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
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated October 13, 2014

Saturday, November 22, 2014

Pakistan: The disease that kills

Hepatitis C has become an epidemic in Pakistan and there is no end in sight since the governments neither have the will nor the wherewithal to control this disease

The press is full of discussions about Ebola, dengue fever, polio and whatever other disease catches the fancy of our media and our ‘ruling class’ at any given time. I do not for a moment wish to denigrate the efforts to control any disease especially the ones I mention above. But there are other health problems that do not get adequate coverage. And no, I am not referring to a simple matter like waterborne diseases that could be controlled if clean water became available for people to drink.

Let me mention a particular condition that afflicts close to 12 million Pakistanis, more than 20000 new patients acquire this disease every year; a number greater than in any other country in the world, and more than 400 Pakistanis die from this disease every day. And in the Punjab alone there are more than six million people infected with the viruses causing this disease. What disease is this? Well dear readers if you have not figured it out yet, it is what we call Hepatitis C. (Statistics from Jang-Mera Shahr Lahore, October 28, 2014).

Statistics presented in a conference on Hep C held under the aegis of the Punjab Department of Health and as reported in the news item mentioned above suggest that the world over, on the average, one person receives one or two injections every year. However, in Pakistan, the average is between 13 and 14 injections every year and 70 percent of these injections are given using unsterilized needles or syringes.

Read more....

Friday, November 21, 2014

Ireland: Early access no cure-all for HepC

Dara Gantly on the pressure to provide full access to powerful new treatments.

It is not often we hear the word ‘cure’ mentioned in the development of a new class of drug, but the direct-acting antiviral (DAAs) agents for people with the hepatitis C virus (HCV) have that exact potential. Indeed, this revolution in treatment could mean the ‘eradication’ for the condition. The only barrier to achieving this will be the ability to access and afford these new therapies. The ‘US$1,000 pill’ tagline has, as you might expect, caused quite a stir among healthcare funders and media alike, with some experts describing the costs of the drugs “as breathtaking as their effectiveness”.

From the standard treatment for chronic HCV genotype 1 with ribavirin, pegylated interferon and a protease inhibitor — which could involve 18 tablets a day, last a year, have a limited response rate and cause severe side-effects — patients with HCV are now being presented with three months or less of oral medications that are offering a 90 to 95 per cent ‘cure’ rate, with experts talking about the eradication of hepatitis C over the next decade.

Read more... 

At The Crossroads: How Will Medicare Grapple With Hep C?

My recent story about the high cost of new hepatitis C treatments focused on the difficulty of deciding who gets these new drugs now and who has to wait. That's because, while new drugs like Sovaldi and Harvoni (both made by Gilead) promise to cure a lot of people, they're so expensive we simply couldn't afford to treat everyone who's infected right now. I looked at how Rhode Island's Medicaid agency is grappling with this question, by restricting treatment to patients with the most advanced liver disease, and placing some other requirements on patients, such as being drug free for at least six months prior to being approved for treatment.

All the experts I've been speaking with for this series tell me that Medicaid covers a disproportionate number of people infected with hepatitis C; it's a disease, in many ways, of the disenfranchised. But it's also been called the disease of a generation, baby boomers - people born between 1945 and 1965 (and if that's you, get tested!). They'll soon age into Medicare.


CHMP Grants Positive Opinions of AbbVie's VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) for the Treatment of Chronic Hepatitis C in Europe

- Major regulatory milestone achieved toward approval in the European Union
- Final decision from the European Commission expected in the first quarter of 2015

NORTH CHICAGO, Ill., Nov. 21, 2014 /PRNewswire/ -- The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted positive opinions for AbbVie's (NYSE: ABBV) investigational, all-oral, interferon-free treatment of VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) with or without ribavirin (RBV) for patients with genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus (HCV) infection. The European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.

"The CHMP positive opinions mark an important milestone in our HCV development program and recognize the potential our treatment brings to people in Europe living with this chronic condition," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse."

