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Alan Franciscus
Editor-in-Chief
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated September 17, 2014

Wednesday, October 1, 2014

UC to Combat Spread of Hepatitis C Among Drug Users

A University of Cincinnati professor is combating the spread of hepatitis C among young adults in Southern Ohio who inject heroin with a $900,000, three-year grant from the Centers for Disease Control and Prevention. 

The purpose of the grant is to identify interventions for young adults ages 18-30 “who inject drugs and either already have hepatitis C or are at risk of contracting hepatitis C,” said Judith Feinberg, professor of internal medicine at UC and principal investigator on the grant.

With the grant funds, researchers will hire and train outreach workers to recruit young injection drug users at risk for or currently with hepatitis C, and who reside within one of 21 counties across Southern Ohio. Those counties are: Adams, Athens, Brown, Butler, Clermont, Clinton, Fayette, Gallia, Greene, Highland, Hocking, Jackson, Lawrence, Meigs, Montgomery, Pike, Preble, Ross, Scioto, Vinton and Warren, according to the university’s press release.

AbbVie Demonstrates Commitment to Continued Research in Hepatitis C with Investigational Data from Clinical Program Being Presented at The Liver Meeting®

Data from 25 accepted abstracts include results from:

-- AbbVie's investigational treatment in liver transplant recipients with recurrent genotype 1 (GT1) chronic hepatitis C virus (HCV) infection and in GT1 HCV patients with human immunodeficiency virus type 1 co-infection

-- Abstracts evaluating AbbVie's investigational treatment combining two direct-acting antivirals with or without ribavirin (RBV) in patients with genotype 4 chronic HCV infection

-- Trials of other pipeline compounds ABT-493 and ABT-530 in GT1 chronic HCV infection
Oct 1, 2014

NORTH CHICAGO, Ill., Oct. 1, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that data from its ongoing Phase 1 through Phase 3 hepatitis C clinical development programs will be presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014.

Abstracts will be presented highlighting results from AbbVie's investigational treatment combining three direct-acting antivirals (ABT-450/ritonavir, ombitasvir and dasabuvir) with or without ribavirin (RBV) in patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. These abstracts include a Phase 2/3 study in patients co-infected with human immunodeficiency virus type 1 (HIV-1) (TURQUOISE-I) and a Phase 2 study in liver transplant recipients without cirrhosis (CORAL-I). 

Additionally, Phase 2 data will be presented from investigational studies evaluating the combination of ABT-450/ritonavir and ombitasvir with or without RBV in genotype 4 (GT4) patients (PEARL-I). AbbVie will also be presenting data from its two additional pipeline HCV compounds, ABT-493 and ABT-530.

Key AbbVie HCV Data at AASLD 2014 includes:
  • TURQUOISE-I: SVR12 data in HCV/HIV-1 Co-infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir and RibavirinPoster # 1939
    November 11, 2014, 8:00 a.m.12:00 p.m. EST, Poster Hall
    This study evaluates a treatment of ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in treatment-naïve and peginterferon/RBV-experienced adults co-infected with GT1 HCV and HIV-1, with and without cirrhosis (Child-Pugh A).
  • Sustained Virologic Response Rates in Liver Transplant Recipients with Recurrent HCV Genotype 1 Infection Receiving ABT-450/r/Ombitasvir + Dasabuvir Plus RibavirinOral Presentation at the Hepatitis Plenary Session
    November 11, 2014, 9:15 a.m.9:30 a.m. EST
    This ongoing Phase 2 study examines safety and efficacy of ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in non-cirrhotic HCV treatment-naïve since liver transplant recipients with recurrent GT1 HCV infection.
  • Interferon-Free Regimens of Ombitasvir and ABT-450/r with or without Ribavirin in Patients with HCV Genotype 4 Infection: PEARL-I Study ResultsPoster # 1928
    November 11, 2014, 8:00 a.m.12:00 p.m. EST, Poster Hall
    The PEARL-I study assesses safety and efficacy of an all-oral regimen of ABT-450/ritonavir and ombitasvir with or without RBV in treatment-naïve and peginterferon/RBV-experienced non-cirrhotic patients with GT1b and GT4 HCV infection.
Additional HCV Data Highlights
  • Antiviral Activity of ABT-493 and ABT-530 with 3-Day Monotherapy in Patients with and without Compensated Cirrhosis with Hepatitis C Virus (HCV) Genotype 1 InfectionPoster # 1956
    November 11, 2014, 8:00 a.m.12:00 p.m. EST, Poster Hall
    This study evaluates antiviral activity, safety, and tolerability of ABT-493 and ABT-530 administered as monotherapy for three days in treatment-naive adults with chronic GT1 HCV infection with and without compensated cirrhosis.
  • Pharmacokinetics and Safety of Pan-Genotypic, Direct Acting Protease Inhibitor, ABT-493, and NS5A Inhibitor, ABT-530, Following 3-Day Monotherapy in HCV Genotype-1 Infected Subjects with or without Compensated CirrhosisPoster # 1986
    November 11, 2014, 8:00 a.m.12:00 p.m. EST, Poster Hall
    This study explores the safety, pharmacokinetics and antiviral activity of ABT-493 and ABT-530 administered as monotherapy for three days in GT1 HCV infected patients with or without compensated cirrhosis.
The full list of accepted abstracts for The Liver Meeting can be accessed on www.aasld.org.

