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( W Ray Kim ),( Rohit Loomba ),( Selim Gurel ),( John Flaherty ),( Eduardo B Martins ),( Leland J Yee ),( Phillip Dinh ),( Maria Buti ),( Patrick Marcellin ) 대한간학회 2013 춘·추계 학술대회 (KASL) Vol.2013 No.1
Background: Patients with chronic hepatitis B Virus (HBV) infection are at increased risk for hepatocellular carcinoma (HCC). Population-based studies have suggested an increased risk of hepatocellular carcinoma (HCC) in patients with higher levels of HBV-DNA. Therefore, it is possible that anti-viral therapy that reduces HBV-DNA levels may reduce the occurrence of HCC. We examined the clinical and demographic characteristics of HCC cases in patients receiving tenofovir disoproxil fumarate (TDF). Methods: We studied the clinical and demographic characteristics of the 641 patients enrolled in pivotal studies GSUS- 174-0102 and GS-US-174-0103. Results: During the first 288 weeks of studies 102/103, there were 13 cases of HCC. Three cases occurred during the first 48 weeks. 9/13 cases were HBeAg-negative and 3 of these were cirrhotic. 4/13 cases were HBeAg-positive at baseline and 3 of these were cirrhotic. 11/13 cases were male. 2/13 patients had regression of histological cirrhosis on repeat liver biopsies. Among the 13 HCC cases, 5 were genotype (gt)-D, 4 gt-C, 1 gt- B, 1 gt-E, 1 gt-F and 1 unable to genotype. Conclusions: In 288 weeks of TDF therapy, there were only 13 cases of HCC. 3 of the HCC cases were reported within the first 48 weeks of therapy. Despite the small number of cases, HCC surveillance needs to be done in patients on long-time oral antivirals.
( Ki Tae Yoon ),( Seto Wai-kay ),( Kao Jia-horng ),( Lim Seng-gee ),( Peng Cheng-yuan ),( Kwan Soo Byun ),( Inokuma Tetsuro ),( June Sung Lee ),( Flaherty John ),( Yee Leland J ),( Jump Belinda ),( Se 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Background: Tenofovir alafenamide (TAF) has shown similar efficacy to tenofovir disoproxil fumarate (TDF) with better bone and renal safety in 2 Phase 3 trials through 96 weeks. After a protocol amendment, some TDF patients received 96 weeks while others received 144 weeks of TDF treatment before rolling over to open-label (OL) TAF. Aim: To examine whether duration of prior TDF treatment impacted changes in bone and renal parameters after 48 weeks of OL TAF treatment in the subset of East Asian (EA) patients with chronic HBV. Methods: Among 190 EAs randomized to TDF, changes in bone mineral density (BMD) by DXA scans and renal parameters were assessed from OL baseline to Week 48 following switch to OL TAF. Results: At Week 48, mean (SD) percent changes from OL baseline in hip-BMD were +0.92 (2.32) and +0.79 (2.47) and in spine-BMD were +1.52 (2.68) and +2.27 (3.51) for DB-TDF-144wks and DB-TDF-96wks, respectively. Similarly, median (Q1, Q3) changes from OL baseline in creatinine clearance (eGFR<sub>CG</sub>) were +2.4 (-4.2, +10.8) and +3.0 (-3.0, +8.4) mL/min for DB-TDF-144wks and DBTDF-96wks, respectively. Similar trends in BMD and eGFR<sub>CG</sub> changes were seen in non-EAs. Following switching to OL TAF, improvements in bone and renal biomarkers were also observed. Conclusions: In EA patients who switched to TAF from TDF, improvements were seen in bone and renal parameters.
( Won Young Tak ),( Sang Hoon Ahn ),( Seung Woon Paik ),( Jia-Horng Kao ),( Hie-won Hann ),( Fung Scott ),( Trinh Huy ),( Nguyen Tuan Trong ),( Gaggar Anuj ),( Flaherty John ),( Yee Leland J ),( Jump 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Aims: In a recent Phase 3 study (Study 4018) in HBV patients suppressed on TDF treatment, switching to TAF demonstrated noninferior efficacy to continued TDF with superior bone and renal safety at Week 48. This study aims assess the safety and efficacy of switching to TAF from TDF in patients of Asian descent with risk factors for TDF toxicity as per current EASL and AASLD guidelines. Methods: Virally suppressed patients (HBV DNA <20 IU/mL at screening) on TDF were randomized (1:1) to switch to TAF or continue TDF for 48 weeks in a double-blind fashion. Viral suppression and changes in bone (BMD by DXA) and renal (creatinine clearance [eGFR<sub>CG</sub>]) parameters were assessed over 48 weeks. Results: Among the 400 Asian patients enrolled, 288 (72%) had at least 1 TDF RF. At Week 48, similar proportions with ≥1 RF had HBV-DNA <20IU/mL (TAF 97%; TDF 97%) and normal ALT by 2018 AASLD criteria (TAF 76%; TDF 73%). TAF subjects with ≥1 RF had increases in eGFR<sub>CG</sub> compared to decreases on TDF [median (Q1, Q3) change; TAF: +2.6 (-2.01, 7.34); TDF: -2.7 (-7.56, +15.79); P<0.0001)]. Among patients with ≥1 RF, improvements were seen in BMD for TAF vs. continued declines in TDF patients at both spine (P<0.0001) and hip (P<0.0001). Conclusions: Virally suppressed Asian patients with CHB and risk factors for TDF who switched to TAF showed improved bone and renal safety while efficacy was well-maintained.