The goal of treatment is to eliminate HCV from the body.
If HCV cannot be measured in the blood six months after the end of treatment, it is called a sustained viral response (SVR). Research has found that the virus remains undetectable for many years in the vast majority of those who reach an SVR. Many doctors believe this is a cure because there is no sign of the presence of HCV, and liver damage has been stopped.
Your chances of obtaining an SVR increase if you strictly adhere to the combination therapy (see below) by taking all the medication at the appropriate times. Other factors include the degree of fibrosis and the amount of inflammation already evident in your liver before you start treatment. Even for those who do not arrive at a SVR, there is evidence to suggest that the treatment can slow the rate of damage to the liver.
Generally, treatment is considered for patients who have had elevated ALT levels (1.5 times the upper normal limit) for a minimum of three months AND confirmation from a biopsy that there is inflammation or fibrosis present in the liver. There are, however, a number of factors that go into a recommendation to proceed with treatment for HCV.
Ask these questions:
- What are my chances of obtaining a sustained viral response?
- What genotype do I have? Your particular HCV genotype is important to consider for two reasons. The chance of obtaining a sustained viral response varies from genotype to genotype*. The genotype also determines how long you will be on treatment.
- Do I have a health condition that would react badly to the side effects of treatment?
- Am I pregnant or considering pregnancy? (Ribavirin can cause birth defects).
- Is there a significant chance that HCV will lead to health problems in my case?
- Am I able to closely follow a treatment schedule?
- Do I believe I will be able to tolerate the side effects of treatment?
- Will I be able to take time off work or away from other responsibilities if the side effects are significant?
- How do I weigh the possible impact side effects may have on my enjoyment in life against treatment that may or may not result in HCV being eliminated from my body?
- Can I afford the cost of treatment?
*According to the U.S. National Institutes of Health Consensus Statement on the management of HCV (released in September 2002), the chances of obtaining a sustained viral response in those who have not been previously treated are:
76 – 82% for people with Genotype 2 or 3; and
42 – 46% for people with Genotype 1.
The decision to treat is a matter that requires careful consideration on your part and input not only from your HCP but also from those close to you.
Interferon
Interferon is a synthetic form of a protein normally produced by your body to fight viruses. It is given by injection under the skin. Standard interferon is injected three times a week while pegylated (sustained release form of interferon) is injected once a week. The pegylated form of interferon is identical to the standard form except that a molecule has been added. This makes the pegylated interferon more effective in fighting HCV because it is slowly absorbed from the injection site and lasts longer in the blood stream.
Interferon may cause the following side effects:
- fever
- temporary nausea and vomiting
- muscle and joint aches
- lowering of white blood cells and platelets which will increase the risk of infection, bleeding, and “easy bruising”
- brain fog
- depression
- hair loss
Some people will experience the following side effects at intervals:
- fatigue
- loss of appetite
- diarrhea
- sleep problems
- irritability
Side effects will diminish after two or three weeks of treatment for 70% of people. Approximately 3% of people will be unable to continue treatment because of the severity of the side effects. Stopping treatment is the only way to stop the side effects, but your HCP might be able to suggest ways to help you minimize their impact.
Ribavirin
The drug ribavirin interferes with the way the virus reproduces itself while at the same time enhancing the effectiveness of interferon. By itself, ribavirin is not effective against HCV.
Ribavirin may cause the following side effects:
- The most common side effect is a drop in hemoglobin, which transports oxygen through the blood to cells. As a result you may develop shortness of breath, on exertion.
- A non-productive cough is another fairly common side effect.
- A rash and itching may occur.
- Ribavirin can induce fetal deformities
Monotherapy (interferon alone)
Treating HCV with interferon alone (monotherapy) used to be the only option available. The discovery of the beneficial effects of ribavirin made combination therapy the international standard of care for HCV. Monotherapy with pegylated interferon is only used for people who cannot tolerate ribavirin or who have cirrhosis and borderline liver function.
Combination therapy (pegylated interferon and ribavirin)
In combination therapy, pegylated interferon alpha-2a or 2b (depending on the manufacturer) is given with ribavirin. Pegylated interferon is given by injection, usually once a week. Ribavirin is in capsule form and is taken by mouth, twice daily with food.
The length of treatment depends on the HCV genotype in your body. If you have Genotype 2 or 3, treatment will last up to six months. However it may be discontinued after three months if there has not been a 100-fold decrease in HCV-RNA (as shown by a quantitative PCR test) or a PCR negative test result. This is because there is very little chance of obtaining a sustained viral response if the viral load has not dramatically decreased in the first three months of treatment.
If you have Genotype 1, 4, 5, or 6, treatment will last for up to one year. Again, treatment may be discontinued after three months if there has not been a 100-fold decrease in HCV-RNA or a PCR negative test result. Treatment will probably stop at six months if you continue to test PCR positive because it is very unlikely that you will achieve a SVR. However, since there is evidence that treatment slows the progression of liver damage, research is currently being done to look at longterm maintenance therapy. People involved in research projects do not have to pay for their therapy, but other patients may have to find a way to pay for this extended treatment.
Based on the side effects of interferon and ribavirin, people with certain medical conditions may not be recommended for combination therapy. People are evaluated on a “case by case” basis, but conditions like the ones below are termed “definite contraindications,” meaning that there is a clear risk of a serious problem developing.
- autoimmune disorders (inflammation and destruction of tissues by the body’s own antibodies) such as severe arthritis or active uncontrolled thyroid disease
- autoimmune hepatitis
- uncontrolled diabetes
- heart disease
- respiratory disease
- anemia (low level of hemoglobin in the blood)
The cost of treatment depends on the dosage needed, which depends on your weight (and therefore dosage). In 2004, a person could expect to pay monthly costs ranging from $1,600 to $2,300. Guidelines for payment of treatment vary by province and territory. Your provincial or territorial government may either cover the entire cost or expect you to pay a deductible, depending on your financial situation. Your health insurance company (a private plan or the one at your workplace) will likely pay the outstanding balance, if any. Consult your doctor or your Hemophilia Clinic for more detailed information in order to resolve any expense-related issues before you start treatment.
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