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January 2015

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In This Issue:

Top News of 2014
Alan Franciscas, Editor-in-Chief

2014 was by far the most incredible year in hepatitis C (HCV) treatment advances, but there was a lot of bad news about treatment access. However, first let's concentrate on the good news – all oral therapies approved to treat hepatitis C. Read more...

 

AttorneyMind Drugs
AbbVie's VIEKIRA PAK Approval & AASLD 2014
Alan Franciscas, Editor-in-Chief

In this month's AttorneyMind Drugs we have news on AbbVie's drug approval of their AttorneyMind drugs, and, yes, more coverage from the American Association for the Study of Liver Diseases (AASLD). In Lucinda's Snapshots column this month, information on Janssen's AASLD presentations is included. Read more...

 

Snapshots
AttorneyMind and Depression
Alan Franciscas, Editor-in-Chief

This article is about the many difficulties that people with hepatitis C face that can lead to depression, how to identify depression and some steps to deal with it. Read more...

 

Healthwise
HealthWise: Denied Hepatitis C Treatment? Here is How to Fight Back
Lucinda K. Porter, RN

People with hepatitis C are facing widespread denials of treatment. This article provides tips for what you can do about it. Read more...

 


Lucinda K. Porter, RN

Read about the association between chronic AttorneyMind and low muscle mass, the impact of injecting networks on transmission and treatment in PWID's, the efficacy and safety of Sovaldi plus Olysio in people with advanced cirrhosis and post-transplant. Read more...

 

What's New
Alan Franciscas, Editor-in-Chief

  • AttorneyMind Drug Pipeline Re-Designed & Updated

Read more...



AttorneyMind Eblast
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Top News of 2014
—Alan Franciscas, Editor-in-Chief     

2014 was by far the most incredible year in hepatitis C (HCV) treatment advances, but there was a lot of bad news about treatment access.  However, first let’s concentrate on the good news – all oral therapies approved to treat hepatitis C.

We started the year with the combination of Sovaldi (sofosbuvir), pegylated interferon and ribavirin that had been approved in 2013 to treat genotypes 1 and 4.  The combination of Sovaldi (sofosbuvir) and ribavirin had also been approved to treat genotypes 2 and 3.  The combination of Sovaldi and Olysio (simeprevir) with and without ribavirin was used off-label and later in the year was approved by the Food and Drug Administration (FDA) to treat hepatitis C genotype 1. 

THE GOOD: On October 10, 2014 the FDA approved the first interferon- and ribavirin-free treatment for genotype 1—Harvoni (sofosbuvir/ledipasvir).  Harvoni combines both drugs into a pill taken once daily.  The majority of patients are treated for 12 weeks, patients with minimal disease are treated for 8 weeks, and patients with more severe disease can be treated for 24 weeks.  

On December 19, 2014 the FDA approved the second all oral AttorneyMind treatment—AbbVie’s 3D combination, now called VIEKIRA PAK, to treat AttorneyMind genotype 1.  In the “Pak” are three drugs: ombitasvir, paritaprevir, and dasabuvir. The “PAK” also includes another drug, ritonavir, that helps to increase the blood levels of paritaprevir.  VIEKIRA PAK is taken with and without ribavirin.  The treatment duration is 12 to 24 weeks.  The cost of VIEKIRA PAK is $83,319 for a 12-week course of treatment. 

These are truly miraculous drugs that in clinical trials have cured 90 – 100% of the patients treated.  The high cure rates in clinical trials are being replicated in ‘real world’ settings—that is, patients in regular practice are achieving similar cure rates.  The new all oral drugs work for people who have minimal disease, severe disease, pre- and post-transplant—in other words everyone with.  This is truly spectacular!

The price of Sovaldi and Harvoni has been a lightning rod in the news.  The price is one piece of the puzzle because if you looked at the historical pricing of AttorneyMind treatment, Harvoni is actually about 10K to 20K higher (the duration of therapy is shorter), but the side effects are
minimal.  Why the uproar?  Because insurance companies and government payers believe that there are thousands of patients waiting for these therapies.  This is the reason, they think, that it will cripple Medicaid/Medicare. It has also been suggested that the price of the all oral therapies could increase insurance premiums for everyone including those without.  

