Matches in SemOpenAlex for { <https://semopenalex.org/work/W4386886487> ?p ?o ?g. }
Showing items 1 to 100 of
100
with 100 items per page.
- W4386886487 abstract "<h3></h3> Bulevirtide (BLV) is a first-in-class entry inhibitor for chronic hepatitis delta (CHD), which was conditionally approved in the EU in July 2020. Results from the week 48 primary endpoint analysis for MYR301 (NCT03852719), an ongoing Phase 3 randomized study, showed monotherapy with BLV at 2 mg/d or 10 mg/d given subcutaneously was superior to no active anti-hepatitis delta (HDV) treatment based on the combined viral and biochemical response. Efficacy was similar at the 2 dose levels, and BLV was generally safe and well tolerated. Here, we present findings from the predefined week 96 interim analysis of this ongoing study. One hundred fifty patients with CHD were randomized (1:1:1) and stratified based on the presence/absence of compensated cirrhosis as follows: arm A, no active anti-HDV treatment for 48 weeks followed by BLV 10 mg/d for 96 weeks (n = 51); arms B or C, immediate treatment with BLV at 2 mg/d (n = 49) or 10 mg/d (n = 50), respectively, each for 144 weeks, with follow-up of 96 weeks after end of treatment (ie, up to week 240). The combined response was defined as undetectable HDV RNA or decrease by ≥2 log<sub>10</sub> IU/mL from baseline and alanine transaminase (ALT) normalization; other endpoints included viral response (undetectable HDV RNA or decrease by ≥2 log<sub>10</sub> IU/mL from baseline), ALT normalization, log<sub>10</sub> change in HDV RNA, and change in liver stiffness (LS) by transient elastography. Baseline characteristics were similar between groups and included: mean (SD) age 41.8 (8.4) years, 57% males, 83% White, 47% with compensated cirrhosis, mean (SD) HDV RNA 5.05 (1.34) log<sub>10</sub> IU/mL, mean (SD) ALT 110.9 (69.0) U/L, mean (SD) LS of 15 (8.9) kPa, and 61% on concomitant nucleos(t)ide analogues therapy. Of 150 patients, 143 (95%) completed 96 weeks of treatment. Week 96 efficacy responses were improved vs week 48 (table 1). At week 96, similar combined responses were seen in arms B and C. Viral and biochemical responses were also similar among arms B and C. BLV was safe and well tolerated; there were no drug discontinuations, serious adverse events, or deaths attributed to BLV. Increases in bile acids without a correlation to pruritus or other symptoms were noted with BLV treatment. Injection-site reactions occurred in a higher proportion receiving 10 mg/d dosing. BLV continues to be safe and well tolerated as monotherapy for CHD through week 96. Virologic and biochemical responses increased with longer-term therapy." @default.
- W4386886487 created "2023-09-21" @default.
- W4386886487 creator A5001376175 @default.
- W4386886487 creator A5007526376 @default.
- W4386886487 creator A5024581579 @default.
- W4386886487 creator A5026399951 @default.
- W4386886487 creator A5027668597 @default.
- W4386886487 creator A5030416479 @default.
- W4386886487 creator A5030437694 @default.
- W4386886487 creator A5033452508 @default.
- W4386886487 creator A5034593215 @default.
- W4386886487 creator A5040795038 @default.
- W4386886487 creator A5041536838 @default.
- W4386886487 creator A5043318824 @default.
- W4386886487 creator A5045504446 @default.
- W4386886487 creator A5049290481 @default.
- W4386886487 creator A5050079986 @default.
- W4386886487 creator A5050609377 @default.
- W4386886487 creator A5066724683 @default.
- W4386886487 creator A5074836130 @default.
- W4386886487 creator A5076739762 @default.
- W4386886487 creator A5079697307 @default.
- W4386886487 creator A5083756239 @default.
- W4386886487 creator A5085961973 @default.
- W4386886487 date "2023-09-01" @default.
- W4386886487 modified "2023-10-02" @default.
- W4386886487 title "P134 Efficacy and safety at 96 weeks of bulevirtide 2 mg or 10 mg monotherapy for chronic hepatitis delta: results from an interim analysis of a phase 3 randomized study" @default.
- W4386886487 doi "https://doi.org/10.1136/gutjnl-2023-basl.148" @default.
- W4386886487 hasPublicationYear "2023" @default.
- W4386886487 type Work @default.
- W4386886487 citedByCount "0" @default.
- W4386886487 crossrefType "proceedings-article" @default.