About AbbVie's HCV Clinical Development Program The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible. AbbVie's multinational Phase 3 program using an investigational treatment combining three direct-acting antivirals includes more than 2,300 patients in over 25 countries. The program is designed to identify ways to maximize response rates in a broad spectrum of GT1 patient populations, including those with compensated cirrhosis, liver transplant recipients and those with human immunodeficiency virus type 1 co-infection. AbbVie's development programs using all-oral investigational treatments combining two direct-acting antivirals are studying additional hepatitis C virus (HCV) genotypes.

AbbVie's pipeline of multiple direct-acting antiviral compounds for the treatment of hepatitis C aims to investigate interferon-free treatments that target multiple HCV genotypes. 

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Safety Information for Ribavirin and RitonavirRibavirin and ritonavir are not approved for the investigational uses discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score >6.

See approved product labels for more information.

About AbbVieAbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

SOURCE AbbVie
For further information: Media: David Freundel, +1 (847) 937-4522, david.freundel@abbvie.com, or Javier Boix, +1 (847) 937-6113, javier.boix@abbvie.com, or Investor Relations: Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

HIV and hepatitis is on the rise in Europe: Rigshospitalet

There is an urgent need to change our strategy for testing for HIV and hepatitis in Europe. The number of people infected is increasing and many are still not aware that they are infected. The problem is greatest in Southern and Eastern Europe, but it is also an increasing problem in other European countries, and new testing strategies are therefore required. Late diagnosis means a higher mortality rate, greater risk of onward transmission and increased financial costs.

European Union/CIA
European Union/CIA

More than two million Europeans are HIV positive. About 15 million adults are infected with hepatitis C and 13 million with hepatitis B. Most of these people are unaware of their infection. The lack of knowledge about their own infection means that most people are treated too late, and that a great number of people have HIV for many years before infections are discovered. In order to reverse this upward curve, there is an urgent need for European health authorities to change strategy in order to provide HIV and hepatitis testing to far more people than today.

Coupling of two widespread infections
Experience shows that challenges in connection with diagnosing HIV and hepatitis patients have many overlaps. This topic will be debated at a conference in Barcelona on 5-7 October 2014. The ‘HIV in Europe’ initiative, coordinated by CHIP, a research unit under Rigshospitalet, is co-organising the conference.

Read more....

Corinna Dan Reflects on Her Commitment to Fighting Viral Hepatitis and Introduces Viral Hepatitis Action Plan

Many of our colleagues in the HIV/AIDS and viral hepatitis fields have both personal and professional commitments to their work, formed by diverse life experiences that continue to inspire them. Recently, we visited with our colleague Ms. Corinna Dan, R.N., M.P.H., who serves as Viral Hepatitis Policy Advisor in the HHS Office of HIV/AIDS and Infectious Disease Policy. During our conversation, she reflected on her prior experience, including serving as the Adult Viral Hepatitis Prevention Coordinator for the Chicago Department of Public Health. Watch Corinna’s reflection below.

 - See more at: http://blog.aids.gov/2014/10/corinna-dan-reflects-on-her-commitment-to-fighting-viral-hepatitis-and-introduces-viral-hepatitis-action-plan.html#sthash.k4su0ght.dpuf

Tuesday, September 30, 2014

J&J goes 'nuc'lear with $1.75 billion buyout of Alios BioPharma

Johnson & Johnson will buy South San Francisco’s Alios BioPharma Inc. in a $1.75 billion cash deal that will boost the big pharmaceutical company’s profile in hepatitis C and other virus fighters.

The deal has been approved by the boards of both companies and is expected to close yet this year.

Partner Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) has an Alios-developed hepatitis C drug, called ALS-2200 or VS-135, in mid-stage human studies, but Alios’ power for J&J may rest deeper in the company’s portfolio. A number of drugs that Alios is studying, as well as VS-135, tap into the hot area of nucleotides.

Read more...