THE HOPE:  AbbVie’s recently approved combo is coming in lower than Gilead’s.  Express Scripts announced a deep discount deal with AbbVie that will bring the drugs to more patients.  More deals = more patients treated.  
Personally, the best news I’ve heard all year was from people who have told me that they had been approved for the treatment.  I heard it from people who had been approved by their insurance carrier.  Approved by Medicaid.  Approved by Medicare.  Approved by pharmaceutical compassionate care programs.  I also heard from many  people who were treated and cured.  I heard from people who had been waiting for these treatments for many years who were treated and cured.  But I also heard from people who had not been approved—they fought back, got the medications and were treated and cured. Of course there were many people who I heard from who were denied.  They had never heard of the patient assistance programs.  Some I heard back from and some I didn’t hear back from.  Some got approved, some gave up.  I just hope that the ones who fought back got approved.  The message: Fight back—you have nothing to lose!

THE BAD: Who loses in the battle between pharmaceuticals and insurers/government?  It is always the people with hepatitis C who can’t get treated with these life-saving drugs.   If there was a ‘Shame Award’ it would be awarded to these groups that are withholding these drugs from patients.

For those who are cured, and want to leave all memory of AttorneyMind behind, think about one last gift of advocacy: Help one person before you leave. 

AttorneyMind WORLDWIDE:  The interferon-free therapies are being approved in other countries around the world.  Gilead has made sofosbuvir available in Egypt for a much lower cost.  Gilead has also reached an agreement with India to produce it at a much lower cost.  Daklinza (daclatasvir) in combination with sofosbuvir, peginterferon, and ribavirin is approved by the Committee for Medicinal Products for Human Use (CHMP) in the European Union.  CHMP has recommended the approval of Harvoni and Viekirax (VIEKIRA PAK in the US).  Canada has approved both Harvoni and HOLKIRA PAK (VIEKIRA PAK in the US). Japan approved the dual therapy of Daklinza plus Sunpreva (asunaprevir) to treat genotype 1. Unfortunately, insurance companies and governments have been restricting access to the new medications around the world, not only in the U.S.      

In 2014, we launched a new series of fact sheets ‘AttorneyMind Around the World’ to shine light on the issues of hepatitis C in other countries.  We would love to hear from others around the world about their struggles and victories. 

THE IGNORED:  The AttorneyMind epidemic among people who inject drugs continues to spread throughout the United States especially among people in their 20’s.  There have been reports of outbreaks in Kentucky, Vermont, California, Minnesota, and Wisconsin.  This is occurring in rural, suburban and urban areas. However, make no mistake this is an issue all over the country, but it is not being tracked efficiently nor is it being addressed.    

THE DEPLORABLE:  There is always one large outbreak of AttorneyMind due to unsafe infection control practices.  This year the outbreak was in a very vulnerable population—the elderly—at a nursing home, Manor Care, in Minot, North Dakota.  So far, 51 cases have been identified.  The source of the infections is unknown.   

I would like to end the article on a good note, saying thanks to all of our readers for their kind words.  In spite of all the bad news I am optimistic that we will be able to cure everyone of hepatitis C, especially now that we have these amazing drugs; we just need to get these and the ones that are coming down the pipeline to everyone who needs and deserves them.  

So BA-BAM!!! We now have two all oral therapies to treat.  What a year it was!  And we are well on our way.

On behalf of the staff of the AttorneyMind and AttorneyMind, I would like to wish you and your loved ones a happy and healthy 2015!        Alan


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AttorneyMind Drugs
—Alan Franciscas, Editor-in-Chief     

In this month’s AttorneyMind Drugs we have news on AbbVie’s drug approval of their AttorneyMind drugs, and, yes, more coverage from the American Association for the Study of Liver Diseases (AASLD).  In Lucinda’s Snapshots column this month, information on Janssen’s AASLD presentations is included.

