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Conference Paper: Preliminary results of a Phase 2 study of VIR-2218, an X-targeting RNAi therapeutic, in patients with chronic hepatitis B: sub-analyses of HBeAg-negative and HBeAg-positive patients

TitlePreliminary results of a Phase 2 study of VIR-2218, an X-targeting RNAi therapeutic, in patients with chronic hepatitis B: sub-analyses of HBeAg-negative and HBeAg-positive patients
Authors
Issue Date2021
PublisherSpringer (India) Private Ltd. The Journal's web site is located at http://www.springer.com/medicine/internal/journal/12072
Citation
The 30th Annual Conference of the Asian Pacific for The Study of Liver (APASL), Hybrid Meeting, Bangkok, Thailand, 4-6 February 2021. In Hepatology International, 2021, v. 15 n. Suppl. 1, p. S3-S4 How to Cite?
AbstractObjectives: VIR-2218 is a GalNAc-conjugated short interfering ribonucleic acid in development for chronic hepatitis B virus infection (CHB). VIR-2218 is designed to silence HBV transcripts from cccDNA and integrated DNA across all 10 HBV genotypes. We present safety and antiviral data from a Phase 2 study in CHB patients, focusing on baseline virologic characteristics and post-treatment HBsAg reductions in HBeAg-negative and HBeAg-positive subgroups. Materials and methods: Noncirrhotic, virologically suppressed CHB patients received 2 subcutaneous doses of VIR-2218 or placebo (Day 1 and day 29). HBeAg-negative patients received 20, 50, 100 or 200 mg and HBeAg-positive patients received 50 or 200 mg. Cohorts included 4 or 8 subjects randomized 3:1 (VIR-2218:placebo). Assessments included safety for 12 weeks post-treatment and HBsAg follow-up for 48 weeks. Preliminary 24-week data are presented. Results: 24 CHB patients received VIR-2218 (n = 18 HBeAg-negative; n = 6 HBeAg-positive). Most adverse events were mild in severity with no events leading to treatment discontinuation. No clinically significant changes in safety laboratory parameters were observed. At baseline, HBeAg-positive patients had higher burdens of HBsAg, HBV RNA and HBcrAg. Similar maximum post-treatment HBsAg declines were observed for both subgroups, with magnitude of reduction related to dose. For the 200 mg dose, the mean HBsAg reduction was ≥ 1 log by week 12 and sustained through week 24 in both subgroups. Conclusion: VIR-2218 was tolerated across all dose levels with no safety signals observed. Similar magnitude of HBsAg reduction in HBeAg-positive and HBeAg-negative CHB patients suggests that it could silence transcripts from both cccDNA and integrated DNA.
DescriptionOral presentation - Hepatitis B and Hepatitis D - no. 2
Persistent Identifierhttp://hdl.handle.net/10722/305538
ISSN
2023 Impact Factor: 5.9
2023 SCImago Journal Rankings: 1.813

 

DC FieldValueLanguage
dc.contributor.authorYuen, RMF-
dc.contributor.authorLim, YS-
dc.contributor.authorCloutier, D-
dc.contributor.authorShen, L-
dc.contributor.authorCathcart, A-
dc.contributor.authorDing, X-
dc.contributor.authorArizpe, A-
dc.contributor.authorPang, P-
dc.contributor.authorHuang, S-
dc.contributor.authorGane, E-
dc.date.accessioned2021-10-20T10:10:49Z-
dc.date.available2021-10-20T10:10:49Z-
dc.date.issued2021-
dc.identifier.citationThe 30th Annual Conference of the Asian Pacific for The Study of Liver (APASL), Hybrid Meeting, Bangkok, Thailand, 4-6 February 2021. In Hepatology International, 2021, v. 15 n. Suppl. 1, p. S3-S4-
dc.identifier.issn1936-0533-
dc.identifier.urihttp://hdl.handle.net/10722/305538-
dc.descriptionOral presentation - Hepatitis B and Hepatitis D - no. 2-
dc.description.abstractObjectives: VIR-2218 is a GalNAc-conjugated short interfering ribonucleic acid in development for chronic hepatitis B virus infection (CHB). VIR-2218 is designed to silence HBV transcripts from cccDNA and integrated DNA across all 10 HBV genotypes. We present safety and antiviral data from a Phase 2 study in CHB patients, focusing on baseline virologic characteristics and post-treatment HBsAg reductions in HBeAg-negative and HBeAg-positive subgroups. Materials and methods: Noncirrhotic, virologically suppressed CHB patients received 2 subcutaneous doses of VIR-2218 or placebo (Day 1 and day 29). HBeAg-negative patients received 20, 50, 100 or 200 mg and HBeAg-positive patients received 50 or 200 mg. Cohorts included 4 or 8 subjects randomized 3:1 (VIR-2218:placebo). Assessments included safety for 12 weeks post-treatment and HBsAg follow-up for 48 weeks. Preliminary 24-week data are presented. Results: 24 CHB patients received VIR-2218 (n = 18 HBeAg-negative; n = 6 HBeAg-positive). Most adverse events were mild in severity with no events leading to treatment discontinuation. No clinically significant changes in safety laboratory parameters were observed. At baseline, HBeAg-positive patients had higher burdens of HBsAg, HBV RNA and HBcrAg. Similar maximum post-treatment HBsAg declines were observed for both subgroups, with magnitude of reduction related to dose. For the 200 mg dose, the mean HBsAg reduction was ≥ 1 log by week 12 and sustained through week 24 in both subgroups. Conclusion: VIR-2218 was tolerated across all dose levels with no safety signals observed. Similar magnitude of HBsAg reduction in HBeAg-positive and HBeAg-negative CHB patients suggests that it could silence transcripts from both cccDNA and integrated DNA.-
dc.languageeng-
dc.publisherSpringer (India) Private Ltd. The Journal's web site is located at http://www.springer.com/medicine/internal/journal/12072-
dc.relation.ispartofHepatology International-
dc.relation.ispartofThe 30th Annual Conference of the Asian Pacific for The Study of Liver (APASL), 2021-
dc.titlePreliminary results of a Phase 2 study of VIR-2218, an X-targeting RNAi therapeutic, in patients with chronic hepatitis B: sub-analyses of HBeAg-negative and HBeAg-positive patients-
dc.typeConference_Paper-
dc.identifier.emailYuen, RMF: mfyuen@hku.hk-
dc.identifier.authorityYuen, RMF=rp00479-
dc.description.natureabstract-
dc.identifier.hkuros327147-
dc.identifier.volume15-
dc.identifier.issueSuppl. 1-
dc.identifier.spageS3-
dc.identifier.epageS4-
dc.publisher.placeIndia-
dc.identifier.partofdoi10.1007/s12072-021-10213-7-

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