PEGASYS is the first and only pegylated interferon approved by the FDA for the treatment of chronic hepatitis B.
The Centers for Disease Control and Prevention (CDC) estimates that 1.25 million people in the United States have chronic hepatitis B. Over time, an untreated hepatitis B infection can lead to liver scarring (cirrhosis), loss of function, liver cancer, or even death. However, these effects take time, and many people are now turning to treatments that can help.
In 2005, the US Food and Drug Administration (FDA) approved PEGASYS for the treatment of chronic hepatitis B. Already the most prescribed hepatitis C medication in the United States, PEGASYS is the first and only pegylated interferon approved for the treatment of chronic hepatitis B, including both main types of the virus.
PEGASYS helps in two important ways:
- PEGASYS slows replication of the hepatitis B virus.
- PEGASYS boosts the body's immune system.
Read more:
How We Know It Works
About Chronic Hepatitis B
The Importance of Your Liver's Health
How We Know It Works
Two large international trials included more than 1500 people with chronic hepatitis B who were treated with PEGASYS (including people with the HBeAg-positive and the HBeAg-negative variations of chronic hepatitis B).
Hepatitis B patients treated with PEGASYS had higher rates of response than with lamivudine in these common tests of hepatitis B infection. (These results were published in September 2004 in the New England Journal of Medicine—a leading medical publication.)
- Reduction in viral load (suppressed HBV DNA response): a measure of how much virus there is in the blood (and therefore how active the infection is in the liver)
- Normalization of ALTs (bringing liver enzymes back to normal)—a good indication of your liver's health
- HBV "seroconversion" (for HBeAg-positive patients): when antibodies appear, it is a good sign that your immune system has a full reaction. Viral levels drop to very low levels, liver damage stops (and often starts to recede).
PEGASYS is a medication that is taken once a week for 48 weeks and then not again. Lamivudine is a medication that is taken long-term. Lamivudine works in a different way than PEGASYS and most of its effects are not usually still present 24 weeks after the end of therapy. It is therefore difficult to compare the effectiveness of the 2 drugs.
Results from a long-term follow-up study indicate that 59% of patients (105 of 177) with HBeAg-negative chronic hepatitis B responded to treatment with PEGASYS and maintained the benefit for at least 1 year after treatment.
Special Concerns for People With Chronic Hepatitis B
People with chronic hepatitis B need to be monitored closely for changes in their liver enzyme levels. If your doctor finds elevations in your liver enzymes, more frequent monitoring of your liver's function could be ordered. In some cases, the dose of PEGASYS may be reduced or stopped temporarily. PEGASYS therapy may be resumed after these elevations subside. Or your doctor may decide that treatment should be stopped permanently.
About Chronic Hepatitis B
Hepatitis B is an inflammation of the liver that affects over 1.25 million people in the United States. About 70,000 people each year are infected with hepatitis B. The number of new infections in the United States has decreased in recent years, in part due to the introduction of the hepatitis B vaccine in 1982.
Almost all (90-95%) adults who contract hepatitis B clear the virus from their systems within a few months and develop immunity. However, the remainder of the infections become chronic, which is when the virus stays in the blood, infecting liver cells and possibly damaging them over time.
In the United States, the most common modes of transmission of the hepatitis B virus are through sexual and blood-to-blood contact, although the disease can also be transmitted from pregnant women to their infants.
The Importance of Your Liver's Health
Your liver is an important part of your digestive system. In fact, almost everything that enters your body goes through your liver at some point. Your liver is responsible for so many things that any damage to it can cause problems in other parts of your body. That's why a disease like chronic hepatitis B, which affects the liver, is very serious.
Here's what your liver does:
- Filters toxins and waste products from your blood
- Manages cholesterol and other chemicals in your body
- Makes protein, bile, and the agents that clot your blood
- Helps your body process medications
- Stores vitamins, minerals, iron, and sugars
- Keeps your hormones at the right level.
And here's what hepatitis can do to your liver:
- Liver cells are damaged—they cannot function well and many die.
- Some of these cells may grow back, but severe injury may lead to fibrosis (a buildup of scar tissue on the liver).
- Fibrosis slows down the liver's ability to circulate blood and remove toxins—affecting your overall health.
- If left untreated, hepatitis can result in cirrhosis—permanent liver damage in which healthy tissue is replaced by scar tissue.
- Liver cancer may also result from damage to the liver.
You need your liver to stay alive, just as much as you need your heart to keep pumping blood to stay alive.
To learn more about side effects, click here.
For information about support organizations, visit our resources page.
Print this page