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PEGASYS (peginterferon alfa-2b) RATIONALE FOR INCLUSION IN PA PROGRAM Hepatitis B Pegasys is an antiviral indicated, as monotherapy, for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication or as either a monotherapy or part of a combination regimen, for the treatment of chronic hepatitis C in patients with compensated liver disease (1). Hepatitis C Pegasys is indicated for the treatment of chronic hepatitis C in patients 5 years of age and older with a detectable viral load in the serum. Patients must have compensated liver disease and not previously treated with an interferon alpha. Pegasys monotherapy is indicated for chronic hepatitis only if patient has contraindication to or significant intolerance to other hepatitis C antiviral drugs. Pegasys used in combination with Ribavirin therapy is recommended unless patient has contraindication to or significant intolerance to ribavirin (1,2). Boxed Warning: Risk of Serious Disorders Pegasys may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Physicians should monitor patients closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders (1). Pegasys alone or in combination with ribavirin without additional hepatitis antiviral drugs is not recommended for treatment of patients with chronic hepatitis C who previously failed therapy with an interferon-alfa (1). Pegasys is not recommended for treatment of patients with chronic hepatitis C who have had solid organ transplantation (1). Ribavirin may cause birth defects and fetal death: avoid pregnancy in female patients and female partners of male patients (1, 3). Summary Hepatitis C is a viral disease caused by the hepatitis C virus (HCV) that leads to inflammation of the liver. Untreated, chronic infection can lead to liver cirrhosis and/or liver cancer. The most common treatment regimens are based on combinations of pegylated interferon alfa, ribavirin, and a protease inhibitor (1,2). Pegasys FEP Clinical Rationale PEGASYS (peginterferon alfa-2b) Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Pegasys while maintaining optimal therapeutic outcomes. References 1. Pegasys. Prescribing Information. South San Francisco, CA. Genentech USA, Inc. March 2015. 2. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009; 49(4):1335-1374. 3. Ribavirin capsules [package insert]. Sellersville, PA: Teva Pharmaceuticals USA; March 2011. Pegasys FEP Clinical Rationale