the two currently approved HCV medications—Sovaldi plus ribavirin and Daklinza plus Sovaldi.  More HCV medications are under development to meet this unmet medical need.

3. Myth: HCV has no symptoms!
Fact: Come on! Anyone who is living with hepatitis C can tell you that there are many symptoms from hepatitis C.  They may come on so gradually that some people with hepatitis C may not even notice that the symptoms are from hepatitis C.  When cured, however, the symptoms for the most part fade away.  The most common symptoms are fatigue.  The type of fatigue can be mild, moderate or severe.  It is difficult to measure some of the symptoms and that is the reason that they are many times dismissed.  There are many other symptoms such as muscle and joint pain, brain fog, skin problems, insomnia, and of course there can be some very severe symptoms and problems associated with hepatitis C.

4. Myth: There is a hepatitis C vaccine!
Fact: BIG FALSE! This myth is because people get hepatitis A, B, C confused and lump them all together.  There is a vaccine to protect against hepatitis A and hepatitis B.  But, don’t we wish there was a vaccine for hepatitis C?  There are also other confusing myths out there like:  “Isn’t that the one you get from eating bad food?”; “Isn’t hepatitis C that one when hepatitis A gets worse, turns into hepatitis B, gets even worse and turns into hepatitis C—all of these are myths.

Note:  It is important to remember, however, that people with hepatitis C should be vaccinated against hepatitis A and hepatitis B if they are not immune.  You don’t want to get another hepatitis virus on top of hepatitis C.

 
5. Myth: Hepatitis C is a sexually transmitted disease!
Fact: Hepatitis C is not classified as a sexually transmitted disease. It can be transmitted sexually, but it is uncommon among people who are in a stable long-term monogamous relationship.  In people who are not in a stable long-term monogamous relationship the risk of sexual transmission is higher.  If you fall within this group safer sex practices should be followed. 


http://hcvadvocate.org/news/newsLetter/2015/advocate0815_mid.html#3

Liver damage in hepatitis C patients significantly underestimated, says Henry Ford study

DETROIT - The number of hepatitis C patients suffering from advanced liver damage may be grossly underestimated and underdiagnosed, according to a study led by researchers at Henry Ford Health System and the U.S. Centers for Disease Control and Prevention.

The findings were the result of a study of nearly 10,000 patients suffering from hepatitis C, and could have a significant effect on patient care and healthcare policy regarding the chronic disease.

"Knowledge of the prevalence of liver damage will help decision making regarding screening for the effects of hepatitis C, when to start anti-viral therapy, and the need for follow-up counseling," says Stuart Gordon, M.D., lead researcher and Director of Hepatology at Henry Ford Hospital.

Read more...

Balance Billing by Out-of-Network Providers —Jacques Chambers, CLU

You may think you do not need this information because you “always use In-Network Providers? Surprise! Not necessarily so. Surprise Balance Billing is growing.

Balance Billing is becoming an important health insurance issue and is causing substantial problems to insured people and is occurring more often now that insurance companies offer Managed Care health insurance policies almost exclusively, and at the same time are reducing the number of “preferred” providers in their provider networks.

For Example: Let’s say you have good health insurance, and it is a Managed Care Plan such as an HMO or PPO, as almost all plans are today. You need to go into the hospital for some minor surgery. You are a wise user of healthcare so you check your plan’s network provider directory to be sure your surgeon and the hospital are in your provider network.

The surgery goes well. The bills come, and you wait for the insurance company to process the claim before making any payments. The hospital and surgery discount their bills as in-network or preferred providers so that you only owe the remaining portion of the guaranteed amount, either a co-pay or percentage of a smaller amount that is contracted between your plan and the provider.  As long as it is a network provider, you are only legally obligated to pay your portion of the contracted amount. The provider is prohibited by their contract with the insurance company for billing you for any additional amount.

But then, you receive more bills, this time from an Assistant Surgeon and an Anesthesiologist, two doctors you never encountered before, at least not while conscious. The insurance plan processes their claims and, when the Explanations of Benefits arrive; you suddenly learn those doctors were not “preferred” providers. They were out-of-network doctors who had no contract with your insurance company. Those doctors bill you for a substantial amount of money that the insurance did not cover.

If you are in an HMO; which requires you to use network providers, the HMO will pay $0 of those bills. If you are in a PPO that provides some coverage for out-of-network providers, the plan may pay a small portion of the bills. However, without a contract with the insurance company those two doctors can bill you their full rate and you will be legally on the hook to pay them. By using out-of-network providers, you lost the ability to have your portion of the bills limited.

But wait! That’s not fair! You were never given a chance to make sure those treating physicians were part of the insurance network. I agree, it is not fair, but, unfortunately, it is legal and is happening more frequently. You must pay the bill in full, work out a discounted payment with each doctor, or risk having your credit rating affected.

Do You Have Any Protection from Balance Billing?
Actually, there is very little protection from Balance Billing, although some states have passed legislation to provide some relief. Prevention is the best way to avoid Balance Bills.

The Affordable Care Act does include a provision that helps people who must use out-of-network Emergency Rooms (ERs). It requires insurance plans to cover charges in an ER, even if out-of-network. In those cases, it must pay out-of-network providers no less than what Medicare would pay for such services regardless of what the plan normally pays out-of-network providers. Usually, the providers will accept that payment without balance billing. However, that does not guarantee that out-of-network providers will not still bill you for the balance.

You should also be aware that even though a hospital may be in-network, the doctors staffing the ER may not be. Note that in most jurisdictions, although coverage in an out-of-network ER is limited to “life-threatening” emergencies, courts have interpreted that to be “life-threatening is a condition which appears to be life-threatening by a reasonable lay person.” That means if you have chest pains that are later determined to be bad indigestion, it would still be considered “life-threatening” for insurance purposes.

In addition to Balance Billing in a hospital or an emergency room, another possible source is when you are referred for a consultation to a specialist. This can happen when the health plan’s provider directory is inaccurate or outdated. It can also occur when the referring physician makes the referral without realizing it is to an out-of-network provider. This happens more frequently that you would expect since most doctors belong to several “networks.”

Finally, of course, some people will opt to intentionally go out-of-network to see the medical provider of his or her choice for specific reasons, realizing that they will have to pay more out-of-pocket.

