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Pegasys® (peginterferon alfa-2a)

in Hepatitis C

Pegasys® (peginterferon alfa-2a) is a once-a-week medication approved by the U.S. Food and Drug Administration to treat adults who have a chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) who show signs of liver damage with no prior treatment with interferon. Pegasys is also used in patients coinfected with HCV and HIV. Pegasys works to reduce the amount of HCV in the blood, helping the body fight the virus1. Pegasys may be taken alone or in combination with Copegus® (ribavirin) tablets for HCV, an antiviral drug that works by slowing down the growth of the virus1. Patients in clinical studies, including genotypes 1-4, had a better than 50 percent chance of reducing HCV to undetectable levels.1,2,3

Pegasys is the most prescribed interferon therapy for HCV in the United States and has been used in approximately 1 million patients worldwide4. Pegasys is also the most frequently studied interferon in combination with oral antivirals in development5. An estimated 4 million people in the United States have been infected with HCV, and about 75 percent of the infected population is unaware that they have the disease. Chronic viral hepatitis infections are three to five times more frequent than HIV in the United States.6

Mechanism of Action

Interferon is a natural protein produced by white blood cells in the body that helps fight off infection. For some infections, such as HCV, patients can inject more interferon into their bodies to help fight the virus. The interferon in Pegasys is slightly different from the interferon that the body makes because it is pegylated7. Pegasys is a pegylated interferon that is created by a process called pegylation, in which polyethylene glycol (PEG) molecules attach to synthetic interferon. Pegylation technology helps keep the drug in the bloodstream longer, allowing Pegasys to be given once-weekly, and makes it more effective against HCV than a non-pegylated form of interferon.1,8

Clinical Trial Data

Pegasys was granted FDA approval in 2002 for use alone or in combination with Copegus in patients with chronic HCV based on two prospective randomized controlled registration trials.1,2,3

  • In the first study, Pegasys 180 mcg weekly and daily Copegus 1000-1200 mg combination therapy was shown to be tolerated as well as interferon alfa-2b plus daily ribavirin 1000-1200 mg and yielded higher sustained virologic response (SVR), or continued undetectable HCV viral load six months after treatment was completed8, compared with interferon alfa-2b plus ribavirin. Genotype 1 (most difficult to treat) SVR for Pegasys plus ribavirin vs. interferon alfa-2b plus ribavirin was 46% vs. 21% (p = .01), and genotype 2 or 3 SVR Pegasys plus ribavirin vs. interferon alfa-2b plus ribavirin was 76% vs. 45% (p = .005).1,2
  • In the second study, Pegasys 180 mcg weekly for 24 or 48 weeks plus a low dose 800mg/day or standard weight-based dose (1,000 or 1,200mg/day) of ribavirin was compared. The study found that HCV treatment with Pegasys plus Copegus may be individualized by genotype. Patients with genotype 1 treated for 48 weeks and a standard dose of ribavirin achieved an SVR of 52% [95% CI: 46 - 58%] and were more likely to achieve an SVR when treated for 48 weeks vs. 24 wks (p < .001) and when treated with standard weight based vs. low dose ribavirin (p=.005). In patients with genotype 2 or 3, response rates were more uniform. Genotype 2 or 3 patients treated for 24 weeks with a low dose of ribavirin achieved an SVR of 84% [CI: 77% -92%], which was the highest response rate observed in the study and not significantly different than longer treatment durations or higher ribavirin dose regimens.1,3

Pegasys has demonstrated efficacy in a broad range of patient types with HCV, even those with poor prognostic factors such as those with HCV genotype 1 and patients with high viral load, cirrhosis or bridging fibrosis of the liver, patients who are heavy weight (more than 85 kg/187 lbs) and patients with HCV genotype 1 who are African American or Latino.1,3,10,11,12

Pegasys "Firsts" in Hepatitis

Pegasys in combination with Copegus is the first and only regimen approved by the FDA for the treatment of chronic HCV in patients co-infected with clinically stable HIV. Pegasys in combination with Copegus is the first pegylated interferon regimen FDA approved for patients chronically infected with HCV who have severely damaged but still functioning livers (i.e., compensated Child Pugh Class A cirrhosis). Pegasys is also the only pegylated interferon indicated for the treatment of adult patients with chronic HBV who have livers that are damaged but still functioning (compensated liver disease), evidence of HBV multiplying (viral replication) and liver inflammation.1,9

