- Treating HCV
- Treatment Results
- Follow Up
- Side Effects
- Improving Response
- Am I Eligible?
- More Information
Until recently, there were only two drugs approved for the treatment of hepatitis C (pegylated interferon and ribavirin). These medications are taken for a limited period of time, not lifelong. In May 2011, the U.S. Food and Drug Administration (FDA) approved two new drugs: boceprevir (Victrelis) and telaprevir (Incivek). Both are intended to be used in combination with the existing drugs.
Patients sometimes ask whether there are ways to treat hepatitis C other than taking medicines. There are no vaccines to prevent hepatitis C, and once a person is infected, the only way to treat it is with drugs. Some patients worry that having hepatitis C means they will need a liver transplant. Although a fraction of people with hepatitis C do require a liver transplant, most people with hepatitis C do not. A transplant is performed only when damage to the liver is extremely advanced and the liver is unable to perform its basic functions. A transplant provides a new liver, but a transplant does not actually cure hepatitis C. It does not get rid of the virus.
Why use Medications for Hepatitis C?
The purpose of using medications for hepatitis C is threefold:
- To clear the hepatitis C virus from the bloodstream
- To slow down or prevent progression of inflammation and scarring in the liver
- To reduce the likelihood of developing cirrhosis and liver cancer
Also, if patients have complications outside the liver, such as hepatitis C-related kidney problems, then these medications can be used to treat the kidney problems as well. But this is not the most common reason to use hepatitis C drugs. Most often, the drugs are used solely for the purpose of preventing further liver damage.
Most patients with hepatitis C usually do not have any symptoms, and the drugs for hepatitis C virus are not intended to manage any symptoms (such as fatigue or abdominal pain) that they do have. More often, the drugs themselves have side effects, and patients can feel more run down during the time when they are taking hepatitis C medication.
What Medications are Available for Hepatitis C?
- Interferon alpha (short acting) Initially, this was the only medication available and it was used alone; later, it was used in combination with ribavirin. It is rarely used at all now.
- Pegylated interferon alpha (long acting) 2 types are available. Pegylated interferon has essentially replaced the use of short-acting interferon. It can be used alone, but almost always is used in combination with ribavirin.
- Ribavirin This is used only in combination with interferon; it never can be used alone.
What is Interferon?
The drug interferon is similar to a protein made by your own body. The protein is part of the body’s natural defense system and helps the body fight infection. And since hepatitis C is an infection, it makes sense that the drug would benefit patients with the disease. The drug not only attacks liver cells that have been infected with the hepatitis C virus, it also protects healthy liver cells so that they are more resistant to infection.
How are these Drugs Taken?
Pegylated interferon is a solution, self-injected by the patient, under the skin, once per week, during the time period of treatment.
Ribavirin is a pill, taken by mouth, twice per day, every day, during the time period of treatment.
The Advantage of Combining Drugs
Pegylated interferon and ribavirin taken together give the patient the highest chance of permanently clearing the hepatitis C virus from their body so there is no detectable hepatitis C virus at all in a blood sample. This combination has higher rates of treatment success than any type of interferon taken alone, and higher than the short-acting interferon combined with ribavirin.
How Long is the Treatment?
For most patients taking the combination of pegylated interferon and ribavirin, the recommended duration of treatment is 48 weeks.
For patients with genotype 2 or 3 who do not have cirrhosis, the recommended duration of treatment may be 24 weeks.
- A class of drugs, called protease inhibitors (because of the way they act to stop the virus), has been investigated as a third type of medication that can be used to treat hepatitis C. The new drugs boceprevir and telaprevir are protease inhibitors.
- Either of these drugs can be used in combination with pegylated interferon and ribavirin, for a 3-drug combination treatment.
- Neither telaprevir nor boceprevir can be used alone, and neither can be used only with ribavirin. They must be used together with both pegylated interferon and ribavirin.
- The benefit of these 2 new drugs is that they increase the likelihood of treatment success for patients with genotype 1 hepatitis C infection.
