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PART IX: DEALING WITH INTERFERON THERAPY

IX.1.0         General Tips From Schering

IX.2.0         How Does Interferon Work?

IX.2.1         What Will Interferon Achieve?

IX.2.2         Clinical Trials

IX.2.3         Will I Be Able To Continue Work?

IX.2.4         How Will I Know If The Interferon Is Working?

IX.3.0         Side Effects

IX.3.0a       Nausea

IX.3.0b       Hair Loss

IX.3.0c       Fatigue

IX.3.0d       Mouth Problems

IX.3.0e       Infections

IX.4.0         Importance of Water

IX.5.0         Storage

IX.5.0a       Traveling With Interferon

IX.6.0         Timing of Injections

IX.7.0         Injection Hints

IX.7.0a       Inject Ease:

IX.7.0b       Bruising And Diluent Amounts

IX.7.0c       Needle Size

IX.8.0         Help! I Think I Hit a Vein!

IX.9.0         What to do When You Can’t Afford the Interferon

IX.10.0       Interferon Treatment Of HCV With Cirrhosis

 

PART X: WHERE DO WE GO FROM HERE?

X.1.0          Long-Term Prognosis (Am I Going to Die?)

X.2.0          Current Research, Testing, New Drugs

   
 

PART IX - DEALING WITH INTERFERON THERAPY

 “’Tis better to suffer the slings and arrows of outrageous interferon, than to be sawed in half for a transplant.” - Cindy Torchin  cindyt@cpcug.org

Taking care of yourself during your interferon therapy is important. It can lessen some of the physical side effects you may experience.

A few simple tips can make a big difference in how you feel, and knowing some ways to take care of yourself can give your emotions a boost at a time when you may be feeling that much of what’s happening to you is out of your control.

This feeling can be easier to deal with when you discover how much you can contribute to your own well-being. Remember though, that self-help is never a substitute for professional medical care. Be sure to ask your doctor and nurse any questions you may have about your medication, and tell them about any side effects you may experience.

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IX.1.0  GENERAL TIPS FROM SCHERING

To help relieve some of the side effects of Intron A (interferon alfa-2b, recombinant) for Injection therapy, follow this simple A-B-C approach:

·      A  nalgesics such as acetaminophen or ibuprofen can be used to prevent or partially aleviate the fever and headache.

·      B  edtime administration of Intron A therapy will allow you to sleep through the “flu like” symptoms of therapy.

·      C  onserve your energy; try to get plenty of rest.

·      D  rink plenty of fluids; keep yourself well hydrated before and during therapy.

·      E  at balanced meals; make sure your are getting an adequate amount of calories in you diet.

·      F  ocus on the positive; maintain a healthy mental outlook.

The most common side effects associated with Intron A therapy are mild to moderate flu-like symptoms, which usually diminish after the first few weeks of therapy. These may include fever, headache, fatigue, weakness, chills, and muscle and joint pain.

Other frequently occurring symptoms are nausea, loss of appetite, diarrhea, and hair loss. They are common at the start of therapy and should not alarm you. If you have any questions about your side effects or medication, make sure to call your doctor.

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IX.2.0 HOW DOES INTERFERON WORK?

Alpha interferon works differently in the various diseases it is used to fight. In hepatitis C the virus invades and destroys liver cells; interferon lowers the virus population to a level where it no longer causes injury. Interferon helps by stimulating immune cells that in turn repel the invasion. Some hepatitis patients don’t respond to interferon at all; others do, but some of them relapse when they stop taking it.

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IX.2.1  WHAT WILL INTERFERON ACHIEVE:

Even when the interferon does not cure the disease, it can help to put the virus into remission for awhile, giving your liver a much needed break, and helping you to live longer and more comfortably.

A study presented at the AASLD 50th Annual Meeting (Nov 1999) showed that even non-responders to interferon treatment have positive results.  Interferon has been shown to halt and even reverse fibrosis in non-responders, and to slow down the rate of progression by reducing the rate of inflammation, and lowering the viral load.

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IX.2.2  CLINICAL TRIALS:

Your doctor may also suggest that you join a clinical trial for new treatments, or you may want to bring up this option with your doctor. Clinical trials are carefully designed research studies that test promising new HCV treatments. Patients who take part in research may be the first to benefit from improved treatment methods. These patients also can make an important contribution to medical care because the results of the studies may help many people. Patients participate in clinical trials only if they choose to and are free to leave at any time.