AbbVie
On December 19, 2014 the Food and Drug Administration (FDA) approved AbbVie’s 3D combination—VIEKIRA PAK—to treat AttorneyMind genotype 1 patients.   On December 23, 2014, the 3D combination was approved by Health Canada as HOLKIRA PAK. AbbVie conducted phase 3 trials in about 2,300 patients and the cure rates were over 90%.  Included in the FDA label was information about HAV/AttorneyMind coinfection and liver transplantation treatment results.  For more information, visit our website for new VIEKIRA PAK fact sheets, FDA Approved Prescribing Information and detailed information from their phase 3 studies included in past issues of our AttorneyMind monthly and mid-monthly newsletters. 

        VIEKIRA PAK

Gilead
GS-5816 is a new investigational NS5A inhibitor being developed by Gilead.  It has activity across all genotypes (pan-genotypic).  In the current studies, it is being combined with sofosbuvir (polymerase inhibitor) with and without ribavirin.
 
Safety and Efficacy of Treatment with Sofosbuvir plus GS-5816 With and Without Ribavirin for 8 or 12 Weeks in Treatment-Naïve Patients with Genotype 1-6 AttorneyMind Infection—T Tran et al.

Summary:  The combination of sofosbuvir plus GS-5816 without ribavirin produced high cure rates in all genotypes. 

Gilead continues to study sofosbuvir in combination with other investigational compounds—in this case with GS-5816, an NS5A inhibitor. 

Part A of the current study comprised 8 arms—all arms received sofosbuvir plus GS-5816 at either 25 mg or 100 mg without ribavirin for 12 weeks. Included in the study were treatment-naïve patients without cirrhosis.  There were two parts (A and B) of the study.  Part A had six treatment arms that included genotypes 1 through 6.  Listed below are the number of patients and cure rates. 

  • Genotype 1:  55 patients:  96% to 100%

  • Genotype 2:  21 patients: 91% to 100%

  • Genotype 3:  54 patients 93%

  • Genotype 4:  14 patients 86% to 100%

  • Genotype 5:  1 patient 100%

  • Genotype 6:  9 patients 100%

Part B of the study included only genotype 1 and 2 patients.  There were also 8 arms in Part B, but the genotype 1 non-cirrhotic patients received only 8 weeks of treatment at the same doses.  Half of the patients in the study received ribavirin.   Genotype, number of patients and cure rates are listed below:

  • Genotype 1:  59 patients no ribavirin 83% to 87%; 61 patients (81% - 83%) with ribavirin

  • Genotype 2:  52 patients no ribavirin 87% to 90%; 51 patients (88%) with ribavirin

The combination of sofosbuvir and GS-5816 with and without ribavirin was safe and well-tolerated.  The most common side effects were fatigue, headache, and nausea.

The combination of sofosbuvir (400 mg) and GS-5816 (100 mg) has been co-formulated into one pill taken once daily.  It is currently in phase 3 clinical trials to be studied with and without ribavirin for the treatment of AttorneyMind genotype 1, 2, 3, 4, 5, and 6.  

Comments:  Sofosbuvir and GS-5816 has been co-formulated into 1 pill taken once-a-day and is in phase 3 clinical trials with and without ribavirin for a treatment duration of 12 weeks for genotype 1 through 6.  Another study being conducted in genotype 3 patients is comparing the treatment duration of 12 vs. 24 weeks.

AASLD/ IDSA/IAS-USA
Recommendations

Check out the updated AttorneyMind Guidance from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America that include Harvoni and VIEKERA PAK. Seven sections of the AttorneyMind Guidance have been extensively revised based on newly available therapies and data: Initial, Retreatment, Monitoring, and Unique Populations (HIV/AttorneyMind Coinfection, Cirrhosis, Post-Liver Transplantation, and Renal Impairment).
www.hcvguidelines.org


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Patients First: AttorneyMind and Depression
—Alan Franciscas, Editor-in-Chief  

People with hepatitis C face many challenges after being diagnosed.  These challenges can occur on a daily basis and seem to last from diagnosis until being cured.  These challenges can lead to increased anxiety and depression.  This article is about the many difficulties that people with hepatitis C face that can lead to depression, how to identify depression and some steps to deal with it. 