The marketing authorization applications (MAAs) were submitted to the EMA on May 6, 2014 under an accelerated assessment, designated to new medicines of major public health interest. Review of the MAAs is being conducted under the centralized licensing procedure, which if approved will result in marketing authorizations valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

Robust Clinical Program Supported Positive OpinionsThe CHMP opinions are supported by a robust clinical development program consisting of six pivotal Phase 3 studies (SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II)1,2,3,4,5 including more than 2,300 GT1 patients in over 25 countries. In addition, the positive opinions were supported by a Phase 2 study, PEARL-I, in GT4 patients without cirrhosis6, as well as preliminary data from the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients7 and from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection who were new to treatment after transplantation.8

Approximately nine million people in Europe are infected with HCV, which over time may lead to cirrhosis and liver failure in about 10-20 percent of people with chronic HCV.9,10 Genotype 1 is the most common type of HCV genotype9, accounting for 60 percent of cases worldwide.10 In Europe, the most prevalent genotype is 1b (47 percent).11  Genotype 4, most common in the Middle East, sub-Saharan Africa and Egypt, is becoming increasingly prevalent in several European countries including Italy, France, Greece and Spain.12 

The U.S. Food and Drug Administration (FDA) granted priority review for AbbVie's treatment for patients with GT1 chronic HCV infection on June 13, 2014. AbbVie's treatment was also granted Breakthrough Therapy designation by the FDA, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy.

About AbbVie's Investigational Chronic HCV TreatmentVIEKIRAX™ + EXVIERA™ is being investigated for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX consists of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily, with or without ribavirin, dosed twice daily.

AbbVie's chronic HCV treatment combines three direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.
For genotype 4 chronic HCV patients, AbbVie's treatment consists of the fixed-dose combination of paritaprevir/ritonavir (150mg/100mg) with ombitasvir (25mg) only, dosed once daily with ribavirin, dosed twice daily.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Additional information about AbbVie's HCV development program can be found on www.clinicaltrials.gov.


New York State Poised to Deny Hepatitis C Treatment to Thousands

FOR IMMEDIATE RELEASE | November 20, 2014
CONTACT: Matt Curtis, 646-234-9062, matt@vocal-ny.org.

People Living with Hepatitis C, Healthcare Providers, and Advocates Demand Medicaid Coverage for New Treatment Medications

NYS Medicaid placing arbitrary restrictions on hepatitis C treatment, denying the cure to thousands of low income New Yorkers.

More than 200,000 New Yorkers are living with chronic hepatitis C, which causes serious liver disease, including cirrhosis and liver cancer. New medications can cure the disease in as little as 8 weeks.

Albany, NY – Today dozens of people living with hepatitis C (HCV), healthcare providers, and advocates rallied outside of a New York State Department of Health meeting where the state discussed imposing onerous restrictions on how newly approved HCV treatments will be covered by Medicaid. More than 200,000 New Yorkers have chronic HCV, which causes serious liver disease including cirrhosis and liver cancer.

At issue is the breathtaking price that Gilead, which produces two new HCV medications, has set for them: $95,000 for a single 12 week course of treatment in the case of its newest medication, Harvoni. Advocates at once criticized the company for profiteering, noting that the cost of production is in the low hundreds of dollars, and New York Medicaid for excluding thousands of sick patients. Advocates are calling on the state to press negotiations with the pharmaceutical industry to reduce prices while making it easier for patients to benefit from the new drugs.

“Now that we can cure Hepatitis C, we need to make treatment access universal,” said Charles King, president of Housing Works and co-chair of a task force established by the governor to work toward ending the AIDS epidemic. “Anything less than that is both immoral and counter to the basic principles of sound public health policy.”

Liam Gibson, a resident of Suffolk County who provides hepatitis services at NY Harm Reduction Educators and is a member of the activist group VOCAL-NY, has been living with HCV for nearly 20 years. But he was recently denied treatment by Medicaid because his liver disease is not advanced enough. “I have a swollen liver, fibrosis, exhaustion and weakness, and mental effects,” said Mr. Gibson. “Just because Gilead is putting their profits before my life does not mean the state of New York can pretend I don’t exist. I need treatment now, not when I’m on death’s door.”