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IX.2.3  WILL I BE ABLE TO CONTINUE WORKING WHILE I’M TAKING INTERFERON:   

Most people are able to continue working while they are being treated with interferon. It may be possible to schedule your shots late in the day or right before the weekend, (or whenever you determine your worst side effects - if any - occur) so they interfere with work as little as possible.

If your interferon treatment makes you very tired, you might want to think about adjusting your work schedule for a while. Speak frankly with your employer about your needs and wishes at this time. You may be able to agree on a part-time schedule, or perhaps you can do some of your work at home. Under Federal and state laws, some employers may actually be required to allow you to work a flexible schedule to meet your treatment needs. 

IX.2.4  HOW WILL I KNOW IF THE INTERFERON IS WORKING?

Your doctor and nurse will use several methods to measure how well your treatments are working. You will have frequent physical exams and blood tests. Don’t hesitate to ask the doctor about the test results and what they show about your progress.

While tests and exams can tell a lot about how the interferon is working, side effects tell very little. Sometimes people think that if they don’t have side effects, the drugs aren’t working or that if they do have side effects, the drugs are working well.

But side effects vary so much from person to person, that having them or not having them usually isn’t a sign of whether the treatment is effective. If you do have side effects, there is much you can do to help relieve them. The next section of the FAQ describes some of the most common side effects the people may experience while taking interferon, and gives you some hints for coping with them.

If you are reading this section before you begin taking interferon, you may feel overwhelmed by the wide range of side effects it describes. But remember: Every person doesn’t get every side effect, and some people get few, if any. In addition, the severity of side effects varies greatly from person to person. Whether you have a particular side effect, and how severe it will be, depends on your own particular dosage and injection schedule, and how your body reacts. Be sure to talk to your doctor and nurse about which side effects are most likely to occur for you, how long they might last, how serious they might be, and when you should seek medical attention for them.

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IX.3.0  SIDE EFFECTS

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IX.3.0a NAUSEA

Nausea and vomiting can often be controlled or at least lessened. If you experience this side effect, your doctor can choose from a wide and ever-growing range of drugs that help curb nausea and vomiting. Different drugs work for different people, and it may be necessary to use more than one drug to get relief.

Don’t give up. Continue to work with your doctor and nurse to find the drug or drugs that work best for you.

You can also try the following ideas:

·      Avoid big meals so your stomach won’t feel too full. Eat small meals throughout the day.

·      Drink liquids at least an hour before or after mealtime, instead of with your meals.

·      Eat and drink slowly.

·      Stay away from sweet, fried, or fatty foods.

·      Eat foods cold or at room temperature so you won’t be bothered by strong smells.

·      Chew your food well for easier digestion.

·      If nausea is a problem in the morning, try eating dry foods like cereal, toast, or crackers before getting up.

·      Drink cool, clear, unsweetened fruit juices, such as apple or grape juice, or light-colored sodas, such as ginger ale, that have lost their fizz.

·      Suck on ice cubes, mints, or tart candies.

·      Try to avoid odors that bother you, such as cooking smells, smoke, or perfume.

·      Prepare and freeze meals in advance for days when you don’t feel like cooking.

·      Rest in a chair after eating, but don’t lie flat for at least 2 hours.

·      Wear loose-fitting clothes.

·      Breathe deeply and slowly when you feel nauseated.

·      Distract yourself by chatting with friends or family members, listening to music, or watching a movie or TV show.

·      Popsicles

·      Sea Bands are elastic bands worn around the wrist, with a small built-in “bump” which presses against an accupressure point on your wrist. Many people find these to be extremely helpful for both nausea and dizziness. Sea Bands can be found in most Sporting Goods departments, or fishing supply stores.

·      Peppermint tea works wonders for nausea, as does a small (very small) drop of peppermint essential oil on the tip of your tongue.

·      Many people find chewing on candied ginger helpful. You can find candied ginger available in the spice department, or in the Oriental foods section of your grocery store.  Or you can put a pinch of dried ginger in powder on the tip of the tongue or chew a piece of the root. Or drink a tea: boil one cup of water with a slice of fresh ginger root (or 1/2 teaspoon of dried ginger powder) for 10 minutes. Strain it and add a few drops of lemon.

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IX.3.0b HAIR LOSS

Some people experience hair loss as a side effect of interferon, but it doesn’t always happen. It may range from a slight to moderate amount of hair loss, but I have never seen anyone become completely bald from the dosages given for hepatitis.