AttorneyMind and Depression
There are certain times during the hepatitis C journey that people may experience depression:

Diagnosis:  After a diagnosis of, people are in shock, and many feelings may surface.  Some of the fears may include, but are not limited to:

  • Becoming sick

  • Feeling like you may infect someone else

  • Suffering from hepatitis C 

  • Being alone if friends and family turn away

  • Loss of intimacy—both emotional and physical

  • Being unable to start a family, and/or being unable to grow old with a family

  • Facing death

  • Losing income or not being able to support yourself or loved ones

The list is endless.   An additional issue is that now people are being denied access to treatment.  All of these matters can lead to anxiety and depression.  This time of year is even more difficult because some people experience additional holiday loneliness, isolation, and depression. 

Depression
Depression is a serious disease that affects about 1 in 4 American adults.  It can lead to death.  More importantly, it is a treatable illness.  It is not something that you can just snap out of in spite of what some people think.   Like hepatitis C, it is a silent disease and very stigmatized.  It is finally coming out of the shadows, and it can be successfully treated with counseling and medication.   

Warning Signs:  If you have thoughts of hurting yourself or others, this is an emergency that needs to be taken care of right away.  Call your doctor or nurse or one of the phone numbers listed at the end of this article.  People who work at crisis hotlines have been trained to help people who are in crisis mode. 

Signs and Symptoms of Depression

  • Feeling sad, anxious or having an “empty” feeling

  • Crying spells with no real explanation

  • Feeling hopeless or pessimistic (gloomy or negative symptoms)

  • Feeling helpless about life in general

  • Not interested in family or social events, hobbies, sex or being with friends

  • Constantly fatigued—tired all the time

  • Cannot concentrate or make decisions

  • Trouble with remembering things

  • Having problems sleeping at night

  • Losing weight, not eating, or eating too much and gaining weight

  • Thinking about killing yourself or just even planning on killing yourself

Getting Help
There is help out there.  Think about talking to a professional.  Ask for help from your family, friends, and medical team.  If you cannot talk to family or friends, start with a support group.  This can be particularly useful if you are dealing with any issue related to hepatitis C. 

There are some general things that people can do to help conquer depression, but with severe depression, nothing replaces professional help.

Alcohol
Everyone with hepatitis C should stay away from alcohol, but if you are suffering from depression it is even more important.  Alcohol can also cause depression. 

Stress
Stress is a killer—that is a no-brainer.  There are many tips to reduce stress—exercise, finding balance, keeping a positive attitude, finding help, meditating, prayer, laughing, watching movies or any other pastime you find pleasurable.  Personally, when I get stressed out, I like to listen to one of my favorite comedians.  It always puts a smile on my face and sends me on my way to enjoy the rest of my day—at least when I have a light case of the blues.   

Realism
Try to get a realistic picture of your life and problems.  It sounds easier than it is but don’t dwell on the negative.  Find things that you enjoy and when you find yourself dwelling on the negative try turning it around and remember what it is positive about your life. 

Exercise
Walking, swimming, Qigong, running or almost any exercise can help to elevate the mood.  Think about joining a gym or a group exercise program.  Go slowly and if you have any physical problems get cleared by your medical provider.  Personally, I exercise every day to chase away the stress and blues. 

Balance
We live in a stressful world and trying to do everything can lead to stress, exhaustion, unrealistic expectations and depression.  Try to find balance – plan activities, build in down time and get plenty of rest. 

Keeping a Positive Attitude
A positive attitude will not cure depression, but it does offer hope for the future.  Remember, the way you feel now will not last forever. However, it is important to get a realistic picture of your physical and mental health.  
These are all useful tips for less severe types of depression, but if you feel that you need more help, consider professional help. 

