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HCV Advocate Newsletter

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November 2013 HCV Advocate

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In This Issue:

Game Changers: AbbVie and Gilead
Alan Franciscus, Editor-in-Chief

Snapshots
Lucinda K. Porter, RN

HEALTHWISE: Military Veterans and Hepatitis C)
Lucinda K. Porter, RN


Prescription Drugs – Off-label Use
Alan Franciscus, Editor-in-Chief

Flu-Shots
Lucinda K. Porter, RN



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Game Changers: AbbVie and Gilead
—Alan Franciscus, Editor-in-Chief

Currently, AbbVie and Gilead are conducting Phase 3 studies of interferon-free hepatitis C drug therapies.  These drugs have the potential to revolutionize treatment of hepatitis C genotype 1.  The Food and Drug Administration (FDA) is expected to approve these combinations by mid to the end of 2014.   This article will focus on the drug combinations being studied, with a very short recap of the data from the Phase 2 clinical trials.  It is important to know that Phase 2 cure rates are typically higher than the cure rates seen in Phase 3 studies due, in part, to a larger patient population.  Although these drugs have been well-studied in a large number of patients and different populations, the expected approval date is never guaranteed.  But a delay in the approval is unlikely since these interferon-free therapies represent one of the biggest advancements in treatment of hepatitis C for genotype 1—the most common genotype in the United States. Genotype 1 patients have the greatest need for new treatments with higher cure rates that also have considerably fewer side effects than current therapy.

AbbVie
Earlier this year AbbVie’s drug development program received “Breakthrough Therapy” designation from the Food and Drug Administration (FDA)—the first HCV drug therapy to receive this special designation. This means that the FDA will work with AbbVie on their development program, which should speed up the FDA approval process.  It is expected that the clinical trial data will be submitted to the FDA for marketing approval towards the end of this year.

Study Drugs:

  • ABT-450/r (plus ritonavir)—protease inhibitors; once-a-day

  • ABT-267 (NS5A inhibitor); once-a-day

  • ABT-333 (polymerase inhibitor); twice daily

  • Ribavirin; twice daily

The Phase 3 studies will include HCV genotype 1a and 1b treatment naïve and treatment experienced patients. There will also be separate arms in the study with HCV genotype 1a and 1b and genotype 1 treatment experienced patients with compensated cirrhosis.  Finally, and importantly, the studies will include arms with and without ribavirin.

Treatment Duration: 12 weeks.

Note:  ABT-450/r and ABT-267 are being co-formulated into one pill taken once-a-day; ribavirin consists of pills taken twice daily.  

Phase 2 Results:  Top-line results in those who received the entire 4-drug combination resulted in over 90% cure rates for people with HCV genotype 1a and 1b in both treatment-naïve and treatment-experienced patients. 

Side Effects:  The drugs were generally safe and well-tolerated.  The majority of the reported side effects were mild.  There were 4 treatment discontinuations that were linked to the study drugs. 

FDA Approval:  Mid 2014 to the end of 2014

Gilead
Probably everyone has heard about Gilead’s new therapies—there has been a lot of news about them in the last couple of years.  The backbone of Gilead’s development program is sofosbuvir.  Sofosbuvir has already completed Phase 3 studies of the combination of sofosbuvir, pegylated interferon plus ribavirin to treat HCV genotype 1 (and genotypes 4, 5, 6)  and sofosbuvir plus ribavirin for the treatment of HCV genotypes 2 and 3.  Those therapies are waiting for FDA marketing approval, which is expected towards the end of 2013 or the beginning of 2014.

The new interferon-free studies are finishing up and the application to the FDA for marketing approval is expected before the end of 2013.   

Study Drugs:

  • Sofosbuvir (polymerase inhibitor); once-a-day

  • Ledipasvir (NS5a inhibitor); once-a-day

  • Ribavirin; twice daily

Note: Sofosbuvir and ledipasvir are being co-formulated into one pill taken once daily; ribavirin is a pill taken twice daily.

The Phase 3 studies of sofosbuvir and ledipasvir will include arms with and without ribavirin in HCV genotype 1 treatment-naïve and treatment-experienced patients.   

