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:

• Harvoni (sofosbuvir/ledipasvir) FDA-Approved Prescribing Information
• Harvoni (sofosbuvir/ledipasvir) Patient Information
• Sovaldi (Sofosbuvir) FDA-Approved Prescribing Information
• VIEKIRA PAK FDA-Approved Prescribing Information
• Ribavirin Warning!

http://hcvadvocate.org/news/newsLetter/2015/advocate0715.html#4

Patients First: Overview – Preparing for Treatment: Part 2, by Alan Franciscus, Editor-in-Chief

Part 2 of this article discusses Medical Tests, Medications and Side Effect Management, among other things.

Medical Tests:
There may be tests your medical provider will order before you start treatment:

• Pregnancy test—If ribavirin is part of your treatment you will need to verify that you are not pregnant before starting treatment.  This is also true if you are a female partner of a male patient starting treatment.
• HCV-RNA or viral load test—This is used to confirm active infection and as a baseline test. 
• Genotype test—This test determines the strain of hepatitis C—there are seven genotypes.  Genotype 1 is the most common followed by genotype 2 and 3.  Genotype information is used to determine what HCV treatment to take and for how long to take it.
• Baseline tests—These include a variety of tests, such as a complete blood count (CBC), diabetes, thyroid and liver tests.  Your general health will be assessed, especially if you are older than 40 or 50 years old or at risk for various medical problems. 
• Medical and dental procedures—In some cases, it may be a good idea to have any serious medical, and dental procedures completed well in advance prior to beginning HCV therapy.  If the medical or dental procedure is not severe, you may be able to postpone it until after treatment, so your body has a chance to recover from treatment. Discuss this with your doctor.
• Immunizations—You can be immunized while on treatment.
• Anxiety—Current therapy can cause anxiety and though uncommon, depression. Talk with your medical provider if you are concerned about this.  Medication can provides relief relatively quickly. 

Medications
HCV treatment consists of pills.  Talk to your medical provider about how and when to take them.  Be prepared—ask your medical provider ahead of time if you miss a dose, when you should take the next dose.  If you plan on traveling, make a copy of your prescriptions to take with you. 
You may have to use a specialty/mail order pharmacy, rather than a brick and mortar pharmacy like Walgreens or CVS.  They both have similar services:

• Specialty pharmacies ship to your home or office.  With a regular pharmacy you control where and when to pick up the prescription.
• Both can offer support services—nurses, websites and other services to help manage your therapy.
• Both can remind you when to re-order or will automatically refill orders.

Side Effect Management
A favorable treatment outcome is associated with your ability to stay on the prescribed dose of medication for the entire duration of treatment.  In addition, completion of treatment goes hand in hand with good side effect management—this means treating the side effects before they become worse.  For more information about side effect management see the Resource section at the end of this article. 

Treatment side effects are usually temporary and should gradually fade away after treatment is completed.  This may take weeks or months; rarely up to a year. 

The most common side effects of current therapy are fatigue, headache, nausea, diarrhea, and insomnia.  However, it is important to know that not everyone has these particular side effects, and most people do not have severe side effects.  In clinical trials for current therapies, less than 1% of individuals had side effects that required discontinuation of treatment.

Preparing Your Body
HCV treatment is a process that requires getting the mind and body ready and in shape.  Alcohol, especially in large quantities, can accelerate HCV disease progression.  Some insurance companies and medical providers are denying HCV treatment to people who consume alcohol and drugs, including medical marijuana.  You may be required to abstain from alcohol and drugs for 6 months and attend a 12-step program.  Talk to your medical provider about any concerns or questions. 

Light to moderate exercise is recommended for most people with hepatitis C.  Check in with your medical provider before starting any exercise program.  Before beginning treatment, slowly build up to a comfortable level.  There are many ways to get exercise such as walking, yoga, and dancing to name a few.

Birth Control
If ribavirin is part of HCV treatment:
Women of childbearing age, their partners and female partners of male patients taking ribavirin must practice two forms of reliable contraception during to 6 months post-treatment.

It is essential that pregnancy be avoided throughout treatment and for six months after treatment has ended.  The guidelines are to use two reliable forms of birth control.  Reliable means using medically accepted contraceptive methods and using them correctly.  Whatever you choose, know how to use the method correctly.  Also, notice the word two.  This means that if you use two forms of birth control and one fails, then you have back-up protection.  If you or your partner needs information about birth control, talk to your medical provider or family planning center. 

