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385 results on '"Hayden, Frederick G"'

1. Heterogeneity of treatment effect of interferon-β1b and lopinavir–ritonavir in patients with Middle East respiratory syndrome by cytokine levels

Author

Arabi, Yaseen M., Asiri, Ayed Y., Assiri, Abdullah M., Abdullah, Mashan L., Aljami, Haya A., Balkhy, Hanan H., Al Jeraisy, Majed, Mandourah, Yasser, AlJohani, Sameera, Al Harbi, Shmeylan, Jokhdar, Hani A. Aziz, Deeb, Ahmad M., Memish, Ziad A., Jose, Jesna, Ghazal, Sameeh, Al Faraj, Sarah, Al Mekhlafi, Ghaleb A., Sherbeeni, Nisreen Murad, Elzein, Fatehi Elnour, Hayden, Frederick G., Fowler, Robert A., AlMutairi, Badriah M., Al-Dawood, Abdulaziz, and Alharbi, Naif Khalaf

Published
2022
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2. Oral Favipiravir Exposure and Pharmacodynamic Effects in Adult Outpatients With Acute Influenza.

Author

Hayden, Frederick G, Lenk, Robert P, Epstein, Carol, and Kang, Lih Lisa

Subjects
*CLINICAL trials, *INFLUENZA, *PHARMACOKINETICS, *PHARMACODYNAMICS, *TITERS
Abstract

Background The pharmacokinetics of oral favipiravir and the relationships of plasma concentrations to antiviral effects are incompletely studied in influenza. Methods Serial plasma samples were collected from adults with uncomplicated influenza who were randomized to favipiravir (1800 mg twice a day on day 1, 800 mg twice a day on days 2 to 5; n = 827) or placebo (n = 419) in 2 phase 3 trials. Post hoc analyses assessed the frequency of reaching an average minimum concentration (Cmin) ≥20 µg/mL, its association with antiviral efficacy, and factors associated with reduced favipiravir exposure. Results Wide interindividual variability existed in favipiravir concentrations, and this regimen failed to reach an average Cmin > 20 µg/mL in 41%–43% of participants. Those attaining this threshold showed greater reductions in nasopharyngeal infectious virus titers on treatment days 2 and 3 and lower viral titer area under the curve compared to those who did not. Those with average Cmin <20 µg/mL had over 2-fold higher mean ratios of the metabolite T-705M1 to favipiravir, consistent with greater metabolism, and were more likely to weigh > 80 kg (61.5%–64%). Conclusions Higher favipiravir levels with average Cmin > 20 µg/mL were associated with larger antiviral effects and more rapid illness alleviation compared to placebo and to favipiravir recipients with lower average Cmin values in uncomplicated influenza. Clinical Trials Registration. NCT1068912 and NCT01728753. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Comparative Effectiveness of Baloxavir Marboxil and Oseltamivir Treatment in Reducing Household Transmission of Influenza: A Post Hoc Analysis of the BLOCKSTONE Trial.

Author

Ikematsu, Hideyuki, Baba, Takamichi, Saito, Masaya M., Kinoshita, Masahiro, Miyazawa, Shogo, Hata, Ayano, Nakano, Saki, Kitanishi, Yoshitake, and Hayden, Frederick G.

Subjects
INFLUENZA, HOUSEHOLDS, POISSON regression, OSELTAMIVIR, VACCINATION status, SWINE influenza
Abstract

Background: The transmission of influenza virus in households, especially by children, is a major route of infection. Prior studies suggest that timely antiviral treatment of ill cases may reduce infection in household contacts. The aim of the study was to compare the effects of oseltamivir (OTV) and baloxavir marboxil (BXM) treatment of index cases on the secondary attack rate (SAR) of influenza within household. Methods: A post hoc analysis was done in BLOCKSTONE trial—a placebo‐controlled, double‐blinded post‐exposure prophylaxis of BXM. Data were derived from the laboratory‐confirmed index cases' household contacts who received placebo in the trial and also from household members who did not participate in the trial but completed illness questionnaires. To assess the SAR of household members, multivariate analyses adjusted for factors including age, vaccination status, and household size were performed and compared between contacts of index cases treated with BXM or OTV. Results: In total, 185 index cases (116 treated with BXM and 69 treated with OTV) and 410 household contacts (201 from trial, 209 by questionnaire) were included. The Poisson regression modeling showed that the SAR in household contacts of index cases treated with BXM and OTV was 10.8% and 18.5%, respectively; the adjusted relative reduction in SAR was 41.8% (95% confidence interval: 1.0%–65.7%, p = 0.0456) greater with BXM than OTV. Similar reductions were found in contacts from the trial and those included by questionnaire. Conclusion: BXM treatment of index cases appeared to result in a greater reduction in secondary household transmission than OTV treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Critical care management of adults with community-acquired severe respiratory viral infection

Author

Arabi, Yaseen M., Fowler, Robert, and Hayden, Frederick G.