How Likely is it that Treatment will Work?
- Sustained virologic response (SVR): a complete response; the hepatitis C virus becomes undetectable during treatment and remains undetectable 6 months after treatment has been completed and stopped
- Nonresponse: the hepatitis C virus did not become undetectable as a result of the treatment; there was virus measured in the blood through the treatment course
- Relapse: the hepatitis C virus does become undetectable but then becomes present in the blood again, either during treatment or after treatment is stopped.
The aim of the treatment for hepatitis C is to have an SVR. This means the patient is cured.
Factors that Affect Treatment Results:
Many factors determine the likelihood of achieving an SVR. The most important factor is the genotype of the patient’s hepatitis C. Viruses have genes, and based on its genes, the hepatitis C virus belongs to a particular group, called a genotype. Three in four hepatitis C patients in the U.S. have genotype 1 (1a or 1b), and the rest have type 2 or 3. In the past, treatment was more likely to work in patients with genotype 2 or 3. The benefit of these 2 new drugs is that they increase the likelihood of treatment success for patients with genotype 1.
Other factors that make it more likely the treatment will result in an SVR:
- A low hepatitis C viral load
- Female patient
- Younger patient
- Moderate scarring of the liver (fibrosis) but not severe scarring (cirrhosis)
- Ability to take the medications properly and at the full prescribed dosage
- Shorter time of having hepatitis C infection
Expected Treatment Results
A 3-drug regimen (pegylated interferon + ribavirin + either boceprevir or telaprevir) significantly increases the likelihood of an SVR for genotype 1 patients.
The SVR rates of telaprevir and boceprevir cannot be directly compared to each other because no study has looked at them head to head. (Each has been studied only in comparison to pegylated inteferon + ribavirin alone.) The SVR rates of telaprevir and boceprevir, however, are very similar overall.
In genotype 1 patients being treated in trials:
Telaprevir trials: Pegylated interferon + ribavirin alone = 44% SVR With the addition of telaprevir = 69-75% SVR
Boceprevir trials: Pegylated interferon + ribavirin alone = 38% SVR With the addition of boceprevir = 63-66% SVR
How will your Doctor Monitor you During Treatment?
In addition, many blood tests are necessary during the course of treatment and for 6 months after treatment is stopped. Each doctor should give you a schedule of planned visits and blood tests during the treatment course.
The blood tests will include:
- ALT, or alanine aminotransferase: this is one of the “liver enzymes” and the level usually comes down if the treatment is working
- White blood cells and neutrophils: the white blood cell and neutrophil “count” can be reduced by taking interferon. If it comes down a little bit, that is usually fine. If it comes down too much, then sometimes your doctor will either adjust the dosage of the pegylated interferon or add another medication (called GCSF) to boost the cell count back up.
- Hemoglobin and hematocrit: the red blood “count” is measured by hemoglobin and hematocrit, it can be reduced by taking ribavirin. If it comes down a little bit, that is usually fine. If it comes down too much, then sometimes your doctor will either adjust the dosage of the ribavirin or add another medication (called Procrit) to boost the cell count back up.
- Platelets: the platelet “count” can be reduced by taking interferon. If it comes down a little bit, that is usually fine. If it comes down too much, then sometimes your doctor will adjust the dosage of the pegylated interferon.
How is the virus checked during the treatment?
The level of hepatitis C virus should be checked often during the course of treatment. It usually is checked with 2 types of measurements:
- HCV RNA quantitative test: “the viral load”; this test measures the exact amount of virus in the bloodstream and is reported in international units per milliliter (such as 2,462,514 IU/mL).
- HCV RNA qualitative test: this test determines only the presence or absence of any detectable virus in the bloodstream. It is reported as “detected or not detected” but there is no number of viral units reported. This test is able to detect very, very low levels of virus. Sometimes, if there is a very small number of HCV viral units in the bloodstream, the quantitative test will not be able to measure any virus and will yield a negative result, but the qualitative test will find the lower levels of virus, meaning that virus is still present but at very low levels. The goal of treatment is for the qualitative test result to become “not detected” and to stay “not detected” permanently, even after treatment is stopped.