Treatment Duration:  8 to 24 weeks  

Phase 2 Results: Interim top-line results from Phase 2 studies found that patients who were treated for 8 or 12 weeks achieved cure rates over 90%.  Sofosbuvir, in general, has been extensively studied in phase 1 and 2 studies. 

Side Effects: The drugs were generally safe and well-tolerated.  In one trial 8% (2 patients) experienced serious side effects and 4% (1 patient) discontinued therapy—it is not known if the reason for the discontinuation was  related to the study drug.  

FDA Approval: Mid 2014 to end of 2014. 

The 2013 American Association for the Study of Liver Diseases (AASLD) will be held in Washington, D.C. at the beginning of November.  There will be more information about these therapies and other drugs in development at the conference, and the HCV Advocate will be posting the latest information on our website as soon as it occurs.  The data from these drugs and other drugs reported at AASLD will be included in the December HCV Advocate.  Additionally, the data and the information in this article will be updated in a new fact sheet.

As I stated above, these drugs could be a game changer.  There are even more drugs being developed that could push the cure rates up to 100%.  Could these drugs effectively end the epidemic of hepatitis C?  Probably not, but they are part of the solution.  Realistically we must test more people, develop better surveillance programs for the newly infected and incorporate effective strategies to stop the spread of hepatitis C.  Even with all of these measures put into place, the biggest obstacle to the elimination of HCV is access to care, but with the approval and use of DAA combinations, we are a step closer to ending the hepatitis C epidemic.


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Praise for Hepatitis C One Step at a Time:

“Like a Lonely Planet guidebook, this well-written and timely volume will be dog-eared and wrinkled by the end of treatment; likely, too, it will be passed on to the next traveler.” Review from Publishers Weekly September 16, 2013

“As we make progress in health care and reaching the 3.2 million people in the U.S. who have hepatitis C, patients seeking treatment will need practical tools and genuine hope. This book offers both.”—Henry C. “Hank” Johnson, Jr., U.S. Representative (D-GA), co-chair, Congressional Viral Hepatitis Caucus”

Available from Amazon:
Hepatitis C One Step at a Time


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Snapshots
—Lucinda K. Porter, RN

Article: Mortality among Persons in Care with Hepatitis C Virus Infection—Chronic Hepatitis Cohort Study (CHeCS), 2006 -2010.  Reena Mahajan, et al.  Centers for Disease Control and Prevention (CDC)
   Source: Presentation at Infectious Diseases (ID) Week 2013

Although the death rate from hepatitis C virus (HCV) infection is increasing, it is relatively low compared to other causes of death—or so we thought.  CDC researchers gathered data from health records of 2,143,369 adults seen in four health care systems (CHeCS) in the U.S. Looking at all-cause and liver-related mortality along with evidence of HCV, these were compared to mortality rates of 12 million death certificates for U.S. residents in the years 2006-2010.

Of the HCV patients seen at the CHeCS, the primary cause of death was liver disease unrelated to alcohol. However, HCV was listed as a cause of death only 19% of the time. Estimated mortality rate was twelve times higher than the general population. Regardless of whether the cause of death was liver-related or not, mortality in HCV-infected persons was 15 years younger compared with the national average in non-HCV infected persons.

The Bottom Line: These data suggest that the mortality rate of those with HCV could be as high as 75,000 persons per year and that the HCV mortality data may be underreported at 15,000 annual deaths.

Editorial Comment: In the early days, I said what many people said, “That more people will die with HCV than of HCV. We abandoned that practice at the HCV Advocate many years ago, concerned that it sent a confusing message. After seeing this report, I know we made the right decision. With the mortality rate twelve times higher and death occurring 15 years younger, HCV should be a health policy priority.

Article: Association of HIV Infection, Hepatitis C Virus Infection, and Metabolic Factors with Liver Stiffness Measured by Transient Elastography.  M. Rami Bailony
  Source: The Journal of Infectious Diseases; First published online July 2013

This study looked at fibrosis by comparing liver stiffness measurements of HIV negative/HCV negative women (N=57), HIV negative/HCV positive women (n=14), HIV positive/HCV positive women (N=78), and HIV positive/HCV negative women (N=165).