Subjects
Medical research -- Usage, Medicine, Experimental -- Usage, Adults -- Usage, Severe acute respiratory syndrome -- Usage, Coronaviruses -- Usage, Health care industry, Infectious Diseases Society of America
Abstract

With the expanding use of molecular assays, viral pathogens are increasingly recognized among critically ill adult patients with community-acquired severe respiratory illness; studies have detected respiratory viral infections (RVIs) in 17-53% of such patients. In addition, novel pathogens including zoonotic coronaviruses like the agents causing Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) and the 2019 novel coronavirus (2019 nCoV) are still being identified. Patients with severe RVIs requiring ICU care present typically with hypoxemic respiratory failure. Oseltamivir is the most widely used neuraminidase inhibitor for treatment of influenza; data suggest that early use is associated with reduced mortality in critically ill patients with influenza. At present, there are no antiviral therapies of proven efficacy for other severe RVIs. Several adjunctive pharmacologic interventions have been studied for their immunomodulatory effects, including macrolides, corticosteroids, cyclooxygenase-2 inhibitors, sirolimus, statins, anti-influenza immune plasma, and vitamin C, but none is recommended at present in severe RVIs. Evidence-based supportive care is the mainstay for management of severe respiratory viral infection. Non-invasive ventilation in patients with severe RVI causing acute hypoxemic respiratory failure and pneumonia is associated with a high likelihood of transition to invasive ventilation. Limited existing knowledge highlights the need for data regarding supportive care and adjunctive pharmacologic therapy that is specific for critically ill patients with severe RVI. There is a need for more pragmatic and efficient designs to test different therapeutics both individually and in combination., Author(s): Yaseen M. Arabi [sup.1] [sup.2] [sup.3], Robert Fowler [sup.4] [sup.5] [sup.6], Frederick G. Hayden [sup.7] Author Affiliations: (1) grid.412149.b, 0000 0004 0608 0662, College of Medicine, King Saud Bin [...]

Published
2020
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7. Macrolides in critically ill patients with Middle East Respiratory Syndrome

Author

Arabi, Yaseen M., Deeb, Ahmad M., Al-Hameed, Fahad, Mandourah, Yasser, Almekhlafi, Ghaleb A., Sindi, Anees A., Al-Omari, Awad, Shalhoub, Sarah, Mady, Ahmed, Alraddadi, Basem, Almotairi, Abdullah, Al Khatib, Kasim, Abdulmomen, Ahmed, Qushmaq, Ismael, Solaiman, Othman, Al-Aithan, Abdulsalam M., Al-Raddadi, Rajaa, Ragab, Ahmad, Al Harthy, Abdulrahman, Kharaba, Ayman, Jose, Jesna, Dabbagh, Tarek, Fowler, Robert A., Balkhy, Hanan H., Merson, Laura, and Hayden, Frederick G.

Published
2019
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12. Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial

Author

Wang, Yeming, Zhou, Fei, Zhang, Dingyu, Zhao, Jianping, Du, Ronghui, Hu, Yi, Cheng, Zhenshun, Gao, Ling, Jin, Yang, Luo, Guangwei, Fu, Shouzhi, Lu, Qiaofa, Du, Guanhua, Wang, Ke, Lu, Yang, Fan, Guohui, Zhang, Yi, Liu, Ying, Ruan, Shunan, Liu, Wen, Jaki, Thomas, Hayden, Frederick G., Horby, Peter W., Cao, Bin, and Wang, Chen

Published
2020
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16. Feasibility of using convalescent plasma immunotherapy for MERS-CoV infection, Saudi Arabia

Author

Arabi, Yaseen M., Hajeer, Ali H., Luke, Thomas, Raviprakash, Kanakatte, Balkhy, Hanan, Johani, Sameera, Dawood, Abdulaziz Al-, Qahtani, Saad Al-, Omari, Awad Al-, Hameed, Fahad Al-, Hayden, Frederick G., Fowler, Robert, Bouchama, Abderrezak, Shindo, Nahoko, Khairy, Khalid Al-, Carson, Gail, Taha, Yusri, Sadat, Musharaf, and Alahmadi, Mashail

Subjects
Mortality -- Research -- Risk factors -- Saudi Arabia, Middle East respiratory syndrome -- Research -- Care and treatment -- Identification and classification, Immunotherapy -- Health aspects -- Usage, Health
Abstract

Middle East respiratory syndrome coronavirus (MERS-CoV) was initially identified in September 2012 when a patient in Saudi Arabia with a severe, acute respiratory infection and acute renal failure died (1). [...]