France uses tax to put pressure on hepatitis C drug prices

PARIS (Reuters) - France will tax drugmakers whose costly hepatitis C drugs threaten to throw off course its healthcare budget, the government has said, heaping pressure on pharmaceutical companies like Gilead Sciences to cut their prices.

The Socialist government said it had designed a "progressive contribution scheme" ensuring all patients can access new and more effective treatments against the liver-destroying virus, while limiting the burden of these drugs on state finances.

The government will selectively tax drugmakers when the total cost to the state from their hepatitis C drugs exceeds a certain amount each year, Health Minister Marisol Touraine said, as she unveiled the country's 2015 social security budget bill on Monday.

Read more...

Monday, September 29, 2014

HCV Meets Managed Care Health Insurance, by Jacques Chambers, CLU

Jacques Chambers, CLU
Benefits Counselor


As this country plays catch-up with the other industrialized nations that make health insurance available to everyone, a lot of people are getting coverage for the first time. Unfortunately, the health plans being offered today are complicated; they are virtually all Managed Care Plans. Also, unlike countries that cover everyone under one plan, our health coverage is handled primarily through health insurance companies so there are major differences in coverage and what an insured person is expected to pay out-of-pocket.

Managed Care Plans attempt to direct a person’s health care in a way that will be more cost efficient yet still provide quality medical care. How well they succeed with those goals is regularly questioned, but for us, as consumers, we have little choice.

These plans guide health care by limiting when and how we access medical providers as well as who. They also guide us through plan design as to how much they pay and how much they ask us as the insured person to pay out of our pocket.

While it appears that the growth of Managed Care Plans is helping to slow the growth in medical costs, the design of these plans requires us as insured members to take a more active role in our care and treatment choices. 

On the market today, whether it is through government insurance exchanges or through private agents and companies, there are three primary types of Managed Care health plans, HMOs, EPOs, and PPOs. 

HMO (Health Maintenance Organization) – This type of health plan has been around for several years. The main feature is the requirement that it will only cover medical costs when the member uses medical providers (doctors, laboratories, hospitals, etc.) that have signed a contract with the HMO to become a Network Provider. Except for charges related to a life threatening emergency, they do not pay anything for treatment performed Out-of-Network.

The distinctive feature of an HMO is that all care must go through a designated Primary Care Physician (PCP), appropriately nicknamed “The Gatekeeper.” If you have a rash and need to see a dermatologist, you must first go to your PCP who will refer you to a panel dermatologist, assuming the Gatekeeper agrees that you should see one or it is a simple enough issue that he or she can provide the necessary salve or medication. The same would usually apply to a person with HCV who needs to see their specialist.

NOTE: Some HMOs will work with their members who are dealing with a chronic condition. For example, they may name a PCP for a member dealing with HCV, but will allow a “permanent” referral so the member can go directly to the specialist who will treat the HCV and function as the PCP on other medical issues.

EPO (Exclusive Provider Organization) – EPOs are similar to HMOs with one major exception, they do not require a Primary Care Physician or Gatekeeper. If a member wants to see a dermatologist, he or she finds one on the list of Network Providers and makes the appointment.

Other than that, they are similar to HMOs. You must use a Network provider to get any coverage.
There are a couple of areas where HMOs and EPOs are similar:
  • Emergency Care – As mentioned, either type of plan would cover you if you went to an Out-of-Network Emergency Room for a life-threatening emergency. In most jurisdictions, courts have ruled that “life-threatening” means as it appears to a lay person, not a physician. A person who goes to an ER with chest pains should have coverage whether it’s a heart attack or simply a bad stomach ache.
  • Choice of Providers – Almost all HMOs and EPOs contract with large groups of providers who work under a corporate structure. In addition, rather than sign contracts with individual physicians in independent offices, physicians and other providers will form an Independent Practice Association (IPA) and the plan will contract with that umbrella group.
Rather than being able to see any provider in a plan’s Directory, you will be limited to the medical group or IPA in which you enrolled at the time of enrollment.

Preferred Provider Organization (PPO) – This type of plan provides greater flexibility in the choice of providers—unfortunately at the cost of a higher premium. Under a PPO plan, the plan will pay a benefit regardless of which provider is used; however, it will pay more of the medical bill if you use a Network Provider than an Out-of-Network one. A typical plan will pay 80% if you go to a Network Provider, but only 60% if using an Out-of-Network Provider.

A PPO plan “manages” your care through encouraging you to use their Network providers by paying more of the bill. While you can choose a Primary Care Physician from the Network if you wish, you have the right to see a specialist or other physicians in or out of the Network. Obviously, it is to your advantage financially to use Network Providers whenever possible.