The Bottom Line: HCV infection but not HIV infection is associated with greater liver stiffness when infected women were compared with those with neither infection. Women living with hepatitis C are more inclined to have liver stiffness if they have larger waistlines.

Editorial Comment: Larger waist circumference is associated with multiple health risks, such as diabetes, heart disease, and fatty liver disease. Eating a healthy diet, maintaining a normal weight, getting adequate sleep, exercising and practicing stress reduction are ways to reduce waist circumference.

Article: Incidence and Prevalence of Hepatitis C in Prisons and Other Closed Settings: Results of a Systematic Review and Meta-Analysis.   Sarah Larney, et al.
  Source: Hepatology October 2013; Volume 58, Issue 4, pages 1215–1224

These researchers performed a systematic review and analysis to determine the rate of HCV infection and the prevalence of anti-HCV among people detained in prisons and other closed settings. Using summary estimates from the general population and injection drug users (IDUs), they estimated the prevalence of anti-HCV positive prisoners globally.

The estimate of anti-HCV in general detainees was 26%, and in detainees with a history of IDU, 64%. Globally, they estimated there are 2.2 million detainees who are anti-HCV positive. The largest populations are in North America (668,500; range: 553,500-784,000) and East and Southeast Asia (638,000; range: 332,000-970,000).

The Bottom Line: Data was difficult to obtain, nonetheless, HCV is a significant concern among the incarcerated, with one in four is anti-HCV positive.

Editorial Comment: Occasionally I receive letters or emails about inmates who become infected with HCV in prison. Reading this is certainly a call for more data, education and action.  

Article: Hepatitis C Eradication Reduces Liver Decompensation, HIV progression, and Death in HIV/HCV-coinfected Patients with non-Advanced Liver Fibrosis.  Juan Berenguer, et al.
  Source: Presentation at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2013

People with HIV have a higher incidence of liver cancer (hepatocellular carcinoma /HCC).  HCC occurs at a younger age and is an increasing cause of death in HIV. This study analyzed data from 695 HIV/HCV coinfected patients with HCC who were treated for HCV at various clinics in Spain from 2000 – 2008.

The Bottom Line: HIV/HCV patients who resolved HCV infection were more likely to have minimal fibrosis (F0 – F2), and reduced mortality risk and liver-related complications.

Editorial Comment: This research offers a strong argument for treating HIV/HCV coinfected patients. The easier-to-tolerate HCV treatments with high efficacy rates in the pipeline cannot come soon enough. 


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HEALTHWISE: Military Veterans and Hepatitis C
—Lucinda K. Porter, RN

Every November we observe Veterans Day, and a Healthwise article about military veterans and hepatitis C is long overdue. I’ve been writing this monthly column since 1998, and I have never felt so overwhelmed and heart-broken by a subject matter before. I wondered, “Where do I start?” I’ll begin with Gary Lupole.

Gary enlisted in the Marines during the Vietnam era when he was 17 year old. Gary served his country, and one can only imagine the stories that Gary brought back with him. Little did anyone know that he’d also bring back a potentially deadly virus—hepatitis C (HCV). In December 2011, Gary was diagnosed with advanced liver cancer related to HCV. He died in less than two months at the age of 61. Before his death, Gary and his wife Tricia founded HCVets.com.  HCVets.com is devoted to increasing awareness about hepatitis C exposure during service, and helping past and present members of the U.S. military who have HCV.

Here are some statistics, although frankly, finding reliable numbers was harder than finding bin Laden. The U.S. Veterans Affairs (VA) website states, “The true prevalence of hepatitis C infection among veterans is unknown.” Here is what we do know:

  • The VA’s epidemiologists estimate that veterans have a minimum of a three times higher HCV risk than the general population.1

  • A study published by Sloan and colleagues showed a prevalence of more than 10 times the general population.2

  • Among HCV-positive veterans, the majority served during the Vietnam War era (~63%), while the post-Vietnam rate is around 18%. Those serving during WWII and the Korean War had roughly 4% each. Those serving in the Persian Gulf had less than 3% of HCV infections. The prevalence in active duty military personnel appears to be lower than the prevalence in veterans. However, that prevalence exists.

