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題名 COVID-19疫情藥物緊急使用授權之醫學法律整合研究
A Medical-Legal Integration Research for Emergency Use Authorization of Drugs in the COVID-19 Pandemic作者 蔡東湖
Tsai, Tung-Hu貢獻者 吳秦雯
Wu, Chin-Wen
蔡東湖
Tsai, Tung-Hu關鍵詞 嚴重特殊傳染性肺炎(COVID-19)
緊急使用授權(EUA)
公共準備與緊急準備法(PREP)
對策傷害補償計畫(CICP)
大流行和全災害準備重新授權法案(PAHPRA)
冠狀病毒援助、救濟和經濟安全法案(CARES)
藥事法
法律豁免
行政補償
COVID-19
Emergency Use Authorization (EUA)
Public Readiness and Emergency Preparedness Act (PREP)
Countermeasures Injury Compensation Program (CICP)
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)
Coronavirus Aid, Relief, and Economic Security Act (CARES)
Pharmaceutical Affairs Act
Legal Immunity
Administrative Compensation日期 2026 上傳時間 2-Feb-2026 13:58:30 (UTC+8) 摘要 背景：面對一場前所未有的公共衛生緊急事件，嚴重急性呼吸道症候群冠狀病毒 2（SARS-CoV-2）的迅速散播，引發了全球性之 COVID-19 疫情。本論文的緣起，緣自於一項在COVID-19疫情期間緊急使用授權(EUA)藥物瑞德西韋、莫努皮拉韋和倍拉維，的臨床前藥物動力學、生物屏障、及轉運蛋白機轉的研究。回顧疫情，一般藥物的研發大約要10年以上，為何COVID-19疫情期間可以在約一年多的時間，即可完成抗病毒藥物開發上市，在法律層面上做了那些因應且適時的協助。 研究設計與方法：為了探討這一系列醫學和法律的問題，我們的研究假說是，EUA像是一把鑰匙，啟動了後續醫藥研究法律的免責、補償，加速藥物開發。因此，本研究以EUA為基礎，探討COVID-19疫情期間醫療和法律整合問題，包括：1. EUA在醫學層面的創新研究與發展；2. EUA在法律層面的法律解析；以及3. EUA在政策層面的法律韌性的加強。 結果：檢視在新冠疫情期間，如何運用《公共準備與緊急準備法案》（PREP）在緊急情況下提供有效的法律責任豁免。PREP法案賦予疫情期間參與研發、生產和分銷藥物的實體和個人責任豁免權，從而鼓勵藥物研發並減緩疫情傳播，然而，這種豁免權並非讓受害者失去追索權。相反地，《對策傷害補償計畫》（CICP），作為行政補償機制。當EUA啟動後，PREP的免責機制，和CICP的行政補償機制也同步啟動，EUA-PREP-CICP連動機制的框架，讓受害者的權益受到保護。此外還有兩套法律，扮演聯邦和州政府協同機制的角色，即《大流行和全災害準備重新授權法案》(PAHPRA)放寬 EUA 的啟動門檻，和《冠狀病毒援助、救濟和經濟安全法案》(CARES)促成可立即撥款，最終完成PAHPRA-EUA-PREP-CICP- CARES連動機制的論述。 結論：本文的主要新發現是：利用臨床前藥物動力學，探討 COVID-19 抗病毒藥物穿過生物屏障的動態機制；結合醫學與法律解析，促成醫學快速發展；提出政策參考，建立緊急公共衛生的處理連動機制「PAHPRA-EUA-PREP-CICP-CARES」。
Background: This research addresses the unprecedented public health emergency of the global COVID-19 pandemic, caused by the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The aim of the research stems from a preclinical pharmacokinetic study, as well as an understanding of the biological barriers and transporter mechanisms of Remdesivir, Molnupiravir, and Paxlovid, which received Emergency Use Authorization (EUA) during the COVID-19 pandemic. Traceback at pandemics, drug development typically takes over 10 years. Why were antiviral drugs developed and launched in just over a year during the COVID-19 pandemic? What timely and appropriate legal assistance was provided? Research Design and Methods: To explore these medical and legal issues, our research hypothesis is that EUA acts as a key, unlocking subsequent legal exemptions and compensations for pharmaceutical research, thus accelerating drug development. Therefore, this