The hair grows back after the treatments are over. When your hair does begin to grow back in, it may come in thicker, curlier, or straighter than it did before your interferon therapy.

Hair loss can occur on all parts of the body, not just the head. Facial hair, arm and leg hair, underarm hair, and pubic hair may all be affected.

Hair loss usually doesn’t happen right away; more often, it begins after a few weeks. At that point, hair may fall out gradually or breaks at or near the skin, and the scalp may become tender.  Any hair that is still growing may become dull and dry.

To care for your scalp and hair:

·      Use mild shampoos. 

·      Use soft hair brushes. 

·      Use low heat when drying your hair. 

·      Don’t use brush rollers to set your hair. 

·      Don’t dye your hair or get a permanent. 

·      Have your hair cut short. A shorter style will make your hair look thicker and fuller. It will also make hair loss easier to manage if it occurs.

 

There is a special type of shampoo and conditioner designed specifically for people undergoing chemotherapy. Many people have reported good results using it while taking interferon. The brand name is “Nioxin” and it is sold only in salons.

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IX.3.0c FATIGUE

Fatigue is a common symptom of hepatitis, and it can become worse while you are taking interferon. Here are some things you can do to help yourself feel better:

1.   Get plenty of rest. Sleep more at night and take naps during the day if you can. Try to schedule regular rest periods each day. 

2.   Limit your activities: Do only the things that are most important to you. 

3.   Delegate tasks. Don’t be afraid to get help when you need it. Ask family and friends to pitch in with things like child care, shopping, housework, or driving. 

4.   Eat well, and be sure to include plenty of healthy foods.

5.   When sitting or lying down, get up slowly. This will help prevent dizziness. 

6.   Don’t stand when you can sit. 

7.   Plan your activities and assemble everything before you start. 

8.   Reschedule daily tasks so you do some only 3 or 4 times a week so you have time to rest each day. 

9.   Use a cart, wagon or basket to carry things from one part of the house to the other to eliminate retracing your steps.

10. Sit on a stool in the bathroom while shaving or applying makeup. Prop elbows up on counter if you can. 

11. Use warm, not hot water for baths or showers. Hot water increases muscle fatigue. 

12. If your fatigue is severe, think about asking your doctor for a handicap sticker for your car. 

13. Shop when you are at your peak energy. 

14. When shopping alone, ask a grocery clerk to carry out groceries. 

15. If you arrive home from grocery shopping tired, put away only the perishables. A family member of friend can do the rest. 

16. Shop by phone whenever possible. 

17. Avoid peak shopping/traffic hours.

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IX.3.0d MOUTH PROBLEMS

If mouth dryness bothers you or makes it hard for you to eat, try these tips:

·      Ask your doctor if you should use an artificial saliva product to moisten your mouth.

·      Drink plenty of liquids.

·      Suck on ice chips, popsicles, or sugarless hard candy. You can also chew sugarless gum.

·      Moisten dry foods with butter, margarine, gravy, sauces, or broth.

·      Dunk crisp, dry foods in mild liquids.

·      Use lip balm if your lips become dry.

   avoid food with a lot of condiments (chiles, salt, acidity).

·      If possible, see your dentist before you begin taking interferon to have your teeth cleaned and to take care of any problems such as cavities, abscesses, gum disease, or poorly fitting dentures.

·      Brush your teeth after every meal. Use a soft toothbrush and a gentle touch; brushing too hard can damage soft mouth tissues.

·      If your gums are too sensitive for even a soft toothbrush, use a cotton swab or gauze. Use a nonabrasive toothpaste or a paste of baking soda and water.

·      Rinse your toothbrush well after each use and store it in a dry place.

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IX.3.0e INFECTIONS

Interferon can decrease your white blood cell count (these are the cells that fight infections). Your doctor will check your blood cell count often while you are taking interferon, and if your white cell count falls too low, your doctor may lower the dosage of interferon for a while to give your body a chance to rebuild its defenses.

When your white count is lower than normal, it is very important to try to prevent infections by taking the following steps: 

·      Wash your hands often during the day. Be sure to wash them extra well before you eat and before and after you use the bathroom.

·      Clean your rectal area gently but thoroughly after each bowel movement. Ask your doctor or nurse for advice if the area becomes irritated or if you have hemorrhoids.

