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Alan Franciscus

Editor-in-Chief

HCV Advocate



Monday, July 27, 2015

Weekly Special Topic: Advocates & Activists Needed!


Advocates & Activists Needed!

World Hepatitis Day is approaching - What Can YOU do to help raise the level of awareness of viral hepatitis:



World Hepatitis Day: July 28, 2015

July 28, 2015

400 MILLION PEOPLE IS 400 MILLION TOO MANY

Worldwide 400 million people are living with hepatitis B or C. Every year 1.4 million people die from viral hepatitis and yet all of these deaths could be prevented. With better awareness and understanding of how we can prevent hepatitis we can eliminate this disease and save 4,000 lives a day.

A New Powerful HCV Health Tool, by Alan Franciscus, Editor-in-Chief

Originally published July 1, 2015


In this age of technology, hepatitis C finally has it is own App!  This technology is brought to you by Help-4-Hep which provides peer-to-peer counselling services for people with hepatitis C.  It is available on the internet and mobile devices.

The application includes everything you need to stay healthy living with hepatitis C and if undergoing treatment: 
  • Appointment Calendar
  • Personal Journal
  • Medication Tracker
  • Symptom tracker
  • Weight Tracker
  • Daily Moods
  • HCV Lab Tracker
  • Meal Tracker
This is another powerful new tool that Help-4-Hep provides nationwide.  Help-4-Hep is a non-profit, peer-to-peer helpline — 877‑HELP‑4‑HEP (877‑435‑7443) — where counselors work with patients to meet the challenges of hepatitis C head-on.  Callers talk one-to-one with a real person, typically someone who’s had hepatitis C touch their own life.  This is a fantastic service.

If you need help or know someone who needs help, please refer them to this service.  Alan



Patients First: Antacid, Pregnancy Categories and Herbs, by Alan Franciscus, Editor-in-Chief

Originally published July 1, 2015

I was recently looking on Facebook and the topic was antacids and Proton Pump Inhibitors.  It was interesting because everyone had a different take on how and when to take them.  As a result I thought I would talk about what they are, when it is safe to take them and a couple of other common topics such as—pregnancy categories and herbal supplements. 

The current standard of care for treating hepatitis C by genotype includes: 
  • Genotype 1:  Harvoni (sofosbuvir/ledipasvir) and Viekira Pak with and without ribavirin
  • Genotype 2 and 3:  Sovaldi (sofosbuvir) plus ribavirin
  • Genotype 4:  Sovaldi (sofosbuvir) plus pegylated interferon and ribavirin
The drugs listed above were approved by the Food and Drug Administration (FDA). The approval process went through vigorous testing that included testing to find out what type of other drugs (drug-drug interactions) affected the absorption of the HCV medicines into the blood stream.  This could change how well these drugs work and affect cure rates. This includes herbs since these can be considered a type of medicine.  It is important to remember that herbs are not regulated. 

Drug-Drug Interactions

• Harvoni/Viekira Pak: 
Proton Pump Inhibitors are drugs that work by reducing the amount of stomach acid made by glands in the lining of your stomach.  The package label specifically lists omeprazole (Priolsec)—talk with your medical provider if you take this type of medication. 

• Harvoni:
  Check with your medical provider if you take any acid reducing agents (antacids).  There are specific times you can and can not take them.  

• Herbal Supplements:
Harvoni/Sovaldi/Viekira Pak:  Do not take St. John’s wort. 

Note:  People who are taking any protease inhibitor (HIV or HCV protease inhibitor) should not take St. John’s wort).  People taking Olysio should not take the herb Milk Thistle.
 
Note:  Make sure to talk with your medical provider about any herb, supplement or medicine to make sure there is no drug-drug interaction.  For information about liver toxic herbs see this edition of the HCV Advocate newsletter. 

Pregnancy Categories
Harvoni, Sovaldi and Viekira Pak are classified as Pregnancy B drugs.  This means that there have been no studies in humans and that they should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus or if needed. 

Ribavirin is a Pregnancy X drug and as such pregnancy has to be avoided.  Women of child bearing potential and their male partners can not receive ribavirin unless they are using two forms of effective contraception during treatment with ribavirin and for six months after treatment has concluded.  Women should have a pregnancy test before starting treatment, during treatment and the six month period after treatment. 

Women are encouraged to sign up with the ribavirin registry at:  www.ribavirinpregnancyregistry.com

Comment:  If a woman is contemplating pregnancy most medical providers recommend HCV treatment first and starting a family afterwards.  Talk with your medical provider about your options. 

