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2. A population pharmacokinetic model based on HPTN 077 of long‐acting injectable cabotegravir for HIV PrEP

Author

Yu, Yifan, Bigos, Kristin L, Marzinke, Mark A, Landovitz, Raphael J, McCauley, Marybeth, Ford, Susan, Hendrix, Craig W, Bies, Robert R, Weld, Ethel D, and Team, the HPTN 077 Study

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Trials and Supportive Activities, HIV/AIDS, Clinical Research, Infectious Diseases, Prevention, Infection, Anti-HIV Agents, Body Weight, Diketopiperazines, Female, HIV Infections, Humans, Injections, Intramuscular, Male, Pyridones, antiretrovirals, HIV, AIDS, infectious diseases, pharmacometrics, HPTN 077 Study Team, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

AimsCabotegravir delivered as a long-acting intramuscular injection has shown superior efficacy to oral tenofovir-emtricitabine as pre-exposure prophylaxis (PrEP) for HIV. Cabotegravir pharmacokinetics (PK), like those of other long-acting depot preparations, exhibit variability between individuals and between injection occasions. The aim of this study is to describe the population pharmacokinetics of long-acting cabotegravir (CAB-LA).MethodsUsing available PK measurements from 133 participants in the HIV Prevention Trials Network (HPTN) 077 trial, we analysed CAB-LA PK data using nonlinear mixed-effects modelling to develop a population PK model.ResultsA two-compartment model with first order absorption best described the CAB-LA PK. The analysis identified between-occasion variability (BOV, i.e., differences in PK within one individual from one injection to the next) as a significant covariate affecting the absorption rate, with an estimated contribution of BOV to PK variability on the absorption rate (ka ) of 38.5%. Sex and body weight were identified as significant covariates influencing the absorption rate and apparent clearance of CAB-LA after intramuscular injection at various doses and frequencies. Male participants had 67% higher ka than female participants. Serially adding to the model body weight on clearance, sex on ka , and BOV on ka led to a decrease in the objective function value (OFV) of 24.4, 36 and 321.4, respectively.ConclusionThe public availability of this model will facilitate and enable a wide variety of future clinically relevant simulations to inform the optimal use of CAB-LA.

Published
2022

6. Malaria in pregnancy: Modern approaches—Spotlight commmentary.

Author

Vujevic, Andro and Weld, Ethel D.

Subjects
*PREGNANT women, *MEDICAL personnel, *PUBLIC health infrastructure, *LOW birth weight, *NEGLECTED diseases, *ABORTION, *PREECLAMPSIA
Abstract

This article provides an overview of the burden of malaria in pregnancy and recent advancements in prevention and treatment strategies. It highlights the use of intermittent preventive treatment in pregnancy (IPTp) as a targeted approach to administer antimalarial medication to pregnant women in endemic areas. The article also addresses challenges such as accessibility, affordability, and drug resistance in malaria treatment. It emphasizes the need for comprehensive programs and guidelines to effectively address malaria in pregnancy. The article also discusses the safety of antimalarials in pregnancy and explores potential alternatives to quinine-based treatment. Additionally, it calls for more research on the pharmacokinetics and pharmacodynamics of antimalarials in pregnancy and the potential use of malaria vaccines. Overall, the article emphasizes the importance of improved public health infrastructure, updated guidelines, and innovative strategies to tackle the challenges of malaria in pregnancy. [Extracted from the article]

Published
2024
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8. Preferences and feasibility of long‐acting technologies for treatment of hepatitis C virus in low‐ and middle‐income countries: A survey of providers and policymakers

Author

Gupta, Neil, primary, Swindells, Susan, additional, Scarsi, Kimberly K., additional, Furl, Renae, additional, Thomas, David L., additional, Weld, Ethel D., additional, Ofimboudem, Joelle Dountio, additional, Desalegn, Hailemichael, additional, Hamid, Saeed, additional, Rosas, Alethse de la Torre, additional, Miranda, Angelica E., additional, Owen, Andrew, additional, Rannard, Steve, additional, Hiebert, Lindsey, additional, Sun, Katherine, additional, and Ward, John W., additional

Published
2024
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10. Tenofovir Douche as HIV Preexposure Prophylaxis for Receptive Anal Intercourse: Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics (DREAM 01).

