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, the HCV drug pipeline, and for more information on HCV clinical trials
click here

Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.


Alan Franciscus

Editor-in-Chief

HCV Advocate



Monday, November 9, 2015

Friday, November 6, 2015

Diabetes Thought to Increase Risk for Hepatic Cancer

A retroactive study presented at the 2015 Annual Meeting for the American College of Gastroenterology (ACG) suggests that diabetes increases the risk for hepatocellular carcinoma. Hepatocellular carcinoma is the most common form of liver cancer. The disease generally occurs secondary to hepatitis C infection or in cirrhosis from other causes.

The study authors used data from MarketScan, which is a database for insurance claims of all kinds. They found 7,473 patients with hepatocellular carcinoma. The authors also included 22,110 controls matched for comorbidities, age, sex, and gender, leading to a 1-to-3 ratio of subjects to controls for 99% of the case subjects. The patients included in the case group had hepatocellular carcinoma with hepatitis C with DM, without DM, and DM alone. The study also looked at the impact of metabolic syndrome, hypertension, and dyslipidemia.

Read more...

HIV, Hepatitis C outbreak continues in Indiana

BATESVILLE, IN (FOX19) - It's been months since the story about southeastern Indiana’s HIV epidemic went national and now, the state is still trying to bounce back from what Governor Pence called 'the worst outbreak in state history.' The outbreak is stemming from the widespread heroin problem in the region.

On Thursday, FOX19 NOW spoke with a doctor in Batesville, Indiana who told us if users don't get tested for HIV soon, the problem is only going to get worse.

The heroin crisis in Indiana has caused an explosion of not only HIV cases but Hepatitis C cases in the area as well.

Read more....

Thursday, November 5, 2015

OBAMA ADMINISTRATION GUIDANCE WILL INCREASE ACCESS TO HEPATITIS C CURE DRUGS Urges State Medicaid Programs to Lift Restrictions for the Nation’s Most Vulnerable


National Policy Office - Washington, DC: 202-835-8373
Program and Administrative Office - Tampa, FL: 813-258-5929

For Immediate Release: 11.05.15   


Media Contact: Carl Schmid: (202) 669-8267 cschmid@theaidsinstitute.org
                                                                                    
OBAMA ADMINISTRATION GUIDANCE WILL INCREASE ACCESS TO HEPATITIS C CURE DRUGS
Urges State Medicaid Programs to Lift Restrictions for the Nation’s Most Vulnerable  
Washington, DC – The AIDS Institute praises the Obama Administration for their letter sent today to State Medicaid Directors that suggests states lift their onerous restrictions that have prevented people living with hepatitis C access to medications that can cure them.  “Denying drugs that can cure people of a deadly infectious disease is just bad public health policy. This announcement demonstrates that Medicaid beneficiaries with hepatitis C, who represent some of the Nation’s most vulnerable, deserve access to a cost-effective cure just like anyone else,” commented Carl Schmid, Deputy Executive Director of The AIDS Institute.
The AIDS Institute, a national public policy and advocacy organization dedicated to ensuring people living with HIV and hepatitis have access to quality and affordable health care, along with others, have urged the Centers for Medicare and Medicaid Services (CMS) to take this corrective action.  Most state Medicaid programs have instituted barriers to accessing hepatitis C cure drugs by limiting them to only individuals with advanced liver disease.  States have also used a number of other restrictions which have no scientific basis such as limits on who can obtain and prescribe the drugs. In one recent study, 46 percent of Medicaid beneficiaries were denied access to hepatitis C drugs. 
Medicaid is a joint federal-state funded program.  States must cover all medications produced by pharmaceutical manufactures that participate in the Medicaid Drug Rebate Program.  While states may be putting the hepatitis C drugs on their formularies, many are making it extremely difficult for patients in need of the drugs to access them. Today’s announcement makes it clear that this is wrong and states need to remove restrictions that have no clinical or scientific basis. 
Nationwide, an estimated 3.2 million people are living with hepatitis C; however, up to 75 percent have not yet been diagnosed.  There are approximately 20,000 deaths attributed to hepatitis C annually in the U.S. and it is the leading cause of costly liver cancer and liver transplants. 
Clinical experts at the American Association for the Study for Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) have recently updated their guidance on the treatment of hepatitis C virus.  They have concluded that treatment would benefit nearly all of those who are chronically infected and the goal should be to treat all patients as promptly as feasible to improve their health and to reduce HCV transmission.
Since many Medicaid beneficiaries are now being served by Medicaid Managed Care Organizations (MCOs), the directive announced today makes it clear that MCOs cannot impose restrictions on patient access that are more restrictive than the state’s fee-for-service program.  In some states, Medicaid MCOs have instituted even far wider restrictions than the state run programs.
“Now, we call on all state Medicaid programs to remove patient barriers to hepatitis C treatment that the federal government has called to be eliminated,” said Michael Ruppal, Executive Director of The AIDS Institute.  “In the long run, it will save the health care system billions of dollars, save the lives of hundreds of thousands of people, and help eradicate a deadly infectious disease.” 
# # #

The AIDS Institute is a bipartisan, national nonprofit organization that promotes action for social change through public policy, research, advocacy and education.

For more information and to become involved, visit www.TheAIDSInstitute.org or write to us at Info@theaidsinstitute.org, and follow The AIDS Institute on Twitter @AIDSAdvocacy and Facebook at www.facebook.com/The-AIDS-Institute.