HCV Treatment FDA-Approved Prescribing Information:
http://hcvadvocate.org/news/newsLetter/2015/advocate0715.html#4

Snapshots, by Alan Franciscus, Editor-in-Chief

Originally published July 1, 2015

Article: Long-term treatment outcomes of patients infected with Hepatitis C virus: a systematic review and meta-analysis of the survival benefit of achieving a Sustained Virological Response–B Simmons, et. al
  Source:  Clin Infect Dis. 2015 May 17. pii: civ396. [Epub ahead of print]
Results and Conclusions:  In the current study the authors conducted an electronic search to identify if achieving a cure improved long term outcomes. The records of 33,360 patients from 31 studies were examined with a medium follow-up period of more than five years. The people who were cured were compared to those who were not cured. 

The Bottom Line:  The survival after five years from being cured was significant compared with those who did not achieve a cure.  This included three populations of people—those who were HCV mono-infected, those who had cirrhosis and those who were coinfected with HIV and hepatitis C. 

Editorial Comment:  In science studies are needed for everything, and this is an important one because it proves that successful treatment works to prolong lives.  More of these studies (with larger patient populations) are required to convince insurance companies and other payers that in the long run paying for treatment saves them money and, more importantly, lives.

Article:  Methadone continuation versus forced withdrawal on incarceration in a combined US prison and jail: a randomised, open-label trial—RD Josiah
  Source: The Lancet DOI: http://dx.doi.org/10.1016/S0140-6736(14)62338-2

Results and Conclusions:  Methadone is used for withdrawal/substitute for opioid use.  In this study people who were entering Rhode Island Department of Corrections and who were currently enrolled in a methadone maintenance program at the time of arrest were asked to enroll in a study that would continue them on methadone maintenance while they were in prison.  Participants were only included in the study if they were to be incarcerated for more than 1 week but less than six months.  The participants in the study were randomized by a computer-generated program by sex and race.  The trial took place between June 2011 - April 2013.  
  • The 114 participants in the methadone maintenance group were randomized to receive methadone at their regular dose.
After release from prison the study paid for ten weeks of methadone for the methadone group if financial help was needed.
  • The 109 forced-withdrawal group followed standard guidelines forforced withdrawal. 
The standard withdrawal protocol was to receive methadone for 1 week at the dose at the time of their incarceration, then a tapered withdrawal regimen (for those on a starting dose >100 mg, the dose was reduced by 5 mg per day to 100 mg, then reduced by 3 mg per day to 0 mg; for those on a starting dose >100 mg, the dose was reduced by 3 mg per day to 0 mg).
The Bottom Line: The participants who were given methadone were more than twice as likely than the forced withdrawal group to return to a community methadone clinic in their community within 1 month of release—96% vs. 78%.  There were no serious side effects in either group. 
  • Methadone groups:  one death, one non-fatal overdose, one hospital admission and 11 emergency-room visits
  • Forced-withdrawal groups:  no deaths, two non-fatal overdoses, four admissions to hospitals, 16 emergency-room visits
Editorial Comments:  Providing methadone seems very humane.  It also reduces hospital admission, emergency-room visits and greatly increases the chances that once a prisoner is released they would seek out a methadone clinic.

http://hcvadvocate.org/news/newsLetter/2015/advocate0715.html#3

HealthWise: Hepatitis C and Pain—Part 2, by Lucinda K. Porter, RN

Originally published July 1, 2015

Last month, I talked about hepatitis C and pain, and presented information about over-the-counter and prescription pain medication. Nonsteroidal anti-inflammatory drugs (NSAIDS) and opioids are effective painkillers, but they are associated with the risk of medical complications. This month I focus on pain management techniques that have little or no risk of injuring the liver or other organs in the body. I start with the controversial one—marijuana.  

Cannabis
Marijuana (Cannabis sativa) is slowly emerging from its status as the cause of “reefer madness” to a more reputable one showing potential medical benefits. However, before running out and buying some weed and a bag of Cheese Doodles, let’s explore these questions:
  • Is marijuana effective for reducing pain?
  • What is marijuana’s affect on the liver and hepatitis C?
First, let’s get one big frustrating fact out of the way: Marijuana is classified as a Schedule 1 drug. Drugs with a schedule 1 designation are deemed as having a high potential for abuse and no accepted medical use. Marijuana is tucked in there along with heroin, LSD, peyote, and ecstasy. Politicians determined this, not scientists. Because of this classification, marijuana is nearly impossible to obtain and test in clinical research. The bureaucracy is enormous, and permission is hard to get. In 2010, Time magazine summed it up this way, “Pot is listed as Schedule 1 because science hasn’t found an accepted medical use for it, but science can’t find a medical use for it because it is listed as Schedule 1.”