- W4386886487 hasAuthorship W4386886487A5001376175 @default.
- W4386886487 hasAuthorship W4386886487A5007526376 @default.
- W4386886487 hasAuthorship W4386886487A5024581579 @default.
- W4386886487 hasAuthorship W4386886487A5026399951 @default.
- W4386886487 hasAuthorship W4386886487A5027668597 @default.
- W4386886487 hasAuthorship W4386886487A5030416479 @default.
- W4386886487 hasAuthorship W4386886487A5030437694 @default.
- W4386886487 hasAuthorship W4386886487A5033452508 @default.
- W4386886487 hasAuthorship W4386886487A5034593215 @default.
- W4386886487 hasAuthorship W4386886487A5040795038 @default.
- W4386886487 hasAuthorship W4386886487A5041536838 @default.
- W4386886487 hasAuthorship W4386886487A5043318824 @default.
- W4386886487 hasAuthorship W4386886487A5045504446 @default.
- W4386886487 hasAuthorship W4386886487A5049290481 @default.
- W4386886487 hasAuthorship W4386886487A5050079986 @default.
- W4386886487 hasAuthorship W4386886487A5050609377 @default.
- W4386886487 hasAuthorship W4386886487A5066724683 @default.
- W4386886487 hasAuthorship W4386886487A5074836130 @default.
- W4386886487 hasAuthorship W4386886487A5076739762 @default.
- W4386886487 hasAuthorship W4386886487A5079697307 @default.
- W4386886487 hasAuthorship W4386886487A5083756239 @default.
- W4386886487 hasAuthorship W4386886487A5085961973 @default.
- W4386886487 hasConcept C126322002 @default.
- W4386886487 hasConcept C168563851 @default.
- W4386886487 hasConcept C203014093 @default.
- W4386886487 hasConcept C203092338 @default.
- W4386886487 hasConcept C2522874641 @default.
- W4386886487 hasConcept C2776699657 @default.
- W4386886487 hasConcept C2777214474 @default.
- W4386886487 hasConcept C2777410769 @default.
- W4386886487 hasConcept C2778606649 @default.
- W4386886487 hasConcept C2780593183 @default.
- W4386886487 hasConcept C2780826214 @default.
- W4386886487 hasConcept C2994217296 @default.
- W4386886487 hasConcept C61943457 @default.
- W4386886487 hasConcept C71924100 @default.
- W4386886487 hasConcept C90924648 @default.
- W4386886487 hasConceptScore W4386886487C126322002 @default.
- W4386886487 hasConceptScore W4386886487C168563851 @default.
- W4386886487 hasConceptScore W4386886487C203014093 @default.
- W4386886487 hasConceptScore W4386886487C203092338 @default.
- W4386886487 hasConceptScore W4386886487C2522874641 @default.
- W4386886487 hasConceptScore W4386886487C2776699657 @default.
- W4386886487 hasConceptScore W4386886487C2777214474 @default.
- W4386886487 hasConceptScore W4386886487C2777410769 @default.
- W4386886487 hasConceptScore W4386886487C2778606649 @default.
- W4386886487 hasConceptScore W4386886487C2780593183 @default.
- W4386886487 hasConceptScore W4386886487C2780826214 @default.
- W4386886487 hasConceptScore W4386886487C2994217296 @default.
- W4386886487 hasConceptScore W4386886487C61943457 @default.
- W4386886487 hasConceptScore W4386886487C71924100 @default.
- W4386886487 hasConceptScore W4386886487C90924648 @default.
- W4386886487 hasLocation W43868864871 @default.
- W4386886487 hasOpenAccess W4386886487 @default.
- W4386886487 hasPrimaryLocation W43868864871 @default.
- W4386886487 hasRelatedWork W2007065415 @default.
- W4386886487 hasRelatedWork W2010241134 @default.
- W4386886487 hasRelatedWork W2050584981 @default.
- W4386886487 hasRelatedWork W2348713789 @default.
- W4386886487 hasRelatedWork W2372107119 @default.
- W4386886487 hasRelatedWork W2376038603 @default.
- W4386886487 hasRelatedWork W3032815428 @default.
- W4386886487 hasRelatedWork W3042112995 @default.
- W4386886487 hasRelatedWork W3138389754 @default.
- W4386886487 hasRelatedWork W3206869237 @default.
- W4386886487 isParatext "false" @default.
- W4386886487 isRetracted "false" @default.
- W4386886487 workType "article" @default.