Pill Containers/ Calendars
It is important to remember to take the pills every day.  The makers of HCV drugs make it very easy, but no one is perfect.  Plan ahead—get a calendar.  Mark off the day when you take the pill(s).  This can be a great motivation to know that you have completed one day of treatment, and you can look forward to the end of treatment and hopefully a cure. 

A Final Word
It is important to set a goal before treatment.  Why do you want to be treated?  Write them down and refer to them while on treatment.  It is an excellent way to stay motivated.  Just remember that, even though, the cure rates are very high not everyone can be cured at this time.   Planning ahead and staying the course will give you the best opportunity to be cured, and that is really all you can do.

Resources: Patient Assistance Programs

• Help with Medicines
  www.hcvadvocate.org/hepatitis/easyfacts/
  e_Patient_Assistance.pdf
• Patient Assistance Programs
  www.hcvadvocate.org/hepatitis/factsheets_pdf/
  Patient_Assistance.pdf
• Pregnancy Drug Categories
  www.hcvadvocate.org/hepatitis/factsheets_pdf/
  Treat_pregcat.pdf
• Making Treatment Decisions
  www.hcvadvocate.org/hepatitis/
  Treatment_Decisions.asp

For Part 1 of this article click here

http://hcvadvocate.org/news/newsLetter/2015/advocate0515.html#2

Patients First: Price Wars, Treatment Outcomes, Longevity Alan Franciscus, Editor-in-Chief

This month’s Patients First is full of good news (for a change) for patients.  The HCV price war between Gilead and AbbVie is lowering drug prices, which will hopefully equal more treatment access for patients.  Curing hepatitis C improves emotional well-being and improves long-term survival in people with cirrhosis.

Price Cuts/Value
Since AbbVie’s approval  of Viekira Pak to treat HCV genotype 1 there have been many negotiations between the various insurance companies and pharmacies for price reductions.  This has led to steep price cuts.  The California Technology Assessment Forum (CTAF) met earlier this year and voted that Harvoni represented a “LOW” health system value based on the price of $95,000 for the 12 week price.  CTAF reasoned that this would increase Medicaid costs by over 5% in a single year if all patients with HCV were treated.  Now, that the price is in the $34,000 to $42,000 range for the average course of therapy, CTAF has changed its assessment to “HIGH” health system value.  This is good news for the state Medicaid budgets and patients.  Hopefully, this will translate  into treatment for more patients.

 

Treatment: Mental and Physical Health Outcomes
The Chronic Hepatitis Cohort Study (CheCS) is a large ongoing national study.  Electronic health records from four sites for the period between 1/1/2006 and 12/31/2010 were provided for this study.   Overall 4,781 surveys were completed.  Of these, the average age was 57 yo, 71% were white, 57% male, 51% had past injection drug use, 34% were current smokers, and 18% abused alcohol in the past year.  In regards to treatment, 47% had been treated previously and 15% had achieved SVR12.

Overall, about 30% met the criteria for depression—this compared to 9% of the general population who have depression.  About 25% of those with hepatitis C had poor physical health—this is a very large number for any disease condition.

The article discussed how having depression and being on interferon-based therapy affected many areas of life more than interferon-free therapies, “However, achieving SVR was associated with improved emotional well-being—at least the absence of depression—in these patients.  Conversely, there appeared to be little physical or mental health benefit for those who did not achieve SVR, for whatever reason, after starting antiviral therapy.”

 

Curing HCV = Living Longer
A recent study from the Netherlands sheds some very positive light on how being cured affects long-term survival. The researchers analyzed data between 1990 and 2003 from 5 hepatology centers in Europe and Canada.  The patients were treated, and were followed beginning 24 weeks after treatment ended.  Follow-up was competed in 454 patients—median age was 48, most were male (70%) and 36% patients were cured.  The median follow-up period was 8.4 years (6.4 to 11.4 years).  Importantly, all of the patients had advanced fibrosis.

The 10-year survival of the people who were cured was 91%, which did not differ from the age- and sex-match of the general population – in other words being cured of hepatitis C and advanced fibrosis meant that people would live as long as someone without hepatitis C—that’s pretty important and impressive.


http://hcvadvocate.org/news/newsLetter/2015/advocate0315.html#3

Patients First: HCV and Depression —Alan Franciscus, 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. 

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

Diagnosis:  After a diagnosis of HCV, 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://www.hcvadvocate.org/hepatitis/factsheets_pdf
  /Patient_Assistance.pdf
  

http://hcvadvocate.org/news/newsLetter/2015/advocate0115.html#3