study, based on the Emergency Preparedness Act (EUA), explores the integration of medical and legal aspects during the COVID-19 pandemic, including: 1. the EUA's role in innovative research and development at the medical level; 2. the EUA's role in legal interpretation at the legal level; and 3. the EUA's role in strengthening legal resilience at the policy level. Results: This study examines how the Public Preparedness and Emergency Preparedness Act (PREP) can be used to provide effective legal liability exemptions in emergency situations during the COVID-19 pandemic. The PREP Act grants liability exemptions to entities and individuals involved in the research, development, production, and distribution of drugs during the pandemic, thereby encouraging drug development and mitigating the spread of the virus. However, this exemption does not deprive victims of their right to recourse. Instead, the Countermeasures Injury Compensation Program (CICP) serves as an administrative mechanism for compensation. When the EUA is activated, the PREP's exemption mechanism and the CICP's administrative compensation mechanism are simultaneously activated. This EUA-PREP-CICP linkage mechanism protects the rights of victims. In addition, two other sets of laws act as a coordination mechanism between the federal and state governments: the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), which relaxes the threshold for EUA activation, and the Coronavirus Aid, Relief, and Economic Security Act (CARES), which facilitates immediate funding, ultimately completing the PAHPRA-EUA-PREP-CICP-CARES linkage mechanism. Conclusion: The main new findings of this research are: utilizing preclinical pharmacokinetics to explore the mechanism by which COVID-19 antiviral drugs cross biological barriers; combining medical and legal analysis to promote rapid medical development; and proposing policy references to establish a linkage mechanism for emergency public health responses: "PAHPRA-EUA-PREP-CICP-CARES".參考文獻 一、英文文獻 Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fätkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. 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Nat Commun. 2020 Aug 6;11(1):3910. doi: 10.1038/s41467-020-17796-z. 二、中文文獻 林怜伶、張雅姿、江柏榮、王怡雅、藍一逢、林千玉、蕭慶瞬、劉慧蓉、楊靖慧，台灣COVID-19疫情初期實施居家檢疫/隔離措施探討，台灣衛誌 2020, Vol.39, No.6, 602-610. 孔常喜、梁立霖、呂宗學，台灣COVID-19疫情流行期間之超額死亡估計，台灣衛誌 2024；43(2)：144-154. 許瑜真、林詠青、周玉民，2024年國際衛生條例(2005)修正要點評析。疫情報導2024；40(21)：329–341。 童耀申、郭丁吉、江沛錡、吳靜怡、楊玉英、楊佩玉、施珮筑，中台灣區域教學醫院2020 年使用不同新冠檢測平台的經驗，秀傳醫學雜誌Show–Chwan Med J 2023; 22(3): 326-332. 