It is hard to imagine that marijuana is classified as a Schedule 1 drug when there has never been a reported death from marijuana overdose. Compare this to annual deaths from acetaminophen (300) or nonsteroidal anti-inflammatory drugs (7,000-10,000), and opioids (16,000). Compare marijuana’s zero deaths to those from legally obtainable substances, such as alcohol (88,000) or tobacco (480,000 including second-hand), and cannabis seems much safer.

This is not to say that marijuana isn’t without risk. In Colorado, two cannabis-related deaths are under investigation; one a suicide, the other a homicide in which other substances were involved. Also disturbing is the fact that the number of auto accidents have risen in Colorado since the legalization of pot.

These few deaths are hardly worth condemning pot for, especially since marijuana use may be causing a drop in the number of deaths from prescription opioids. States with liberal marijuana laws had a 25 percent reduction in opioid deaths. Cannabis is also associated with lower death rates in patients with traumatic injuries. That is just the beginning. The potential benefits are so many, that U.S. Surgeon General, Vivek Murthy said, “We have some preliminary data showing that for certain medical conditions and symptoms, marijuana can be helpful.”

Is marijuana effective for pain? Yes! I could write pages on this. The bottom line is that cannabinoids (a chemical compound found in a number of plants, including Cannabis sativa) interact with specific receptors in the brain. This appears to reduce pain and inflammation.

Will marijuana cause liver injury? It’s not well researched, but probably not. A Canadian study of 690 participants led by Laurence Brune and colleagues found, “Marijuana smoking does not accelerate progression of liver disease in HIV–Hepatitis C coinfection.” (Clinical Infectious Disease, Sep 2013). Previous studies have had mixed results.

What is marijuana’s effect on hepatitis C? The studies have been mixed. There is some research suggesting that marijuana may lower immune response. However, cannabis is being used in cancer studies with favorable results. In short, we don’t know.

What are the downsides of marijuana use? There are quite a few, such as risks of addiction, cognitive impairment, increased bleeding risks, etc. Frankly, we don’t know all the risks since marijuana has not been rigorously researched. I suspect that a day will come when marijuana will come with a paper insert that will list all the potential drug interactions, side effects, and warnings. Until then, keep this in mind:  We don’t know if cannabis interacts with hepatitis C medications. Marijuana may interfere with drugs that are metabolized via the liver’s cytochrome P450 enzyme system. This may affect the dose of your hepatitis C medications. If you use marijuana, work with a doctor who will prescribe it, and show you how to use it medically and responsibly.
 
Note: If you are on or are being considered for liver transplantation, marijuana use can be a disqualifier. The state of California recently introduced legislation to prohibit marijuana use as a factor for disqualification for organ transplantation. Other states may follow suit, especially in the light of Congress’s latest legislation banning federal interference on state medical marijuana laws.
Some insurance companies and state Medicaid programs are requiring drug testing prior to approval of hepatitis C treatment. If your medical provider has prescribed treatment and you use pot, find out if there will be drug testing. If so, educate yourself about the washout period, or how to pass the test; it varies depending on how often you use marijuana.

Drug-Free Pain Control
Ideally, relieving pain without drugs is the safest approach. The trick is to work with a specialist who is trained in the art of introducing drug-free pain measures while slowly reducing pain medication. All sorts of drug-free techniques are used, such as acupuncture, massage, hypnosis. Below are three drug-free techniques worth considering.
 
1. Exercise: I was surprised to learn that exercise topped the list of ways to reduce chronic pain, particularly arthritic and inflammatory pain. Exercise also helps fibromyalgia, migraine headaches and back pain. Aerobic exercise seems to be the best, and the intensity is determined by what you can tolerate. Walking is great exercise because it doesn’t require anything more than a good pair of shoes, sunscreen, and a safe place to walk. Gardening, dancing, bicycling, swimming, yoga, and tai chi are other fun ways to stay fit. If you are new to exercise, be sure to talk to your medical provider before starting. Start slow and only do what feels comfortable. 