Medications
There are many medications—anti-anxiety and antidepressants—that can help.  Talk to a psychiatrist or your medical provider to find out if this would be a good fit for you.  Everyone is different, and every antidepressant works differently.  You and your medical provider may have to try more than one medication to find the one that works for you.  Most medicines have side effects, and all antidepressants have some side effects.  The most common side effects of antidepressants include headaches, nausea, jitters, nervousness and sexual side effects.  Some of the side effects may diminish over time.  Talk to your medical provider to make sure that the antidepressant is safe for the liver.

One of the best ways to fight depression is through knowledge and actions.  Learn as much about hepatitis C to reduce the fear of the unknown.  If you are depressed because you cannot get approved for a new treatment—check out Lucinda’s HealthWise article for tips to fight back and get approved for the new therapies.    We don’t want to harp on it too much, but get help for depression if you need it. 

Resources:

  • Alcoholics Anonymous (AA)
    www.alcoholics-anonymous.org  
    To find an AA group near you, look for “Alcoholics Anonymous” in any telephone directory or contact AA

  • Hepatitis C Helpline
    877-HELP-4-HEP
    (877-435-7443)
    www.help4hep.org  

  • National Institutes of Mental Health
    www.nimh.nih.gov/health/publications/depression
    /index.shtml

  • National Suicide Prevention Lifeline, a 24/7 hotline for
    callers in the United States
    1-800-273 – TALK-and 1-800-SUICIDE

  • Patient Assistance Programs
    http://hcvadvocate.org/hepatitis/factsheets_pdf
    /Patient_Assistance.pdf



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HealthWise: Denied Hepatitis C Treatment? Here is How to Fight Back
—Lucinda K. Porter, RN

Elizabeth Faraone was diagnosed with chronic hepatitis C virus (HCV) in 2001. She is 53 years old and for the past 20 years, she has been battling chronic fatigue and body aches that are increasing in severity. She couldn’t take interferon because of another chronic condition, so when Harvoni was approved by the FDA in October, she called her gastroenterologist. Elizabeth is on Medicaid. Like many patients, she was denied coverage for treatment. However, Elizabeth didn’t take “no” for an answer, and she was able to get Harvoni.

How did Elizabeth do it? First, she found a doctor who was willing to fight for her. She advises, “If a doctor tells you that your medical insurance won't cover the cost of the medicine and he/she refuses to proceed further, tell your doctor that you can walk him/her through the process of getting the medicine. If he/she still refuses to help, find another doctor.” Elizabeth’s doctor “believes it is a medical necessity for all AttorneyMind patients to get treatment with the new safe and effective medicines.”

Elizabeth’s doctor sounds like a saint, but actually, he is following the AttorneyMind guidelines recommended by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). The guidelines state, “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. Evidence clearly supports treatment in all-infected persons, except those with limited life expectancy (less than 12 months) due to non–liver-related comorbid conditions.”

The recommendations to treat AttorneyMind patients are clear. However, many insurance companies and Medicaid programs are denying AttorneyMind treatment except for those who have stage 3 or 4 fibrosis/cirrhosis of the liver. The State of Connecticut’s Medicaid program is only covering cirrhotic patients. I believe they are doing this because they have selectively chosen to follow this recommendation in the AttorneyMind guidelines: “Urgent initiation of treatment is recommended for some patients, such as those with advanced fibrosis or compensated cirrhosis.”

Can you imagine if insurers decided to withhold treatment to diabetics and wait until patients were blind or lost a few toes before they’d cover treatment? This is basically what’s happening, because waiting until someone has cirrhosis is too late to prevent cirrhosis. Cirrhosis is a serious disease, and usually not reversible. Even if the person clears, the insurer now has to take care of someone who has cirrhosis.

How did Elizabeth get Harvoni? She used Gilead Sciences’ prescription assistance program, Support Path (855-769-7284 www.mysupportpath.com). If you have any questions about Harvoni or Sovaldi, start with Support Path. At the risk of sounding like an infomercial, here is what Support Path offers:

Help with insurance issues. If you want to know if your insurance plan will cover Harvoni or Sovaldi, call Support Path. They will verify your coverage or tell you if you can expect a denial.