USAF Colonel Smith (name changed) enlisted in 1985 and is hepatitis C positive. Smith’s only obvious risk factor is the military’s former practice of using air guns for administration of vaccines.  Air guns, AKA multi-use-nozzle jet injectors, are needle-less medical devices that penetrate skin using high-pressure fluid. Multiple published studies have demonstrated that jet injectors have the capacity to transmit significant amounts of blood and with it, the potential to transmit blood-borne pathogens.

Picture a line of recruits all being vaccinated from a single device much like a pneumatic tool and you get the idea. This is how Gary Lupole came to be infected, and there is actually a photo of him standing in line to get his shots in each arm. That is how Jim Hanley thinks he came to be infected with hepatitis C after joining the Marines in 1972. Not only does he remember the jet guns, he also recalls that the devices weren’t cleaned between people. Jim said, “If you were lucky they cleaned the tip of the air gun with a bloody towel!” He has undergone four difficult, unsuccessful HCV treatments. Little did Jim know that giving his life for his country would have continued long after his active military duty ended.

According to the National Immunization Program Centers for Disease Control, “To date, the transmission of the hepatitis C virus by ‘air gun’ vaccination has not been documented.” I believe in evidence, but this statement does not sit well with me. Saying it hasn’t been documented is like saying that Hurricane Sandy was theoretically possible, while getting blown about on the beach in Atlantic City. One only needs to sift through the data to be convinced. Also, there is documentation of hepatitis B virus being transmitted via jet injectors.

In 1985, a hepatitis B outbreak occurred following the use of jet guns. For the record, this was not a military use of jet guns. Multi-use jet guns have been used in the general population, such as for immunizations. The 1985 incident occurred in a weight loss clinic.

What does the VA say about jet guns as a possible mode of transmission?
“There has been considerable interest expressed by veterans and organizations representing them concerning the possible relationship between hepatitis C virus infection and immunization with jet injectors (air gun injection) or other military-related blood exposures. Although there have been no case reports of hepatitis C being transmitted by a jet gun injection, it is biologically plausible.

Any veteran enrolled in the VA health care system who has concerns about hepatitis C infection because of jet gun injectors, other blood exposure during military service, any of several risk factors, or for any other reason, is welcome and encouraged to request testing for hepatitis C at his or her nearest VA hospital.

In case you breezed through the above quote, I’d like to point out that it mentions other blood exposure during military service.Veterans were exposed to blood (and possibly HCV) in multiple ways, including blood splatter, helping the wounded, handling dead bodies, receiving blood transfusions, and during medical procedures. (See HCVets for a listing of possible HCV transmission routes.)

Army veteran Dennis Larocque of Florida is not sure how he got HCV in Vietnam. Perhaps he got it when he was vaccinated. Dennis certainly was exposed to blood, as having blood on you was common. “You didn’t think much about it. You just wiped the blood from your eyes and your weapon and kept on going.”

Tragically, Dennis brought hepatitis C home to his wife Hope. Although sexual transmission risk between monogamous, heterosexual partners is low, Hope doesn’t know how else she would have gotten it. The only other possibility is she was exposed to Dennis’s blood helping to care for his skin condition caused by Agent Orange. Hope and Dennis both underwent HCV treatment in 2003; she cleared it, he relapsed.

Even dependents who are not infected with HCV are affected by it. As caregivers of these brave soldiers, their dreams are often shattered. They may experience the loss of income, or worse, loss of their loved ones.  Dependents may be hurt financially. Tricia Lupole said, “If the Vet dies in the process, the claim does too. The widow must file a new claim and is not entitled to help from a lawyer.”

What Can the VA Do?
Most of the people I talked to felt that when it came to testing veterans for HCV, the VA fell short. Veterans often had to request the test, or even worse, didn’t know they had a potential exposure, so didn’t know they should have been tested.  Additionally, not every veteran receives medical care from the VA, so a community medical provider may not think about military-related exposure to HCV. Have you ever seen an HCV risk factor survey that asks about military service or about vaccinations via jet guns?

Although this risk factor is not included, in 2005 the Board of Veterans Appeals ruled in favor of a veteran’s claim that he contracted hepatitis C in service as a result of his receiving shots via a multi-use jet gun injector. (www.va.gov/vetapp05/files5/0531165.txtSadly, litigation did not motivate the VA to include jet gun vaccination as a transmission mode for HCV screening.

