A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.

A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis

This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is <50.

Inclusion Criteria:

• adult patients, >/=18 years of age
• chronic hepatitis D
• positive for HBsAg >/=6 months, for anti-HDV >/=3 months and for HDV-RNA at screening
• negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study

Exclusion Criteria:

• antiviral therapy for chronic hepatitis D within the previous 6 months
• previous therapy with pegylated interferon alfa
• treatment with conventional interferon alfa for >12 months
• hepatitis A or C, or HIV infection
• decompensated liver disease (Childs B-C)
• history or evidence of medical condition associated with chronic liver disease