Carl Schmid
Deputy Executive Director
The AIDS Institute
Washington DC
202/462-3042-office
202/669-8267-cell
202/328-0467-fax
cschmid@theaidsinstitute.org

cid:image001.jpg@01CDFA3B.D55DEF50

International Advisory Group Assesses Hepatitis C Elimination Program

A conference of international advisers has been held in the frames of the Hepatitis C Elimination Program of Georgia. The international partners will support and carry out consultations for implementing long-term strategies in monitoring, prevention and controlling systems.

The International Advisory Group, whose members are the heads of the US Center for Disease Control and Prevention, Emory and Hopkins Universities, World Health Organization and other international partners, attended the conference. They aim to encourage development of Hepatitis C elimination and also to increase public awareness.

The results of the Hepatitis C Elimination Program and its current conditions were discussed. According to the Ministry of Healthcare, 130-150 million people suffer from Hepatitis C and, in the WHO’s criteria, Georgia is considered as a high-prevalence country

Read more....

Wednesday, November 4, 2015

New Syringe Design Not Particularly Effective at Curbing Spread of Hepatitis C Virus

As many as 21 million people worldwide inject drugs, putting them at heightened risk for infection from blood-borne pathogens such as the hepatitis C virus (HCV), especially if syringes are shared.

A newer type of syringe designed to reduce HCV transmission by decreasing the so-called dead space—the volume that exists between the syringe hub and needle in comparison to standard and widely used high dead space designs—is not particularly effective, a new Yale School of Public Health-led study has found.

The research is published today in the journal PLOS ONE.

Read more....

Tuesday, November 3, 2015

Hepatitis C patients who use drugs need multidisciplinary treatment: B.C. study

Treating patients with hepatitis C who inject illegal drugs using only medication is ineffective without also addressing the complex social issues they face, finds a new study from the University of Victoria.

Although new hepatitis C drugs can cure the liver-wasting disease in most patients, new research suggests the treatment does little to help patients who inject drugs, some of society’s most vulnerable citizens who are also the most challenging to help.

“There’s quite a bit of attention to medical advances (in hepatitis C treatment), but it doesn’t really impact the people most affected (by hepatitis C),” said Bruce Wallace, co-author of the study and an assistant professor at UVic’s School of Social Work. “People are being excluded from access to treatment and it is the people who need it the most.

Read more....

Advocates work on stigma, treatment of hepatitis C

Like many hepatitis C patients, Anthony Lo Russo, 64, lived with the virus for years before he knew he had it. Even after a routine blood test flagged it in 1995, he eschewed hep C drugs because of their side effects. “I felt fine, so I waited,” Lo Russo said.

After the 2013 introduction of kinder drugs, Lo Russo agreed to a standard 16-week treatment. Two weeks into it, he heard the word that’s music to hep C patients’ ears; his blood was “clear” of hep C. He was cured.

“I’m happy to be alive,” said Lo Russo, of Lake Worth, Fla. He bowls in three leagues, swims and chats with fellow patients on Facebook.

Read more....

Monday, November 2, 2015

Primrose Healthcare Provides an Innovative Calculator Tool, Giving Insight into the Costs of Hepatitis C beyond Anti-Virals First-in-industry tool for payers

PHOENIX--(BUSINESS WIRE)--Primrose Healthcare has just launched an innovative calculator tool to help health insurers and other payers uncover and better understand the total costs associated with the hepatitis C virus (HCV) within their populations. The calculator references the data and analysis from the Milliman, Inc. study, “The burden of hepatitis C virus disease in commercial and managed Medicaid populations,” and other user-input assumptions to estimate costs for a payer’s specific population.

While many payers may concentrate on managing anti-viral medication treatment costs, they may not closely focus on the underlying medical cost drivers within the population. The calculator analysis provides payers with a complete picture of typical non-antiviral treatment costs, including prevalence and key cost drivers such as stage of liver disease (i.e. chronic HCV, cirrhosis, etc.), other non-antiviral medication treatment costs and medical costs.

“Calculator analyses run to date clearly show that new medication treatments are not the only reason for high costs among the HCV populations,” said Henri Cournand, CEO of Primrose Healthcare. “Payers focused on medication costs alone are missing out on a valuable opportunity to improve health and reduce per-member-per-month costs related to managing these patients. This really comes to light when you consider that the average annual incremental non-antiviral drug medical costs for an individual with HCV are $21,888—four times higher than those without HCV.

Read more....

Saturday, October 31, 2015

Up to 4,800 patients potentiall exposed to hepatitis C at Ogden hospital

OGDEN — Up to 4,800 people may have been exposed to hepatitis C by a now-fired nurse at McKay-Dee Hospital between June 2013 and November 2014, according to the Standard Examiner.

Per information released by the hospital Friday, 49-year-old nurse Elet Neilson (also known as Elet Hamblin), of Layton, was released in November 2014 after her admission of diverting emergency department drugs intended for patients, the Examiner reports. Neilson and a patient treated in the emergency department were both infected with the same hepatitis genotype, the Utah Department of Health reported, and the infections could be connected.

Due to concerns of exposure to the virus, letters to 4,800 people who may have been in contact with either individual were sent out Friday, the Examiner reports. It was unclear who infected whom or the method by which the infection took place, a hospital spokesman said, and officials are unsure if the disease has spread further.

Read more....

Medicaid officials want to expand access to pricey hepatitis C drug

Health care officials in Washington state thought thousands of Medicaid patients would line up to receive a breakthrough hepatitis C treatment that went on the market late last year.

Yet by June, the state had treated only a third as many hepatitis C patients as it had planned for — about 1,200 people.