Imagine that you contracted hepatitis C while serving your country.
You came home, pulled your life together, and started a family. Perhaps you didn’t know you had hepatitis C, and you drank a couple of beers every night, more on weekends. You might have smoked for a couple of decades, but gave it up when your grandchildren entered into the scene. When you were in your 50’s you noticed you were tired—really tired. It was getting harder to do basic tasks, and you finally went to the doctor and found out you had cirrhosis. You felt too sick to go to work, yet Social Security and Medicare were years away. Disability would help, but getting assistance for  a service-related virus is not the same as getting help for a service-related combat injury. Without VA acknowledgement of jet guns as a possible HCV risk factor, the claims process is difficult.

As for the VA system, nearly everyone I talked to felt grateful that they had medical care, and the complaints I heard about the VA were similar to complaints I’ve heard about community healthcare practices.  However, the evidence contradicts these anecdotes. In a paper published in the February 2012 Journal of Hepatology, Jennifer R. Kramer and colleagues, identified more than 99,000 VA patients with HCV. Of those, 11.6% received combination therapy and 6.4% completed treatment. The bottom line is that too few veterans were treated, and fewer still made it through a full course of treatment. African Americans and Latinos were disproportionately affected.3

Those who are actively serving use Military Treatment Facilities rather than the VA system.  Col. Smith is still actively serving in a noncombat role, and going through her second treatment. Her military medical providers have acknowledged the guns are a probable culprit.

What about jet guns now?
The U.S. Military stopped using multi-use jet gun devices in 2006. Harry Hooks was instrumental in seeing that jet guns were put out of commission. Hooks, an Army veteran who ran dangerous missions in Vietnam, is the Director of HCVets. His heroism continues with his ongoing service to veterans with hepatitis C.

The discontinuation of jet guns is too late for Gary Lupole and the many others who died HCV-related deaths. The only way we can help them is to speak up. Get involved, contact your government representatives, support organizations that serve veterans, and this Veterans Day remember those who served, as well as those who are now serving, our country.

Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of recently released Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com

Further Information

Endnotes

  • Kralovic SM, et al. National Hepatitis C Surveillance Day in the Veterans Health Administration of the Department of Veterans Affairs. Mil Med 2002;167:756-759

  • Sloan KL, et al. Hepatitis C Tested Prevalence and Comorbidities among Veterans in the US Northwest. J Clin Gastroenterol 2004;38:279-284

  • Kramer, J, et al. Gaps in the Achievement of Effectiveness of HCV Treatment in National VA Practice J Hepatology, February 2012



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Prescription Drugs – Off-label Use
Alan Franciscus, Editor-in-Chief

Medications that are approved by the Food and Drug Administration (FDA) go through a vigorous clinical development process to find out if the drug is safe and effective in treating a specific condition.  The pharmaceutical company will compile the data from one or more Phase 3 studies and submit it to the FDA.  If the medications are approved the pharmaceutical company will develop a package label that is used by medical providers. The package label is also called the prescribing information.

The prescribing information includes the dosage(s) of the medications, when to take the medication, what, if any, food requirements to take or avoid, the duration of the treatment, side effects including the more severe side effects, important warnings about the drug, who should not take the drug, and additional important information.  This information should be read by medical providers, patients and patient advocates. 

The FDA will review the label put together by the pharmaceutical company, make recommendations or changes to the label, and once all parties agree, will authorize the drug for use.  After the drug has been used by a large population with the condition, other uses of the drug may come to light.  This can happen after research into the benefits of the drug or it may come about by accident when a person has a condition for which the drug seems to have a positive effect.  For example, a drug was being tested to treat depression, but during the development process it was also found to help with insomnia.  A medical provider may decide to prescribe it for a patient with insomnia “off label.”  It may turn out that there is such a need for the drug used off-label that the pharmaceutical company may decide to study the drug for this other condition.  Off-label use has many benefits, but it could also be dangerous.

