Background:

Compassionate use of REP 2139-Mg clears HDV and HBsAg in patients with compensated and decompensated cirrhosis, removing the need for liver transplant.

Purpose:
To evaluate REP-2139-Mg in cirrhotic HBV/HDV/HIV co-infection.

Methods:
Compassionate use of REP 2139-Mg was approved by Health Canada in a 53 y.o. Caucasian male with HBV/HDV/HIV co-infection and cirrhosis (Child Pugh A5). Under EVG/COB/FTC/TAF therapy, HBV and HIV infection are well controlled. No HDV antiviral response was observed during a previous 1-year course of pegIFN. Current therapy was supplemented with REP 2139-Mg (250mg SC QW) and pegIFN (90µg SC qW).

Results:
Administration of REP 2139-Mg is accompanied by moderate but transient pain. Decline in platelet count has stabilized at 78x109/mL. No other adverse events have been observed. Mild ALT elevation (57 U/L) has normalized (25 U/L). At week 8, decline in HBsAg (2348 to 1977 IU/mL) and HDV RNA (1.3 log10 copies/mL decline from baseline) (8.60x105 copies/mL) have occurred.

Conclusion:
Initial exposure of REP 2139-Mg in HBV/HDV/HIV co-infection is well tolerated and accompanied by early antiviral responses in HDV infection.