·      Stay away from people who have diseases you can catch, such as a cold, the flu, measles, or chickenpox. Also try to avoid crowds.

·      Don’t cut or tear the cuticles of your nails. Use cuticle cream and remover instead.

·      Be careful not to cut or nick yourself when using scissors, needles, or knives.

·      Use an electric shaver instead of a razor to prevent breaks or cuts in your skin.

·      Use a soft toothbrush that won’t hurt your gums.

·      Don’t squeeze or scratch pimples.

·      Take a warm (not hot) bath, shower, or sponge bath every day.

·      Pat your skin dry using a light touch. Don’t rub.

·      Use lotion or oil to soften and heal your skin if it becomes dry and cracked.

·      Clean cuts and scrapes right away with warm water, soap, and an antiseptic.

·      Wear protective gloves when gardening or cleaning up after animals.

·      Do not get any immunization shots without checking first with your doctor to see if it’s all right.

 

Even if you take extra care, you may still get an infection. Be alert to the signs that you might have an infection and check your body regularly for its signs, paying special attention to your eyes, nose, mouth, and genital and rectal areas. The symptoms of infection include:

·      Fever over 100 degrees F.

·      Chills.

·      Sweating.

·      Loose bowels

·      A burning feeling when you urinate.

·      A severe cough or sore throat.

·      Unusual vaginal discharge or itching.

·      Redness or swelling, especially around a wound, sore, pimple, or boil.

 

Report any signs of infection to your doctor right away.

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IX.4.0  IMPORTANCE OF WATER

It is extremely important to drink all of the water that you can stand (and then drink some more) when you are taking interferon. It not only dramatically decreases the severity of side-effects, but there is also a danger of serious kidney infections if you do not drink enough. Milk/soda/coffee/tea don’t count.

You need genuine water.

 

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IX.5.0  STORAGE

According to a Schering representative: Intron is stable undiluted for 7 days at room temp and 30 months in the refrigerator.

Reconstituted Intron is stable for 1 month in the refrigerator and never at room temp.

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IX.5.0a TRAVELING WITH INTERFERON

When flying with interferon, it won’t be affected by going through the x-ray machine. If you are worried about it, you can always just stick it in your pocket and walk through the metal detector. Since the horror of September 11th, it might be advisable to carry your prescription with you, as proof as to why you are carrying syringes.

In order to keep the interferon cool, you can pack it in a Thermos bottle, or freeze a blue ice pack and put it into a soft thermal lunch bag, and wrap the interferon in newspaper so that it doesn’t sit directly on the ice. This should last you for a few days.  Do Not put ice in a glass Thermos.  It can break the glass (personal experience).  If possible get a stainless steel Thermos.  I don’t know if they’re as good, but they don’t break.

When in a hotel you can just fill the ice bucket and then put a glass with the interferon bottles on top so if the ice melts the interferon will not get wet.

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IX.6.0  TIMING OF INJECTIONS

Schering (the manufacturers of Intron-a) recommend giving yourself the injections in the evening so that you can sleep through the worst of the side effects. 

A better idea is to keep track of when your worst side effects occur, and then time your shots so that they occur when you are asleep. For some people, this may even mean giving yourself the injections in the morning.

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IX.7.0  INJECTION HINTS

First, wash your hands before beginning.

Take the box to where you inject, open up the box and take the vial out. 

Clean the injection site with an alcohol wipe.

Wipe the vial top with an alcohol wipe also. 

Now its time to find out where you are going to make a hole. The nursing term is “clean to dirty.” You put the pad at the spot where you are going to inject and using a circular motion clean from that point out a few inches. 

Fill the syringe. Pull the top off the syringe. Pull the cover off the needle. Holding the vial in one hand, have the syringe in the other and brace both hands together. The reason is to not miss the center of the vial and nick or blunt the needle.

(This part applies only to the powdered form of interferon. You can skip this paragraph if you’re using the new pre-mixed, already in the syringe stuff.) Turn the vial upside down and draw in the IF. If its real cold, or the syringe is a 29g or smaller getting the stuff in can be a problem. Let it calm down and push out the air. (vial and syringe still upside down) Then draw to the full dose, occasionally pushing out air bubbles. I draw a little more past the fill level, so if its a 3mil dose instead of the .5cc I go to a couple of small marks beyond .5. Flick the syringe near the vial with your finger, this makes air bubbles gather and go out the needle.

Take the needle out of the vial.