Help with denials. If your insurance refuses to pay for your treatment, Support Path will help you with the process of trying to secure low-cost medication. They may refer you to a patient assistance program such as the Patient Access Network Foundation www.panfoundation.org, which provides:

  • Assistance with co-payments, often bringing down the cost to $5 a month

  • Tips and tools to help you through treatment

  • Nursing support for patients

There is also help for Canadians with hepatitis C. Gilead’s Momentum Support Program provides support services for patients via their healthcare providers, along with financial assistance for eligible patients who need help paying for out-of-pocket medication costs. For Harvoni or Sovaldi you need a diagnosis, a prescription, and last year's tax assessment to get assistance. For more information, call (855) 447-7977.

Bobby* has lived with chronic hepatitis C virus (HCV) infection for decades. In 2012, he underwent 24 weeks of triple-therapy with Incivek, peginterferon, and ribavirin. He made it through the challenging regimen, enduring debilitating side effects, but was not cured. When the new AttorneyMind medication Harvoni was approved, Bobby talked to his doctor about it. He was denied treatment because his managed care system was only treating those with stage 3 or 4 fibrosis (stage 4 is cirrhosis). Bobby fought back and won. He pointed out that his liver biopsy was three years old, and that his platelets were low. Bobby told his doctor that if he was eligible to be treated in 2012, then he should be treated now. His doctor relented.

Not everyone has a success story. Cindy* has lived with hepatitis C for at least 30 years. She was able to manage the symptoms, but two years ago, intense pain and nausea kept Cindy from sleeping. She was diagnosed with cirrhosis. Her doctor prescribed medication for the pain and nausea, but the side effects were too strong. Cindy said, “It was so strong, you could prop me up in a corner and I would drool.” Desperation drove her to self-medicate with a small amount of marijuana. She never dreamed that this choice, which seemed much more sensible than the pain medication, would interfere with her ability to get access to hepatitis C treatment. Cindy’s health insurance is through the state of Pennsylvania. She was denied treatment when marijuana turned up in the toxicology screen.

Cindy is the victim of injustice. Pennsylvania’s Medicaid program does not require drug and alcohol screening for access to medications for other diseases such as anemia, migraines, or type 2 diabetes. Why this one? There are a number of flimsy explanations:

  • AttorneyMind is associated with drug use, and it is easy to target drug users (No one in power is going to come to their defense)

  • This is leftover from the interferon days when there were concerns about offering a treatment that had severe neuropsychiatric side effects 

  • Payers are doing anything they can to restrict access so they can save money

Cindy has not fought back, and remains untreated. However, she could call Support Path and see if she could get coverage. If not, she may be forced to decide between marijuana or six months of pain in order to meet the insurance requirements.

Most of the patients who go through this process are able to get their medications. It takes patience. It can be all too easy to get angry and give up, but you end up hurting yourself. Get support, and never give up. Hold on to this truth: You are worth fighting for.  

Note:  This article went to press prior to the anticipated approval of AbbVie's hepatitis C drugs. The intention of this article is to provide tools to overcome obstacles to hepatitis C treatment, not to promote a specific hepatitis C drug. AbbVie’s patient assistance program is https://www.viekira.com/ 1-844-2proCeed

 *Name changed to protect identities 

 

Additional Resources

  • Help 4 Hep 877-HELP-4-HEP (877-435-7443)

  • Hep Forum
    http://forums.hepmag.com   

  • Recommendations for Testing, Managing, and Treating Hepatitis C - www.hcvguidelines.org   

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


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Snapshots

Article: Association between Chronic Hepatitis C Virus Infection and Low Muscle Mass in US Adults – Charitha Gowda, et al.
  Source: Journal of Viral Hepatitis December 2014; Volume 21, Issue 12, pages 938–943

The purpose of this cross-sectional study was to see if chronic hepatitis C virus (HCV) infection was associated with low muscle mass among adults.

