GSK 3228836 enters 2 Phase III B-Well trials for hepatitis B
Ionis Pharmaceuticals announced that GSK has initiated two randomized, double-blind, placebo-controlled Phase III studies evaluating the safety and efficacy of GSK 3228836 (bepirovirsen) (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B infection (CHB)
They are: Phase III Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) and Phase III Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2).
B-Well 1 is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: Double-blind treatment (bepirovirsen or placebo) for 24 weeks; Nucleos(t)ide analogue (NA) treatment for 24 weeks; NA cessation with 24 week follow up OR Continue NA for 24 weeks, follow up for further 24 weeks for participants who stopped NA treatment at Week 48.
B-Well 2 is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: Double-blind treatment (bepirovirsen or placebo) for 24 weeks; Nucleos(t)ide analogue (NA) treatment for 24 weeks; NA cessation with 24 week follow up OR Continue NA for 24 weeks, follow up for further 24 weeks for participants who stopped NA treatment at Week 48.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins