METHOD OF TREATING CHRONIC HEPATITIS B
The present disclosure is related to methods for treating chronic hepatitis B. The methods comprise administering to a subject in need thereof a therapeutically effective amount of bepirovirsen, wherein the subject has a HBsAg baseline level of not greater than a threshold level.
1 . A method for treating chronic hepatitis B in a human in need thereof, the method comprising administering to the human a therapeutically effective amount of bepirovirsen, wherein the human has a HBsAg baseline level of not greater than a threshold level.
2 . (canceled)
3 . (canceled)
4 . (canceled)
5 . (canceled)
6 . The method of claim 1 , wherein the threshold level is about 1000 IU/mL.
7 . The method of claim 1 , wherein the threshold level is about 3000 IU/mL.
8 . The method of claim 1 , wherein the human is not treated with another HBsAg reducing agent or immunomodulating agent.
9 . The method of claim 1 , wherein bepirovirsen is administered by subcutaneous injection.
10 . The method of claim 1 , wherein bepirovirsen is administered at a dose of about 300 mg once weekly.
11 . The method of claim 1 , wherein bepirovirsen is administered for 12 weeks to 48 weeks.
12 . The method of claim 10 , wherein bepirovirsen is administered weekly with additional loading doses in the first two weeks on Day 4 and Day 11 following the first dose.
13 . The method of claim 1 , wherein the human is on stable nucleoside or nucleotide analogue (NA) therapy.
14 . The method of claim 13 , wherein the NA therapy is lamivudine, adefovir, adefovir dipivoxil, telbivudine, entecavir, tenofovir, tenofovir disoproxil fumarate, or tenofovir alafenamide, or a pharmaceutically acceptable salt thereof.
15 . The method of claim 1 , wherein the human is not treated with a nucleoside or nucleotide analogue (NA).
16 . The method of claim 1 , wherein the human is HBeAg negative prior to the bepirovirsen treatment.
17 . The method of claim 1 , wherein the human is HBeAg positive prior to the bepirovirsen treatment.
18 . (canceled)
19 . (canceled)
20 . The method of claim 1 , wherein the threshold level is about 3000 IU/mL, wherein bepirovirsen is administered at a dose of about 300 mg once weekly for 24 weeks with additional loading doses in the first two weeks on Day 4 and Day 11 following the first dose.
21 . The method of claim 20 , wherein the human is on stable nucleoside or nucleotide analogue (NA) therapy.
22 . The method of claim 21 , wherein the NA therapy is lamivudine, adefovir, adefovir dipivoxil, telbivudine, entecavir, tenofovir, tenofovir disoproxil fumarate, or tenofovir alafenamide, or a pharmaceutically acceptable salt thereof.