Can I Avoid Getting a Surprise Balance Bill?
Unfortunately, there is no way to guarantee you will never receive a Balance Bill, but there are several things you can do to help prevent them:

1. Do your homework. Before seeing any provider, do not rely on the provider directory. Contact the provider’s billing/insurance department, and confirm they are in the specific network that you belong to. Note that many insurance providers use different networks for different plans; make sure the provider is in your specific plan’s network. Also write down the date, time, department, and name of the person you speak with.
   
   
2. If you know you will be going into a facility, see if your doctor can give you the names of any other providers you will be seeing, such as radiologists, pathologists, assistant surgeons, anesthesiologists, etc. Check their network status before entering the facility by the same methods.
   
   
3. If your Managed Care Plan does not provide a network specialist you need, or, if an out-of-network provider is a leader in the specific area of the specific procedure you need or in the specific condition you have, see if the Plan will agree to authorize your visit and charge you only your in-Network portion of the bill. This will be easier if your Network physician supports the referral.
   
   
4. If you go into an Emergency Room or are in a hospital and an unknown physician wants to treat you, try to find out their status with your plan. This may be difficult, as many physicians do not personally keep track or even know to which networks they belong.
   
   
5. Check with your state’s Department of Insurance to see if there is legislation that provides you some protection from Balance Billing. A few states have added some protection, but the level of protection substantially varies among the states.

What Do I Do If I Get An Unexpected Balance Bill?

1. Do Not pay any bill from a medical provider until you receive the Explanation of Benefits (EOB) from the insurance company explaining how they processed the bill. If the EOB is slow in coming, you may want to inform the provider’s billing office so they will not think you are ignoring the bill.
   
2. Call the phone number on the EOB and review it with a Claims Representative. If it does concern an out-of-network provider, there could be several possibilities:

a. Hopefully, the provider was actually in-network and it was just a coding error; which will be corrected when the bill is reprocessed.

b. If it is not a coding error, ask about your appeal rights. Appeal rights are also listed in your plan booklet. This is especially valid if it is due to an error that is at least partially the plan’s fault, or if it is a surprise Balance Bill from a provider you had no option in choosing.

c. Also, ask what the carrier is willing to do to help resolve the situation. Ideally, they should contact the provider and take you out of the middle, but admittedly, that may not happen.

3. Call the out-of-network provider and try to arrange a reduced payment. This will be easier if the insurance company agrees to make some payment.

Following those guidelines should reduce your chances of getting a Balance Bill to a minimum. Health insurance is wonderful to have, but you should not assume it will take care of itself and always be correct in its processing. Remember, to all the people handling your bills and insurance claims only you have a stake in making sure it is processed accurately.


http://hcvadvocate.org/news/newsLetter/2015/advocate0815_mid.html#2

HCV Drugs: AbbVie, BMS, Merck —Alan Franciscus, Editor-in-Chief

AbbVie:

TECHNIVIE:
On July 24, The Food and Drug Administration (FDA) approved the first interferon-free combination therapy to treat HCV genotype 4. The combination called TECHNIVIE (ombitasvir, paritaprevir and ritonavir) is taken with ribavirin and for 12 weeks.  There was a total of 135 patients in the study—91 received TECHNIVIE with ribavirin and 41 received TECHNIVIE without ribavirin.  None of the trial participants had cirrhosis.  In the group that received TECHNIVIE with ribavirin there was a 100% cure rate; in the group that did not receive ribavirin there was a 91% cure rate.  Since the study did not include people with cirrhosis the FDA did not approve TECHNIVIE for the treatment of genotype 4 with cirrhosis.  AbbVie has indicated that there are on-going studies of genotype 4 cirrhotic patients and they will pursue an indication for cirrhotic patients on the TECHNIVIE product label. 

Genotype 4 is uncommon in this country—the estimated prevalence is between 1.3% to 2.3%.  There are some higher populations in areas around New York City, Los Angeles and Southern California estimated between 2 to 3%.   Genotype 4 is the fourth most common genotype worldwide.  It also accounts for 90% (6,030,000) of the hepatitis C population in Egypt.  The remaining HCV population is genotype 1.  The total HCV population of Egypt is 6.7 million. 

Source:  FDA Press Release (The total HCV population of Egypt is 6.7 million.

Be sure to check out our fact sheet on hepatitis C in Egypt: http://hcvadvocate.org/hepatitis/factsheets_pdf/HCAW_Egypt.pdf  

New Combo:
A new phase 2 study of ombitasvir, paritaprevir and ritonavir—once-a-day  combination of AbbVie drugs to treat 181 genotype 1b patients for a treatment period of 12 weeks ( without cirrhosis) or 24 weeks (with cirrhosis).   The cure rates among the groups are listed below:

• No-cirrhosis group: 95.2% cure rate among people who had never been treated (treatment naïve (42 patients); 90% cure rate among people who had been previously treated (treatment experienced  (40 patients))
• Cirrhosis group: 97.9% cure rate among treatment naïve (47 patients);  96.2% cure rate in the treatment-experienced group (52 patients)

The most common side effects were headache, lack of energy, itching, and diarrhea. There was one treatment discontinuation due to treatment-related side effects.

This combination without interferon or ribavirin in a once-a-day pill for people with HCV genotype 1b would be a welcome addition to the landscape of hepatitis C treatment. 

Source: Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-label Study of Patients With Genotype 1b Chronic Hepatitis C Virus, With and Without Cirrhosis—Erica Lawtz– et al. http://dx.doi.org/10.1053/j.gastro.2015.07.001

Bristol-Myers Squibb
On July 24, 2015, the FDA approved BMS’s Daklinza (daclatasvir) in combination with Gilead’s sofosbuvir to treat HCV genotype 3.  In the phase 3 studies of patients who were treated with Daklinza and sofosobuvir for 12 weeks the cure rates broken down by cirrhosis and prior treatment response are listed below:

• Without Cirrhosis:  Treatment naïve—98%;
  Treatment experienced—92%
• With Cirrhosis:  Treatment naïve—58%;
  Treatment experienced—69%

The most common side effects were fatigue and headache.

