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What treatment is available?
Currently there is no cure or vaccine for HCV, however medications are available to slow down or stop the damage to the liver that HCV can cause. The primary medication available to treat HCV is interferon. There are several interferons available on the market, and your health care provider can recommend the one that is most appropriate for you. The following chart summarizes the interferon products:

What are the side effects of interferon products and how do I manage them?
Like all medications, interferons do have side effects. The key to successful treatment and outcomes with interferon therapy is learning how to manage these side effects and communicating with your doctor and pharmacist so they can help you. Below is a list of common side effects experienced by patients while on interferon therapy. Remember, you may experience only one or two (or none) of these side effects. After each, you will find valuable information and tips on how to manage the possible effect.

1. Flu-like symptoms - By far, this is the most common side effect experienced by patients undergoing interferon treatment. Flu-like symptoms commonly present as fever, chills, muscle aches and pains, and headaches. Many patients will consider stopping treatment because of these very troublesome side effects, however they can be managed. Furthermore, most of these symptoms disappear after a few weeks of interferon therapy. Some suggestions to minimize flu-like symptoms are:
   • Perform the injection at bedtime, so that you sleep through most of the symptoms.
   • During the day, drink lots of water to keep yourself hydrated. It is best to steer clear of alcoholic and caffeine-containing beverages, and stick to water.
   Discuss this side effect with your health care professional if it becomes troubling to you, so that management strategies can be identified. Your doctor may recommend acetaminophen or ibuprofen to minimize flu-like symptoms, however you should not take these without speaking to your doctor first.

2. Fatigue - Fatigue, or loss of energy can be a very troubling problem to patients who are normally very energetic and "on the go". Again, administering the interferon at bedtime can be helpful to overcome this side effect. Getting plenty of sleep, as well as light exercise can be invigorating. It is also important to stick to a balanced diet and maintain adequate fluid intake - this can be as much as 10-12 glasses of water (or as much as you can manage). Although these tips apply to any healthy lifestyle, they can be particularly effective in overcoming fatigue or the feeling of tiredness.

3. Depression/Mood changes/Anxiety - Many patients report psychological symptoms such as these while taking interferon. These are serious side effects and should not be ignored. Contact your doctor right away if you experience any of the following:
   • Sadness, hopelessness, anxiety
   • Difficulty sleeping and/or concentrating
   • Weight loss or weight gain
   • Loss of interest in favorite activities
   • Thoughts of suicide or death
   Help is available and your doctor will recommend the most appropriate treatment for you.

4. Gastrointestinal symptoms - Gastrointestinal symptoms include nausea, vomiting, diarrhea, decreased appetite, and stomach pains. You may experience one or more (or none) of these side effects. Some suggestions to overcome these effects include eating more frequent, small meals throughout the day, rather than few large meals. It is easier for your body to digest small meals than large ones. If you are experiencing nausea, avoid greasy and fattening foods. Drink plenty of clear fluids, and try a light exercise routine if possible. If you do experience substantial weight loss, report this to your doctor. Most importantly, check with your health care provider before taking any over the counter preparations to treat nausea or diarrhea.

5. Skin reactions - As with many injectable medications, interferons may cause irritation at the site of injection. This can include redness, swelling, or itching. The best method to overcome this side effect is to rotate injection sites - in other words, avoid injecting in the same spot as your last injection. Also, use a moisturizing, non-perfumed soap for showers and baths to prevent your skin from drying. If you notice severe redness and swelling at the injection site, contact your doctor.

• Thyroid problems
• Elevated blood sugar
• Heart problems - rapid heart rate, high blood pressure
• Thinning hair - which is reversible when stopping interferon
• Low platelets and/or low white blood cell counts

Side effects of ribavirin (Rebetol®) - If your doctor recommends Rebetron for the treatment of your hepatitis, you should know that this treatment consists of 2 medications - an interferon (Intron-A) and a daily oral medication called ribavirin (Rebetol). Ribavirin does not work by itself for the treatment of HCV, and therefore must be taken together with Intron-A. If you are taking this combination therapy, you should be aware of the side effects that are associated with ribavirin. The most common one is anemia (low red blood cell count), which may cause you to feel drained, fatigued, or tired. Your doctor will monitor your blood during treatment with ribavirin to make sure that your anemia is under control. Other side effects associated with ribavirin include fatigue, irritability, and skin rash. One important side effect to know is that ribavirin may cause birth defects, therefore if you are a woman who is taking this Rebetron, be sure to use appropriate contraceptive methods. If you do become pregnant, notify your doctor immediately.