Holding the syringe upside down, and push the plunger to the correct level (e.g., .5cc). This gets rid of any air in the needle. 

With one hand pinch the skin/fat layer at the injection site.

As fast as possible push the needle into the layer with the syringe almost parallel to the skin (hold the syringe similar to the way in which you hold a pencil). The faster the needle goes in the less pain there is. 

Very slightly pull back on the plunger to check for blood. If the syringe fills with blood, it means you’ve hit a vein and need to start the procedure over again.

If there is no blood in the syringe, you can then push the plunger.

Pull the syringe straight back. You get less bleeding if you don’t play twister. Drop the syringe in the sharps container. 

Syringes: I’ve found that the .5cc ½ inch 29 (or 28) gauge insulin syringe to be the best. Gauges that are numbers like 24 or 22 are bigger and hurt more. 

 

Things that happen after injection:

Sometimes there will be a tiny bit of blood after an injection.

This just means you’ve probably popped some capillaries or punctured a small vein. It’s nothing to worry about; just cover it up with a bandage and let it clot.

The day after a shot, a red area is quite normal. They can range from dime size to silver dollar size and may feel hot and tender.

A small area is fine, but if it gets much bigger and hotter, or you see something that looks infected, contact your doctor.

Bruising is also very common after shots.

Sites: Most people use their thighs for injections. Some people find the lower abdominal area (*not* around the belly button) to be the least painful spot for injections. 

Sharps containers: You should be provided with one, either from where you get your interferon (pharmacy or home delivery) or your doctor’s office. If you have a problem getting one, puncture-proof soda bottles can be used to temporarily hold the used syringes until you can take them to your doctor’s office and ask them what to do with them. If you do this enough times, eventually, someone might get the idea you need a real sharps container. If you have children and/or cats, keep your sharps container locked up. The hole is inviting to small hands and paws.

Some find it helpful to numb the injection site beforehand. An icepack (or a bag of frozen peas) placed on the injection site a few minutes ahead of time will make the shot relatively painless.

To help prevent bruising, some people recommend using only half of the diluent provided (this applies to the powdered formulation only, and not to the new pre-mixed syringes).

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IX.7.0a INJECT-EASE:

If you are having a problem giving yourself a shot, ask your pharmacist for a B-D Automatic Injector, Inject-Ease.

They cost about $25.00, and are well worth every penny. You simply load the syringe into the automatic injector, place it on the injection site, and push a button. It is virtually painless, and also makes it much easier to choose a site to inject, thereby giving you more sites per thigh.

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IX.7.0b BRUISING AND DILUENT AMOUNTS

If you are experiencing a lot of bruising after your injections, you may find that it helps to reduce the amount of diluent used when mixing the powdered form of interferon. Schering always overfills their diluent bottles or syringes. When using the powdered form of Intron-A, you only have to use enough diluent to dissolve the powder. 0.4 to 0.5cc is a comfortable volume for subcutaneous injection. The only time you need to absolutely use a known volume is when you use a 3mu vial for multiple doses and you have to know how much you put in so you know how many mu per cc and what the volume will be for fewer than 3mu a dose.

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IX.7.0c NEEDLE SIZE

Many “Interferon Rangers” recommend not using the syringe that comes with your interferon prescription, for the actual injection. Use that one to mix the interferon powder, and buy a box of ½ cc Microfine IV 29 gauge syringes to use for the injection. The needle that comes with your interferon is a fairly large gauge and inserting it through the rubber stopper of the interferon vial dulls it a little. Using a smaller gauge needle will make the injection more comfortable, and using a separate needle to mix the diluent with the powder will keep your injection needle sharper.

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IX.8.0  HELP! I THINK I HIT A VEIN!

When giving yourself an injection, it’s recommended that you pull back slightly on the plunger, to check for blood, before actually injecting. But, occasionally people forget, and it’s almost a sure thing that at least once you will pull the needle out and find blood and bruises. Unless you are injecting into your neck and hit the jugular you have no problem! And even then, with the size of needles we use, it would be real hard to have a bleeding problem. The skin is “rich” with blood supply, so its just a matter of time before you “nail” something that bleeds or shows up as a bruise (not just the normal interferon reaction).

Normally, if you hit an actual vein, there will be no doubt in your mind, as the blood tends to come up into the needle very quickly. If you see that happen before you actually inject, just start over again with a fresh dose. If you only see bruising or a small drop or two of blood, chances are that you only went through some capillaries and it’s nothing to worry about.

