Product information and disease description Place of product in therapy Approaches to treatment

Ongoing post-approval monitoring

7 evidence topics · 3 sources

Adverse reaction reporting

“To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” (opens the prescribing information at this quote)

Laboratory monitoring after bepirovirsen discontinuation

“Laboratory tests must be measured prior to, during, and following discontinuation of treatment.” (opens the prescribing information at this quote)
“In all patients with abnormal values at the time of HIBSAGO discontinuation, obtain ALT and total bilirubin values at 4, 12, and 24 weeks post-treatment to assess recovery of ALT values to within the normal range, as appropriate” (opens the prescribing information at this quote)
“In all patients with abnormal values at the time of HIBSAGO discontinuation, obtain repeat platelet counts 4 and 12 weeks post-treatment to assess for platelet count recovery, as appropriate.” (opens the prescribing information at this quote)
“In all patients with abnormal values at the time of HIBSAGO discontinuation, obtain repeat eGFR 4 and 12 weeks post-treatment to assess for renal function recovery, as appropriate.” (opens the prescribing information at this quote)

Monitoring after nucleos(t)ide analog discontinuation

“Patients should be closely monitored with both laboratory (HBsAg, HBV DNA, and hepatic function) and clinical follow-up for at least one year following NrtI therapy cessation, with routine monitoring as clinically indicated afterwards, to detect acute exacerbations of HBV infection and the possible need for resumption of HBV treatment.” (opens the prescribing information at this quote)
“If NrtI therapy is discontinued after completing HIBSAGO treatment, advise patients of the importance of frequent monitoring to assess the possible need for resumption of HBV treatment” (opens the prescribing information at this quote)

Monitoring statements in the Medication Guide

“Your healthcare provider will do blood tests to check your liver and platelet count, before you start HIBSAGO, during treatment, and if you have abnormal blood tests for up to 24 weeks after you stop HIBSAGO.” (opens the prescribing information at this quote)
“After you finish your treatment with HIBSAGO, do not stop taking your NrtI treatment unless your healthcare provider tells you to. If you stop taking NrtI treatment, your HBV may return. It is important that you make sure you still get blood tests done.” (opens the prescribing information at this quote)

Companion diagnostic for monitoring during treatment

“to assist in monitoring patients throughout the course of treatment” (opens the source at this quote in a new tab)
“Patients need regular blood tests and follow up with their healthcare provider before and during treatment to monitor these risks.” (opens the source at this quote in a new tab)

Durability of response off all treatment through week 96 in B-Well 1 and B-Well 2

“HIBSAGO recipients who met the criteria to discontinue NrtI therapy and discontinued NrtI therapy at Week 48 (295/1,220 across both trials) were monitored for an additional 48 weeks with assessments at Week 72 to assess the primary endpoint and Week 96 to evaluate the long-term durability of response” (opens the prescribing information at this quote)
“At Week 72, 24 weeks after stopping NrtI therapy, 79% (233/295) of these participants met the primary endpoint. Of the 233 participants who met the primary endpoint at Week 72, 91% (211/233) maintained response off all HBV treatment at Week 96.” (opens the prescribing information at this quote)

Long-term follow-up study of durability: B-Sure

“This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response.” (opens the source at this quote in a new tab)
“Participants rolling over from studies 202009 and 219288 who have stopped NA treatment during the parent study will be included in this arm. Participants will be followed up for 33 months. No study treatment will be administered in this study.” (opens the source at this quote in a new tab)

Risk evaluation and mitigation strategy

No evidence found.

Pregnancy exposure registry

No evidence found.