Efficacy

PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

Study design

Multicenter, randomized, partially double-blind study compared the efficacy and safety of 48 weeks of PEGASYS 180 ug/week plus lamivudine (100 mg/d), PEGASYS monotherapy, or lamivudine alone in patients with HBeAg-positive chronic HBV (N=814). Patients were followed for an additional 24 weeks. 87% of patients who received PEGASYS were Asian.1

In HBeAg-positive chronic HBV, PEGASYS provides sustained post-treatment response

HBV DNA suppression at 24 weeks post-treatment1

HBV DNA suppression at 24 weeks post-treatment
NS
=not significant.

HBeAg seroconversion rates 24 weeks post-treatment1

HBeAg seroconversion rates 24 weeks post-treatment Next: Safety
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Important Informationclose

INDICATIONS AND USAGE

PEGASYS® (peginterferon alfa-2a) is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

IMPORTANT SAFETY INFORMATION

Alpha interferons, including PEGASYS, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy.

DOSE MODIFICATION

If severe adverse reactions or laboratory abnormalities develop during PEGASYS therapy, the dose should be modified until the adverse reactions abate. If intolerance persists after dose adjustment, PEGASYS therapy should be discontinued. Refer to the full prescribing information for guidelines pertaining to dose modifications and discontinuation of PEGASYS based on laboratory abnormalities and patient's depression status.

In patients with CrCL less than 30 mL/min, including patients with end-stage renal disease requiring hemodialysis, dose reduction to 135 mcg PEGASYS is recommended. Signs and symptoms of interferon toxicity should be closely monitored.

CONTRAINDICATIONS

PEGASYS is contraindicated in patients with:

  • Known hypersensitivity reaction such as urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome to alpha interferons, including PEGASYS, or any of its components
  • Autoimmune hepatitis
  • Hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic patients before treatment

PEGASYS is contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurologic and other complications in neonates and infants, which are sometimes fatal.

WARNINGS AND PRECAUTIONS

Patients should be monitored for the following serious conditions, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should have their therapy withdrawn:

  • Neuropsychiatric reactions (suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction and drug overdose)
  • Cardiovascular disorders (hypertension, supraventricular arrhythmias, chest pain and myocardial infarction)
  • Bone marrow suppression (severe cytopenias and, rarely, aplastic anemia). Pancytopenia has been reported with concomitant use of azathioprine
  • Autoimmune disorders (including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis and systemic lupus erythematosus)
  • Endocrine disorders (hypothyroidism, hyperthyroidism, hyperglycemia, hypoglycemia and diabetes mellitus)
  • Ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema and serous retinal detachment)
  • Cerebrovascular disorders (ischemic and hemorrhagic cerebrovascular events)
  • Hepatic Failure (Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation and death)
  • Pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension and sarcoidosis, some resulting in respiratory failure and/or patient deaths)
  • Infections (bacterial, viral, or fungal), some fatal
  • Colitis (ulcerative and hemorrhagic/ischemic colitis), sometimes fatal
  • Pancreatitis, sometimes fatal
  • Hypersensitivity (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) and serious skin reactions, including Stevens-Johnson syndrome.
  • Peripheral neuropathy (in combination with telbivudine)

ADVERSE REACTIONS

Chronic Hepatitis B:

Six percent of PEGASYS treated subjects in the hepatitis B studies experienced one or more serious adverse events. The most common or important serious adverse events, all of which occurred at a frequency of less than or equal to 1%, in the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis, influenza), hepatitis B flares, and thrombotic thrombocytopenic purpura.

The most commonly observed adverse reactions in patients treated with PEGASYS were pyrexia (54%), headache (27%), fatigue (24%), myalgia (26%), alopecia (18%), and anorexia (16%).

Please see PEGASYS full Prescribing Information for boxed WARNINGS and additional important safety information.

PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-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.

Download the full Prescribing Information View full Safety Information

INDICATIONS AND USAGE

PEGASYS® (peginterferon alfa-2a) is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

IMPORTANT SAFETY INFORMATION

Alpha interferons, including PEGASYS, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy.

DOSE MODIFICATION

If severe adverse reactions or laboratory abnormalities develop during PEGASYS therapy, the dose should be modified until the adverse reactions abate. If intolerance persists after dose adjustment, PEGASYS therapy should be discontinued. Refer to the full prescribing information for guidelines pertaining to dose modifications and discontinuation of PEGASYS based on laboratory abnormalities and patient's depression status.

In patients with CrCL less than 30 mL/min, including patients with end-stage renal disease requiring hemodialysis, dose reduction to 135 mcg PEGASYS is recommended. Signs and symptoms of interferon toxicity should be closely monitored.

CONTRAINDICATIONS

PEGASYS is contraindicated in patients with:

PEGASYS is contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurologic and other complications in neonates and infants, which are sometimes fatal.

WARNINGS AND PRECAUTIONS

Patients should be monitored for the following serious conditions, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should have their therapy withdrawn:

ADVERSE REACTIONS

Chronic Hepatitis B:

Six percent of PEGASYS treated subjects in the hepatitis B studies experienced one or more serious adverse events. The most common or important serious adverse events, all of which occurred at a frequency of less than or equal to 1%, in the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis, influenza), hepatitis B flares, and thrombotic thrombocytopenic purpura.

The most commonly observed adverse reactions in patients treated with PEGASYS were pyrexia (54%), headache (27%), fatigue (24%), myalgia (26%), alopecia (18%), and anorexia (16%).

Please see PEGASYS full Prescribing Information for boxed WARNINGS and additional important safety information.

PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-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.

Reference
 
1.
Lau GKK et al. Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med. 2005;352(26):2682-2695.