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      • HBV : Clinical Characteristics of Patients who Developed HCC While Receiving Tenofovir Disoproxil Fumarate (TDF) Up to 288 Weeks of Therapy

        ( 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.

      • Viral Kinetics in Women of Child Bearing Potential with Chronic HBV Following Treatment with Tenofovir Alafenamide or Tenofovir Disoproxil Fumarate

        ( Brunetto ),( Carla Coffin ),( Audrey Lau ),( Shuyuan Mo ),( John F. Flaherty ),( Anuj Gaggar ),( G Mani Subramanian ),( Mindie H. Nguyen ),( Selim Gurel ),( Alexander Thompson ),( Edward J. Gane ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

        Aims: Suppression of the HBV in women of childbearing potential (WOCBP) has important implications in preventing transmission of HBV from mother to infant. Antiviral therapy that reduces HBV DNA to < 2x105 IU/mL at delivery in mothers can substantially reduce the risk of perinatal transmission. We evaluated the viral kinetics of TAF and TDF in WOCBP. Methods: : In two Phase 3 studies (HBeAg positive and negative patients), 1301 patients (37% female) were randomized (2:1) to receive TAF 25 mg QD or TDF 300 mg QD. All patients were required to have HBV DNA >2x104 IU/mL at screening and serum ALT >2 times AASLD criteria.WOCBP were defined as nonmenopausal females 18 years or older without history of hysterectomy, bilateral oophorectomy, or ovarian failure. For this subanalysis, patients were stratified by baseline HBV DNA levelsand the endpoints were virologic suppression to HBV DNA <29 IU/mL or < 2x105 IU/mL. Results: 365(76%) female were identified as WOCBP with 118 (32%) having HBV DNA >1x108 IU/mL at baseline. Suppression rates were generally similar between TAF and TDF groups and within viral load strata for HBeAg positive and negative patients. After 12 weeks of treatment with TAF or TDF, 77% of WOCBP with baseline HBV DNA <2x105 IU/mL had full suppression to <29 IU/mL compared to 1% of those at the highest baseline viral load (Figure A). By Week 24, 54% of all WOCBP had achieved complete viral suppression. Of WOCBP with baseline viral load ≥2x105 IU/mL (n=305), 76%, 89%, and 93% achieved viral load reduction to <2x105 IU/mL by Weeks 4, 8, and 12, respectively (Figure B). Conclusions: After 12 weeks of treatment the majority of WOCBP had HBV DNA to <2x105 IU/mL. In women with higher baseline viral loads, longer treatment duration may be necessary to achieve viral suppression below recommended thresholds.

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