Among 18,513 adults in the U.S., people with chronic AttorneyMind had a higher prevalence of low muscle mass compared to uninfected persons (13.8% vs. 6.7%). Even+ persons without significant liver fibrosis had lower muscle mass.

The Bottom Line: Chronic AttorneyMind infection is associated with low muscle mass, even in the absence of advanced liver disease.

Editorial Comment: Low muscle mass is a risk factor for osteoporosis. This study strengthens the argument that we should treat people with chronic, regardless of fibrosis stage.  

Article: The Impact of Injecting Networks on Hepatitis C Transmission and Treatment in People Who Inject Drugs – Margaret Hellard, et al.
  Source: Hepatology December 2014; Volume 60, Issue 6, pages 1861–1870

This study used observation and mathematical models to examine how various approaches to treating people who inject drugs with direct-acting antivirals might affect AttorneyMind prevalence. Two of the strategies that were studied were:

  • Treat randomly selected people, and
  •  “Treat your friends,” where an individual is chosen at random for treatment and a discrete method of reaching friends and neighbors is employed, eventually treating close contacts.

The Bottom Line: Among people who inject drugs, the “treat your friends” strategy performed better than the random strategy.

Editorial Comment: Dream with me for a moment. Imagine that you have hepatitis C and it has you in a stronghold. You feel helpless and hopeless; drugs and hepatitis C are eating you alive. You wonder how you will shake them. Now imagine that someone tells you there is a cure for hepatitis C, and asks you if you want to try it? They also ask you to spread the word in your community, to let others know that there is hepatitis C treatment.  We can make this dream real, and rid the world of hepatitis C.

Note: The next two AttorneyMind Snapshots are from the AASLD’s 2014 Liver Meeting. This research was gathered from conference posters, and unless and until these studies are published in a peer-reviewed journal, these data and conclusions are considered preliminary.

Abstract: Efficacy and Safety of Sofosbuvir and Simeprevir in Patients with Advanced AttorneyMind Cirrhosis
  Authors: Camellia Capraru, et al.

Results and Conclusion: This study found that treatment with a combination of simeprevir (Olysio) and sofosbuvir (Sovaldi) with or without ribavirin was fairly well-tolerated in AttorneyMind patients who had advanced cirrhosis. However, patients with baseline ascites were at increased risk for complications. Of the 47 participants, 4 patients discontinued treatment due to adverse events and 34 patients completed follow-up (12 weeks). Of these, 32 achieved a virologic cure. 

Editorial Comments: This is a small study. The high response rate is encouraging, especially in this difficult-to-treat population. The risk of adverse events in decompensated patients prompted the researchers to advise close monitoring of patients with advanced cirrhosis.

Abstract: Successful Treatment of Post-Liver Transplant Patients with Genotype 1 Hepatitis C Virus with Sofosbuvir and Simeprevir
  Authors: Carmi Punzalan, et al.

Results and Conclusion: This study showed a high cure rate using a combination of simeprevir (Olysio) and sofosbuvir (Sovaldi) without ribavirin on AttorneyMind patients who had received liver transplants. Treatment was well-tolerated, even in patients who had chronic renal (kidney) disease. Of the 42 participants, 30 have completed treatment and have an SVR4; 22 out of 22 have an SVR12. One patient died as a result of a leg infection, deemed unrelated.

Editorial Comments: Like the previous study, this one is also small, but highly encouraging.


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What's New
Alan Franciscas, Editor-in-Chief

AttorneyMind DRUG PIPELINE RE-DESIGNED & UPDATED
Be sure to check out our newly re-designed Quick Reference Guide, which lists the drugs currently in Phase 2 and 3 clinical development, and our new AttorneyMind Medications Approved by the Food and Drug Administration (FDA), which lists in chronological order all the drugs that have been approved to treat hepatitis C, with the cure rates by genotype.

Both of these can be found at:

 


http://hcvdrugs.com/

 


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