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A hepatitis C epidemic has been steadily growing throughout the world over the past 20 years. Hepatitis C currently affects over 4 million Americans — four times more people than HIV. Worldwide, it is estimated that 170 million people are infected with hepatitis C. Each year an estimated 30,000 new infections arise and about 10,000 deaths occur.

The impact of hepatitis C on the healthcare professional and the healthcare system is already enormous and promises to grow even more in the near future.

Experts believe that only about one quarter of existing cases of hepatitis C have been diagnosed in the United States
The death toll due to complications of hepatitis C is expected to triple within the next 10 to 20 years, to over 25,000 individuals per year
85% of hepatitis C infections persist for life and require frequent and costly medical interventions
Since most hepatitis C patients are symptom-free, they may be infected for a decade or more without knowing it. When symptoms emerge, they can be devastating - the consequences of a severely damaged liver
Prior to mid-1998, the only indicated treatment for chronic hepatitis C was interferon. In mid-1998, another option — combination treatment composed of ribavirin capsules and interferon injection — was made available and soon became the standard of care for chronic hepatitis C. Approved by the FDA in 2001, PEG-INTRON™ (peginterferon alfa-2b) Powder for Injection represents the first once-weekly pegylated interferon for the treatment of chronic hepatitis C in adult patients (18 years or older) not previously treated with interferon alpha who have compensated liver disease

This Web site is designed to help you understand what you might be facing as a healthcare professional who is involved in treating chronic hepatitis patients. You may browse through the diverse topic areas, including:

The natural history of hepatitis
Current medical concepts regarding chronic viral hepatitis
Recent treatment and outcomes data for initial treatment and treatment of relapsed patients

Other parts of this Web site provide information for patients with hepatitis, and their friends and family members. We hope the information provided will help you as a healthcare professional in treating your patients and their loved ones.

PEG-INTRON™
Important Safety Information

WARNING

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

There are no new adverse events specific to PEG-INTRON™ as compared to INTRON® A (Interferon alfa-2b, recombinant) for Injection, however, the incidence of some (eg, injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON™ were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (ie, bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON™. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON™.

Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON™, but similar to INTRON® A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON™.

PEG-INTRON™ is contraindicated in patients with autoimmune hepatitis and decompensated liver disease.

The following serious or clinically significant adverse events have been reported at a frequency <1% with PEG-INTRON™ or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.

Renal failure patients should be closely monitored for signs and symptoms of interferon toxicity and PEG-INTRON™ should be used with caution in patients with creatinine clearance <50 mL/min. Patients on PEG-INTRON therapy should have hematology and blood chemistry testing before the start of treatment and then periodically thereafter.