2. Meditation: There are countless studies documenting meditation’s profound effect on reducing pain. Personally, I couldn’t imagine sitting still while relaxed, let alone in pain, so I had to experiment with this one myself. It works. It wasn’t as good as a spinal block or sedation, but it was free and without risk. There are many ways to meditate, but probably the most well-known in the U.S. is mindfulness-based stress reduction (MBSR) developed by Jon Kabat-Zinn. MBSR is taught in hospitals, clinics, and communities. 

3. Quitting Smoking:  In “Prevalence and risk factors for patient-reported joint pain among patients with HIV/Hepatitis C coinfection, Hepatitis C monoinfection, and HIV monoinfection,” Alexis Ogdie and colleagues reported that hepatitis C patients who smoked, had higher levels of joint pain. (BMC Musculoskeletal Disorders 2015) (See review of this article by Alan Franciscus here.) Granted, the study did not show that tobacco cessation would reduce pain, but we all know that smoking presents huge health risks. If you do decide to quit, seek professional help. Perhaps MBSR and exercise will help.

Final Words
I have tried to simplify a very complicated subject. Pain management deserves more than I gave it here. In nursing, I learned that pain is the fifth vital sign. In short, pain should be taken seriously. However, the tragic reality is that pain is understudied and poorly misunderstood. Some physicians over-prescribe painkillers; some under-prescribe them. The bottom line is that if your pain is not well controlled, ask to see a pain specialist.

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

Resources
http://hcvadvocate.org/news/newsLetter/2015/advocate0715.html#2

A Brief Overview of Liver Toxic Herbs —Alan Franciscus, Editor-in-Chief

Originally Published July 1, 2015

A recent article appeared in Gastroenterology that provided an overview of herbal products. This review will focus on the important issues regarding the lack of standardization, possible contamination, some deceptive claims and a list of the herbs that have the most potential to harm the liver.

In the February 2015 edition of the HCV Advocate Mid-Month Newsletter, I wrote “Herbal Supplement Crackdown.”  The article was about four major chains selling herbal supplements in New York State that contained substances not listed on the package label.  Even more disconcerting was that many of the listed herbs when tested, could not be verified as being the actual labeled herbs. 
Some of the important issues raised in the current study included:
 
Standardization:
There are many factors that affect the potency of herbs such as what season grown, location planted and how much sun the herbs receive, fertilizer (and how much) used and many additional factors. 
For instance, a list of 25 commercial ginseng products from a local health food store was analyzed for ingredients—the ginseng concentrations were different than listed on the label. The difference in the concentrations could be correlated to the standardizations issues listed above.

Contamination and Adulteration:
Herbal products were tested and found to have pesticides and toxins as well as unlabeled drugs in the herbal products.  These types of issues were also found in the herbs analyzed in the New York herbal crackdown. 

Deceptive Marketing:
There have been advertisements that promote the use of herbs stating that some herbal products can help to treat certain conditions and even cure viral infections.  Herbs may provide some relief from particular illnesses and provide supportive care.  However, there never has been a study that has shown that an herb can cure a viral disease such as hepatitis C.  Be careful about these types of claims.

Most Common Liver Toxic Herbs:
The herbs listed below are the most common herbs that have been found to cause liver toxicity, liver injury, possible liver failure and death.  I have listed the common name (bolded), scientific name and the most common ailments the herb is used to treat:
  • Black cohosh (Cimicifuga racemose):  menopausal symptoms
  • Chaparral (Larrea tridentate): weight loss, rheumatic pain, antibiotic
  • Comfrey (Symphyturn officinale): Wound healing
  • Germander (Teucrium chamaedrys):  Weight loss
  • Greater celandine (Chelidonium majus):  Liver and biliary tract disease
  • Green tea extract (Camellia sinensis): General health, weight loss
  • Herbalife product line (Multi-ingredient): Mental health and weight loss
  • Kava kava (Piper methysticum):  mental health and well-being
  • Hydroxycut (multi-ingredient):  Weight loss
  • Oxy-Elite Pro (multi-ingredient):  Performance-enhancement,  weight loss
  • Saw palmetto (Serenoa repens):  Prostate disease
The good news about herbs is that the New York attorney general and 13 other states are petitioning Congress to investigate the herbal supplement industry.  Additionally, the states are requesting the Food and Drug Administration to provide more oversight to the herbal supplements industry.  Until that time, it is up to the consumer to advocate for themselves, dig deep and to stick to the old warning to consumers—buyer beware.

Resources:
http://hcvadvocate.org/news/newsLetter/2015/advocate0715.html#1