Now, the state’s Medicaid authority wants to use the $44 million it didn’t spend over the past year to start covering the drug for a wider range of patients, instead of just the sickest ones.

State officials estimate about 75,000 to 100,000 people in Washington have hepatitis C, a blood-borne virus that can cause liver failure or liver cancer if left untreated. Nationwide, many people living with the disease are low-income patients who are eligible for Medicaid, officials said.

Read more....

Tattoos drawing attention

Note:  the article discusses the risk of tattoos and hepatitis C, but as this articles points out that it is a transmission route in unsafe settings--NOT in commercial settings were safety is being carefully followed.

Tattooing, once a fringe, minority pursuit, is going mainstream in Dunedin, local tattoo artists say, with everyone from law students to nurses inking their skin.

But, the council says as legitimate operations flourish, there has been a spike in tattooing of the underground, backyard variety, too.

There were eight registered tattoo studios in Dunedin, but many more illegal operators were working out of private homes, with no training, risky hygiene practices and cheap tools and ink, Dunedin City Council Environmental Health and Animal Services manager Ros MacGill said.

Read more...

Visit our Tattoo Blog HERE

Cherokee Nation Working to Eliminate Hepatitis C

The Cherokee Nation is on a mission to eliminate Hepatitis C, which officials call an epidemic.

According to the Centers for Disease Control and Prevention, the highest increase in Hepatitis C incidence from 2000 to 2013 was among Native Americans.

Dr. Jorge Mera oversees Cherokee Nation Health Services’ infectious diseases division. He said the first step is screening everyone age 20–69 for Hepatitis C, even though two out of three Americans with the disease were born between 1945 and 1965.

Read more...

Study suggests unprecedented 3-week hepatitis C cure


Yet another stunning victory in the drug battle against the liver-damaging hepatitis C virus (HCV) may be in the offing: A small study suggests it may be possible to cure some people of their infections in as few as 3 weeks.

Fresh on the heels of recent approvals of four new combinations of HCV drugs that clear infections of many different types of the virus in about 3 months, a team led by hepatologist George Lau of the Humanity & Healthy GI and Liver Centre in Hong Kong, China, has mixed and matched various compounds to see whether they could further shorten the route to a cure. Following 3 weeks of treatment, 18 HCV infected people given three different combinations of drugs met the standard definition of being cured—at 12 weeks after treatment began, they had no signs of HCV’s genetic material, RNA, in their blood on standard tests. The researchers plan to present this data publicly for the first time at a scientific conference known as The Liver Meeting in 2 weeks.

Until the new HCV drugs emerged, infected people required treatment for 8 months, and the therapies often failed and had severe side effects. Now, standard treatment protocol calls for taking HCV drugs for just 12 weeks. Cutting that treatment time even more dramatically is “really, really intriguing” says Shyam Kottilil, an HCV researcher at the Institute of Human Virology in Baltimore, Maryland. And if the results hold, it could slash the overall treatment cost of $100,000 required by the most popular drugs used for the 12-week treatment. Kottilil’s own study of a 4-week treatment—which tested different drug combinations on a different patient population—had only a 40% cure rate in the 50 participants. (That study is in press at Annals of Internal Medicine.)

Read more....

Friday, October 30, 2015

Findings about WWII-Era Spread of Hepatitis C Could Inform Future Prevention Efforts


The breakneck pace of clinical research means that, by necessity, there is little time to assess the past. But research published earlier this year in the Journal of Virology on the origins of the Hepatitis C virus (HCV) shows that such examination is not a morbid trip down memory lane, but rather can deliver key insights into current prevention efforts.   

The study, from researchers at the University of Glasgow, dates the beginnings of HCV to the 1940s and says it most likely arrived through the mass treatment of soldiers in field hospitals across the country during WWII. Under circumstances of war, hastily organized and overwhelmed care units meant that HCV was easily spread easily between soldiers as their injuries were treated.   

Using statistical analysis to examine the transmission dynamics, the researchers say, can help provide a basis for identifying HCV transmission hotspots. They posit that a more comprehensive understanding of exactly how hepatitis C virus is transmitted during times of significant spread could facilitate public health initiatives to reduce the prevalence of HCV in people who contract it through intravenous drug use.

Read more....

Thursday, October 29, 2015

Article: Hepatitis B Virus Reactivation During Successful Treatment of Hepatitis C Virus with Sofosbuvir and Simeprevi

This article is being re-posted from a previous newsletter.  I have been hearing from patients who have been inquiring about treatment with a DAA and who are also co-infected with chronic hepatitis B.  People co-infected with HCV and HBV should make their medical providers aware that their chronic hepatitis B should be monitored on a regular basis.  The article below recommends that people being treated with a DAA should be monitored every 2 weeks.  -Alan

Snapshots - Alan Franciscus

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) and monitored very closely—every two weeks as listed in the second study—for HBV flares and treated for chronic HBV as needed. 