How is my treatment monitored?
When you are prescribed interferon therapy for HCV, your doctor will schedule appointments to see you periodically in order to measure the effectiveness of the treatment, evaluate any side effects you may be having, and check your bloodwork. Monitoring the bloodwork is very important during interferon and interferon/ribavirin combination therapy because it can notify the physician of any problems and will allow him/her to modify your therapy appropriately. Depending on the side effects that you experience, your doctor may decrease your dose accordingly.

How is treatment initiated, and how effective is it?
It is best to break up the answer to this question into 3 sections

1. patients who have never been treated
2. those who have been treated, but relapsed
3. patients who were treated, but never responded ("nonresponsers").

Patients who have never been treated with interferon, and can take ribavirin If you are a patient who has never been treated before with interferons for HCV AND you have no reasons that would preclude you from taking interferon or ribavirin, the most effective treatment modality available is combination therapy with interferon and ribavirin. It is important to note that combination therapy with pegylated interferon and ribavirin has recently received FDA approval. Physicians can now prescribe PEG-Intron and Rebetol combination therapy. As a pharmacy specializing in HCV, PharmaCare is among the first pharmacies to stock this new combination.

Patients who received combination treatment with these medications have had sustained viral responses (SVR) of 33% after 6 months of treatment and 41% after about a year of treatment. SVR means that a patient has no detectable HCV RNA (antibodies to HCV) in their bloodstream 6 months after discontinuing treatment.

Patients who have never been treated with interferon, but can not take ribavirin (see "Is there any reason I could not take ribavirin?") - Interferon therapy without ribavirin is recommended only if you can not take ribavirin or can not tolerate it due to its side effects. The response rates for interferon monotherapy (only interferon, without additional medications) are 8% if given for 6 months and 12% if given for 12 months. These rates correspond to a dose of 3 MIU 3 times a week. It has been shown that using higher doses of interferon or administering it daily does not improve the response rate. Patients should have an HCV RNA test performed after 3 months of interferon monotherapy. If HCV RNA is detectable at this time, interferon should not be continued.

Pegylated interferon is also indicated as monotherapy -and most recently in combination with Rebetol- for patients with existing liver disease who have not been treated before with interferons. Therefore, this novel treatment may be used in patients who fall under this category (patients who have never been treated). Remember, pegylated interferon is still a relatively new and exciting therapy, but its optimal role is still being determined.

Patients who were previously treated with combination interferon and ribavirin - At this time, there is no definitive data to indicate that retreatment for patients who have relapsed after combination therapy is beneficial. Therefore, the treatment plan for these patients will be individualized based on their current clinical status and the doctorıs protocol. Clinical studies are in progress to evaluate whether pegylated interferon may be of value for these patients. Patients who were previously treated with only interferon (monotherapy) - Patients who have previously been treated with interferon monotherapy may benefit from retreatment with a higher dose of interferon OR combination therapy IF there arenıt any reasons that preclude the patient from taking ribavirin (see "Is there any reason I could not take ribavirin?"). Patients who were retreated with high dose interferon monotherapy (15 mcg 3 times a week) following relapse, had response rates of 28% after 24 weeks of treatment and 58% after almost a year of treatment. Relapsers who received prior monotherapy and were subsequently treated with combination therapy for 6 months experienced response rates of 49%. Therefore, retreatment for this patient group is reasonable.