The only important thing to do if you are bleeding after an injection is to cover it with a band-aid. Even for long-term interferon users there is enough clotting factor to stop the bleeding in a few minutes. The band-aid is to stop making a mess. Interferon is given intramuscularly and intravenously for other conditions, so even if you are “lucky” enough to find a real vein or vessel the interferon won’t hurt you.

Some people say it is not necessary to discard the dose. The caution against injecting the interferon intravenously is because interferon is very irritating and can cause a slight phlebitis (inflammation of the vein). Also it will be painful once the reaction starts, with swelling and redness. If that ever happens to you first apply cold compresses to keep the swelling down and take your favorite painkiller. If after 24 hours the swelling becomes worse, along with increased pain and redness, apply warm compresses and call your doctor or go to the emergency room.

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IX.9.0  WHAT TO DO WHEN YOU CAN’T AFFORD THE INTERFERON   

Schering-Plough, the manufacturers of Intron-A recombinant alpha-interferon 2b, have a cost sharing program called “Commitment to Care” designed to help those in need of interferon therapy who are unable to afford it. The program is based on a sliding-scale based on your income, with the cost to you ranging from free in some cases, to whatever their scale says you can afford. They will first try to find programs in your State that may help, and if none are found they will determine what you are able to pay and absorb the rest of the cost.

In the US: The number to call for the “Commitment to Care” program is 1-800-521-7157, ext 147.

The interview will take approximately a half hour. Some of the questions you will be asked are:

·      name and address of the prescribing doctor -dosage you will be using

·      when you were diagnosed

·      your income (need to send them tax forms or pay stub to verify) 

·      number of people in household

·      why you are unable to pay

·      cost of your rent or mortgage

·      any outstanding loans

·      amount of credit card debt

·      any savings

 

In Canada:  The number to call is 1-800-603-2754 extension 2121.  According to Mike Betel from HepNet:

In response to the emails concerning anyone who was on the SAP (special access program) for ribavirin, or anyone who has received a prescription for Rebetron from their Physician, reimbursement assistance is available.

C.A.R.E., (The Canadian Advisory Reimbursement Exchange) is the reimbursement assistance number for patients who were prescribed Rebetron. There is a very easy to read booklet available.

The new dedicated line is 1-800-603-2754 extension 2121.  The people at C.A.R.E. are fully bilingual and available from 10:00am to 6:00pm Monday to Friday Eastern Standard Time. After hours, patients can leave their name and number, and a medical professional will call them back the next day. Everything is always confidential!

Concerns like these will be answered.

   I don't know who is supposed to pay for my REBETRON

   I don't think I have coverage

   I have no coverage and I can't afford to pay for it myself

   I have insurance but I can't afford my co-pay or deductible

   I have insurance but they won't pay for REBETRON

   My government plan is too complicated for me to understand

   My government plan only pays for a portion of my REBETRON and I can't afford the rest

   They tell me that my REBETRON is not covered, what do I do now?

 

Also in the US:  IV ONE (800) 892-9622

Call for help with interferon costs. This operation will accept whatever your insurance company will pay as full payment in most cases. For dosages above 3 million units, your physician must write a special request to your insurance company first.

They send your prescription in pre-mixed dosage syringes, alcohol swabs, Band-Aids and a Sharp’s biohazard container for the used syringes, each month by FedEx. They deliver nationally, so their office location does not preclude anyone from using their service.

And the staff is available 24 hours a day to answer any questions or give you any assistance you may need.

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IX.10.0  INTERFERON TREATMENT OF HCV WITH CIRRHOSIS   

In patients with hepatitis C who have cirrhosis, the rate of sustained response following interferon therapy is only half that of patients without cirrhosis. Although it has been suggested that a higher dose regime in patients with cirrhosis may improve response, this remains largely untested. The results of a recent Australian study where cirrhotic patients were given an intense interferon program of 4.5 MIU daily for 24 weeks suggests that future studies in cirrhosis should be carried out exploring higher doses and longer durations of therapy. -  “Interferon Treatment of HCV with Cirrhosis,” Journal of Viral Hepatitis 1997 ;4:85-88

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PART X - WHERE DO WE GO FROM HERE?

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X.1.0   LONG TERM PROGNOSIS (WILL I EVER GET CURED? AM I GOING TO DIE?)