Most people would be surprised at the amount of drugs that are prescribed off-label.  A recent report found that 1 in 5 prescriptions were prescribed off-label.  Many doctors and most patients, however, are not aware that the drug they are being prescribed is off-label use.  Unlike FDA approval, off-label use is not regulated, but it is legal for a medical provider to prescribe off-label.  Pharmaceutical companies, however,  can’t promote the off-label use without facing stiff fines by the FDA.  

Below are but a few of the off-label uses for certain approved medications:

  • Propranolol (Inderal), approved for high blood pressure and heart disease, but used off-label for stage fright.

  • Mirtazapine (Remeron), approved to treat major depressive disorder, but used off-label to treat insomnia.

  • Amitriptyline (Elavil), approved to treat depression, but used off-label to treat fibromyalgia and migraines.

Health Risks
Off-label use has the potential to cause serious harm and even death from some drugs used ‘off-label.’ There may be unforeseen drug-drug interactions or the drug may exacerbate an already serious condition like liver disease.  The drugs may also be harmful to certain populations like children or the elderly.  The off-label use of a drug could potentially lead to the development of drug resistance. 

Benefits
There are many benefits to having the opportunity to use drugs off-label.  They may be used to treat a condition that has few treatment options.  This is particularly relevant to cancer patients who have limited approved treatment options and off-label use can save lives for those who can’t wait for clinical studies and FDA approval.   

Prescription Drug Coverage
Medications that are being used off-label may not be covered by medical insurance, which could lead to possible financial ruin.  

The Future
There are many medical professionals who are calling for more regulations to govern off-label use.  But at the same time it is important to recognize that over-regulation can hinder innovation and deny life-saving drugs to people who have very few options.  

Important Questions to Ask
If you are being prescribed a medication talk with your medical provider:    

  • Ask your medical provider if the drug he or she is prescribing is FDA approved or if it is being prescribed off-label.

  • Read the FDA approved package label–your medical provider and/or pharmacist can give you a copy.  The HCV Advocate and HBV Advocate websites have the package label in the treatment sections for FDA approved HBV and HCV medications.

  • Ask if the off-label drug provides more benefits than the approved medication.

  • Ask your medical provider why he or she is prescribing the drug off-label.

  • Ask if the risks and benefits justify off-label use.   

  • Check with your insurance company to find out if your insurance covers the off-label drug; what are the co-pays; what are the deductibles.  

  • Check with a pharmacist about possible drug-drug interaction—they are experts.

HCV and Off-Label Use
Off-label use of pegylated interferon and HCV protease inhibitors is already occurring.  But since only one class (HCV protease inhibitors) is currently used the potential for harm is relatively low.  However, as more HCV inhibitors are FDA approved there is a real possibility that serious harm could result from using an HCV inhibitor therapy off-label.  The dose or duration of treatment could lead to drug resistance.  There is also the issue of possible drug-drug interactions. 

The good news in HCV drug development is that there are many companies that have and are collaborating on HCV drug development.  So far, there have only been Phase 1 and Phase 2 studies.  There have not been any collaborative Phase 3 studies that could lead to FDA approval.  This is due to the pharmaceutical companies deciding to concentrate on their in-house drug pipelines.  However, the Phase 1 and Phase 2 studies have addressed many of the important issues of off-label use including drug-drug interactions, safety and efficacy.  This information can help medical providers feel more comfortable with prescribing the combination of drugs to certain patients who have not responded to the FDA-approved medications.

Some people might not want to be treated with drugs that have not been approved to treat a certain condition.  Check with your medical provider to find out if a medication is being used off-label.

Cross-Company Collaborations

Gilead (Sofosbuvir) and BMS (Daclatasvir)
A small Phase 2 study of HCV genotype 1 (126 patients) and genotype 2 or 3 (44 patients) were treated for 12 or 24 weeks with the combination of 2 HCV polymerase inhibitors (daclatasvir and sofosbuvir) with and without ribavirin.  The genotype 1 patients achieved cure rates of 96 to 98%, while genotype 2 and 3 patients achieved cure rates of 93%.

