Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3, Clinical Trial

( Lai Wei ),( Qing Xie ),( Jin Lin Hou ),( Hong Tang ),( Qin Ning ),( Jun Cheng ),( Yuemin Nan ),( Lunli Zhang ),( Jun Li ),( Jianning Jiang ),( Megan Kim ),( Brian Mcnabb ),( Fangqiu Zhang ),( Gregor 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1

Aims: Chronic hepatitis C virus (HCV) infection remains a major health threat in China, affecting at least 10 million people, with approximately 58% having genotype (GT) 1 infection. There is a critical need for simple, all oral, direct-acting antiviral regimens to treat GT1 HCV in this region. Treatment with ledipasvir (LDV)/sofosbuvir (SOF) results in high sustained virologic response rates 12 weeks after therapy (SVR12) in GT1 HCV infected patients in clinical trials and real-world settings. This study evaluated the efficacy and safety of LDV/SOF for 12 weeks in Chinese patients with chronic GT1 HCV infection. Methods: Treatment experienced and treatment naïve patients with chronic GT1 HCV infection with no cirrhosis or with compensated cirrhosis were eligible to enroll in a single-arm, openlabel trial to receive a fixed dosed combination of LDV/SOF 90/400 mg daily for 12 weeks. The primary efficacy endpoint was SVR12 using the CAP/CTM HCV 2.0 assay (LLOQ =15 IU/mL) and the primary safety endpoint was adverse events (AEs) leading to LDV/SOF discontinuation. Results: A total of 206 Chinese patients were enrolled and treated. Of these, 50% were male, 16% had compensated cirrhosis, 49% were treatment-experienced, 76% had IL28B CC genotype, and 100% had GT1b HCV infection. The mean (range) age and body mass index of enrolled subjects were 47 (21-72) years and 23 (14-34) kg/m2, respectively. The overall SVR12 rate is 100% (206/206). All 32 patients with cirrhosis (15 of whom were treatment-experienced), achieved SVR12. There were no discontinuations due to AEs. No serious or severe AEs were assessed by the investigator as related to study drug and there were no deaths. Conclusions: Treatment with the single tablet regimen of LDV/SOF for 12 weeks resulted in 100% SVR12 and was well tolerated in treatment experienced and treatment naïve GT1 HCVinfected Chinese patients with and without cirrhosis.

Modeling and Design of Zero-Voltage-Switching Controller for Wireless Power Transfer Systems Based on Closed-Loop Dominant Pole

Cheng Chen,Hong Zhou,Qijun Deng,Wenshan Hu,Yanjuan Yu,Xiaoqing Lu,Jingang Lai 전력전자학회 2019 JOURNAL OF POWER ELECTRONICS Vol.19 No.5

Zero-Voltage-Switching (ZVS) operation for a Wireless Power Transfer (WPT) system can be achieved by designing a ZVS controller. However, the performance of the controller in some industrial applications needs to be designed tightly. This paper introduces a ZVS controller design method for WPT systems. The parameters of the controller are designed according to the desired performance based on the closed loop dominant pole placement method. To describe the dynamic characteristics of the system ZVS angle, a nonlinear dynamic model is deduced and linearized using the small signal linearization method. By analyzing the zero-pole distribution, a low-order equivalent model that facilitates the controller design is obtained. The parameters of the controller are designed by calculating the time constant of the closed-loop dominant poles. A prototype of a WPT system with the designed controller and a five-stage multistage series variable capacitor (MSVC) is built and tested to verify the performance of the controller. The recorded response curves and waveforms show that the designed controller can maintain the ZVS angle at the reference angle with satisfactory control performance.

Modeling and Design of Zero-Voltage-Switching Controller for Wireless Power Transfer Systems Based on Closed-Loop Dominant Pole

Chen, Cheng,Zhou, Hong,Deng, Qijun,Hu, Wenshan,Yu, Yanjuan,Lu, Xiaoqing,Lai, Jingang The Korean Institute of Power Electronics 2019 JOURNAL OF POWER ELECTRONICS Vol.19 No.5