The FDA press release noted that the response rates were reduced for HCV genotype 3 patients with cirrhosis.  It should also be noted that the treatment duration is only 12 weeks as opposed to 24 weeks with the current standard of care—Sovaldi plus ribavirin.  Still there is an unmet medical need for people with HCV genotype 3 with cirrhosis. 

Source:  FDA press release. 

Merck
On July 28, 2015, Merck announced that the FDA had accepted their New Drug Application for grazoprevir/elbasvir for the treatment of HCV genotype 1, 4 and 6 infection.  Merck has been granted Breakthrough Therapy designation for grazoprevir/elbasvir for the treatment of patients with HCV genotype 1 with end stage kidney disease who are on hemodialysis, and also for those patients with HCV genotype 4.

The cure rates for grazoprevir/elbasvir (one-pill/once-a-day) are impressive:  genotype 1 up to 100%; genotype 4 up to 100% and up to 80% for genotype 6.

Merck stated that they expected a notification for drug approval from the FDA by January 28, 2016.

Source:  Company press release

http://hcvadvocate.org/news/newsLetter/2015/advocate0815_mid.html#1

Demystifying Hepatitis C for Native Americans: Antonio Gonzalez's Story

When Antonio Gonzalez was diagnosed with hepatitis C in Geneva, Switzerland, doctors told him if he didn't get a new liver within five years, he didn't stand a chance at a long life. As he waited for a new liver, Gonzalez thought about all the moments he'd miss. He wanted to be around for his son's graduation.

Gonzalez hadn't even heard of hepatitis C when he was diagnosed, and didn't know how he got it. A Native American and member of the Comcáac nation, he surmised that he was probably infected with hepatitis C while fighting in Vietnam, where he suffered from many major open wounds.

While he was sick, Gonzalez put together a box of things that people could remember him by after he passed away. When he finally got his liver transplant in 2005, he was able to unpack the box and begin living again. "So beautiful to receive a liver and to unpack, like, 'I'm not going anywhere!'" he said.

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Patient Community Forum on Hepatitis C: Fresno, CA - August 20, 2015

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UK:Hepatitis C patients in England denied lifesaving liver drug

Health experts concerned about decision not to extend Daklinza treatment to patients with genotype 3 strain of virus

Thousands of people in England with a chronic form of liver disease are being denied access to life-saving drugs that are available to patients in Wales, Scotland and Northern Ireland.

Despite being recommended by European regulators and available in countries such as France and Germany, draft guidance recently issued by the National Institute for Health and Care Excellence (Nice), the body that advises NHS England on whether to fund certain drugs, recommends restricting the use of Daklinza in England. The stance will affect the treatment of adult patients with a particular strain of hepatitis C.

The move has dismayed health experts and liver disease charities who say it will mean a large subset of the sickest and most at risk patients in England will not receive the treatment they need to prevent them from potentially fatal liver failure or cancer.

Read more....

Hepatitis C cases prompt public health emergency in Fayette County

FAYETTE COUNTY -State Health Commissioner Jerome Adams, M.D., M.P.H., has declared a public health emergency for Fayette County, allowing the county health department to establish a syringe exchange program as part of a broader effort to reduce the spread of Hepatitis C.

"Fayette County is battling a Hepatitis C epidemic tied to intravenous drug use," said Dr. Adams. "County officials have submitted a comprehensive, multi-pronged plan to combat this epidemic, and a syringe exchange is one part of this effort to help reduce the spread of this devastating disease."

Senate Enrolled Act 461 made syringe exchange programs legal in Indiana for the first time, under certain circumstances. The law lays out a set of procedural and substantive requirements that local communities must meet in order for an emergency declaration to be considered by the state health commissioner. 

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Canada: Sydney advocate praises N.S. coverage of hep C drugs

SYDNEY — A Cape Breton health-care advocate is welcoming the province’s decision to cover a new line of hepatitis C drugs.

Christine Porter, who runs the Ally Centre of Cape Breton in Sydney, said any move to lower prescription drug costs for the marginalized is a step in the right direction.

She said the island is home to the highest per capita rates of the disease in both the province and the country.

“It’s a great thing when the government covers medications for any disease, especially with hepatitis C; the cost is exorbitant unless you have a really, really good medical plan,” said Porter.

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A Time to Cure: The Growing Case for New Hepatitis C Treatments

One out of every 100 Americans is living with a deadly and communicable virus, yet most can't access the cure which will save their lives and halt the disease's lethal trajectory.

Hepatitis C now kills more Americans each year than HIV/AIDS and is 10 times more infectious. It has become a leading cause of liver failure and liver cancer -- the fastest-rising cause of all cancer-related deaths. For too long this blood-borne virus has silently ravaged communities across the country, often going unnoticed and untreated until it was too late. Until 2013, the only treatments for hepatitis C were painful and effective only half the time, leaving many patients with nowhere to turn, despite their diagnosis.

But now the tide is turning. Multiple treatments for hepatitis C currently offer cure rates of near 100 percent with minimal side effects. Now some of the biggest obstacles facing hepatitis C patients are health insurers.

Read more...

Minnesota DOC Sued Over Failure to Provide New Hepatitis C Treatment Protocol

On May 1, 2015, two prisoners at MCF-Stillwater filed a civil rights lawsuit against the Minnesota Department of Corrections, Centurion Managed Care (a division of Centene Corporation), DOC Commissioner Tom Roy and several physicians. The suit alleges that the defendants “refuse to provide the ‘breakthrough’ drug treatment, viz. the hepatitis-C [HCV] treatment community standard-of-care, which will cure Plaintiffs’ HCV infection in three months from its inception.”

According to a press release issued by the International Humanitarian Law Institute, the lawsuit is “the first federal civil rights class action in the nation” to challenge the failure of state prison officials to provide prisoners with a new, more effective hepatitis C treatment protocol.

The plaintiffs, Minnesota state prisoners Ronaldo Ligons and Barry Michaelson, seek to represent a class of similarly situated prisoners. Ligons, incarcerated since 1992, was prescribed the standard 48-week HCV treatment protocol using interferon in 2006. The treatment was not successful. Michaelson initially tested negative for HCV but tested positive for the disease in 2010. The suit states that Michaelson tested positive “only after being double-bunked with a bleeding, HCV-positive cellmate and his exposure to other sources of HCV in MN DOC facilities.”