THE FIVE Clinical Trials – What Patients Need To Know —By Alan Franciscus




THE FIVE: Clinical Trials – What Patients Need To Know
—By Alan Franciscus

In this month’s The Five column, I will provide a simple overview of clinical trials, the pluses and minuses of participating in a clinical study and information about how to find clinical trials your area. I hope this article will help our readers who are interested in participating in a clinical trial to make an educated decision. '

1.  Phases of Clinical Trials – Clinical trials begin with pre-clinical studies conducted in test tubes or animals.  If the results are positive the drugs can move through different phases—1 through 3—and a possibly 4th phase.  A brief recap of the 4 phases is listed below
  • Phase 1 studies usually include healthy people, but can include persons with the particular disorder that the study drug is being tested to treat.  The primary reason for phase 1 studies is to establish the safety of the study drug.  Another important part of a phase 1 study is to find the dose that combines the highest effectiveness with the lowest rate of side effects.  (generally 20 to 80 people are recruited for phase 1 trials),    
  • Phase 2 only includes people who have the disorder or disease that the investigational drug is being tested in to find the efficacy—also called effectiveness.  In some phase 2 studies the study drug may be compared to a current drug approved by the Food and Drug Administration (FDA) or a placebo drug (sugar pill).  Additional safety and side effect information is also  obtained.  (generally 100 to 300 people are recruited for phase 2 studies), 
  • Phase 3 is similar to phase 2 clinical trials but have a larger patient population.  They also compare the study drug to other medicines to treat the same disorder or disease—usually the current standard of care drugs—and in different patient populations.  Since the patient population is much larger the effectiveness, side effect information and other information obtained is more realistic data compared to the information obtained in phase 1 and 2 studies.  (up to 1,000 or more people).
The pharmaceutical company will compile and review the phase 3 data and apply to the FDA for New Drug Application (NDA).  After a period of review and if appropriate the FDA will approve the medication for a particular patient population.  The FDA will also issue a package label
  • Phase 4 is post-marketing studies.  These are studies that the FDA may require as part of the FDA approval process.  Phase 4 studies gather more information about the safety, effectiveness, and/or the use of the approved medication in certain patient populations
2.  Types of Studies – In clinical studies there are various types of studies including:
  • Randomization means that some patients will receive the study drug and some will receive the drug that it is being compared against (an FDA approved drug) or a placebo (sugar pill), 
  • Open-label means that everyone will receive the study drug,
  • Prospective these are studies that look ahead look for certain outcomes.  These are studies that recruit patients to find out if the drugs in development work.
  • Informed Consent – To participate in a clinical study, a document called ‘informed consent’ is filled out.  The subject/patient is required to read, understand and sign the document.  A copy is given to the subject/patient.   A study nurse is assigned to each study. It is the nurse’s responsibilities that every patient in the study understands the benefits and risks of the study.  The informed consent form should be written in language (6th grade and lower) that is simple, and easy to understand.  The sentences should be short, and non-technical. The person who is entering into a clinical trial should be encouraged to ask questions and understand every aspect of the clinical trial.  
Listed below is some general information that should be included in an informed consent form.
  • The nature of the study,
  • Why the candidates are being recruited for this study,
  • What risks, benefits and alternatives are associated with the research, and
  • What rights the subjects/patients have as research subjects.
4. Questions Patients Should Ask – If you are thinking of enrolling in a clinical trial, there are many questions you should ask yourself in order to make an informed choice:
  • Do you think the study drug may be better than the current standard-of-care medications that have been approved by the FDA?  If so, why?
  • What is the current phase of the trial (phase 1, 2, 3 or 4)?  
  • Have you considered the possible side effects and the safety profile of the trial drugs 
  • Is it too early in the clinical trial development that it may pose too many risks?
  • Are your willing to take the possible risks, and side effects?
  • What are the potential benefits?  
  • Is the cost of the study tests covered?
  • Is it an open-label study—that is, does everyone receive the study drug?
  • Is it a randomized study?  If so, if you do not get the study drug are you offered the study drug at the end of the study?
  • Who will be in charge of the patient care?
  • Can you wait until the study drugs are FDA approved?
Note:  Remember you can drop out of a clinical trial any time you want.

5. Next Steps

There are many questions to think about before entering into a clinical trial.  Some people would like to further the knowledge about a particular disease and treatment that will help their community.  Others may want to receive medical care and treatment.  Medical care and treatment may be particularly important for many people who do not have insurance or for those who have been denied coverage.  Still others who have been treated but have not been cured may seek treatment and care through clinical trials.  All of these reasons are valid and clinical trials are a good way to explore HCV treatment and care.  However, as with any HCV treatment you do not want to rush into any decision.  It is always good to do your research and work with your medical provider to make the best possible medical decision that is the best decision for you.

Ask your medical provider and/or gastroenterologist/hepatologist about clinical trials in your area.  Many medical hospitals also conduct clinical trials.

The best website that I have found is www.clinicaltrials.govhttps://www.clinicaltrials.gov/.

Type in ‘HCV’ and away you go…

For more information:  Making sense of Hepatitis C Research and Medical Literature
http://hcvadvocate.org/hepatitis/factsheets_pdf/Making_Sense.pdfhttp://hcvadvocate.org/hepatitis/factsheets_pdf/Making_Sense.pdf

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.

“As the first fixed-dose combination of two pan-genotypic, direct-acting antivirals, SOF/VEL represents an important step forward in the treatment of patients with hepatitis C,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes. SOF/VEL complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing.”

The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for SOF/VEL is supported by data from four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Those who received SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94 percent,while those who received SOF/VEL for 12 weeks and 24 weeks achieved SVR12 rates of 83 percent and 86 percent, respectively.

Read more....