三、網站文獻資料 藥事法第48-2條, COVID-19疫苗/藥品專案製造及輸入之法源依據, 衛生福利部食品藥物管理署. https://www.fda.gov.tw/tc/siteContent.aspx?sid=11739 特定藥物專案核准製造及輸入辦法第3條, 衛生福利部食品藥物管理署. https://www.fda.gov.tw/TC/siteContent.aspx?sid=11843 藥品諮詢窗口Q&A (2018), 衛生福利部食品藥物管理署, file:///C:/Users/USER/Downloads/%E8%97%A5%E5%93%81%E8%AB%AE%E8%A9%A2%E7%AA%97%E5%8F%A3Q&A%20(3).pdf 預防接種受害救濟基金徵收及審議辦法, https://www.cdc.gov.tw/En/File/Get/ijRFDpz38qVXwrZkzorOAA 藥害救濟法- 法規資訊- 政府資訊公開- 衛生福利部食品藥物管理署, https://www.fda.gov.tw/tc/lawContent.aspx?cid=55&id=793 國家衛生指揮中心(NHCC), 衛生福利部疾病管制署, https://www.cdc.gov.tw/Category/MPage/6CJ7RCriP1wF4BmtgAhKuA 臺灣清冠1號國內核准專案製造- 衛生福利部中醫藥司；https://dep.mohw.gov.tw/DOCMAP/lp-5175-108.html FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—the science of safety and effectiveness. https://www.fda.gov/drugs/news-events-human-drugs/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectiveness Coronavirus Aid, Relief, and Economic Security (CARES) Act. https://www.transit.dot.gov/cares-act Jonathan Iwry, FDA Emergency Use Authorization: A Brief History From 9/11 to COVID-19. https://www.fdli.org/2021/09/fda-emergency-use-authorization-a-brief-history-from-9-11-to-covid-19/ U.S.C. Title 21 - FOOD AND DRUGS；https://www.govinfo.gov/content/pkg/USCODE-2011-title21/html/USCODE-2011-title21-chap9-subchapV-partE-sec360bbb-3.htm 21 U.S.C. §360bbb-3；https://www.govinfo.gov/content/pkg/USCODE-2019-title21/pdf/USCODE-2019-title21-chap9-subchapV-partE-sec360bbb-3.pdf Douglas Maffei, PhD, Investors, Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19. https://www.gilead.com/news/news-details/2020/gilead-announces-approval-of-veklury-remdesivir-in-japan-for-patients-with-severe-covid-19#:~:text=Other%20News,May%207%2C%202025 Kaneko Miyuki, Emergency Regulatory Approval System in Japan, Pfizer R&D Japan G.K. https://globalforum.diaglobal.org/issue/september-2022/emergency-regulatory-approval-system-in-japan/ 描述 碩士
國立政治大學
法律科際整合研究所
113652008資料來源 http://thesis.lib.nccu.edu.tw/record/#G0113652008 資料類型 thesis dc.contributor.advisor 吳秦雯 zh_TW dc.contributor.advisor Wu, Chin-Wen en_US dc.contributor.author (Authors) 蔡東湖 zh_TW dc.contributor.author (Authors) Tsai, Tung-Hu en_US dc.creator (作者) 蔡東湖 zh_TW dc.creator (作者) Tsai, Tung-Hu en_US dc.date (日期) 2026 en_US dc.date.accessioned 2-Feb-2026 13:58:30 (UTC+8) - dc.date.available 2-Feb-2026 13:58:30 (UTC+8) - dc.date.issued (上傳時間) 2-Feb-2026 13:58:30 (UTC+8) - dc.identifier (Other Identifiers) G0113652008 en_US dc.identifier.uri (URI) https://nccur.lib.nccu.edu.tw/handle/140.119/161491 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 法律科際整合研究所 zh_TW dc.description (描述) 113652008 zh_TW dc.description.abstract (摘要) 背景：面對一場前所未有的公共衛生緊急事件，嚴重急性呼吸道症候群冠狀病毒 2（SARS-CoV-2）的迅速散播，引發了全球性之 COVID-19 疫情。