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( 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.
( Seung Kew Yoon ),( Maurizia Brunetto ),( Young Suk Lim ),( Ed Gane ),( Wai Kay Seto ),( Marina Osipenko ),( Sang Hoon Ahn ),( Harry L. Janssen ),( Akash Shukla ),( Wan Long Chuang ),( Huy Trinh ),( 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: In this randomized, double blind study in HBeAg- negative patients comparing TAF to TDF, the efficacy of TAF was demonstrated to be noninferior to that of TDF at Week 48 in the proportion with HBV DNA <29 IU/mL with improved bone and renal effects. Here we present the results after two years of treatment. Methods: 425 patients were randomized to receive TAF 25 mg QD (n=285) or TDF 300 mg QD (n=140) and treated for 144 weeks.. Efficacy analyses at Week 96 included virologic (HBV DNA <29 IU/mL), and biochemical (ALT normalization) responses; key secondary safety endpoints were changes in hip and spine bone mineral density (BMD), and changes in serum creatinine and estimated GFR by Cockcroft- Gault method (eGFRCG). Serum markers of bone turnover and urine markers of renal tubular function were also assessed. Results: Baseline characteristics included: mean age 46 years, 61% males, 72% Asians, genotypes A through D (5%, 24%, 38%, 31%); 19% had HBV DNA ≥ 7 log10 IU/mL, and 21% were previously treated with nucleos(t)ides. Efficacy and safety results are summarized in the Table. At Week 96, virologic response rates were similar in the TAF and TDF groups.A greater percentage of TAF patients achieved normalization of serum ALT valuesPatients receiving TAF showed smaller declines in hip and spine BMD compared with TDF patients through Week 96. The smaller decline in eGFRCG and smaller changes in renal tubular markers observed with TAF. The rates of treatment discontinuations for adverse events (<2%) and serious adverse events were (≤11%) were similar. Conclusions: At Week 96, high rates of virologic suppression were maintained with a higher rate of ALT normalization seen in TAF patients relative to TDF and continued improved bone and renal safety with TAF compared with TDF.
Linear Carbon Chains under High-Pressure Conditions
Andrade, N. F.,Aguiar, A. L.,Kim, Y. A.,Endo, M.,Freire, P. T. C.,Brunetto, G.,Galvã,o, D. S.,Dresselhaus, M. S.,Souza Filho, A. G. American Chemical Society 2015 The Journal of Physical Chemistry Part C Vol.119 No.19
<P>A high-pressure resonance Raman spectroscopy study of linear carbon chains encapsulated inside multiwalled carbon nanotubes (MWCNTs) is reported. While the frequencies of the tangential modes of carbon nanotubes (G band) harden as the pressure increases, the vibrational frequencies of the chain modes (around 1850 cm<SUP>–1</SUP>) decrease, thus indicating a softening of the carbon–carbon bonds in this 1D solid. Pressure-induced irreversible structural changes in the linear carbon chains are unveiled by the red shift in the vibrational modes when pressure is released. These results have been interpreted as being due to a coalescence of carbon chains, and this hypothesis is supported by state-of-the-art atomistic reactive molecular dynamics simulations.</P><P><B>Graphic Abstract</B> <IMG SRC='http://pubs.acs.org/appl/literatum/publisher/achs/journals/content/jpccck/2015/jpccck.2015.119.issue-19/acs.jpcc.5b00902/production/images/medium/jp-2015-00902g_0012.gif'></P>
( KR Reddy ),( S Pol ),( PJ Thuluvath ),( H Kumada ),( J Toyota ),( K Chayama ),( J Levin ),( E Lawitz ),( A Gadano ),( W Ghesquiere ),( G Gerken ),( M Brunetto ),( CY Peng ),( M Silva ),( S Strasser 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Background/aims: Daclatasvir plus other direct-acting antivirals (DAAs) and/or peg-interferon/ribavirin has achieved high rates of sustained virologic response (SVR) in multiple clinical studies of patients. This follow-up study evaluates the long-term efficacy and safety outcomes in these patients. Methods: : This 144-week observational study enrolled patients treated with ≥ 1 dose of daclatasvir within 6 months of either completing their parent studies or protocol availability at the study site. The study objectives were to evaluate SVR12 durability, persistence of emergent NS5A and NS3 substitutions in non-responders, and to characterize events of hepatic disease progression or hepatocellular carcinoma. Results: This study enrolled 1503 patients treated with DAA-only (n = 893) or interferon-containing (n = 610) regimens of daclatasvir, of whom 60% were male, 18% were aged ≥ 65 years, 87% had HCV genotype 1 infection, and 18% had cirrhosis. Overall, 1329/1489 evaluable patients archived SVR12 in parent studies; 1316 (99%) maintained SVR until their most recent follow-up visit. 12 responders relapsed after achieving SVR12 (9 on/before and 3 after post-treatment week 24); 1 was re-infected. Relapse occurred in 3/842 (0.4%) and 9/487 responders (2%) treated with DAA-only regimens and interferon-containing regimens, respectively. From parent study end of treatment, hepatic disease progression (n = 15) or new hepatocellular carcinoma (n = 23) were diagnosed in 36 patients (two had both); median time to diagnosis was 70 weeks (range, 0.4-206 weeks). These 36 patients were generally older (median, 61 years versus 56 years), more had cirrhosis at baseline (50% versus 18%), and most were infected with HCV genotype 1a (36%) or 1b (61%). Complete replacement of emergent NS5A, NS3 substitutions by wild-type sequences was observed in 27/157 (17%), 35/47 (74%) non-responders, respectively. Conclusions: The results suggest that SVR12 achieved with daclatasvir- based regimens is durable in the long term. Hepatic disease progression events and new hepatocellular carcinoma were infrequent.