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Home » Directories » FDA Approved Drugs » Pegasys (peginterferon alfa-2a)

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Pegasys (peginterferon alfa-2a)

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    General Information

    Pegasys (peginterferon alfa-2a) was approved in October 2002 for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha, including patients with compensated cirrhosis. Pegasys is a pegylated interferon that remains active in the bloodstream longer and at a more constant level than interferon alpha.

    Pegasys is available as premixed solution. It is administered at a dose of 180 ug as a subcutaneous injection once a week for a recommended duration of 48 weeks.

    Clinical Results

    Three pivotal phase III clinical studies of Pegasys demonstrated that the sustained virological response (defined as undetectable serum hepatitis C RNA levels post-treatment [on or after study week 68]) in the Pegasys treated subjects was as high as 38% in the overall population versus 19% in the interferon alfa-2a group. Subjects with cirrhosis who were treated with Pegasys showed a sustained virological response as high as 30% versus 8% in the interferon alfa-2a group. Subjects with genotype 1 treated with Pegasys showed showed a sustained virological response of up to 23%, compared to 6% in the interferon alfa-2a group.

    In addition, studies indicated that it can be determined at week 12 of treatment whether a subject is unlikely to attain a sustained virological response with Pegasys. This could prevent subjects from continuing a therapy to which they will most likely be unresponsive.

    Side Effects

    In clinical studies, the following adverse events were reported most often:

    • Headache
    • Fatigue
    • Myalagia
    • Pyrexia
    • Rigors
    • Arthralgia
    • Nausea
    • Alopecia
    • Injection-site reaction
    • Neutropenia
    • Insomnia
    • Depression
    • Anorexia
    • Irritability

    Alpha interferons, including Pegasys, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.

    Mechanism of Action

    Pegasys is produced when interferon alfa-2a undergoes the process of pegylation in which one or more chains of polyethylene glycol (also known as PEG) are attached to another molecule. In Pegasys, a large, branched, mobile PEG is attached to the interferon alfa-2a molecule, providing a selectively protective barrier against rapid absorption, metabolism and elimination. At the same time, the PEG maintains the ability of the interferon alfa-2a to attack the virus.

    Additional Information

    For further information about Pegasys, please visit the Roche web site at www.roche.com.

    Approval Date: 2002-10-01
    Date Created: 2002-10-25 12:00:00
    Company Name: Roche
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