Wednesday, October 28, 2015

Hepatitis C: behind new wonder drugs lies a terrible dilemma

There are 160m carriers of the hepatitis C virus across the world. Combined with the hepatitis B virus, which has 240m carriers, this causes 1.4m deaths every year.
Yet there are grounds for optimism around hepatitis C. Numerous pharmaceutical companies have recently brought to market new sets of “direct-acting antiviral” medicines to combat the infection. These have been shown to permanently clear the hepatitis C virus in 90% of patients in only a few short weeks, and with negligible adverse effects. It is not an overstatement to say that these antivirals have the potential to do for hepatitis C what oral vaccination did for polio.
But there is a fly in the ointment. The new drugs are unaffordable. Take the UK as an example, where around 214,000 people live with hepatitis C. Going by the indicated list price of £35,000 per treatment course, it would cost around £7.5 billion to treat every infected person. Even the staunchest hepatitis advocate would concede that since that approaches the entire NHS annual drug budget, treating everyone is not feasible in the short term.

Open Enrollment for Obamacare and Medicare —By Jacques Chambers

Open Enrollment for Obamacare and Medicare
—By Jacques Chambers

Medicare Open Enrollment starts October 15, 2015 and ends December 7, 2015.
All changes made during this time are effective January 1, 2016.

Affordable Care Act Open Enrollment runs from November 1, 2015 through January 31, 2016.
The effective date will be based on when the changes are requested;


  • If made on or before 12/15/2015 – Changes effective on January 1, 2016
  • If made 12/16/2015 through 01/15/2016 – Changes effective on February 1, 2016
  • If made 01/16/2016 through 01/31/2016 – Changes effective on March 1, 2016 


Employer-Provided Benefit Programs also frequently provide an Open Enrollment Period for employees, allowing them to make changes in their employee benefits choices. Although employers can select other times of the year, most employers who offer one have their Open Enrollment in November and/or December for a January 1, 2016 effective date.

Medicare

Medicare beneficiaries have the opportunity to switch their coverage from any to any of several choices:

Original Fee For Service Medicare – Parts A and B of original Medicare are the same for everyone; however, each beneficiary can elect the prescription drug plan in which to enroll. The best way to do this is to compare plans using your own current prescriptions, since your medications may have changed and plan formularies and prices also change.

There is a program on line at www.medicare.gov that allows you to enter your medications, which pharmacy your prefer, and where you live; it will then show you what each plan would cost you out of your pocket based on your medications.  Click on “Find Health and Drug Plans” and follow from there. I recommend the “General Search” rather than the personal one; it is much quicker and just as accurate. If you are on particularly expensive medications, once you find a drug plan, you should confirm the coverage and what you will pay directly with the insurance company as errors sometimes occur.

Even if your current Drug Plan has been serving you well, it is still advisable to run the program. The plans for 2016 are already up on the website.

For persons who are not comfortable with computers, Medicare’s toll-free number (800-MEDICARE) will do the same calculation.  However, I recommend you find a friend or relative who will do it for you on a computer because the results are too long and involved for a telephone operator to spend much time reviewing the options based on your specific needs.  

Medicare Supplement (also called Medigap) Plans – This open enrollment period does NOT apply to the Medigap Plans sold to people with Original Medicare to “fill the coverage gaps” left by Medicare Parts A & B.  To find out when you can purchase them, go to www.medicare.gov and search for “When Can I Buy a Medigap Policy”. It will list the Open Enrollment opportunities for them. They may also be purchased at other times, but the insurance company may require proof of good health.

Medicare Advantage Plans – These are plans offered by insurance companies and health service providers and are an alternative to Fee-for-Service Medicare.  Many of these plans are run by Health Maintenance Organizations (HMOs), but there are also Preferred Provider Organization Plans (PPOs), Exclusive Provider Organizations (EPOs), Special Needs Programs, and Private Fee-For-Service plans, although all types are not available in all areas. All Medicare Advantage Plans must offer all of regular Medicare’s benefits and may add more.  Some plans may also charge an additional premium, usually relatively small.  These plans frequently include the prescription drug coverage in their plan so you don’t have the additional task of finding a Part D drug plan.

During this Open Enrollment Period, persons may switch from one Medicare Advantage Plan to another or move back to or away from Fee-For Service Medicare.

NOTE: If you move from a Medicare Advantage Plan to Original Fee-for-Service Medicare, you have until February 14, 2016 to enroll in a Part D Drug Plan.


Affordable Care Act (Obamacare)
Persons enrolled in coverage, as well as those who have not yet joined, have the opportunity to enroll into or change health plans under the Affordable Care Act.

Many plans are making changes in coverage as well as cost, so I do recommend you go to your state’s health exchange, or to www.healthcare.gov for people in those states that do no operate their own exchange, and search to see if there is better coverage for you.

Since most of these plans use network providers, you should confirm directly with the insurance company that the doctors and hospitals you prefer are part of the network. Also, make sure your medications are on the plan’s formulary.

Employer Provided Benefit Plans 
Employers offering an Open Enrollment period for their employees will publish (or offer online) an Open Enrollment Guide that spells out each employee’s current benefits plus the available options, opportunities, and costs that may be chosen during this period. For persons dealing with a serious medical condition like HCV, it can be an opportunity to alter benefits and, in some cases, actually increase benefits since these programs usually offer more than just health insurance.

Life Insurance. Persons dealing with HBV/HCV are generally unable to purchase life insurance in the individual market. An employer may give all employees a base benefit from $10,000 to $50,000, and a few will allow employees to purchase additional coverage. If your employer offers supplemental life insurance above what he or she offers; see if there is an amount you can purchase that will not require evidence of good health. If it is available, it is an excellent way for an otherwise “uninsurable” person to obtain additional life insurance.

Long Term Disability.  Less common, but still occasionally available, is the opportunity to increase the benefit of your LTD plan.  Some employers will provide a basic benefit for LTD, such as 50% or 60% of your monthly earnings, and allow employees to purchase an additional 10% or 15% to raise the benefit they would receive in the event of disability.