Zero-Voltage-Switching (ZVS) operation for a Wireless Power Transfer (WPT) system can be achieved by designing a ZVS controller. However, the performance of the controller in some industrial applications needs to be designed tightly. This paper introduces a ZVS controller design method for WPT systems. The parameters of the controller are designed according to the desired performance based on the closed loop dominant pole placement method. To describe the dynamic characteristics of the system ZVS angle, a nonlinear dynamic model is deduced and linearized using the small signal linearization method. By analyzing the zero-pole distribution, a low-order equivalent model that facilitates the controller design is obtained. The parameters of the controller are designed by calculating the time constant of the closed-loop dominant poles. A prototype of a WPT system with the designed controller and a five-stage multistage series variable capacitor (MSVC) is built and tested to verify the performance of the controller. The recorded response curves and waveforms show that the designed controller can maintain the ZVS angle at the reference angle with satisfactory control performance.

Do Clinical Features and Survival of Single Hormone Receptor Positive Breast Cancers Differ from Double Hormone Receptor Positive Breast Cancers?

Ng, Char-Hong,Pathy, Nirmala Bhoo,Taib, Nur Aishah,Ho, Gwo-Fuang,Mun, Kein-Seong,Rhodes, Anthony,Looi, Lai-Meng,Yip, Cheng-Har Asian Pacific Journal of Cancer Prevention 2014 Asian Pacific journal of cancer prevention Vol.15 No.18

The significance of the single hormone receptor positive phenotype of breast cancer is still poorly understood. The use of hormone therapy has been found to be less effective for this type, which has a survival outcome midway between double positive and double negative phenotypes. The aim of this study was to investigate differences in patient and tumor characteristics and survival between double-receptor positive (ER+PR+), double receptor negative (ER-PR-) and single receptor positive (ER+PR- and ER-PR+) breast cancer in an Asian setting. A total of 1,992 patients with newly diagnosed stage I to IV breast cancer between 2003 and 2008, and where information on ER and PR were available, were included in this study. The majority of patients had ER+PR+ tumors (n=903: 45.3%), followed by 741 (37.2%) ER-PR-, 247 (12.4%) ER+PR-, and 101 (5.1%) ER-PR+ tumors. Using multivariate analysis, ER+PR- tumors were 2.4 times more likely to be grade 3 compared to ER+PR+ tumors. ER+PR- and ER-PR+ tumors were 82% and 86% respectively less likely to be grade 3 compared with ER-PR- tumors. ER-PR+ tumours were associated with younger age. There were no survival differences between patients with ER+PR+ and ER-PR+ tumors. However, ER+PR- tumors have poorer survival compared with ER+PR+ tumours. ER-PR- tumours had the worst survival. Adjuvant hormonal therapy with tamoxifen was found to have identical survival advantage in patients with ER+PR+ and ER-PR+ tumors whereas impact was slightly lower in patients with ER+PR- tumors. In conclusion, we found ER+PR- tumors to be more aggressive and have poorer survival when compared to ER+PR+ tumors, while patients with ER-PR+ tumours were younger, but had a similar survival to their counterparts with ER+PR+ tumours.

China Consensus Document on Allergy Diagnostics

Chen Hao,Li Jing,Cheng Lei,Gao Zhongshan,Lin Xiaoping,Zhu Rongfei,Yang Lin,Tao Ailin,Hong Haiyu,Tang Wei,Guo Yinshi,Huang Huaiqiu,Sun Jinlyu,Lai He,Lei Cheng,Liu Guanghui,Xiang Li,Chen Zhuanggui,Ma Ha 대한천식알레르기학회 2021 Allergy, Asthma & Immunology Research Vol.13 No.2

The prevalence of allergic diseases has increased dramatically in recent years in China, affecting the quality of life in 40% of the population. The identification of allergens is the key to the diagnosis of allergic diseases. Presently, several methods of allergy diagnostics are available in China, but they have not been standardized. Additionally, cross-sensitization and co-sensitization make allergy diagnostics even more complicated. Based on 4 aspects of allergic disease (mechanism, diagnosis procedures, allergen detection in vivo and in vitro as well as the distribution map of the most important airborne allergens in China) and by referring to the consensus of the European Society of Allergy and Clinical Immunology, the World Allergy Organization, and the important literature on allergy diagnostics in China in recent years, we drafted this consensus of allergy diagnostics with Chinese characteristics. It aims to standardize the diagnostic methods of allergens and provides a reference for health care givers. The current document was prepared by a panel of experts from the main stream of professional allergy associations in China.