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Hepatitis C infection may fuel heart risk

Public Release: 11-Aug-2015

"Results suggest need for vigilant monitoring in those infected with the liver-damaging virus." - Johns Hopkins Medicine

People infected with the hepatitis C virus are at risk for liver damage, but the results of a new Johns Hopkins study now show the infection may also spell heart trouble.

The findings, described online July 27 in The Journal of Infectious Diseases, emerged from a larger ongoing study of men who have sex with men, many but not all of whom were infected with HIV and followed over time to track risk of infection and disease progression. A subset of the participants had both HIV and hepatitis C, two infections that often occur together.

Even though people infected with HIV are already known to have an elevated risk for heart disease, researchers emphasize their results offer strong evidence that hepatitis C can spark cardiovascular damage independent of HIV.

Specifically, the research found that study participants chronically infected with hepatitis C were more likely to harbor abnormal fat-and-calcium plaques inside their arteries, a condition known as atherosclerosis and a common forerunner of heart attacks and strokes.

"We have strong reason to believe that infection with hepatitis C fuels cardiovascular disease, independent of HIV and sets the stage for subsequent cardiovascular trouble," says study principal investigator Eric Seaberg, Ph.D., assistant professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. "We believe our findings are relevant to anyone infected with hepatitis C regardless of HIV status."

Investigators emphasize they don't know exactly how infection with the hepatitis C virus precipitates the growth of artery-clogging plaque but that their evidence is strong enough to warrant vigilant monitoring for cardiac symptoms among people infected with the virus.

"People infected with hepatitis C are already followed regularly for signs of liver disease, but our findings suggest clinicians who care for them should also assess their overall cardiac risk profile regularly," says study author Wendy Post, M.D., M.S., professor of medicine at the Johns Hopkins University School of Medicine and a cardiologist at the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease.

Post says that at a minimum patients with hepatitis C would benefit from an annual cardiac evaluation that includes cholesterol and glucose testing, a blood pressure check and assessment of lifestyle habits.

The study involved 994 men 40 to 70 years old without overt heart disease who were followed across several institutions in Baltimore, Washington, D.C., Pittsburgh, Los Angeles and Chicago. Of the 994, 613 were infected with HIV, 70 were infected with both viruses and 17 were only infected with hepatitis C. Participants underwent cardiac CT scans to detect and measure the amount of fat and calcium deposits inside the vessels of their hearts. Those infected with hepatitis C, regardless of HIV status, had, on average, 30 percent more disease-fueling calcified plaque in their arteries, the main driver of heart attack and stroke risk. People infected with either HIV or hepatitis C, on average, had 42 percent more noncalcified fatty buildup, a type of plaque believed to confer the greatest cardiac risk.

In addition, those who had higher levels of circulating hepatitis C virus in their blood were 50 percent more likely to have clogged arteries, compared with men without hepatitis C. Higher virus levels in the blood signal that the infection is not well controlled by drugs or the immune system. Poorly controlled infection, the investigators add, may lead to more inflammation throughout the body, which can fuel blood vessel damage and thus contribute to heart disease.

Treating hepatitis C infection promptly can ward off long-term liver damage, but researchers say their findings now raise another critical question: whether a new class of medications that help 90 percent of patients clear the virus within a few short months could also halt the formation of plaque and reduce cardiac risk in the long run.

More than 2.7 million people in the United States are infected with the hepatitis C virus, according to estimates from the Centers for Disease Control and Prevention.

###

Other Johns Hopkins investigators involved in the study included Rebeccah McKibben, Sabina Haberlen, Todd Brown and Chloe Thio. Investigators from other institutions included Matthew Budoff, Mallory Witt, Lawrence Kingsley and Frank Palella.

The work was by funded by the National Heart, Lung, and Blood Institute under grant number RO1 HL095129, with additional support from the National Center for Advancing Translational Sciences (grant UL1 TR 001079) and the National Institute of Allergy and Infectious Diseases.

Conflict of interest disclosure: Johns Hopkins investigator Todd Brown, M.D., is a consultant for the following pharmaceutical companies: Gilead Sciences, Bristol-Myers Squibb, Merck, Abbvie, EMD Serono and ViiV Healthcare. These relationships are managed by Johns Hopkins in accordance with its policy on interaction with industry.

Johns Hopkins Medicine
Media Relations and Public Affairs

Media contacts:
Ekaterina Pesheva, epeshev1@jhmi.edu, (410) 502-9433
Stephanie Desmon, sdesmon1@jhu.edu, (410) 955-7619

Read complete press release here: http://www.eurekalert.org/pub_releases/2015-08/jhm-hci081115.php

How the Heroin Crisis Ushered in a Hepatitis C Epidemic

Meanwhile, high prices and stringent requirements from insurers and Big Pharma are limiting access to effective treatment.

The first thing Amy does after rising from the brink of death is apologize.

“I’m sorry,” she says, scanning the small crowd of first-responders who have formed a semi-circle around her. She rummages through her scalp with fingernails painted lime green. By a hair, she has missed becoming the city’s latest casualty of a heroin overdose.

It’s just past 2:30 p.m. on a broiling Tuesday afternoon, and Amy (whose name has been changed to protect her privacy) is lying in a small courtyard on the side of Wing Fook Funeral Home, a few blocks from Boston Medical Center. Earlier in the day she had purchased a $20 bag of heroin and snuck behind the fence and shrubs of the funeral home to a set of semi-private benches, where she shot up and overdosed. Boston Emergency Medical Services responded to the call in less than four minutes. Amy, who is 20, is the second overdose they have fielded since noon. Already, they’d treated a 28-year-old man who had collapsed on the men’s room floor at the East Boston Public Library. In about 25 minutes, they will respond to their third overdose of the day, a 35-year-old man they’ll find unconscious on the lawn of South Boston’s Moakley Park.

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Updated: A Guide to Understanding Hepatitis C: 2015

Click to Download

2 New Easy C Treatment Fact Sheets

Be sure to check out these 2 new Easy C Facts fact sheets on treatment for Genotype 3 and Genotype 4

Click to Download

Click to Download

Huntington mayor ‘not afraid of failure’ when preparing to launch needle exchange program

HUNTINGTON, W.Va. — Huntington Mayor Steve Williams says the city is looking forward to launching a syringe exchange program by Oct. 1.