本論文的緣起，緣自於一項在COVID-19疫情期間緊急使用授權(EUA)藥物瑞德西韋、莫努皮拉韋和倍拉維，的臨床前藥物動力學、生物屏障、及轉運蛋白機轉的研究。回顧疫情，一般藥物的研發大約要10年以上，為何COVID-19疫情期間可以在約一年多的時間，即可完成抗病毒藥物開發上市，在法律層面上做了那些因應且適時的協助。 研究設計與方法：為了探討這一系列醫學和法律的問題，我們的研究假說是，EUA像是一把鑰匙，啟動了後續醫藥研究法律的免責、補償，加速藥物開發。因此，本研究以EUA為基礎，探討COVID-19疫情期間醫療和法律整合問題，包括：1. EUA在醫學層面的創新研究與發展；2. EUA在法律層面的法律解析；以及3. EUA在政策層面的法律韌性的加強。 結果：檢視在新冠疫情期間，如何運用《公共準備與緊急準備法案》（PREP）在緊急情況下提供有效的法律責任豁免。PREP法案賦予疫情期間參與研發、生產和分銷藥物的實體和個人責任豁免權，從而鼓勵藥物研發並減緩疫情傳播，然而，這種豁免權並非讓受害者失去追索權。相反地，《對策傷害補償計畫》（CICP），作為行政補償機制。當EUA啟動後，PREP的免責機制，和CICP的行政補償機制也同步啟動，EUA-PREP-CICP連動機制的框架，讓受害者的權益受到保護。此外還有兩套法律，扮演聯邦和州政府協同機制的角色，即《大流行和全災害準備重新授權法案》(PAHPRA)放寬 EUA 的啟動門檻，和《冠狀病毒援助、救濟和經濟安全法案》(CARES)促成可立即撥款，最終完成PAHPRA-EUA-PREP-CICP- CARES連動機制的論述。 結論：本文的主要新發現是：利用臨床前藥物動力學，探討 COVID-19 抗病毒藥物穿過生物屏障的動態機制；結合醫學與法律解析，促成醫學快速發展；提出政策參考，建立緊急公共衛生的處理連動機制「PAHPRA-EUA-PREP-CICP-CARES」。 zh_TW dc.description.abstract (摘要) Background: This research addresses the unprecedented public health emergency of the global COVID-19 pandemic, caused by the spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The aim of the research stems from a preclinical pharmacokinetic study, as well as an understanding of the biological barriers and transporter mechanisms of Remdesivir, Molnupiravir, and Paxlovid, which received Emergency Use Authorization (EUA) during the COVID-19 pandemic. Traceback at pandemics, drug development typically takes over 10 years. Why were antiviral drugs developed and launched in just over a year during the COVID-19 pandemic? What timely and appropriate legal assistance was provided? Research Design and Methods: To explore these medical and legal issues, our research hypothesis is that EUA acts as a key, unlocking subsequent legal exemptions and compensations for pharmaceutical research, thus accelerating drug development. Therefore, this study, based on the Emergency Preparedness Act (EUA), explores the integration of medical and legal aspects during the COVID-19 pandemic, including: 1. the EUA's role in innovative research and development at the medical level; 2. the EUA's role in legal interpretation at the legal level; and 3. the EUA's role in strengthening legal resilience at the policy level. Results: This study examines how the Public Preparedness and Emergency Preparedness Act (PREP) can be used to provide effective legal liability exemptions in emergency situations during the COVID-19 pandemic. The