Correlation Between Fiber Orientation and Geometrical Shrinkage of Injected Parts Under the Influence of Flow-Fiber Coupling Effect

Chao-Tsai Huang,Jun-Zheng Wang,Cheng-Hong Lai,Sheng-Jye Hwang,Po-Wei Huang,Hsin-Shu Peng 한국정밀공학회 2023 International Journal of Precision Engineering and Vol.10 No.4

Fiber reinforced thermoplastics (FRP) have been widely used in automotive industry. However, how does the flow-fiber coupling effect influence the micro fiber orientation and further affect the geometrical shrinkage of the final part that is not fully understood yet. In this study, a complex center-gated plate has been applied to study the influence of the flow-fiber coupling effect on the fiber orientation variation and the geometrical change through numerical simulation. Then the practical verification through the micro-computed tomography (micro-CT) and image processing technology was carried out. Results show that in the presence of the flow-fiber coupling the required spruce pressure will be higher compared to no coupling case. In addition, the melt flow front pattern will be changed from “convex-flat” to “convex-concave” under the influence of this coupling. Moreover, in the presence of the flow-fiber coupling effect, the wider core width for fiber orientation tensor in the flow direction (A11) can be obtained from upstream to downstream regions for the same model. However, in the downstream region (i.e. in the FR), the flow-fiber coupling effect is more significantly due to the action of less shear rate in that region. Finally, through the measurement of the left–right asymmetrical shape of the FR for Model I (or Model II), the reason is that the flow-fiber coupling effect will switch the fiber orientation from the flow direction (A11) dominate to the cross-flow direction (A22) dominate. This asymmetrical fiber orientation distribution will further create that asymmetrical shrinkage shape of final part. The correlation between fiber orientation and geometrical shrinkage can be achieved.

Antimycobacterial Activity of Fusaric Acid from a Mangrove Endophyte and its Metal Complexes

Jia-Hui Pan,Yi Chen,Yu-Hong Huang,Yi-Wen Tao,Jun Wang,Yan Li,Yi Peng,Tao Dong,Xiao-Min Lai,Yong-Cheng Lin 대한약학회 2011 Archives of Pharmacal Research Vol.34 No.7

Due to the increasing prevalence of multidrug-resistant Mycobacterium tuberculosis, there is an urgent need for new antituberculosis drugs that have novel mechanisms of action. As part of our ongoing search for antimycobacterial metabolites from mangrove endophytes, chemical analysis of the active extract of a strain of Fusarium sp. was performed, which led to the isolation of fusaric acid as the predominant constituent. A variety of metal complexes of fusaric acid were prepared. Antimycobacterial assays showed that Cadmium (II) and Copper (II) complexes exhibited potent inhibitory activity against the M. bovis BCG strain [minimum inhibitory concentration (MIC) = 4 μg/mL] and the M. tuberculosis H37Rv strain (MIC = 10 μg/mL), respectively. This is the first report of the antimycobacterial activity of the mangrove Fusarium metabolite and its coordinating metal complexes.

A Modifi ed Virtual Generator Control for DC Microgrid with Improved Dynamic Characteristics of DC Bus Voltage and Enhanced current Sharing Effect

Zhang Han-Wen,Zhang Qin-Jin,Liu Yan-Cheng,Wang Hong-Lai,Hu Wang-Bao 대한전기학회 2022 Journal of Electrical Engineering & Technology Vol.17 No.6

Traditional virtual DC motor control can suppress the bus voltage fl uctuations caused by load power mutations and distributed generation fl uctuations. However, the dynamic response is poor and the load current sharing cannot be adjusted. Thus, a modifi ed virtual DC generator control strategy is proposed, which combines the average current controller with the virtual DC generator to enhance current sharing eff ect. The adaptive regulation equations of inertia coeffi cient and damping coeffi cient are elaborated simultaneously to improve the system dynamic characteristics. Then the infl uence of key control parameters on system stability is analyzed by establishing the small signal model. Finally, simulations and a StarSim HIL experimental platform of DC microgrid are built. The results show that the proposed method can eff ectively suppress the DC bus voltage fl uctuations and enable them to have a better dynamic response, while realizing the accurate current sharing.