Unfortunately, at this time there are no solid answers regarding treatment of patients who do not respond to interferon therapy. 'Nonresponse' is defined as having detectable HCV RNA at the end of a course of therapy - meaning the HCV was never cleared. Unfortunately, it has been estimated that as many as 60% of all patients who receive combination interferon + ribavirin are non-responders. Clinical studies are currently in progress to determine if pegylated interferon in combination with ribavirin, dosed based on weight, is a viable option for non-responders.

Other clinical studies have indicated that interferon treatment in non-responders may still be beneficial because it can reduce the progression of liver damage. So, even though the HCV is still present, the interferon may still be having some protective effect on the liver.

In summary, there are no clear guidelines on the treatment of non-responders. The treating physician will evaluate each patient on a case-by-case basis and determine the optimal treatment strategy.

• Allergy to interferon or a component of the product
• Hepatitis is due to an autoimmune cause, rather than a virus like HCV
• Present or past history of psychosis or severe depression
• Very low white blood cell count
• Very low platelet count
• Organ transplant (except liver)
• Pregnancy or breast feeding
• Autoimmune disorders, such as lupus, psoriasis, thyroiditis, etc.

• Coronary artery disease
• Diabetes
• Pre-existing anemia
• Kidney disease

Your doctor should evaluate your preexisting conditions to determine if you can take ribavirin.

Your HCV care team and you

What doctors specialize in the treatment of HCV?
When seeking a physician, be sure to ask about their fellowship training, and approximately how many patients they treat who have HCV. If you are HCV/HIV co-infected, it is particularly important to inquire how many patients they treat with this dual diagnosis.

• Infectious disease specialist
  An infectious disease (ID) specialist is expert in treating all infections, bacterial, viral, parasitic, etc. ID doctors attend medical school, then complete an internal medicine residency program, followed by fellowship training in ID. These individuals are extremely knowledgeable about different disease-causing "bugs" and the antibiotics and antiviral agents available to treat them. These physicians can recommend appropriate treatment regimens for infectious conditions and are highly skilled in managing the drug therapy. They should be very familiar with modifying treatment regimens in accordance with the latest therapeutic guidelines and in case the patient experiences particular side effects or is unresponsive to treatment. In some cases, ID doctors develop specific specialties and focus areas. For example, since the AIDS epidemic began in the 1980ıs, many ID doctors have developed a practice focused primarily on caring for patients infected with HIV. For individuals co-infected with HIV and HCV, an ID specialist who treats this patient group may be a good place to start if looking for a physician.

• Hepatologist
  A hepatologist is an expert in the field of diseases associated with the liver. A hepatologistıs training consists of medical school, then an internal medicine residency program, followed by fellowship training in hepatology or gastroenterology and hepatology. A hepatologist is intimately familiar with the structure and function of the liver. They are able to screen, diagnose, and treat conditions of the liver. Hepatologists also work closely with liver transplant recipients and are able to manage their care on an inpatient and outpatient basis. These doctors have skills and ability to manage patients with complicated issues surrounding the liver.

• Gastroenterologist
  A gastroenterologist is a specialist of the gastrointestinal tract. A gastroenterologist's training consists of medical school, then an internal medicine residency, followed by a gastroenterology fellowship. Some gastroenterology fellowships allow the physician to focus on a particular field on interest, namely hepatology (study of the liver). Gastroenterologists are not necessarily liver specialists - it is important to ask this when looking for a doctor. A typical gastroenterologist is intimately aquatinted with conditions of the esophagus, stomach, and bowels (small and large intestine). A sub-specialty for some gastroenterologists is hepatology, however all gastroenterologists are familiar with treating routine conditions of the liver.