Some employers may allow you to add this benefit if you did not elect it originally. Again, it is important to read your Open Enrollment material to see if your employer offers this and if proof of good health is required.

Revising LTD Premium Payment. One additional possibility to explore is the payment of LTD premiums. Some employers will allow you to have the premium they pay for your LTD coverage added to your W-2 making the premiums taxable rather than receiving it as a tax-free gift. If this is possible you may want to jump at the chance, the reason being tax-free disability benefits should you become disabled.

If you pay for the LTD coverage with money that is taxed as income, then the benefits you receive if you become disabled will be income tax free, substantially increasing the spendable dollars you would receive as a disability benefit. The rule is the IRS will tax either the premium paying for the coverage or the disability benefits being paid out, but not both.

Health Related Benefits.  Many employers, especially larger ones, offer a variety of health, dental, and vision plans from which employees can choose.  At Open Enrollment, you have the opportunity to change your coverage from one plan to another regardless of your medical condition, and sometimes have the opportunity to make choices within your plan, such as increase or decrease the size of the deductible.

For someone dealing with HCV, this can be an important choice, especially if this is the first Open Enrollment since diagnosis.  There is no one type of health plan that is best for everyone. There are two main kinds of plans that employers offer most often:

Preferred Provider Organization (PPO) – These plans provide some coverage for all physicians, but pay more if you choose a physician that has contracted with the insurance company, a Participating Provider.  This plan will give you the greatest flexibility in medical providers; however, it will often cost you more out of pocket for both your portion of the monthly premium as well as the plan co-pays and co-insurance.

Health Maintenance Organizations (HMO) – These plans usually offer the lowest out-of-pocket expenses, but limit your choice of physician. Coverage is only provided when using one of their contracting doctors and hospitals.  Also, a Primary Care Physician (also called a Gatekeeper) oversees all your medical care and must refer you to a specialist before the HMO will cover the specialist’s charge.

Exclusive Provider Organization (EPO) – These plans are exactly like an HMO except, there is no Gatekeeper physician. You decide if you need to see a specialist and make the appointment directly.

Which plan is better for you will depend on which doctors you wish to retain and what HMOs or PPO plans they are part of, as well as the cost to you.

National Chocolate Day

Dark Chocolate has some positive health affects.  There is some literature that shows that eating a piece of a quarter size piece of dark chocolate can be healthy.  But remember just one piece!  

In appreciation of National Chocolate Day - Indulge in that one small piece of chocolate!


The Dark Side of Letting Insurance Payers Dictate Hepatitis C Treatment

Imagine that you have a disease and you have two choices of treatment. Both treatments are highly effective at treating your condition. Medication A has mild side effects. Medication B has lots of side effects including, fatigue, nausea, itching, insomnia, and weakness. Pretty much everyone who takes medication B has side effects. Medication A is a pill a day; medication B uses two pills in the morning and one at night, and sometimes additional pills are prescribed that must be taken twice daily. Medication B has the potential to interact with more drugs than medication A does. Which would you pick? I assume you'd pick medication A.

Your doctor would likely recommend medication A. Drug regimens with many side effects means that you are more likely to need assistance from your health care team, perhaps needing additional laboratory tests to monitor your safety. If your doctor has more patients on medication B, then your doctor's schedule will use appointment slots for side effect management, rather than for seeing other patients who also need to be treated.

So, it seems like medication A is the obvious choice. Unfortunately, for many people with hepatitis C, it isn't. In this case, medication A represents Gilead Sciences' Harvoni; medication B represents AbbVie's Viekira Pak or Technivie. Harvoni is not covered under all insurance plans, such as those using Express Scripts. In short, your doctor may want to treat you with Harvoni, but your insurance may not carry it on its drug formulary. Your hep C treatment may be limited to medication B.

Read more....

Tuesday, October 27, 2015

Q&A with AbbVie's Barry Bernstein, MD: Are More FDA Warnings in the Works ?

Note:  In addition to the label change and warning about their currently approved medications Dr. Bernstein gives an estimate on a possible approval of AbbVie's new pan-genotypic combination.  Alan


The effectiveness of the new arsenal of hepatitis C antivirals has elated physicians and patients and been a triumph—and lucrative development--for pharmaceutical companies.

The announcement on Oct. 22 that AbbVie, manufacturer of two such drug products was changing labeling to include new warnings dampened the euphoria. Post-marketing reports alerted the company and the US Food and Drug Administration (FDA) of patient deaths and severe liver damage sometimes requiring transplantation in some patients who received AbbVie’s treatments.

The company, in consultation with the FDA changed its package inserts and labeling for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and Technivie (ombitasvir, paritaprevir, and ritonavir tablets.

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Bristol-Myers Tops Estimates on Cancer, Hepatitis C Sales

Bristol-Myers Squibb Co., a drugmaker increasingly focused on developing new cancer treatments, beat third-quarter profit estimates on better-than-expected revenue from its oncology drug Opdivo and the start of U.S. sales for its hepatitis C drug.

Third-quarter earnings, excluding one-time items, were 39 cents a share, beating the 35-cent average of analysts’ estimates compiled by Bloomberg. Sales rose 3.7 percent from a year earlier to $4.07 billion. Analysts had estimated $3.86 billion on average.