About 50% of HCV infections statewide are among people living Upstate and on Long Island. By the state’s own estimate, coverage criteria could exclude up to 60% of Medicaid patients with the disease – or nearly 40,000 people.

Hepatitis C is increasingly an issue that unites elected officials from both sides of the political aisle.  
Senator Phil Boyle (R-Bay Shore) stated that “as we seek treatment for the thousands of New Yorkers suffering from Hepatitis C,  we must ensure that effective medications are not put out of reach for those who need them,” said Senator Boyle.  “The entire purpose of the research and development of new drugs is to make all of those who are afflicted well, not just a select few.  As with any disease, we need to ensure that all treatments and medications are made available to as many as possible, as soon as possible.”

“New York’s pathbreaking commitment to ending the AIDS epidemic shows just how far we’ve come,” said Senator Gustavo Rivera (D-Bronx). “The same approach can control the hepatitis C epidemic, a life threatening – and curable – disease that affects communities across the state. The first step should be to simply ensure all doctors have access to the medication they need to adequately treat their patients.”

Tracy Swan of the Treatment Action Group made an analogy to healthcare that many have come to take for granted: “We don’t make HIV-positive people in New York wait for treatment until they have AIDS, we don’t tell people who eat meat that they can’t be treated for heart disease, and so we shouldn’t withhold HCV treatment from people who need it. New York should not backslide into unethical cost-cutting.”

“It is clear that Gilead’s prices for Sovaldi and Harvoni are excessive and have no relation to the cost of producing these drugs,” said Luis Santiago of ACT UP New York. “However, the decision of whom to treat must be based on science. Cost and budgetary considerations must be dealt with through negotiations between producers and payers. In no case should they be used to deny access to patients for whom the treatment is indicated.”

Medical providers are already seeing the effects of treatment restrictions. “I have applied for Medicaid and Medicare coverage for various treatments including Simeprevir, Sofosbuvir and Harvoni,” said Angie Woody, a hepatitis C patient navigator in New York City. “It is clear to me that the cost of these medications leaves patients beholden to their insurers for treatment and that doctors and insurers have conflicting criteria for ‘necessary medical care.’ In just the last month, we have had four patients denied treatment due to their lack of advanced liver disease.”

Advocates also point to how treatment access is a necessary precondition to ending the epidemic. “With no restrictions to HCV treatment and a commitment from NYS officials and the governor we can eradicate Hepatitis C in New York State,” said Jules Levin of the National AIDS Treatment Advocacy Project. “This approach will provide access to a cure, save lives, prevent transmission, and ultimately avoid billions of dollars in medical costs for the state. Considering all the other costs associated with HCV disease, it is clearly cost effective.”

Pointing to the global impact of HCV drug pricing, Michael Tikili of Health GAP said that “placing these particular restrictions on who can access Harvoni is a crime against the most marginalized of our communities and will only allow the HCV epidemic to spread further. It is unacceptable that millions of poor people living with hepatitis C around the world are being priced out of treatment because of Gilead’s greed. We will fight for access in our own backyard here in New York State, and around the world, wherever Gilead’s price gouging is leaving people to die without access to a lifesaving cure.”

Source:  http://www.vocal-ny.org/blog/new-york-state-poised-to-deny-hepatitis-c-treatment-to-thousands/

Pakistan: Sovaldi – ‘miracle’ hepatitis C oral drug gets official nod

LAHORE: The Drug Regulatory Authority of Pakistan (DRAP) has finally fixed price of the ‘blockbuster’ oral drug - Sovaldi – after its registration in Pakistan, giving a good news to hepatitis C patients.

The decision was taken in a meeting of DRAP’s Drug Price Committee presided over by Pricing Director Mr Amanullah in Islamabad on Thursday, a senior official in the authority told Dawn.