“I think we did an effective job of letting folks know that this isn’t just needle exchange. This is the first step of being able to save lives and help people find a way toward recovery,” said Williams.

The first-of-its-kind pilot project in West Virginia will involve education and treatment resources along with efforts to stop the spread of infectious diseases through needle exchanges by giving addicts points of contact within the Cabell-Huntington Health Department.

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Rules restricting access to hepatitis C drugs leave patients waiting

INDIANAPOLIS (WISH) — Indiana’s HIV outbreak has generated more concern about another potentially deadly infection – hepatitis C.

But an I-Team 8 investigation has found Indiana’s poorest patients are being denied access to hepatitis C drugs that could potentially cure them.

State Medicaid programs have restricted access to the drugs like Sovaldi, Harvoni and Viekira. Instead of distributing the medications to all those infected, states have set up restrictions that require patients to have certain symptoms – including a fatty liver or liver scarring – before they can get treatment.

It’s not just Indiana – 31 other states require patients to show signs of liver scarring and have a specialty doctor prescribe the medication, according to a June article in the Annals of Internal Medicine.

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Snapshots, by Alan Franciscus, Editor-in-Chief

Originally Published July 15, 2015

Article: Hepatitis C treatment in the elderly: New possibilities and controversies towards interferon-free regimens—Vespasiani-Gentilucci U, et al.
  Source: World Journal of Gastroenterology, 07/06/2015

Results and Conclusions:  In this article the authors discuss some important issues regarding the treatment of elderly patients with interferon-free therapies.  Elderly patients have additional health concerns that affect treatment decisions including:

• A generally faster disease progression to cirrhosis and liver cancer than those who are younger
• More extrahepatic conditions such as fatigue, cognitive issues
• A potential decrease in quality of life
• Possible drug-drug interactions with medications taken by the elderly (diabetes, heart, blood-pressure medications)

The authors recommend that the best case scenario is to treat every elderly patient because of the risk of accelerated disease progression.  If this is not realistic, we should be treating those who need treatment first who are in danger of disease progression.   The patients who are not in immediate need of treatment should be monitored on a regular basis.  As with current recommendations, those who have only a short-term survival are excluded from HCV antiviral treatment.  

The Bottom Line:  In general, the elderly population faces many health complications.  The elderly also face discrimination from healthcare professionals.  It is important that everyone with hepatitis C have an advocate—a family member or friend to help them through the intricacies of monitoring HCV and accessing HCV treatment.  

Editorial Comments:  We now have medications that have fewer side effects and have been found to be safe in people with mild to moderate kidney impairment.  It is important that the newly approved drugs and the investigational drugs be tested with the many medications that are commonly prescribed to the elderly.

Everyone deserves the right to be cured of hepatitis C including the elderly with hepatitis C.  More importantly, don’t we have an obligation to make sure that our elderly population with hepatitis C be treated and cured?  This way they can live their lives in relative health and know that they no longer have to deal with the potential physical and emotional consequences of living with hepatitis C.  

Article:  Hepatitis B Virus Reactivation During Successful Treatment of Hepatitis C Virus with Sofosbuvir and Simeprevir—J. M. Collins et. Al
  Source:  Clinical Infectious Diseases Advance Access

Results and Conclusions: This was a case report of two individuals with hepatitis C. 

The first case was a 55 yo man who was coinfected with hepatitis B and hepatitis C genotype 1a.  He had been previously treated with pegylated interferon plus ribavirin but did not achieve a cure.  He was started on sofosbuvir and simeprevir.  After week 4 he was HCV undetectable, but at week 7 he started to have severe liver symptoms (AST of 1792 IU/L, ALT of 1495 IU/L, total bilirubin of 12.2 mg/dl and INR of 1.96) and his hepatitis B viral load rose to 22 million.  His other tests (antinuclear antibody, ferritin, a-fetoprotein, etc.) were also abnormal.

The HCV treatment was discontinued, and hepatitis B treatment (tenofovir/emtricitabine) was started and the hepatitis B viral load subsequently decreased to less than 20 IU/mL.  The hepatitis B treatment was continued for ongoing hepatitis B suppression.

The second case was a 57 yo man with HCV genotype 1a.  He had been treated for HCV with pegylated interferon plus ribavirin but had not been cured. He was positive for the hepatitis B virus, but the hepatitis B viral load was below the level of detection (20 IU/mL).  He was started on HCV treatment—sofosbuvir and simeprevir and his HCV and hepatitis B viral loads were monitored every two weeks.  After two weeks, his HCV viral load was undetectable and his hepatitis B viral load increased to 353 IU/mL.  After four weeks of HCV treatment, HCV was still undetectable, but the hepatitis B viral load increased to 11,255 IU/mL.  The liver function tests were normal, and there were no other signs of liver disease.  The patient remained on sofosbuvir/simeprevir treatment.  Tenofovir was added to the HCV treatment regime to treat hepatitis B. 

The Bottom Line:  The reactivation of HBV in people who were coinfected with HBV and HCV was rare in the days of pegylated interferon based therapies.  This was most likely because PEG works against HBV whereas the new HCV direct acting antivirals do not have antiviral properties that will suppress hepatitis B while treating HCV.   

Editorial Comment:  A couple of important points:

• Everyone with hepatitis C should be tested for hepatitis B (and A), and if not previously infected should be vaccinated.
• People who are chronically infected with HBV and HCV who are being treated with the direct-acting antiviral medications (Harvoni or Viekira Pak) should be monitored very closely—every two weeks as listed in the second study—for HBV flares and treated for HBV as needed. 

http://hcvadvocate.org/news/newsLetter/2015/advocate0715_mid.html#4

Disability and Benefits:Medicare at Age 65, by Jacques Chambers, CLU

Originally Published July 15, 2015

This column has written about Medicare fairly regularly, however, eligibility for Medicare has usually been focused on those who get it after collecting Social Security Disability benefits for 24 months.

