There will be 2 treatment groups in this study, 15 subjects per group as follows:~Group 1: TAF 25 mg orally (PO) QD for 60 weeks with P1101 450 µg subcutaneously (SC) Q2W add-on at treatment week 12 for 48 weeks.~Group 2: Ursodeoxycholic Acid (UDCA)* 15 mg/kg orally (PO) QD plus TAF 25 mg orally (PO) QD for 60 weeks, with P1101 450 µg subcutaneously (SC) Q2W add-on at treatment week 12 for 48 weeks.~Both groups will have a post-treatment follow-up of 24 weeks.~*: Dose of Ursodeoxycholic Acid (UDCA) will be determined by weight at Day 1 (TW0) in 2-4 divided doses.
This is an open-label, randomized, multi-center study in patients with chronic HBV and HDV co-infection.