NOTE: Keep in mind physicians don’t keep track of which providers are in the PPO Network. When a doctor refers you to another physician or sends out to a laboratory, you should always specify that he or she should only refer you to Network providers including hospitals and laboratories.

What Do I Pay?
As noted earlier, health plans vary greatly, yet there is no plan that will pay all of the medical bills. However, the amount an insured person must pay out-of-pocket falls into several areas that a plan may or may not have in its schedule.

Deductible – This is the amount of money and insured person is expected to pay before the insurance company makes a payment. Sometimes, the deductible must be paid before the carrier pays anything, other than for preventive services. Sometimes the deductible only applies to certain medical charges such has hospital charges or prescription medications.

Deductibles accumulate on a calendar year basis. After each January 1, a new deductible must be met.

Co-Pays – This is the fee that is paid at the point of service. Some plans require you to pay $10 to $25 each time you visit the doctor—sometimes even more for specialists. Most plans charge a co-pay when you pick up a prescription. NOTE: Ask for and keep a receipt of every co-payment in case questions arise later.

Co-Insurance – This is the percentage of a covered medical bill that is paid by the insurance company, leaving you to pay the remainder. Much more common in PPO plans, this is the main reason to use only Network Providers in PPO plans.

Network Providers have agreed to limit what they charge for a procedure. If the PPO pays 80% of the bill, then you are only obligated to pay the remaining 20%, regardless of how much the doctor normally charges.

However, when you use an out-of-Network provider, your plan is only obligated to pay its percentage of the “usual, reasonable, and customary charge” for that procedure. Of course, this is often less than what the doctor is billing. In that case, you would be obligated to pay not only your percentage under Co-Insurance, but also the amount in excess of what the insurance company deemed “Reasonable.”

Out-of-Pocket Limit – Under the new healthcare law, every health plan must limit the amount of money an insured person can pay in any one calendar year for his or her portion of the covered charges. At present the out-of-pocket limit cannot exceed $6,350 for an individual or $12,700 for a family. While this may seem high, such a limit on an insured person’s payment is far better than having to pay 20% of a $200,000 hospital bill, which is not that large of a bill today.

Preventive Services – The new health care law also requires that all health insurance plans cover preventive services at 100% with no deductible or co-pay. This list currently includes over 50 services for adults, women, and children. You can find a complete list at:
https://www.healthcare.gov/what-are-my-preventive-care-benefits/

Regardless of which type of health insurance you have, it is very important that you actively participate in your health care and not rely on your doctor’s recommendations without question.

Thanks to sites like the HCV Advocate and others on the web, there is a lot of information about hepatitis C and its treatment. Thanks to the Internet, you can stay current on new treatments, clinical trials, and new diagnostic methods. It would be nice if everyone could find a physician whose practice consisted only of HCV patients, but that is not possible. But you can become one of your physician’s sources of new information about HCV treatments and trials.

You should feel free to print out information, cut out articles and take them to your physician. Hopefully, he or she is already current, but you may be providing new information. If your doctor is not the type that welcomes such input from the patient, you may be seeing the wrong doctor.

Find a doctor knowledgeable in HCV. This is true whether you are in an HMO and must have a “Gatekeeper” or finding a doctor in an EPO or PPO network to visit regularly.

However, the Network directories of providers will give you only minimal information about your choices, and it won’t tell you which PCPs frequently treat patients with HCV or stay current about it. Clearly, you will need to do some research.

If you attempt to call the Managed Care Plan itself, they will not provide much information, as they are prohibited from “steering” patients to particular clinics or doctors, even if it would mean better health care.

Gastroenterology is the specialty that many people use. If available, you may also use a hepatologist—who may be more knowledgeable about HCV. If you wish, call several doctors’ offices to learn more. Some questions you may want to ask include:
  • Does the doctor treat other patients with HCV?
  • Does he stay current on HCV treatments? Do not hesitate to ask very specific questions, referring to treatments and using terms you have learned in your research on HCV. If they don’t know what you’re talking about, scratch them off your list and move on.
  • Who are the gastroenterologists, hepatologists, infectious disease specialists, or other HCV knowledgeable specialists that the doctor works with and refers patients to?
My colleague, Lucinda K. Porter, R.N. has an excellent Fact Sheet on Choosing a Physician; which you will find very helpful. You can find it at:
http://www.hcvadvocate.org/hepatitis/factsheets_pdf/choosing.pdf

The days are long gone in any healthcare delivery system when patients could put themselves in the doctor’s hands and rest assured that they were getting the best and latest treatment. However, in Managed Care systems, it becomes even more important that you stay actively involved in your medical care. To do that, you must find knowledgeable medical providers who not only know about HCV, but who will listen to you and answer questions candidly when determining the direction of your care.