He said the Ferozsons Laboratories is the sole company which was granted rights to sell and market this much-awaited drug in Pakistan at a price approximately Rs1,940 for each tablet. The company will make available a pack of 28 tablets for total price Rs55,000 [$890 US] after final approval by the federal government.

While highlighting the significance of the new life-saving drug, Technical Advisory Group (TAG) Member Prof Dr Ghiasun Nabi Tayab said presently approximately 10 million people in the country were living with chronic hepatitis C virus (HCV).


Disability & Benefits: Preparing Your Medical Record for Disability

Jacques Chambers, CLU
Benefits Counselor

No one plans on becoming disabled. Even people with chronic diseases plan for and hope for a healthy future. They try to maintain a healthy lifestyle; they stay current with the latest, available treatments.

Yet, no one knows what the future will bring. Although everyone should consider alternatives if the future holds problems, persons with a chronic conditions such as hepatitis C have a special need to look ahead and prepare for alternatives. They should consider carefully in advance at what point, if their disease progresses in such a way, they would prepare to stop work and file for disability.

In addition to knowing what benefits are available should disability arise, there is one other thing you should be doing – just in case. And that involves your medical records.

Whether it is a private disability insurance company or Social Security, disability is virtually always determined by a review of your medical records. Only rarely are you asked to take a physical exam from what they call an “independent” physician who is truly “independent.”

Transitioning from work to disability is a major life event with all the confusion, frustration, and emotional upheaval such events can bring. Being awarded disability benefits can also be a challenge. Sixty per cent of initial applications for Social Security Disability are rejected. Insurance companies don’t release their numbers, but it is probably not much better considering they are profit-making organizations that have to account to stockholders for the level of their profits.

Therefore, it is very important that your medical records be thorough and complete, and now is the time to start getting your medical record into a shape that will support disability, if and when it is needed.

This is not going to happen without your participation. The tendency in modern healthcare is for medical records to be heavy on testing, diagnosing, and treating. Due to the limited amount of time doctors spend with their patients, and the predetermined entries in electronic medical records, there is frequently little information on your symptoms, including their severity and frequency or your quality of life, or lack thereof.

There are items that should be in the medical record in order to be approved for disability that are not always included:

Objective Symptoms are symptoms that can be measured in a laboratory or otherwise confirmed objectively. While blood tests may measure viral load, immune response, and multiple other measurements, they do not directly relate to current symptoms. Unfortunately, most of the symptoms of a person with HCV are “Subjective Symptoms.” However, there may be tests that are not normally part of the tests regularly performed that may provide some evidence or help objectively to explain why certain symptoms are present. The record also rarely describes what symptoms are related to which lab result. That should be spelled out in the record as claims examiners do not usually seek out such connections.

If and when your condition progresses towards cirrhosis, more symptoms will develop which can be measured by laboratory tests or clinical observation by the physician; but you do not have to be at that stage before you are physically and mentally unable to continue working. Subjective Symptoms alone may be disabling.

Subjective Symptoms are symptoms that tend to be self-reported or observed by the physician and not measurable by a lab test. The primary subjective symptoms experienced by persons dealing with HCV can include:
  • Headaches
  • Night sweats or fevers
  • Insomnia
  • Depression
  • Brain fog
  • Feeling very tired, fatigued, or lethargic
  • Joint and muscle pains
  • Nausea or poor appetite
  • Stomach pain
  • Itchy skin
  • A yellow discoloration of the skin and whites of the eyes, called jaundice
  • Abnormalities in urine or bowel movements
Some of these symptoms are “indirectly” documented by certain readings on lab tests or as side effects of the medications being prescribed; but, again, claim examiners usually do not have the time or the training to make such connections unless spelled out in the record. Those symptoms affecting you should be noted in the record even if this is repeated every office visit.

Symptom Diaries are logs, usually kept daily or weekly, that the patient maintains. If, for example, fevers are a symptom, taking the temperature several times a day at regular intervals and recording it can support that. Activities cut short, canceled, or avoided due to fatigue can be entered as well as pain with its location, frequency, and severity.