Perhaps it would be appropriate now, with improved treatments and a cure for HCV, to look at the process of enrolling in Medicare when turning age 65. Unlike those on SSD who are enrolled automatically in Parts A & B of Medicare, people turning age 65 must actively choose whether or not to enroll in Medicare in addition to deciding which parts are appropriate for them.

This is especially important because if you don’t enroll in Medicare at the appropriate times penalty surcharges can be added to the premiums and they will last as long as you are on Medicare.

For people who are already on Medicare due to disability, you are entitled to the same enrollment opportunities at age 65 as those just joining Medicare. It is your chance to make changes.

Here is a summary of the various parts and choices of Medicare:

• Part A Hospital – This covers hospital-related charges as well as Skilled Nursing Facilities and hospice care. Most people have paid sufficiently through MedFICA payroll taxes so there is no charge for Part A. For those that have not, there is a premium charge based on how many “work credits” you accumulated while working.
• Part B Medical – This covers other Medical charges, such as doctors, lab tests, X-rays and other tests, durable medical equipment, and some injection medications. The premium in 2015 is $104.90 per month, although high income persons pay a higher premium.
• Part C Medicare Advantage – These are Managed Care Plans from insurance companies, HMOs, PPOs, etc. Persons who are enrolled in Parts A and B of Medicare can “trade” that coverage for one of these plans. Most of them also cover prescription medications, and many do not charge a separate premium over the Part B premium; which must still be paid.
• Part D Prescription Drug Coverage – This coverage for prescription drugs is offered by private insurance companies, although all plans must meet the federal law’s requirements for such plans. Premiums vary by plan. To find the best Part D plan for you, go to www.medicare.gov; click on Find Health and Drug Plans. You can enter your medications to find the plan that covers them for the least out-of-pocket expense to you.
• Medicare Supplement (Medigap) Plans – These plans are offered by private insurance companies and are designed to accompany Parts A and B and cover portions of medical charges not covered by Parts A and B. There are ten different levels of coverage, and premiums vary by plan and insurance company. Since these plans are private insurance plans, if you do not enroll during the Initial Enrollment Period, you will be required to go through medical underwriting to purchase a plan later.

Initial Enrollment Period. If you are newly eligible for Medicare because of turning age 65, you can enroll in Medicare Parts A, B, and D or a Medicare Advantage Plan (Part C) during the initial 7 month enrollment period. The Initial Enrollment Period begins three months before the month you turn 65, includes the month you turn 65, and ends three months after the month you turn 65. The coverage will be effective on either the first of the month you turn 65 or the first of the month following your enrollment, whichever comes later.

NOTE: You can enroll in Medicare on line at www.ssa.gov, by phone at 800-772-1213, or at your local Social Security office. During this period you also may enroll in a Medigap policy regardless of your medical history or condition; you will need to do that directly with the insurance company or through an insurance agent. 

Late Enrollment. If you do not enroll in Medicare during this Initial Enrollment Period, and you do not qualify for a Special Enrollment Period, described below, then you must wait to enroll in Medicare during the annual General Enrollment Period.

Late Enrollment Penalty. If you do not enroll in Medicare during the Initial Enrollment Period and you do not later qualify for a Special Enrollment Period, the premiums you pay will have a penalty surcharge. The surcharge varies slightly by which part of Medicare is late in being enrolled; however, it is about 10 – 12% additional for each year you could have enrolled in Medicare but chose not to. This surcharge will be added to the regular premium during the entire time you remain on Medicare.

General Enrollment Period. General enrollment is from January 1 through March 31 of each year, with coverage effective the following July 1.

Choices When Enrolling in Medicare. Enrolling in Medicare requires making choices. Before enrolling in a plan you should do some research to make sure you are getting into a plan that meets your needs.

First you will need to enroll in both Part A (hospital) and Part B (Medical); see Special Enrollment Period below for exceptions.

Your primary choices for coverage are:

• Remain with Parts A & B, and add a stand-alone Prescription Drug Plan, Part D. You may also want to add a Medicare Supplement Plan (Medigap) to cover deductibles and co-insurance that Part A and B do not pay.
• Trade your Parts A & B coverage for a Medicare Advantage (Part C) PPO or HMO. You will still have to continue paying the Part B premium. Most Medicare Advantage Plans include Part D Prescription Drug coverage in their plan. For those that do not, you will need to purchase a stand-alone Drug plan to go with it. If you consider this option, make sure the medical providers you wish to continue seeing are contracting or preferred providers with the plan you choose.

As you might imagine, to find the right combination of coverage for you, you will need to do some research and perhaps speak with an insurance agent that specializes in health coverage for people age 65 or over.

Special Enrollment Periods
Not everyone who turns 65 needs or wants to switch their health insurance to Medicare. For those with a valid reason for not joining Medicare at age 65, provisions are made to allow enrollment at a later date without being subject to Late Enrollment Penalties.

Many people who already have health insurance when reaching age 65 want to continue their coverage. That is not always a good idea:

• If you have individual health insurance, and it is not from the Affordable Care Act, you may keep it, but chances are you will have better coverage for a lower premium if you enroll in Medicare A, B and D plus purchase one of the broad Medigap plans.
• If you have individual health insurance that is from the Affordable Care Act, the same would apply as the premium subsidies are no longer available after age 65.
• If you have insurance through an employer due to current employment by you or your spouse, you may wish to postpone signing up for Medicare. You can sign up for Medicare anytime while covered. Also, when your employer-based coverage stops, you have an 8-month Special Enrollment Period to sign up for Medicare.
• NOTE: COBRA Continuation Coverage is NOT considered to be from active employment so the 8-month enrollment period begins when your “active employment” coverage stops.
• To enroll in a Part D Prescription Drug Plan during this period you will need to provide a letter from your employer’s health insurance carrier, called a “Certificate of Creditable Coverage” that states the drug coverage they offered was as good or better than Medicare Part D coverage. Most group plans meet this requirement.
• If you are covered under TRICARE (coverage for active-duty military or retirees and their families), you will be required to enroll in Medicare Part B once you retire.

There are other times when you may take advantage of a Special Enrollment Period:

• You move to an area that is not in your Medicare Advantage Plan’s service area;
• You move to an area that is still in your Medicare Advantage Plan’s service area but which now has options available in your new location; and,
• You move back to the United States after living outside the country.