Why would HCV medications require a specialty pharmacy or expert pharmacist?
Much like choosing a specialist to diagnose and treat HCV, it is equally beneficial to choose a specialty pharmacy that is experienced with HCV for the provision of your pharmaceutical care needs. Like a doctor who is a specialist in treating only conditions of the liver, a specialty pharmacy is an expert in providing pharmaceutical care to certain groups of patients. This means that the pharmacists are experts in the drug therapy management of certain disease states like HCV. They will have undergone rigorous and extensive education in managing complex medication regimens, and are able to address difficult questions with authority and know-how. Also, your pharmacists need to be available around the clock, 7 days a week, 365 days a year, because your HCV medication-related issues do not necessarily occur 9 to 5. The pharmacy should be able to ship the medications to you or have them available to pick up, depending on your preference. A specialty pharmacy (like CVS ProcCare) can address any issue revolving around your medication needs because it benefits from the experience that comes with a specialized focus -as opposed to a retail pharmacy which provides care to patients with any diagnosis. A specialty pharmacy can be especially important when issues involving co-infection and multiple medication regimens arise. Whatever pharmacy you choose, make sure they work together with your general practitioner and specialist to monitor for potential drug interactions. Since many medications put additional stress on your liver, it is especially important for individuals with HCV to talk with your doctor or pharmacist about any concerns you may have or side-effects you may experience.

Living Well with HCV

What else can I do?
If you have been diagnosed with HCV and are under the care of a specialist, there are various steps you can take to help maintain a healthy lifestyle with HCV while preventing the transmission of HCV to your friends and associates.

1. Avoid alcohol. The most important thing is to avoid alcohol consumption completely. Alcohol can accelerate liver damage and make the liver resistant to interferon therapy. There is no safe amount of alcohol to drink if you have HCV. Complete abstinence is essential.
2. Stop smoking. Stopping smoking is also critical to maintain wellness. Smoking can increase the risk of developing liver cancer in HCV patients. Furthermore, liver disease is worse in HCV patients who smoke compared to those who do not.
3. Use precautions to prevent transmission. It is important to know that HCV can be transmitted to your friends and intimate contacts (see How is HCV contracted?). To prevent transmission,
   Use barrier contraceptives for sexual activity
   Properly dispose of needles and syringes in appropriate containers
   Do not share needles, toothbrushes, razors, etc.

Complementary Therapies -Can herbal products help?
Numerous herbal products are available on the market, and frequently patients may ask if there is a natural supplement to help in the treatment of HCV. There is no proven effective herbal product for HCV, however milk thistle has anecdotally been used for this indication. Unfortunately, no clinical evidence is available to support its efficacy, however it does not appear to be harmful. More scientific studies and investigations will have to be conducted to determine if milk thistle can slow down, prevent, or reverse liver damage in patients with HCV.

Another product that may have a possible benefit for HCV is Vitamin E. Vitamin E is essentially free from side effects, and in doses of 400-800 IU per day has been effective in reducing ALT values in patients with chronic HCV. The significance of lowering ALT values in individuals with HCV, however, is unknown at this time.

Just as important as it is to know about natural products that can be helpful, it is equally important to know about herbal products that can be harmful or even dangerous to take for individuals with HCV. Below is a list of herbal products that should be avoided since they may cause liver injury.

Herbal Products to Avoid for Patients with HCV

• Comfrey
• Chaparrel leaf
• Chaparrel
• Gordolobo herbal tea
• Germander
• Mate tea
• Margosa Oil
• Mistletoe
• Pennyroyal Oil
• Valerian root
• Skullcap mixture
• Chinese herb preparations
  Medicinal tea
  Tu-san-chi
  Jin Bu huan

Adapted from Practical Hepatitis Update, 1(5), June/July 2000.

Is it safe to take over-the-counter (OTC) medications?
If you have HCV, you should check with your doctor or pharmacist before you take any OTC product. Many OTC products (ex. Acetaminophen) are metabolized by the liver, or can cause liver damage when taken in higher doses. Since patients with HCV may already have existing liver damage, their liver may not be able to metabolize medications as efficiently as someone without HCV. This may result in drug toxicity or further exacerbate liver injury.

For more information about PharmaCare's specialized pharmacy services and HCV Pharmacy Program call us toll-free at 1-800-238-7828.

This information is provided for educational purposes only. It is not intended to be a substitute for medical advice or treatment from a health care provider or to cover all possible uses, actions, precautions, side effects or interactions. Like any printed material, it may become out-of-date over time. If you have other questions, you should discuss them with your physician or PharmaCare Pharmacist.

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