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.
For more information on how to use this blog click here, the HCV drug pipeline click here, and for more information on HCV clinical trials click here
Drugs in Development / Clinical Trials—Updated October 13, 2014
Friday, November 21, 2014
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.
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
"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.
CONTACT: Matt Curtis, 646-234-9062, email@example.com.
People Living with Hepatitis C, Healthcare Providers, and Advocates Demand Medicaid Coverage for New Treatment Medications
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.”
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).
Night sweats or fevers
Feeling very tired, fatigued, or lethargic
Joint and muscle pains
Nausea or poor appetite
A yellow discoloration of the skin and whites of the eyes, called jaundice
Abnormalities in urine or bowel movements
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.
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?
Thursday, November 20, 2014
The Economic Committee for Health Products (CEPS) has fixed the price of a box of Sovaldi at 13,667 euros before tax, a reduction of 5,000 euros on the original price and "the lowest price in Europe", the Health Ministry said on Thursday.
Twelve weeks of treatment will now cost 41,000 euros ($51,373) before tax, against 56,000 euros previously.