FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2917363934> ?p ?o ?g. }

• W2917363934 endingPage "304" @default.
• W2917363934 startingPage "296" @default.
• W2917363934 abstract "Background Effective and well tolerated nucleos(t)ide analogue treatment exists for patients with chronic hepatitis B, although treatment is generally anticipated to be life-long, with concomitant costs and treatment-related side-effects. We aimed to characterise the outcomes of patients with persistent viral suppression who discontinued nucleotide analogue use after extended treatment. Methods The primary objective of this prespecified analysis was to evaluate the safety of stopping long-term tenofovir disoproxil fumarate therapy in patients enrolled in two (completed) randomised controlled studies, GS-US-174-0102 (ClinicalTrials.gov, number NCT00117676) and GS-US-174-0103 (ClinicalTrials.gov, number NCT00116805). In those studies, patients who had completed 8 years or more of nucleotide analogue treatment, were hepatitis B surface antigen (HBsAg)-positive with hepatitis B virus (HBV) DNA concentration of less than 29 IU/mL, and were unwilling or unable to continue therapy were required by protocol to enter a 24-week treatment-free follow-up (TFFU) phase. We present data for patients in the TFFU phase who were assessed at baseline and monitored every 4 weeks for changes in qualitative serum HBsAg, HBV DNA, and alanine aminotransferase (ALT) concentrations in addition to standard safety assessments. Findings Of 124 patients who entered the TFFU phase, 54 (44%) patients did not complete 24 weeks of follow-up (median 12 weeks; IQR 0–20). Overall, 32 (26%) patients reported an adverse event. Serious adverse events occurred in five (4%) patients, including elevated ALT concentrations in two patients, hepatic flare in two patients, and increased lipase in one patient. 38 (31%) of patients had grade 3 or higher laboratory abnormalities, the majority of which were ALT elevations (36 patients). Of the 106 hepatitis B e antigen (HBeAg)-negative patients who entered the TFFU phase, 63 (59%) were followed for 24 weeks. HBsAg loss was observed in five (5%) of the 106 HBeAg-negative patients who entered the TFFU phase, and 37 (35%) had both HBV DNA concentrations of less than 2000 IU/mL and ALT concentrations less than the ULN at TFFU week 24. 18 HBeAg-positive patients entered the TFFU phase, of whom seven (39%) were followed up for 24 weeks. Of these seven patients, none had HBsAg loss or HBV DNA of less than 2000 IU/mL and one (14%) had an ALT less than the ULN at week 24. Interpretation Within 24 weeks of stopping 8 years or more of nucleotide analogue therapy almost a third of patients experienced a grade 3 or higher laboratory abnormality. Although few patients achieved HBsAg loss, a subgroup of HBeAg-negative patients can achieve a low-replicative state within a short duration of follow-up. Funding Gilead Sciences, Inc." @default.
• W2917363934 created "2019-03-02" @default.
• W2917363934 creator A5002183557 @default.
• W2917363934 creator A5005263512 @default.
• W2917363934 creator A5013246678 @default.
• W2917363934 creator A5014107752 @default.
• W2917363934 creator A5043626370 @default.
• W2917363934 creator A5050079986 @default.
• W2917363934 creator A5051482861 @default.
• W2917363934 creator A5051704140 @default.
• W2917363934 creator A5058746547 @default.
• W2917363934 creator A5061949081 @default.
• W2917363934 creator A5076954519 @default.
• W2917363934 creator A5083247636 @default.
• W2917363934 creator A5083831230 @default.
• W2917363934 creator A5088842832 @default.
• W2917363934 date "2019-04-01" @default.
• W2917363934 modified "2023-10-17" @default.
• W2917363934 title "Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials" @default.
• W2917363934 cites W1996666830 @default.
• W2917363934 cites W2009509017 @default.
• W2917363934 cites W2017354290 @default.
• W2917363934 cites W2040760136 @default.
• W2917363934 cites W2059560167 @default.
• W2917363934 cites W2076571011 @default.
• W2917363934 cites W2090738619 @default.
• W2917363934 cites W2110202840 @default.
• W2917363934 cites W2131203751 @default.
• W2917363934 cites W2173698250 @default.
• W2917363934 cites W2174723704 @default.