PREP Act grants liability exemptions to entities and individuals involved in the research, development, production, and distribution of drugs during the pandemic, thereby encouraging drug development and mitigating the spread of the virus. However, this exemption does not deprive victims of their right to recourse. Instead, the Countermeasures Injury Compensation Program (CICP) serves as an administrative mechanism for compensation. When the EUA is activated, the PREP's exemption mechanism and the CICP's administrative compensation mechanism are simultaneously activated. This EUA-PREP-CICP linkage mechanism protects the rights of victims. In addition, two other sets of laws act as a coordination mechanism between the federal and state governments: the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), which relaxes the threshold for EUA activation, and the Coronavirus Aid, Relief, and Economic Security Act (CARES), which facilitates immediate funding, ultimately completing the PAHPRA-EUA-PREP-CICP-CARES linkage mechanism. Conclusion: The main new findings of this research are: utilizing preclinical pharmacokinetics to explore the mechanism by which COVID-19 antiviral drugs cross biological barriers; combining medical and legal analysis to promote rapid medical development; and proposing policy references to establish a linkage mechanism for emergency public health responses: "PAHPRA-EUA-PREP-CICP-CARES". en_US dc.description.tableofcontents 中文摘要及關鍵詞 i 英文摘要及關鍵詞 iii 縮寫 x 圖次 xi 第一章 緒論 第一節 在COVID-19疫情時程回顧 1 第一款 疫情時間軸分析 3 第二款 中央流行疫情指揮中心 8 第二節 COVID-19疫情期間的台灣法制架構 9 第一款 傳染病防治法的基礎 10 第二款 緊急命令的法律位階 11 第三節 COVID-19疫情爆發歸因 12 第一款 COVID-19疫情初期病例的死亡率 13 第二款 COVID-19首例死亡案例 14 第四節 研究動機 16 第五節 研究架構 23 第二章 冠狀病毒及其治療藥物 25 第一節 冠狀病毒的生活史及小分子藥物作用機轉 25 第一款 冠狀病毒的結構 25 第二款 SARS-CoV-2 的生命週期 26 第二節 病毒變異株演變的時間軸解析 30 第三節 SARS-CoV-2致病機轉 31 第一款 病毒進入和初始複製 32 第二款 病毒的直接細胞病變效應 33 第三款 宿主免疫反應失調 33 第四款 淋巴球減少和免疫細胞功能障礙 34 第五款 多重器官受累 34 第四節 小分子抗新冠病毒藥物的作用機制 35 第一款 瑞德西韋 38 第二款 莫努皮拉韋 44 第三款 倍拉維 47 第三章 美國緊急使用授權(EUA) 58 第一節 頒布EUA流程及效力 58 第一款 公共衛生服務法(PHS)第319條 59 第二款 聯邦食品、藥品和化妝品法案(FD&C)第 564 條 60 第三款 PHS第319條和FD&C第564條的差別 63 第四款 美國衛生與公眾服務部(HHS)部長聲明 63 第五款 美國HHS部長與台灣衛生福利部部長 67 第二節 美國EUA頒布及執行 68 第一款 實施EUA的先決條件 68 第二款 FDA 審查與諮詢 69 第三款 EUA上市後監測和數據收集 70 第三節 EUA 的撤銷和終止 71 第一款 撤銷EUA 72 第二款 終止EUA 74 第四章 我國對於藥物緊急使用授權之相關程序與法規 76 第一節 訂定藥物EUA審查標準 78 第一款 相關修法建議 79 第二款 瑞德西韋 80 第三款 莫納皮拉韋 80 第四款 倍拉維 82 第二節 藥事法專案核准對疫情的重要性 83 第一款 加速藥品與疫苗的取得 84 第二款 應對公共衛生緊急狀況 85 第三款 在效益與風險間取得平衡 85 第四款 促進國內研發與生產 87 第五款 確保資訊公開與後續追蹤 88 第三節 藥事法專案核准可能的爭議 89 第一款 法源依據不明確與模糊地帶 90 第二款 政治干預與信任危機 91 第三款 