The New York-based company also raised its full-year sales forecast to a range of $16 billion to $16.4 billion, from a prior projection of $15.5 billion to $15.9 billion, and increased its full-year adjusted earnings forecast to $1.85 to $1.90 a share, from a previous estimate of $1.70 to $1.80 a share. It’s the third time Bristol-Myers has raised its earnings projections this year.

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Check out the Staff of HCSP / HCV Advocate

About Us

The Hepatitis C Support Project (HCSP) is a registered non-profit organization founded in 1997 by Alan Franciscus and other HCV positive individuals to address the lack of education, support, and services available at that time for the HCV population.
alan_15Alan Franciscus – Executive DirectorHCSP and Editor-in-Chief, HCV Advocate Website. Alan has been working in hepatitis C and HCSP since 1997 and considers HCV advocacy his highest priority.
Clara Maltr├ís is an English to Spanish translator – Clara has over 20 years of experience in the medical field. Clara specializes in translating HIV/Hepatitis C newsletters, pharmaceutical brochures, and information about Cardiology/Neurology implanted devices. Clara has been working with the Hepatitis C Support Project/ HCV Advocate since 2002 and in HIV since 1995.Clara Maltras2
jacquesJacques Chambers, , Benefits Counselor in private practice with over 40 years of experience in public benefits and private insurance. Jacques has been working in Hepatitis C and HCSP since 2003, and in HIV since 1990.
Judith BarlowWebmaster, HCV Advocate Website.Judith consults with a wide variety of small business owners and non-profits about building and/or maintaining existing websites.judy
Kate 0022Kate FryeAdministrative Assistant.Kate started working with HCSP in 2007 and has performed many duties over the years. Her current focus is primarily handling correspondence from prisoners. She answers the many letters we receive and sends information to people that do not have access to our website.
Leslie HoexOwner of Blue Kangaroo Design. Leslie has been doing graphic design and desktop publishing with Alan and the HCV Advocate since 2006. Alan has always allowed her free rein with her designing. She is honored to be working for such a wonderful group, helping to spread their awareness of HCV and HBV.Leslie
lucindaLucinda K. PorterRN has written for the HCV Advocate since 1998. She is the author of Free from Hepatitis C and Hepatitis C One Step at a Time. Lucinda underwent three hepatitis C treatments and is now cured.
Rose ChristensenOffice Manager, Assistant Editor. Rose started as a volunteer with HCSP in 1997 and has become an integral part of the day to day operations of the project.Rose2

Dr. David Mazoff

Dr. David Mazoff

It is with regret that we announce that Dr. Mazoff has retired from the Hepatitis C Support Project (HCSP)/HCV Advocate effective September 30, 2015. We are happy for David, but he will be missed by all of us at HCSP and the hepatitis C community.

David became a full-time employee of HCSP/HCV Advocate on January 01, 2003 although he did volunteer work for us prior to his official start day. David’s responsibilities included webmaster, general editor, and production of our fact sheets/guides, and newsletters, and many additional duties.

From the beginning, David raised our game.  He was an important part of our growth from a small local group in San Francisco, CA to a large national advocacy organization. He helped us implement a new website in early 2000’s, and he designed and implemented our current site that we launched in September 2015.

David took on many duties throughout the years that included the production of our fact sheets, guides, and our newsletters. David also was in charge of posting news items to our blog and many, many more duties.  His shoes will be hard to fill.

David lives in Victoria, B.C., Canada.  He will be spending time playing swing jazz, Latin jazz and Argentine tango with his accordion.  His aim is to join a group and play professionally.  He also plans on hiking, bird watching and volunteering for HepCBC in his spare time.  Knowing David he will accomplish all of his wish list and much more.

We wish David the best of luck as he lives his so-called retirement to the fullest.  I hope that David realizes how much his work has helped thousands of people with hepatitis C and B.

If you happen to run into David, give him a big ole Canadian ‘hi’ and a bear hug for all his great work.

Alan and the staff of the
Hepatitis C Support Project/HCV Advocate

[HAP] NASTAD Releases White Paper on Drug User Health and ACA Opportunities‏

With generous support from the Elton John AIDS Foundation, NASTAD is pleased to announce the release of a new white paper: Modernizing Public Health to Meet the Needs of People Who Use Drugs: Affordable Care Act Opportunities. The paper assesses new financing and delivery models for drug user health services. Working with the O’Neill Institute for National & Global Health Law, the project team focused on coverage and financing opportunities for community-based drug user health and harm reduction services typically not covered by insurance. Research focused on eight states, assessing how health departments, community-based organizations, Medicaid programs and plans and hospitals are working together to better address the needs of people who use drugs.
The need to find creative solutions to ensure that broader health care systems and payers are providing prevention, care, and treatment services for people who use drugs comes in the midst of a public health crisis for this population. Rates of HIV infection and viral hepatitis are substantially higher among persons who use drugs than among persons who do not. Opioid use in particular in the United States is at epidemic proportions. This crisis – coupled with limited federal and state resources for drug user health programs and services – has made leveraging the ACA and partnerships with broader health systems and payers even more critical.
NASTAD has been awarded another year of Elton John AIDS Foundation funding to support a learning collaborative that builds off of the findings of the white paper and supports health departments to partner with broader health care systems and payers to increase access to drug user health services. To see more of NASTAD’s drug user health work, including our Statement of Urgency: Addressing the Opioid Epidemic in the United States and Minimizing Harm, Maximizing Health: The Role of Public Health Programs in Drug User Health, please visit our website.
 For questions, please contact Amy Killelea at akillelea@nastad.org

Cornell Studies Hepatitis C Populations Not Typically Tallied in Survey


New research highlights how government estimates on hepatitis C prevalence in the United States leave out about 1 million people from several groups not regularly included in the tally, say researchers from Cornell University.   

