Browsing by Author "Capital Medical University"

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    Early and Late Virologic Failure after Virologic Suppression in HIV-Infected Asian Children and Adolescents
    (2019-03-01) Weiwei Mu; Adam W. Bartlett; Torsak Bunupuradah; Kulkanya Chokephaibulkit; Nagalingeswaran Kumarasamy; Penh Sun Ly; Rawiwan Hansudewechakul; Lam Van Nguyen; Pagakrong Lumbiganon; Tavitiya Sudjaritruk; Thahira A.Jamal Mohamed; Nik Khairulddin Nik Yusoff; Khanh Huu Truong; Viet Chau Do; Moy Siew Fong; Revathy Nallusamy; Nia Kurniati; Dewi Kumara Wati; Annette H. Sohn; Azar Kariminia; Fujie Zhang; Beijing Ditan Hospital Capital Medical University; VHS Medical Centre India; National Hospital of Pediatrics Hanoi; Universitas Udayana; University of Indonesia, RSUPN Dr. Cipto Mangunkusumo; Capital Medical University; Kirby Institute; Faculty of Medicine, Khon Kaen University; Kuala Lumpur Hospital; The HIV Netherlands Australia Thailand Research Collaboration; Faculty of Medicine, Siriraj Hospital, Mahidol University; Chiang Mai University; Children's Hospital 2; Children's Hospital 1; Hospital Raja Perempuan Zainab II; TREAT Asia/amfAR-The Foundation for AIDS Research; Penang Hospital; Chiangrai Prachanukroh Hospital; Hospital Likas; National Center for HIV/AIDS
    © 2018 Wolters Kluwer Health, Inc. Background:Virologic failure is a major threat to maintaining effective combination antiretroviral therapy, especially for children in need of lifelong treatment. With efforts to expand access to HIV viral load testing, our understanding of pediatric virologic failure is evolving.Setting:An Asian cohort in 16 pediatric HIV services across 6 countries.Methods:From 2005 to 2014, patients younger than 20 years who achieved virologic suppression and had subsequent viral load testing were included. Early virologic failure was defined as a HIV RNA ≥1000 copies per milliliter within 12 months of virologic suppression, and late virologic as a HIV RNA ≥1000 copies per milliliter after 12 months following virologic suppression. Characteristics at combination antiretroviral therapy initiation and virologic suppression were described, and a competing risk time-to-event analysis was used to determine cumulative incidence of virologic failure and factors at virologic suppression associated with early and late virologic failure.Results:Of 1105 included in the analysis, 182 (17.9%) experienced virologic failure. The median age at virologic suppression was 6.9 years, and the median time to virologic failure was 24.6 months after virologic suppression. The incidence rate for a first virologic failure event was 3.3 per 100 person-years. Factors at virologic suppression associated with late virologic failure included older age, mostly rural clinic setting, tuberculosis, protease inhibitor-based regimens, and early virologic failure. No risk factors were identified for early virologic failure.Conclusions:Around 1 in 5 experienced virologic failure in our cohort after achieving virologic suppression. Targeted interventions to manage complex treatment scenarios, including adolescents, tuberculosis coinfection, and those with poor virologic control are required.
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    Phase 2a, open-label, dose-escalating, multi-center pharmacokinetic study of favipiravir (T-705) in combination with oseltamivir in patients with severe influenza
    (2020-12-01) Yeming Wang; Wu Zhong; Alex Salam; Joel Tarning; Qingyuan Zhan; Jian an Huang; Heng Weng; Changqing Bai; Yanhong Ren; Koichi Yamada; Dayan Wang; Qiang Guo; Qiongqiong Fang; Sakurai Tsutomu; Xiaohui Zou; Haibo Li; Annelies Gillesen; Lyndsey Castle; Cheng Chen; Hongyan Li; Jing Zhen; Binghuai Lu; Jun Duan; Liping Guo; Jinfang Jiang; Ruiyuan Cao; Guohui Fan; Jintong Li; Frederick G. Hayden; Chen Wang; Peter Horby; Bin Cao; Chinese Academy of Medical Sciences & Peking Union Medical College; The First Affiliated Hospital of Soochow University; China PLA General Hospital; Fujian Provincial Hospital; Beijing Institute of Pharmacology and Toxicology; Chinese Center for Disease Control and Prevention; University of Virginia School of Medicine; Capital Medical University; Toyama Chemical Co., Ltd.; China-Japan Friendship Hospital; Mahidol University; Nuffield Department of Medicine; HQ Bioscience Co., Ltd.
    © 2020 The Authors Background: The pharmacokinetics and appropriate dose regimens of favipiravir are unknown in hospitalized influenza patients; such data are also needed to determine dosage selection for favipiravir trials in COVID-19. Methods: In this dose-escalating study, favipiravir pharmacokinetics and tolerability were assessed in critically ill influenza patients. Participants received one of two dosing regimens; Japan licensed dose (1600 mg BID on day 1 and 600 mg BID on the following days) and the higher dose (1800 mg/800 mg BID) trialed in uncomplicated influenza. The primary pharmacokinetic endpoint was the proportion of patients with a minimum observed plasma trough concentration (Ctrough) ≥20 mg/L at all measured time points after the second dose. Results: Sixteen patients were enrolled into the low dose group and 19 patients into the high dose group of the study. Favipiravir Ctrough decreased significantly over time in both groups (p <0.01). Relative to day 2 (48 hrs), concentrations were 91.7% and 90.3% lower in the 1600/600 mg group and 79.3% and 89.5% lower in the 1800/800 mg group at day 7 and 10, respectively. In contrast, oseltamivir concentrations did not change significantly over time. A 2-compartment disposition model with first-order absorption and elimination described the observed favipiravir concentration-time data well. Modeling demonstrated that less than 50% of patients achieved Ctrough ≥20 mg/L for >80% of the duration of treatment of the two dose regimens evaluated (18.8% and 42.1% of patients for low and high dose regimen, respectively). Increasing the favipravir dosage predicted a higher proportion of patients reaching this threshold of 20 mg/L, suggesting that dosing regimens of ≥3600/2600 mg might be required for adequate concentrations. The two dosing regimens were well-tolerated in critical ill patients with influenza. Conclusion: The two dosing regimens proposed for uncomplicated influenza did not achieve our pre-defined treatment threshold.