• W2917363934 cites W2237172879 @default.
• W2917363934 cites W2605785536 @default.
• W2917363934 cites W2737414455 @default.
• W2917363934 cites W2793642542 @default.
• W2917363934 doi "https://doi.org/10.1016/s2468-1253(19)30015-9" @default.
• W2917363934 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30795958" @default.
• W2917363934 hasPublicationYear "2019" @default.
• W2917363934 type Work @default.
• W2917363934 sameAs 2917363934 @default.
• W2917363934 citedByCount "23" @default.
• W2917363934 countsByYear W29173639342019 @default.
• W2917363934 countsByYear W29173639342020 @default.
• W2917363934 countsByYear W29173639342021 @default.
• W2917363934 countsByYear W29173639342022 @default.
• W2917363934 countsByYear W29173639342023 @default.
• W2917363934 crossrefType "journal-article" @default.
• W2917363934 hasAuthorship W2917363934A5002183557 @default.
• W2917363934 hasAuthorship W2917363934A5005263512 @default.
• W2917363934 hasAuthorship W2917363934A5013246678 @default.
• W2917363934 hasAuthorship W2917363934A5014107752 @default.
• W2917363934 hasAuthorship W2917363934A5043626370 @default.
• W2917363934 hasAuthorship W2917363934A5050079986 @default.
• W2917363934 hasAuthorship W2917363934A5051482861 @default.
• W2917363934 hasAuthorship W2917363934A5051704140 @default.
• W2917363934 hasAuthorship W2917363934A5058746547 @default.
• W2917363934 hasAuthorship W2917363934A5061949081 @default.
• W2917363934 hasAuthorship W2917363934A5076954519 @default.
• W2917363934 hasAuthorship W2917363934A5083247636 @default.
• W2917363934 hasAuthorship W2917363934A5083831230 @default.
• W2917363934 hasAuthorship W2917363934A5088842832 @default.
• W2917363934 hasConcept C126322002 @default.
• W2917363934 hasConcept C197934379 @default.
• W2917363934 hasConcept C203014093 @default.
• W2917363934 hasConcept C2522874641 @default.
• W2917363934 hasConcept C2777382497 @default.
• W2917363934 hasConcept C2777410769 @default.
• W2917363934 hasConcept C2779384505 @default.
• W2917363934 hasConcept C2780593183 @default.
• W2917363934 hasConcept C71924100 @default.
• W2917363934 hasConcept C90924648 @default.
• W2917363934 hasConceptScore W2917363934C126322002 @default.
• W2917363934 hasConceptScore W2917363934C197934379 @default.
• W2917363934 hasConceptScore W2917363934C203014093 @default.
• W2917363934 hasConceptScore W2917363934C2522874641 @default.
• W2917363934 hasConceptScore W2917363934C2777382497 @default.
• W2917363934 hasConceptScore W2917363934C2777410769 @default.
• W2917363934 hasConceptScore W2917363934C2779384505 @default.
• W2917363934 hasConceptScore W2917363934C2780593183 @default.
• W2917363934 hasConceptScore W2917363934C71924100 @default.
• W2917363934 hasConceptScore W2917363934C90924648 @default.
• W2917363934 hasIssue "4" @default.
• W2917363934 hasLocation W29173639341 @default.
• W2917363934 hasLocation W29173639342 @default.
• W2917363934 hasOpenAccess W2917363934 @default.
• W2917363934 hasPrimaryLocation W29173639341 @default.
• W2917363934 hasRelatedWork W1554538335 @default.
• W2917363934 hasRelatedWork W1592743141 @default.
• W2917363934 hasRelatedWork W2040973434 @default.
• W2917363934 hasRelatedWork W2123661325 @default.
• W2917363934 hasRelatedWork W2317791359 @default.
• W2917363934 hasRelatedWork W2373048719 @default.
• W2917363934 hasRelatedWork W2996529356 @default.
• W2917363934 hasRelatedWork W3032884659 @default.
• W2917363934 hasRelatedWork W4295886166 @default.
• W2917363934 hasRelatedWork W4290227086 @default.
• W2917363934 hasVolume "4" @default.
• W2917363934 isParatext "false" @default.
• W2917363934 isRetracted "false" @default.

• next