Important time points during the treatment course for checking the virus with these tests are at 4 weeks, 12 weeks, end of treatment, and 6 months after the end of treatment.
- Rapid Virologic Response: the virus is undetectable at 4 weeks into the course of treatment
- Early Virologic Response: the virus is undetectable at 12 weeks into the course of treatment
- End of Treatment Response: the virus is undetectable at the determined end of treatment (usually either 24 weeks or 48 weeks)
- Sustained Virologic Response: the virus is undetectable at 6 months after treatment is stopped
Coping with Side Effects
Side effects are a major issue with hepatitis C medications. It is very hard to predict which patients will experience which types of side effects. Almost all patients have a few side effects. Some are mild and don’t last long. Some are more significant, require attention, and persist through the course of treatment. Side effects go away after treatment is stopped. Pegylated interferon has many potential side effects. The side effects are similar to the potential side effects of standard interferon.
Possible Side Effects of Various Hepatitis C Drugs:
Pegylated or standard interferon
- Flu-like symptoms
- Mood changes
- Drop in platelet count (thrombocytopenia)
- Drop in white blood cell count (leukopenia)
- Drop in neutrophil count (neutropenia)
- Loss of appetite
- Nausea or change in bowel habits
- Weight gain or weight loss
- Hair loss
- Changes in thyroid function
- Increase in blood sugar level
- Disturbed sleep (insomnia)
- Drop in red blood cell count (anemia)
- Sore throat
- Shortness of breath
- Birth defects (harm to embryo or fetus of pregnant patients)
- Impaired sense of taste
General Recommendations on Side Effects during Treatment:
- Just because you develop an unpleasant reaction to one of the medicines you take to treat hepatitis C doesn’t necessarily mean you should stop treatment.
- Talk to your doctor if you are experiencing side effects.
- You and your partner should use two forms of birth control during treatment and for 6 months after treatment. For example, a man can use a condom and a woman can use a birth control pill or diaphragm.
- Do not immediately stop taking the medicine until your physician instructs you to do so.
- Do not start taking any new over-the-counter or prescription drugs, vitamin or mineral supplements, or herbal remedies without first checking with the physician who is treating your hepatitis.
- If you suffer from too many side effects or if they are too troublesome, your doctor may prescribe additional medication to help you cope with them. For instance, the doctor may prescribe a sedative to help you sleep if insomnia is a problem, or prescribe a drug to help relieve skin itching that may be caused by the treatment.
Improving your Chance of Response on Treatment
You can control some things that can improve your health while on treatment and increase your chances of being able to take it as prescribed, not miss doses, and feel better during the time you are on the treatment.
- Eat well
- Drink 8-10 glasses of water a day
- Get a full night’s sleep
- Talk to your friends and family and use your social support network for help when you need it
- Learn all you can about the benefits and risks of the drugs your doctor has prescribed
- Follow your doctor’s instructions on how to take the medicine
- Tell your doctor about side effects immediately
- Know your doctor’s name and phone number
- Keep your doctor appointments
- Carry the names and amounts of each medicine you are taking with you at all times
- Check with your doctor before starting any new medicine
Why do Some Patients with Hepatitis C take the Treatment and Others do not?
All patients with hepatitis C should be carefully considered for treatment and should work individually with a physician to determine whether treatment is the right choice for them. Treatment is the right choice for many patients, but not all.
- Not all patients with hepatitis C are able to safely take the medications that are available because of other medical problems they have.
- Not all patients wish to take the treatment for hepatitis C even if a physician recommends it.
- Not all patients with hepatitis C necessarily need to take the treatment, perhaps because their liver has little or no scarring and the virus does not seem to be causing damage enough to warrant going through the treatment.
To determine whether hepatitis C treatment is appropriate for you personally, you must talk with a physician to weigh the pros and cons.