Evidence of durable response to bepirovirsen in B-Clear responders: B-Sure first annual report

Background In B-Clear (NCT04449029), some participants with chronic hepatitis B virus infection on and not on nucleos(t)ide analogue (NA) therapy (On-NA and Not-on-NA) achieved a response at end of bepirovirsen treatment, sustained for 24 weeks’ follow-up. We present preliminary data from B-Sure (NCT04954859) examining durability of response for B-Clear complete responders.

Methods Not-on-NA participants will be followed up at Month 3, Month 6, and every 6 months thereafter (up to 36 months) after B-Clear end-of-study. On-NA participants, if eligible, will cease NA 6 months after B-Clear end-of-study. Adverse events were recorded. Durability of response was assessed:

• On-NA: Time from NA cessation to loss of complete response.

• Not-on-NA: Time from achieving a B-Clear complete response to loss of response.

Results 13/16 On-NA and 12/14 Not-on-NA B-Clear complete responders enrolled into B-Sure.

On-NA: 9/13 (69%) ceased NA—7/9 (78%) had complete data with≥3 months of follow-up post-NA cessation, and 6/7 (86%) maintained response; 4/9 (44%) had complete data with≥6 months of follow-up post-NA cessation, and 100% (4/4) maintained response. 3/13 (23%) were not eligible to cease NA, and 1/13 (8%) withdrew before NA cessation. No participants restarted NAs.

Not-on-NA: 9/12 (75%) had complete data with≥3 months of follow-up, and 78% (7/9) maintained response; 3/12 (25%) had complete data with≥9 months of follow-up, and 100% (3/3) maintained response.

No safety signals were reported.

Conclusion These data provide early evidence on bepirovirsen durability of response.

Funding GSK (study 206882)

Previously presented at EASL 2023 (abstract 4132).

 

MissingLinkText

Publikationsverlauf

Artikel online veröffentlicht:
23. Januar 2024