These are the major periods when you can enroll in the parts of Medicare, but not all of them. If you are approaching age 65, you should get more detailed information by downloading the Tip Sheet, “Understanding Medicare Enrollment Periods” at: www.medicaresupplementplans.com/
publications/ Understanding_Medicare_Enrollment _Periods.pdf

http://hcvadvocate.org/news/newsLetter/2015/advocate0715_mid.html#3

The Five: The Next HCV Drugs, by Alan Franciscus, Editor-in-Chief

Originally Published July 15, 2015

The current standard of care for treating HCV is currently Harvoni and Viekira PAK for genotype 1, Sovaldi plus ribavirin to treat genotype 2 and 3, and Sovaldi plus pegylated interferon/ribavirin to treat genotype 4.  There are a couple of combinations of drugs submitted to, and likely to be approved by, the Food and Drug Administration (FDA) by the end of this year or early next year.  Additionally, many more drugs are being developed that are in early to mid-stage development.  These medications hold the promise to cure even more people with HCV genotypes 1 through 6.   This month’s “The Five” will discuss the most promising drugs in development.

1. Merck: Grazoprevir/Elbasvir (one pill/once-a-day) in treatment-naïve and treatment-experienced patients infected with HCV genotype 1, 4 or 6 and treated for 12 weeks.  The cure rates were up to 100%.  There were issues with NS5A resistance, but Merck is conducting more clinical trials with NS5A inhibitors to overcome this problem.  Merck has filed a New Drug Application earlier this year.  Merck was awarded Breakthrough Therapy Designation by the FDA for genotype 4 and to treat those with severe kidney disease—the studies above included patients with genotype 4 and severe kidney problems.  FDA approval is expected by year end.
   
   
2. Bristol-Myers Squibb (BMS): BMS has two drug combinations that are being tested to treat hepatitis C.

Ally-1:  Daclatasvir plus sofosbuvir has been awarded Breakthrough Therapy Designation for patients with advanced cirrhosis and those with HCV genotype 1 with HCV post-liver transplant.  In the Ally-1 study, the cure rates of the patients with advanced cirrhosis were 82% for genotypes 1 and 94% for the post-patients with genotype 1.

Ally-3:  BMS has completed their phase 3 clinical trials of daclatasvir plus sofosbuvir and submitted their data to the FDA for approval.  In the trials treatment naïve people treated for 12 weeks with the combination of daclatasvir/sofosbuvir achieved cure rates of 90%, and 86% in people who are treatment experienced.  In people who did not have cirrhosis, the cure rates were 96%. These are very high cure rates. 

BMS also has a fixed-dose single-pill regime (daclatasvir, asunaprevir, beclabuvir) to treat HCV genotype 1a and 1b that is taken twice daily for 12 weeks.  There were two separate studies that included treatment naïve and treatment experienced patients with and without cirrhosis.  The studies also included arms with and without ribavirin.  The overall cure rates were up to 98% with ribavirin and 93% without ribavirin.  Breaking it down by subtype—genotype 1b had approximately 10% higher cure rates than genotype 1a.  The cure rates observed in the ribavirin groups were not statistically higher. 

The second single-pill combination listed above hasn’t been submitted to the FDA but it is expected to be submitted soon, and approval is expected mid-2016.

3. Gilead:  Sofosbuvir plus GS-5816 with and without ribavirin.  In a phase 2 study of 104 genotype 3 patients treated for eight weeks the cure rates were up to 100%.  GS-5816 is active against genotypes 1-6 (pangenotypic).  It is listed in www.clinicaltrials.gov as a phase 3 trial that is active but not recruiting.  The phase 3 study will be a fixed dose of one pill with both drugs given once a day to treat genotypes 1 through 6.  The treatment duration will be either 8 or 12 weeks. 


4. Janssen: Olysio made a big splash last year as a combination with sofosbuvir with major prescriptions and high cure rates.  They have acquired Vertex’s HCV drugs in development (ALS-2200).  This year Janssen signed an agreement to codevelop and commercialize Achillion’s inhibitors (ACH-3102, ACH-3422 and sovaprevir).  Although no data is available, it should make for a very interesting 2015-2016.  If I can steal a common term, they seem to have a very robust pipeline.  As listed above, Janssen many opportunities to develop and commercialize HCV drugs for the short term and long term.  Keep on eye on Janssen.


5. AbbVie:  In cooperation with Enanta, AbbVie is testing ABT-493, plus ABT-530 with and without ribavirin to treat genotypes 1 through 6 for 8 to 12 weeks.  The drugs are in phase 2 studies. 

The Merck approval is expected soon. The BMS plus sofosbuvir is also expected to be approved soon.  The new Gilead drugs are likely to be approved by next year and will be followed by the second BMS combination, Janssen’s combinations, and AbbVie’s.  Hopefully, more agents will be discovered that will show even more promise, and we just may have a market that is flooded with excellent drugs that will work for everyone.

Be sure to keep an eye out for the return of the HCV Advocate Drug Pipeline in September!

http://hcvadvocate.org/news/newsLetter/2015/advocate0715_mid.html#2

Hepatitis C: The Problem with Numbers, by Alan Franciscus, Editor-in-Chief

Originally Published July 15, 2015

A recently released journal article estimated that the real number of acute hepatitis C cases are much higher than the figures published by the Centers for Disease Control and Prevention (CDC).  This is not a revelation to those who work in HCV.  In this article, I will discuss the published numbers of acute and chronic HCV and what some experts believe is a better estimate of the number of acute, chronic and annual deaths caused by hepatitis C.

Acute
The CDC estimated that there were 29,700 acute cases of HCV in 2013 (range 23,500 to 101,400).  In the article, “Underascertainment of Acute Hepatitis C Virus Infections in the U.S. Surveillance System: A Case Series and Chart Review,” by S Onofrey, MPH et. al., published in the Annals of Internal Medicine, the authors challenged the way the CDC defined an acute case and compared the actual diagnosed cases to the number of diagnosed cases that fit the CDC definition. 

Note:  There are many problems with diagnosing acute HCV—there are no viral markers to distinguish acute vs. chronic.  Another issue is that most people acutely infected have no symptoms.

