P1- HIGH VIRAL SUPPRESSION AND IMPROVED SAFETY PROFILE OF TENOFOVIR ALAFENAMIDE RELATIVE TO TENOFOVIR DISOPROXIL FUMARATE IN CHRONIC HEPATITIS B PATIENTS TREATED FOR 5 YEARS
Wai Kay Seto1, Ting-Tsung Chang2, Abhijit Chowdhry3, Chi-Yi Chen4, Mustafa Kemal Celen5, Xiaoli Ma6, Mang Ma7, Ajay Duseja8, Ki Tae Yoon9, Wan Cheng Chow10, Leland Yee11, Gregor Weber11, Ms Jin Youn11, John F. Flaherty11, Anuj Gaggar11, Bing Gao11, Gregory Camus11, Eric Bassetti11, Jae Seok Hwang12, Tetshuro Inokuma13..., Young- Suk Lin14, Edward J. Gane15Ver más
1 The University of Hong Kong, Hong Kong, Hong Kong
2 National Cheng-Kung University Hospital, Tainan, Taiwan
3 Institute of Post Graduate Medical Education and Research, Kolkata, India
4 Chia-Yi Christian Hospital, Chia-Yi, Taiwan
5 Dicle U¨Niversitesi Hastanesi Enfeksiyon Hastaliklari Anabilim Dali, Diyarbakir, Turkey
6 Xiaoli Ma, P.C., Philadelphia, USA
7 Zeidler Ledcor Centre, Edmonton, Canada
8 Postgraduate Institute of Medical Education & Research, Chandigarh, India
9 Pusan National University Yangsan Hospital, Yangsan, Korea
10 Singapore General Hospital, Singapore, Singapore
11 Gilead Sciences Inc., Foster City, USA
12 Keimyung University Dongsan Medical Center, Daegu, Korea
13 Kobe City Medical Center General Hospital, Kobe, Japan
14 Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
15 Liver Unit University of Auckland, Grafton, New Zealand
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In 2 identically-designed double-blind (DB), randomized (2:1), Phase 3 studies (HBeAg-negative patients [N = 425] and HBeAg-positive patients [N = 873]), TAF demonstrated antiviral efficacy non-inferior to that of TDF with superior renal and bone safety. After completing three years of DB treatment, all patients were eligible to receive open-label (OL) TAF through Year eight. Here we present study results for Year five.</p></span> <span id="abss0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0002">Materials and Methods</span><p id="spara002" class="elsevierStyleSimplePara elsevierViewall">Efficacy was assessed by serial virologic, biochemical, and serologic assessments, while safety data included changes in renal function and changes in hip and spine bone mineral density. Resistance testing and phenotyping were performed annually through Year 5.</p></span> <span id="abss0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0003">Results</span><p id="spara003" class="elsevierStyleSimplePara elsevierViewall">Of 1298 randomized and treated patients, 1157 (89%; 775 TAF; 382 TDF) entered OL, at year 5, 999 (77%; 675 TAF, 136 TDFTAF OL 3y, 188 TDF-TAF OL 2y) patients remained on treatment. High rates of virologic control were achieved and maintained in patients receiving TAF throughout and for TDF patients who switched to TAF at Weeks 96 or 144. Rates of ALT normalization and serologic responses were also comparable among groups. Eight patients are undergoing phenotypic testing to assess resistance. Adverse events (AEs) leading to discontinuation were low and similar among groups. Renal and bone outcomes were improved following the switch to OL TAF from TDF.</p></span> <span id="abss0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0004">Conclusions</span><p id="spara004" class="elsevierStyleSimplePara elsevierViewall">After five years of treatment, virologic suppression rates remained high, and TAF was safe and well tolerated, with improved renal and bone safety in patients switching from TDF.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abss0001" "titulo" => "Introduction and Objectives" ] 1 => array:2 [ "identificador" => "abss0002" "titulo" => "Materials and Methods" ] 2 => array:2 [ "identificador" => "abss0003" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abss0004" "titulo" => "Conclusions" ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/16652681/00000028000000S1/v2_202308150516/S1665268123000091/v2_202308150516/en/main.assets" "Apartado" => null "PDF" => "https://static.elsevier.es/multimedia/16652681/00000028000000S1/v2_202308150516/S1665268123000091/v2_202308150516/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1665268123000091?idApp=UINPBA00004N" ]
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