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All-oral Dual Therapy with Daclatasvir and Asunaprevir in Patients with HCV Genotype 1B Infection
Michael Manns,Stanislas Pol,Ira M. Jacobson,Patrick Marcellin,Stuart C. Gordon,Cheng-Yuan Peng,Ting-Tsung Chang,Gregory T. Everson,Jeong Heo,Guido Gerken,Boris Yoffe,William J. Towner,Marc Bourliere,S 한국간담췌외과학회 2014 한국간담췌외과학회 학술대회지 Vol.2014 No.4
( Won Young Tak ),( Henry Lik-yuen Chan ),( Patrick Marcellin ),( Calvin Q. Pan ),( Andrea L Cathcart ),( Neeru Bhardwaj ),( Yang Liu ),( Stephanie Cox ),( Bandita Parhy ),( Eric Zhou ),( John F Flahe 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Presented herein are the post Week 48 through Week 96 resistance analyses for Phase 3 studies evaluating tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF). Methods: Patients were randomized 2:1. HBV pol/RT population or deep sequencing was conducted for patients with viremia at Week 96 or at early discontinuation post Week 48. Deep sequencing was conducted for patients with HBV DNA >159 IU/mL and sequence changes at the consensus sequence level are reported. Phenotypic analysis was performed for Virologic breakthrough (VB) patients who were adherent to study drug, patients with conserved site substitutions, or for polymorphic substitutions emergent in >1 patient. Results: TAF and TDF were treated in 866 and 432 patients, respectively. A similar percentage of patients in the arms qualified for sequence analysis. In the TAF arm, 87 (10.5%) patients qualified: 31 had no sequence change from baseline, 15 were unable to sequence (UTS), 32 had polymorphic site substitutions, and 9 had conserved site substitutions. In the TDF arm, 45 (10.9%) patients qualified: 26 had no sequence change, 6 were UTS, 11 had polymorphic site substitutions, and 2 had conserved site substitutions. Each detected conserved site substitution other than rtA181T was observed in one patient. The rtA181T substitution in 2 patients, 1 from each arm, was not associated with increasing plasma HBV DNA levels. At Week 96, a small percentage of patients experienced VB, and VB was often associated with nonadherence. 27 patients qualified for phenotypic analysis and no patient isolates tested showed a reduction in susceptibility to TAF or tenofovir, respectively. Conclusions: The proportion of patients analyzed and the HBV sequence changes observed were similar between patients in the TAF and TDF arms. Most substitutions occurred at polymorphic positions and no substitutions associated with resistance to TAF were detected through 96 weeks of treatment.
( 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.