NOTE: Many with HCV have been dealing with it for several years. When observing your symptoms, do not compare them to yesterday or last month. Spend some time remembering what your life was like well before infection. It was probably a lot different than it was last month. Think of the things you used to do without a thought that you would not consider attempting now. Also, think back to all the accommodations you made due to your condition:  What short cuts or easier methods have you adopted to make life easier for you? Any changes should not automatically be attributed to aging.

Clinical Observations are your doctor’s (and nurse’s) observations while meeting with you. He or she may observe symptoms or results of symptoms as well as how you appear. In addition to looking for signs of fatigue or jaundice, the doctor may also observe changes in your posture, gait as you walk, your mood, attentiveness, and other factors that can help confirm some of your subjective symptoms. These observations should be noted in the file.

Other medical conditions frequently accompany HCV. Whether it is Fibromyalgia, Major Depression, or HIV, they should be included in the medical records used to claim disability whether from the same treating physician or another doctor.

Restrictions and Limitations are the effects of your symptoms on your ability to function. Restrictions are activities your doctor believes you should not do at all. Limitations are activities you should do only with limits. The specific restrictions and limitations should be noted along with itemized justification for them.

Listing of Impairments, by the Social Security Administration, is the best tool to use when applying for Social Security Disability and can be helpful with private disability plans as well. This booklet lists specific events, diagnoses, and laboratory tests, which they believe are sufficient to qualify for disability.

The listing for HCV is located under “Digestive Disorders – Chronic Liver Disease” which is found at http://www.ssa.gov/disability/professionals/bluebook/5.00-Digestive-Adult.htm#5_05 . There is a long list of conditions that will support disability. If you have any of those conditions, they should be clearly noted in the medical record along with any lab tests or supporting evidence. Also, note the various explanations at the beginning of that chapter. They explain how Social Security defines or measures the various conditions in the listing. 

Talk to your doctor
Now you know what should be in your medical record to demonstrate disability. How do you discuss this with your doctor(s)? Not all physicians are going to welcome this discussion, and what is being recommended here may be somewhat idealistic, but you won’t know how successful this will be unless you try.

This is probably not going to be easy. Doctors do not have a lot of extra time, and do not like to deal with insurance companies. But, remember, it will benefit both you and your doctor in the long run if everything is in the record and your doctor doesn’t have to deal with repeated requests for more information later.

Remember a doctor is focused on treating you and your condition, not preparing for disability so, in most cases, you will be asking him or her to maintain your record differently than is probably customary.

The next time you see your doctor, ask if you can discuss your medical record and what is going into it. If a doctor says there is no time, ask for a separate appointment or try to have this discussion with the doctor’s lead nurse.

You may want to go to the appointment early and ask if you can take a look at your medical record while waiting to see the doctor. You may determine that the record is more complete than might be expected or find areas you want to emphasize with the doctor.

During this discussion, there are several points you want to make:
  • While I am doing fine now, I realize that this condition may someday cause me to have to leave work and file for disability.
  • I have learned that neither private insurance nor Social Security will accept your word without some documentation and the best documentation is the complete medical record.
  • I believe that if we build a thorough medical record now that includes more than office notes and laboratory results, it will save both you and me time should we have to deal with insurance companies and/or Social Security. 
  • Would you highlight any objective symptoms you find and any subjective symptoms you discover through clinical observation? The insurance companies and/or Social Security may not connect the lab result with the symptoms unless it is noted in the record, and some of the subjective symptoms may have to be repeated every visit.
  • Would you list and explain the reason for any Restrictions and Limitations in my activities that you recommend?
  • If I bring you a Symptom Diary that I keep between visits, would you see that it gets entered into my record each time we meet?
While following these suggestions can make transitioning to disability easier and less stressful, be aware that, emotionally, such a close examination of your medical problems is not pleasant. Be aware of that. Better to deal with it in small doses over a period of time and avoid the frustration and stress of having to appeal denied claims.