A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)

Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)

This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.

Inclusion Criteria:

• Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening
• Positive anti-delta for at least 3 months prior to screening
• Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
• A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
• Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug

Exclusion Criteria:

• Antiviral therapy for CHD within the previous 6 months
• Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
• Evidence of decompensated liver disease
• Other medical condition associated with chronic liver disease
• Women with ongoing pregnancy or who are breast feeding