Indications

Pegasys® (peginterferon alfa-2a) is a prescription medication that is used alone or with COPEGUS® (ribavirin, USP) to treat some adults with chronic (lasting a long time) hepatitis C infection who have certain types of liver problems and have not taken alpha interferon, and also in some adults coinfected with chronic hepatitis C and HIV. If you have chronic hepatitis C, you should not take PEGASYS by itself unless you are not able to take COPEGUS.

COPEGUS is a medicine used with another medicine called PEGASYS to treat chronic hepatitis C infection in people whose liver still works normally, and who have not been treated before with a medicine called an interferon alpha.

Important Safety Information

PEGASYS, like other alpha interferons, may cause or make fatal or life-threatening problems worse (like mental, immune system, heart, liver, lung, intestinal and infections). If patients show signs or symptoms of these conditions, their doctor may stop their medication. In many patients, but not all, these conditions get better after they stop taking PEGASYS (see the Medication Guide for more information and Warnings).

Ribavirin, including COPEGUS®, can cause birth defects and/or death to an unborn baby. Female patients and the female partners of male patients should avoid getting pregnant. Ribavirin is known to cause anemia (low red blood cells), which can make heart disease worse (see the Medication Guide for more information and Warnings).

  • COPEGUS in combination with PEGASYS may cause birth defects or death of a patient's unborn baby.
  • PEGASYS therapy may cause patients to develop mood or behavioral problems.
  • Some people who take PEGASYS alone or in combination with COPEGUS may get heart problems.
  • Stroke or symptoms of a stroke.
  • Some people taking PEGASYS develop new or worsening autoimmune problems.
  • Some people who take PEGASYS may get an infection.

PEGASYS alone or in combination with COPEGUS can cause serious side effects. Some of these side effects may cause death. Patients must tell their healthcare provider right away if they have any of these symptoms while taking PEGASYS.

Patients must not take PEGASYS if they:

  • have certain other liver problems
  • have certain types of hepatitis caused by their immune system attacking the liver (autoimmune hepatitis)
  • have had a serious allergic reaction to another alpha interferon medicine or to any of the ingredients in PEGASYS.

Patients must not take PEGASYS in combination with COPEGUS if they:

  • are pregnant, or planning to get pregnant during treatment or during the 6 months after treatment
  • are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while they are being treated with COPEGUS or during the 6 months after their treatment has ended
  • have certain blood disorders such as thalassemia major or sickle-cell anemia
  • take didanosine (Videx® or Videx® EC)

PEGASYS cannot be given to a baby under 1 year of age. PEGASYS contains benzyl alcohol.

Before taking PEGASYS, patients must tell their healthcare provider about all their medical conditions or problems, and if they are pregnant or breastfeeding, or plan to become pregnant or breast feed during treatment with PEGASYS.

Patients must tell their healthcare provider about all the prescription and non-prescription medicines, vitamins and herbal supplements they take.

PEGASYS can cause serious side effects including: blood problems, thyroid problems, blood sugar problems, serious eye problems, serious liver problems, worsening of liver problems including liver failure and death, lung problems, inflammation of the pancreas, inflammation of the intestines, serious allergic reactions and skin reactions, effect on growth in children, and nerve problems.

The most common, but less serious, side effects of PEGASYS include: flu-like symptoms, tiredness and weakness, stomach problems, loss of appetite, skin reactions, hair thinning, trouble sleeping.

Patients must tell their healthcare provider if they have any side effect that bothers them or that does not go away.

Please see the PEGASYS full Prescribing Information and Medication Guide, including Boxed WARNINGS, for additional Important Safety Information.

PEGASYS® and COPEGUS® are registered trademarks of Hoffman-La Roche Inc. All other brands for listed products are trademarks or registered trademarks (as indicated) of their respective owners and are not trademarks of Genentech, Inc. or Hoffmann-La Roche Inc.

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