Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (PEG) Versus TDF or PEG Monotherapy in Chronic Hepatitis B

Status:	Completed
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	4/21/2016
Start Date:	April 2011
End Date:	July 2015

A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

This study will evaluate the safety and efficacy of tenofovir disoproxil fumarate (TDF) plus
peginterferon α-2a (PEG) combination therapy versus standard of care TDF monotherapy or PEG
monotherapy in non-cirrhotic adults with chronic hepatitis B virus (HBV).

The study will consist of 2 phases for participants in the TDF+PEG 48 week, TDF 48 week+PEG
16 week, and PEG 48 week groups. Following an initial 48 weeks of treatment, participants in
these groups will be monitored for 24 weeks for signs of worsening HBV, and those with new
signs and/or symptoms will be eligible to receive TDF monotherapy during a retreatment
phase, up to Week 120.

Inclusion Criteria:

- Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen
(HBsAg) or HBV DNA for at least 6 months) prior to baseline

- Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside
therapy with the last dose ≥ 24 weeks prior to screening are also eligible.

- Positive or negative for hepatitis B e antigen (HBeAg)

- HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml
(HBeAg-negative participants)

- Alanine aminotransferase (ALT) > 54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300
U/L for women

- Creatinine clearance ≥ 70 mL/min

- Negative serum pregnancy test for females of childbearing potential

- Sexually active females of childbearing potential must agree to use a
protocol-recommended method of contraception throughout the study and for 30 days
following the last dose of study medication

- Lactating females must agree to discontinue nursing before initiation of study
investigational medicinal product

Exclusion Criteria:

- Known bridging fibrosis or cirrhosis and/or decompensated liver disease

- Evidence of hepatocellular carcinoma

- Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease
(eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis,
multiple bone fractures)

- Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL
(female) or < 11 g/dL (male)

- History of severe depression or severe psychiatric disease

- Thyroid dysfunction

- Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)

- Pregnant

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