The government estimates are from a 2014 report of the National Health and Nutrition Examination Survey (NHANES), a health assessment from a representative sample of the country’s population, according to an article posted on the university web site. Out of an estimated 3.6 million people who have the hepatitis C virus antibodies, the survey indicates that 2.7 million are currently infected with the virus.  

Results of a study from Weill Cornell Medicine published this month in the journal Hepatology say that a closer analysis of data from various sources revealed that the government estimate excludes six populations, including some that are stigmatized and live on the margins of society. The study authors say that the number of US residents who have antibodies for hepatitis C is probably closer to or exceeding 4.6 million and that 3.5 million are infected

Read more.....

Medication Adherence Trial In Hepatitis C Patients Launched

A new medication adherence application from emocha helps keep HCV patients on track.

According to the CDC, approximately three to four million individuals are chronically infected with Hepatitis C Virus (HCV) in the United States and at least three quarters of those who become infected will develop chronic infection which, if left untreated, can produce long-term complications and even death.

HCV therapy has been revolutionized by recent developments in treatments, including oral options that achieve high levels of HCV cure when taken as directed. That means medication adherence is a high priority for both healthcare providers and payers, both in terms of the potential benefits and because of the high costs of these medications, which can be up to $1,000 per pill or more than $80,000 for an entire course of treatment.

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Sunday, October 25, 2015

AASLD / IDSA Guidance - Treat All Patients with Chronic Hepatitis C

WHEN AND IN WHOM TO INITIATE HCV THERAPY

Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. When the US Food and Drug Administration (FDA) approved the first IFN-sparing treatment for HCV infection, many patients who had previously been “warehoused” sought treatment, and the infrastructure (experienced practitioners, budgeted health-care dollars, etc) did not yet exist to treat all patients immediately. Thus, the panel offered guidance for prioritizing treatment first to those with the greatest need. Since that time, there have been opportunities to treat many of the highest-risk patients and to accumulate real-world experience of the tolerability and safety of newer HCV medications. More importantly, from a medical standpoint, data continue to accumulate that demonstrate the many benefits, within the liver and extrahepatic, that accompany HCV eradication. Therefore, the panel continues to recommend treatment for all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy. Accordingly, prioritization tables are now less useful and have been removed from this section.

Despite the strong recommendation for treatment for nearly all HCV-infected patients, pretreatment assessment of a patient’s understanding of treatment goals and provision of education on adherence and follow-up are essential. A well-established therapeutic relationship between practitioner and patient remains crucial for optimal outcomes with new direct-acting antiviral (DAA) therapies. Additionally, in certain settings there remain factors that impact access to medications and the ability to deliver them to patients. In these settings, practitioners may still need to decide which patients should be treated first. The descriptions below of unique populations may help physicians make more informed treatment decisions for these groups. (See sections on HIV/HCV coinfection, cirrhosis, liver transplantation, and renal impairment).

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Saturday, October 24, 2015

Cures for hepatitis C are an investment worth making

New cures for hepatitis C are helping Medicare beneficiaries live longer, healthier lives. It is disingenuous to look at Medicare spending on these treatments without considering the substantial rebates and competition in the program [“Medicare spending for hepatitis C drugs surges,” news, Oct. 18].

Competition and robust negotiation in Medicare Part D are controlling costs. Private plans command steep discounts on prescription prices under Part D, including groundbreaking cures for hepatitis C. In fact, additional treatment options approved in the past year led to competition-generated savings for a variety of payers, including Medicare. Average rebates on some of these products increased from 22 percent in 2014 to 46 percent in 2015. Average rebate levels in Part D have increased each year of the program. Even the 2015 Medicare trustees report that rebates are substantial.

Moreover, researchers at Harvard University suggest new hepatitis C therapies may generate cost savings for the health-care system over the long run. Medicare is uniquely positioned to take advantage of these savings, as beneficiaries remain in the program once they become eligible.

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Thursday, October 22, 2015

Harm Reduction Is Essential to Combat the Addiction Epidemic

Talking about injection drug use is not comfortable for many people. Yet nearly 7 million U.S. citizens inject drugs every year. For those who suffer from debilitating addictions, our silence is deafening. The majority of injection drug users are infected with either HIV or hepatitis C, both devastating illnesses with life-long consequences. Medically, they are at high risk for overdose and a multitude of diseases. Socially, they face enormous stigma, homelessness and violence. Each of them is someone's family. All of their lives matter.

What is there to be done? The good news is that for decades, both injection drug users and doctors have been advocating for harm reduction, a rational and proven way to reduce infections. The idea is simple: lower the risks associated with using drugs. Doctors use these principles every day in the clinic, such as when they encourage patients to use condoms and birth control. We've learned the hard way that abstinence-based methods actually increase risky sexual activity. By instead providing knowledge and safer-sex supplies, they make the behavior safer. Drug use is no different.

The main example of harm reduction for injection drug users is needle exchange, and like harm reduction in general, it's easy to understand. A needle exchange provides a safe, anonymous way for needle users to throw away old syringes, thus keeping them out of public parks and trash cans, where they may wind up otherwise. Next, needle exchanges provide a way to obtain clean injection supplies, so that clients are protected from disease. These simple operating principles have incredible, proven results among clients: a 33% reduction in the risk of contracting HIV, a 61% reduction in hepatitis B, and a 65% reduction in hepatitis C. If needle exchange was a prescription, it would a blockbuster

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