Current studies indicate that most (80%) people infected with hepatitis C will develop a chronic state of infection. About 30% those with chronic infection will go on to develop cirrhosis of the liver. The disease appears to progress slowly, symptoms often do not appear for ten or twenty years.

After an average follow-up of 18 years, a prospective study of patients who received blood transfusions showed no difference in overall mortality between HCV-infected cases and noninfected controls. Liver-related mortality, though rare, was twice as high in the cases (3.2 percent vs. 1.5 percent). A European study showed survival among HCV patients with compensated cirrhosis was 91 percent at 5 years and 79 percent after 10 years. Among patients developing decompensated cirrhosis, however, 5-year survival was only 50 percent. -  National Institutes of Health Statement on Hepatitis C 1997

The latest study shows that incidences of hepatocellular cancer due to hepatitis C and deaths caused by hepatitis C are almost double the rate given a few years ago.  An article in the July issue of Gut reveals that ‘“of the 416 patients, 60 developed HCC with a 5-year rate of 13.4%...and 83 died (including 34 with HCC), with a 5-year death rate of 15.3%.’ According to the authors, these results contrast with previous studies, which cite 5-year mortality rates of 9%, and HCC rates of 5% or 7%.”

The overall severity of chronic hepatitis C is controversial. There is no question that HCV can lead to cirrhosis and hepatocellular carcinoma (HCC) and that end-stage chronic hepatitis C is now the leading indication for liver transplantation. At question is how frequently and how soon these serious consequences occur.

A controlled prospective study (Seeff) has shown that after 20 years of follow-up, patients with transfusion associated hepatitis C had no increase in overall mortality and only a slight increase in liver-related mortality compared to controls who did not develop hepatitis. Another prospective study (Koretz) has shown that the probability of developing clinical cirrhosis or liver related mortality was 20% and 5%, respectively after 16 years; comparable values were 24% and 3% in the NIH series. The paradox between the relatively benign mortality figures and the observed fatal outcomes resides in the indolent nature of progressive HCV infection.

Progression is generally measured in decades and most subjects acquiring infection in mid-life or later will succumb to their underlying disease or old age before they develop end-stage chronic hepatitis C. By inference, it appears that the HCV mortality risk is approximately 4% in the first two decades and the risk will increase over time in those that do not succumb to other events.  “Natural History and Clinical Aspects of HCV Infection.” H.J. Alter. Department of Transfusion Medicine, National Institutes of Health, Bethesda, Maryland. Cancer Biotechnology Weekly, 01-29-1996, pp 20.

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X.2.0   CURRENT RESEARCH, TESTING AND CERTIFICATION OF NEW DRUGS AND TREATMENTS IN THE U.S. AND ABROAD

There is a great deal of research going on, regarding the possible prevention and treatment of hepatitis.

The following table is from the website at http://www.frontiernet.net/~monty/hcvpipel.html and was last updated August 16, 2001. © Frank Montmarquet.

HEPATITIS C NEW DRUG PIPELINE

Drugs specific for Hepatitis C

Company

Drug Type

Development
Pre Clinical
Clinical Phase I
Clinical Phase II
Clinical Phase III
NDA

Boehringer Ingelheim  

Protease Inhibitor BILN2061  

xxxxxxxxxxx

xxxxxxxx

xxxxxxx

 

 

 

Intercell  

Therapeutic vaccine

xxxxxxxxxxx

xxxxxxxx

xxxxxxx

xx

 

 

Viro Pharma  / AHP

New lead

xxxxxxxxxxx

xxxxxxxx

 

 

 

 

Isis Pharmaceutical

 ISIS 14803 Antisense

xxxxxxxxxxx

xxxxxxxx

xxxxxxx

xxxxxxxx

 

 

XTL

Monoclonal antibody

xxxxxxxxxxx

xxxxxxxx

xxxxxxx

 

 

 

Innogenetics

Therapeutic vaccine

xxxxxxxxxxx

xxxxxxxx

xxxxxxx

xx

 

 

Enzo Biochem

Immune Regulator

xxxxxxxxxxx

xxxxxxxx

xxxxxxxx

 

 

 

Rigel Pharm

 R803

xxxxxxxxxxx

xxxxxxxx

xxxxx

 

 

 

Epimmune / Genencor

Therapeutic vaccine

xxxxxxxxxxx

xxxxxxx

 

 

 

 

Ribapharm

Viramidine

xxxxxxxxxxx

xxxxxxx

x