Published
2016
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21. Enterovirus Meningitis in Adults

Author

Brennan, P. J., Fife, Kenneth H., Romero, Jose R., Griffin, Johanna A., McKinlay, Mark A., and Hayden, Frederick G.

Published
1998

22. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol

Author

Arabi, Yaseen, Balkhy, Hanan, Hajeer, Ali H., Bouchama, Abderrezak, Hayden, Frederick G., Al-Omari, Awad, Al-Hameed, Fahad M., Taha, Yusri, Shindo, Nahoko, Whitehead, John, Merson, Laura, AlJohani, Sameera, Al-Khairy, Khalid, Carson, Gail, Luke, Thomas C., Hensley, Lisa, Al-Dawood, Abdulaziz, Al-Qahtani, Saad, Modjarrad, Kayvon, Sadat, Musharaf, Rohde, Gernot, Leport, Catherine, and Fowler, Robert

Published
2015
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31. Comparison of the Safety and Immunogenicity of 2 Respiratory Syncytial Virus (RSV) Vaccines—Nonadjuvanted Vaccine or Vaccine Adjuvanted with Alum—Given Concomitantly with Influenza Vaccine to High-Risk Elderly Individuals

Author

Falsey, Ann R., Walsh, Edward E., Capellan, Jose, Gravenstein, Stefan, Zambon, Maria, Yau, Eddy, Gorse, Geoffrey J., Edelman, Robert, Hayden, Frederick G., McElhaney, Janet E., Neuzil, Kathleen M., Nichol, Kristen L., Simões, Eric A. F., Wright, Peter F., and Sales, Valérie M.-P.

Published
2008
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40. Favipiravir Treatment of Uncomplicated Influenza in Adults: Results of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Trials.

Author

Hayden, Frederick G, Lenk, Robert P, Stonis, Lucille, Oldham-Creamer, Catherine, Kang, Lih Lisa, and Epstein, Carol

Subjects
*INFLUENZA, *CLINICAL trial registries, *NEUTRALIZATION tests, *VIRUS diseases, *ADULTS, *HETEROCYCLIC compounds, *EVALUATION research, *RESEARCH funding, *BLIND experiment, *TREATMENT effectiveness, *FEVER, *RANDOMIZED controlled trials, *RNA, *ANTIVIRAL agents, *RESEARCH, *RESEARCH methodology, *COMPARATIVE studies
Abstract

Background: We conducted double-blind, placebo-controlled trials assessing the efficacy and tolerability of favipiravir in acute influenza.Methods: Otherwise healthy adults with influenza-like symptoms and fever of ≤48 hours were randomized to favipiravir (1800 mg twice daily [BID] on day 1, 800 mg BID on days 2-5) or placebo tablets (1:1 in US316; 3:1 in US317). The primary efficacy endpoint was the time to illness alleviation when 6 influenza symptoms were self-rated as absent or mild and fever was absent in the intention-to-treat, influenza-infected participants.Results: In US316 (301 favipiravir, 322 placebo), favipiravir was associated with a 14.4-hour reduction (median, 84.2 vs 98.6 hours; P = .004) in time to illness alleviation vs placebo. In US317 (526 favipiravir, 169 placebo), favipiravir did not significantly reduce time to alleviation (median, 77.8 vs 83.9 hours). In both trials favipiravir was associated with reduced viral titers, RNA load area under the curve over days 1-5, and median times to cessation of virus detection (P < .001). Aside from asymptomatic hyperuricemia, no important differences in adverse events were found.Conclusions: This favipiravir dosing regimen demonstrated significant antiviral efficacy but inconsistent illness alleviation in uncomplicated influenza. Studies of higher doses and antiviral combinations for treating serious influenza and other RNA viral infections are warranted. Clinical Trials Registration. NCT02026349; NCT02008344. [ABSTRACT FROM AUTHOR]

Published
2022
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