Gilead (Sofosbuvir) and Simeprevir (Janssen)
The Phase 2 trial included HCV genotype 1 patients who were treated with sofosbuvir and simeprevir (HCV protease inhibitor) with and without ribavirin for 12 weeks. There were two cohorts. The first cohort included treatment-naïve and null-responder patients who were staged at F-0 and F-1 (no or minimal liver disease).  The interim top-line results reported cure rates 4-weeks post treatment of 93 and 96%.  The second cohort included patients who were F-3 (fibrosis) and F-4 (compensated cirrhosis) and interim findings of 96% and 100% cure rates. 

There are many other on-going collaborations including:

  • Simeprevir, daclatasvir and VX-135 for treatment of treatment-naïve and prior null-responders.

  • Daclatasvir and VX-135 for the treatment of HCV genotype 1 treatment-naïve patients.

  • PPI-668, BI 207127, Faldaprevir with and without ribavirin to treat HCV genotype 1a treatment-naïve patients.

 

A Guide to the
Affordable Care Act (ACA):

by Jacques Chambers, CLU
Updated

 

Table of Contents
Introduction

  • Health Insurance Exchanges and Medicaid Under the Affordable Care Act (Obamacare)?

  • Affordable Care Act in 2014

  • Medicaid & The ACA

  • Affordable Care Act (ACA): Exchanges Prepare to Open

  • Obamacare is OpenWhat Do I Do Now? (Oct 16, 2013)

  • Resources

 

Download the ACA Guide here:

www.hcvadvocate.org/hepatitis/factsheets_pdf/ACA_Guide.pdf


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Flu-Shots
—Lucinda K. Porter, RN

Around this time every year, each of us needs to make a decision—should I get a flu shot? This decision is especially important to those living with diseases such as hepatitis C. Influenza, aka the “flu,” affects an average of 5% to 20% of the United States’ population. The flu is not just a bad cold – it is a potentially serious illness.

According to the Centers for Disease Control (CDC), every year more than 200,000 people are hospitalized and depending on the strain, 3,000 to 49,000 people die from flu-related complications. Infants, young children, elderly and people with certain health conditions such as liver disease are at the greatest risk for serious complications.

The best way to prevent passing the flu is by not getting it. The best way to avoid getting the flu is through vaccination. Contrary to popular myths, vaccination does not give us the flu—it protects us from getting it.

The CDC recommends annual flu shots for everyone over the age of 6 months, unless you have had a severe allergic reaction to a prior flu shot. The formulation of the flu shot changes every year to protect people from current strains. This year there are six flu vaccines from which to choose:

  • The standard trivalent shot – protects against three strains of flu; approved for people 18 and older

  • An egg-free trivalent shot for those who are allergic to egg proteins – approved for people 18 through 49 years of age

  • A standard dose micro-needle trivalent shot, which is injected into the skin instead of the muscle and uses a much smaller needle than the regular shot – less painful, but more costly; approved for people 18 through 64 years of age

  • A high-dose trivalent shot – Higher dose for older immune systems which don’t always mount a strong immune response; approved for people 65 and older

  • The standard quadrivalent shot – protects against four strains of flu

  • The quadrivalent nasal spray – protects against four strains of flu; approved for healthy people 2 through 49 years of age

The flu shot contains “killed” virus. The only “side effects” are a sore, possibly red injection site, aches, and possibly a low-grade fever caused by your body’s immune response. The nasal spray vaccine contains live, weakened virus. Unlike the flu shot, the spray can cause mild flu-like symptoms and intensify asthma. Both types provide flu protection approximately 2 weeks after administered. It is best to get the shot as soon as it is available; October is optimal. Getting a flu shot in December or later is better than not getting one at all.

People undergoing hepatitis C treatment are generally encouraged to get a flu shot. Treatment may provide an excellent time to get a flu shot since interferon stimulates the immune response.

Those who should not get a flu shot are:

  • Children younger than 6 months of age.

  • People who have had a severe allergic reaction to influenza vaccine

  • People who have a moderate-to-severe illness with or without a fever (they should wait until they recover to get vaccinated)

  • People with a history of Guillain–Barré Syndrome that occurred after receiving influenza vaccine, and who are not at risk for severe illness from flu, should generally not receive vaccine. A doctor will help them decide whether the vaccine is recommended.

This reprinted article first appeared at
http://lucindaporterrn.com/?p=3420


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