The current study took place in Massachusetts from 2001 to 2011.  There were 183 patients diagnosed with acute HCV, but only 149 cases were reported to the Massachusetts Department of Public Health.  Of these, 130 were classified as potential acute infection.  But only ONE met the national case definition that was reported to the CDC.  

This means that only 1% of acute HCV cases were ever reported to the CDC.  We know that there have been outbreaks of acute HCV around the country including recent outbreaks in regions in or near the Appalachia area. 

Chronic Hepatitis C
The CDC estimated that in 2013 there were 2.7 to 3.9 million people who were chronically infected with hepatitis C.  However, the NHANES survey doses not count certain populations such as prisoners, homeless, nursing home residents, people in mental institutions, nor active duty military—many of these populations have a very high incidence of hepatitis C.  If the populations that were excluded from the NHANES survey were to be included the number of people with chronic hepatitis C could reach 5 million Americans. 

Also if you include the surge of the new acute infections that would turn chronic this would also increase the total chronic infections.  It is all connected. 

HCV Deaths
The CDC estimated that there were 19,368 deaths caused by HCV in 2013.  There was also a footnote that read “Current information indicates these represent a fraction of deaths attributable in whole or in part to chronic hepatitis C.” 

Another article, “Mortality among Persons in Care with Hepatitis C Virus Infection—The Chronic Hepatitis Cohort Study (CHeCS), 2006–2010,” by R Mahajan and colleagues, was published in Clin Infect Disease 2014 Jun; 59(12)1792.  The study estimated the number of deaths caused by hepatitis C

In the study, 2,143,369 patients (MCOD group—all patients) seen between 2006 – 2010 at the CHeCS clinics were included in the analysis.  There were 11,703 (0.5%) HCV patients.  A total of 1,590 (14%) died and had HCV listed as the cause of death.  The majority were born between 1945 and 1965 (75%), white (50%), and male (68%).  The mean age was 59 yo. 

To illustrate why HCV is under reported on death certificates the following was mentioned in the study:

“Among the 1590 CHeCS members who died, only 306 (19%) had HCV infection listed as an underlying cause on their death certificate. Among people who died of liver cancer, only 32% had HCV listed as an underlying cause. Death certificates did not list HCV for most deaths regardless of whether the deaths were liver-related or not. Among CHeCS members who died, medical records (ICD-9 codes) noted liver disease in 63%, and FIB-4 scores indicated liver disease in 76%.”

The conclusion of the authors was that in 2010 listed deaths from hepatitis C only represent 1/5 of the 80,000 people with HCV who died that year—this figure includes 53,000 patients who had indications of chronic liver disease in their medical records. It’s important to remember that behind all these numbers are real people who have family, friends and loved ones.  As such they deserve to have medical care and treatment. And no one should die of hepatitis C!

http://hcvadvocate.org/news/newsLetter/2015/advocate0715_mid.html#1

'Sensational' HCV response rates in HIV coinfection trial

Researchers in the C-EDGE study found that a combination of a protease inhibitor and an NS5A inhibitor led to a sustained virologic response in patients infected with both HIV and hepatitis C virus (HCV).

Researchers in the C-EDGE study found that a combination of a protease inhibitor and an NS5A inhibitor led to a sustained virologic response in patients infected with both HIV and hepatitis C virus (HCV). Jurgen Rockstroh, MD, of the University of Bonn in Germany, reported that the sustained virologic response was 96.3% overall after stopping treatment for 12 weeks. The response rate for the 35 patients with cirrhosis at baseline was 100%. Of the study's 218 patients, two experienced a relapse after stopping therapy, but both had been reinfected with HCV. The Phase III study included patients infected with HCV genotypes 1, 4, or 6, and HIV. All patients received grazoprevir 100 mg and elbasvir 50 mg, which were coformulated by Merck into one tablet that was taken once daily for 12 weeks. No patients experienced any serious drug-related adverse events during the study. The results were presented at the International AIDS Society Conference in Vancouver.

Read more...

Urban ERs see high rates of hepatitis C infection

American College of Emergency Physicians

WASHINGTON --An urban emergency department that set up a hepatitis C testing protocol saw high rates of infection among intravenous drug users and Baby Boomers, with three-quarters of those testing positive unaware they were infected. The results of a screening and diagnostic testing program for hepatitis C were reported online Tuesday in Annals of Emergency Medicine ("Results of a Rapid Hepatitis C Virus Screening and Diagnostic Testing Program in an Urban Emergency Department").

"Given skyrocketing rates of injection heroin use around the country, we expect the already high rates of hepatitis C infection to explode," said lead study author Douglas White, MD, of Highland Hospital, Alameda Health System in Oakland, Calif. "Intervention by emergency departments, in the form of screening and referral for treatment, could help slow the spread of this potentially deadly, communicable disease."

Researchers tested 10 percent of emergency department patients for hepatitis C virus (HCV), mostly but not exclusively focusing testing on those considered high-risk, such as intravenous drug users, Baby Boomers and patients with unspecified liver disease. Of patients tested, 10.3 percent tested positive for HCV, with 70 percent of those confirmed as chronically infected. Only 24 percent of patients who tested positive for the virus had prior knowledge of HCV infection.

Hepatitis C virus is the most common chronic blood-borne infection in the U.S., affecting an estimated 3 million people and is a leading cause of end-stage liver disease, liver cancer and liver transplants. It is estimated that HCV prevalence in the United States among people born between 1945 and 1965 (the "Baby Boom") is as high as 4 percent. Baby Boomers account for 75 percent of people living with HCV infection and as many as 1.75 million of them do not know they are infected.

"In addition to the myriad public health functions they already perform, urban emergency departments may play an important role as safety net providers for HCV screening," said Dr. White. "We have a better than even chance of reaching many of the three million people who are infected since they tend to be heavy emergency department users already. It gives us a chance to connect these people to ongoing care at HCV clinics or elsewhere in the health care system."

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Annals of Emergency Medicine is the peer-reviewed scientific journal for the American College of Emergency Physicians, the national medical society representing emergency medicine. ACEP is committed to advancing emergency care through continuing education, research, and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies. For more information, visit http://www.acep.org.

Press Release Source:  http://www.eurekalert.org/pub_releases/2015-08/acoe-ues080615.php