上市後監測與風險管理機制待強化 91 第四款 權責分工與配套措施未盡完善 93 第五章 世界衛生組織(WHO)及其他國家對藥物緊急使用授權法規 95 第一節 WHO的職能定位與藥物緊急使用清單 95 第一款 WHO的職能定位 96 第二款 WHO藥物緊急使用清單 96 第二節 日本對EUA的法規及作法 98 第一款 緊急情況下特別批准制度 98 第二款 日本新的緊急審核系統 99 第三款 實踐與注意事項 100 第三節 英國對EUA的法規及作法 101 第一款 英國緊急使用臨時授權 101 第二款 英國有條件上市許可 102 第三款 英國在新冠疫情期間的主要做法與特點 103 第四節 德國對EUA的法規及作法 104 第一款 歐洲藥品管理署快速審批途徑 104 第二款 德國國家主管機關的角色 105 第三款 德國國家具體情況及實踐 106 第五節 法國對EUA的法規及作法 107 第一款 歐洲藥品管理署集中程序 107 第二款 法國早期已有的國家機制 108 第三款 法國主要國家級醫藥機構 109 第六節 歐盟對EUA的法規及作法 110 第一款 歐盟有條件上市許可 110 第二款 歐盟主要機構及其職責 112 第三款 歐盟在實務運作與會員國權益保障 113 第七節 其他國家對EUA的法規及作法 115 第一款 加拿大 115 第二款 澳洲 117 第三款 新加坡 118 第四款 韓國 119 第五款 印度 120 第六章 COVID-19疫情期間藥物EUA之法理解析 121 第一節 藥物EUA的法理解析 121 第一款 美國藥物EUA的法理解析 121 第二款 歐盟藥物EUA有條件上市許可的法理解析 124 第三款 我國藥物EUA專案核准的法理解析 125 第二節 藥物EUA的免責條款解析 128 第一款 美國藥物EUA的免責條款解析 129 第二款 歐盟藥物EUA有條件上市許可的免責條款解析 131 第三款 我國藥物EUA專案核准的免責條款解析 132 第三節 瑞德西韋、莫努皮拉韋、倍拉維三個藥物EUA後的命運 133 第一款 瑞德西韋獲得FDA正式核准 134 第二款 莫努皮拉韋沒有獲得FDA正式核准 135 第三款 倍拉維獲得FDA正式核准 136 第四節 EUA到責任豁免法理解析 138 第五節 責任豁免到行政補償法理解析 140 第六節 EUA–PREP–CICP法理解析 141 第七節 PAHPRA–EUA–PREP–CICP–CARES法理解析 142 第八節 PAHPA、PAHPRA、PAHPAIA法理解析 145 第七章 結論 149 第一節 從COVID-19疫情緣起到藥物研究 149 第二節 從基礎實驗到法規探索 150 第三節 藥物EUA法律制度啟示 152 第四節 本論文的原創性探討 154 第五節 總結醫學法律整合研究 155 參考文獻 158 zh_TW dc.format.extent 5316375 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0113652008 en_US dc.subject (關鍵詞) 嚴重特殊傳染性肺炎(COVID-19) zh_TW dc.subject (關鍵詞) 緊急使用授權(EUA) zh_TW dc.subject (關鍵詞) 公共準備與緊急準備法(PREP) zh_TW dc.subject (關鍵詞) 對策傷害補償計畫(CICP) zh_TW dc.subject (關鍵詞) 大流行和全災害準備重新授權法案(PAHPRA) zh_TW dc.subject (關鍵詞) 冠狀病毒援助、救濟和經濟安全法案(CARES) zh_TW dc.subject (關鍵詞) 藥事法 zh_TW dc.subject (關鍵詞) 法律豁免 zh_TW dc.subject (關鍵詞) 行政補償 zh_TW dc.subject (關鍵詞) COVID-19 en_US dc.subject (關鍵詞) Emergency Use Authorization (EUA) en_US dc.subject (關鍵詞) Public Readiness and Emergency Preparedness Act (PREP) en_US dc.subject (關鍵詞) Countermeasures Injury Compensation Program (CICP) en_US dc.subject (關鍵詞) Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) en_US dc.subject (關鍵詞) Coronavirus Aid, Relief, and Economic Security Act (CARES) en_US dc.subject (關鍵詞) Pharmaceutical Affairs Act en_US dc.subject (關鍵詞) Legal Immunity en_US dc.subject (關鍵詞) Administrative Compensation en_US dc.title (題名) COVID-19疫情藥物緊急使用授權之醫學法律整合研究 zh_TW dc.title (題名) A Medical-Legal Integration Research for Emergency Use Authorization of Drugs in the COVID-19 Pandemic en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 一、英文文獻 Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fätkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. 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