ALL ABOUT HEPATITIS - Hepatitis C

Treatment

For some people with mild hepatitis C, the only treatment needed may be eating a nutritious diet, avoiding alcohol, exercising regularly, and visiting a doctor regularly to monitor the disease. But for others with hepatitis C, drug therapy may be appropriate.

The FDA has approved two different treatment regimens for chronic hepatitis C.

  • Monotherapy - using the single drug alpha interferon.
  • Combination therapy - using two drugs, interferon and ribavirin.

Interferon is injected into the bloodstream and works by bolstering the immune response to HCV. It is a genetically engineered product originally licensed in 1986 to treat hairy cell leukemia and is a copy of a protein found naturally in low levels in the human body.

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The FDA approved interferon in 1991 to treat hepatitis C. Three interferon products for HCV have been approved by the FDA: Intron A (made by Schering-Plough), Roferon-A (Hoffmann-La Roche Inc.), and Infergen (Amgen). These three products are injected three times a week.

Ribavirin is taken orally and works by preventing the virus from reproducing (viral replication). Ribavirin is a nucleoside analogue, which stimulates the T cells in the body to fight the virus. The drug increases the rate at which the hepatitis C virus mutates. This process causes the virus' genetic material to change so much that it cannot survive. Ribavirin does not effectively suppress levels of the virus in the bloodstream. The FDA approved ribavirin in the U.S. is called Rebetol (Schering-Plough).

Studies have shown that the interferon and ribavirin combination, approved in 1998 by the FDA, is more effective than interferon alone. The combination of the two drugs is called Rebetron (Schering-Plough). Both the U.S. (1998) and Canada (1999) have approved the Rebetron therapy for the treatment of chronic hepatitis C patients. This is presently the standard treatment. Combination therapy shows better results than interferon alone: about 55 percent of patients initially respond, and 25 to 45 percent of those treated sustain the response.

Pegylated Interferon

Modified versions of interferons, called pegylated interferons, or long-acting interferons, are presently being made available. These are alpha interferons that are modified by polyethylene glycol (PEG) so that they can be given once a week and provide a sustained level of interferon within the patient. The new versions of interferons may be especially beneficial to those who have relapsed following monotherapy or combination therapy.

The FDA approved PEG-Intron (pegylated interferon made by Schering-Plough) in January 2001 [EU approval in May 2000] as a monotherapy for treating chronic hepatitis C in adult patients not previously treated with interferon and whose livers are still working normally. PEG-Intron shows a slightly higher sustained response rate in published studies. Hoffman La Roche plans to have FDA approval in 2002 for its version of pegylated interferon called Pegasys. This product has been approved in Switzerland, Mexico and Venezuela.

PEG-Intron and Rebetol combination therapy (Schering-Plough) received FDA approval in August 2001 for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age. The combination therapy was approved for hepatitis C in the European Union in March 2001. Several clinical trials are ongoing to study the effects of combining pegylated interferon with ribavirin. Doctors predict that peginteferon plus ribavirin will become the standard treatment for chronic hepatitis C.

The goal of treatment is sustained response; meaning that the virus is not measurable in the blood after drug therapy is completed (usually for at least six months). Those who continue to have measurable levels of the virus after treatment are considered non-responders. Relapsers "clear" the virus during therapy or shortly thereafter, but the virus returns after therapy ends.

About half of the people who initially respond to monotherapy (interferon alone) relapse. Only 10 percent to 20 percent of those treated with monotherapy have a sustained response, depending on the type of interferon used.

There is no absolute way to know who will or won't respond to therapy. But health-care providers try to predict responsiveness using research tests to determine viral "load" and genotype.

An HCV genotype, which is also determined by a blood test, reflects the variation in the genetic makeup of the virus. At least six different genotypes and many more subtypes of HCV exist. In North America and Europe genotype 1 is most common and also more resistant to treatment. People with genotypes 2 and 3 are more likely to respond to therapy.

Genotyping also is used to determine the duration of treatment for many people. For those with genotype 2 or 3, a 24-week course of combination therapy is appropriate, but for genotype 1, a 48-week treatment is usually prescribed.

Common side effects of interferon and ribarivin

The topic of side effects from interferon and ribavirin is one that patients need to pay close attention to.

Common side effects of interferon (occurring in more than 10 percent of patients) include: influenza-like symptoms, fatigue, muscle aches, headaches, nausea and vomiting, skin irritation at the injection site, low-grade fever, weight loss, irritability, depression, mild bone marrow suppression and hair loss (reversible).

The most common side effects of ribavirin are: anemia, fatigue and irritability, nausea, itching, skin rash, nasal stuffiness, sinusitis, and cough.

Once diagnosed, CDC recommends the following:

  • Stop using alcohol. Drinking alcohol can make your liver disease worse.
  • See a doctor regularly.
  • Don't start any new medicines or use over-the-counter, herbal, or other drugs without consulting with a doctor.
  • Get vaccinated against hepatitis A, a food- and water-borne virus, if liver damage is present.

Complementary (alternative) therapies

There have been few research trials to check the effectiveness of natural therapies, but many people report positive benefits. The question of what constitutes a cure for hepatitis C must be discussed.

The most popular herbal remedy that has proven to protect the liver is milk thistle (silybum marianum). The common milk thistle contains some of the most potent liver-protective substances known, collectively referred to as silymarin. Silymarin has demonstrated positive effects in treating liver diseases of various kinds, including chronic hepatitis, cirrhosis, fatty infiltration of the liver and inflammation of the bile duct.

NOTE: The topics of treatment with drugs, alternative and complementary therapies, side effects and response rates are discussed in more detail in the Managing Hepatitis and Living With Hepatitis sections.


    All information provided in this site is offered for educational purposes only, and it is not intended nor implied to be a substitute for professional medical advice. Always consult your own physician or healthcare provider with any questions you may have regarding a medical condition.