Author

Weld, Ethel D, McGowan, Ian, Anton, Peter, Fuchs, Edward J, Ho, Ken, Carballo-Dieguez, Alex, Rohan, Lisa C, Giguere, Rebecca, Brand, Rhonda, Edick, Stacey, Bakshi, Rahul P, Parsons, Teresa, Manohar, Madhuri, Seigel, Aaron, Engstrom, Jared, Elliott, Julie, Jacobson, Cindy, Bagia, Christina, Wang, Lin, and Al-khouja, Amer

Subjects
*ANAL sex, *TENOFOVIR, *CLINICAL trial registries, *PHARMACODYNAMICS, *PHARMACOKINETICS
Abstract

Background Despite highly effective HIV preexposure prophylaxis (PrEP) options, no options provide on-demand, nonsystemic, behaviorally congruent PrEP that many desire. A tenofovir-medicated rectal douche before receptive anal intercourse may provide this option. Methods Three tenofovir rectal douches—220 mg iso-osmolar product A, 660 mg iso-osmolar product B, and 660 mg hypo-osmolar product C—were studied in 21 HIV-negative men who have sex with men. We sampled blood and colorectal tissue to assess safety, acceptability, pharmacokinetics, and pharmacodynamics. Results The douches had high acceptability without toxicity. Median plasma tenofovir peak concentrations for all products were several-fold below trough concentrations associated with oral tenofovir disoproxil fumarate (TDF). Median colon tissue mucosal mononuclear cell (MMC) tenofovir-diphosphate concentrations exceeded target concentrations from 1 hour through 3 to 7 days after dosing. For 6–7 days after a single product C dose, MMC tenofovir-diphosphate exceeded concentrations expected with steady-state oral TDF 300 mg on-demand 2-1-1 dosing. Compared to predrug baseline, HIV replication after ex vivo colon tissue HIV challenge demonstrated a concentration-response relationship with 1.9 log10 maximal effect. Conclusions All 3 tenofovir douches achieved tissue tenofovir-diphosphate concentrations and colorectal antiviral effect exceeding oral TDF and with lower systemic tenofovir. Tenofovir douches may provide a single-dose, on-demand, behaviorally congruent PrEP option, and warrant continued development. Clinical Trials Registration. NCT02750540. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Tenofovir Douche as HIV Pre-Exposure Prophylaxis for Receptive Anal Intercourse: Safety, Acceptability, Pharmacokinetics, & Pharmacodynamics (DREAM 01)

Author

Weld, Ethel D, primary, McGowan, Ian, additional, Anton, Peter, additional, Fuchs, Edward J, additional, Ho, Ken, additional, Carballo-Dieguez, Alex, additional, Rohan, Lisa C, additional, Giguere, Rebecca, additional, Brand, Rhonda, additional, Edick, Stacey, additional, Bakshi, Rahul P, additional, Parsons, Teresa, additional, Manohar, Madhuri, additional, Seigel, Aaron, additional, Engstrom, Jared, additional, Elliott, Julie, additional, Jacobson, Cindy, additional, Bagia, Christina, additional, Wang, Lin, additional, Al-khouja, Amer, additional, Hartman, Douglas J, additional, Bumpus, Namandje N, additional, Spiegel, Hans M L, additional, Marzinke, Mark A, additional, and Hendrix, Craig W, additional

Published
2023
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12. Challenges in optimizing preexposure prophylaxis development, engagement, and access for HIV prevention

Author

Scully, Eileen P., Weld, Ethel D., and Blankson, Joel N.

Subjects
Prophylaxis -- Health aspects, AIDS vaccines -- Health aspects, Highly active antiretroviral therapy -- Health aspects, HIV -- Prevention -- Control -- Health aspects, Infection -- Prevention -- Health aspects, Antiretroviral agents -- Health aspects, Sexually transmitted disease prevention -- Health aspects, Vaccines, Health care industry
Abstract

One of the greatest successes of modern science is the development of effective antiretroviral therapy (ART) for control of HIV-1 infection. Arguably one of the more innovative responses to the [...]

Published
2019
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15. Your Outpatient has Coronavirus Disease 2019: What Are the Treatment Options in the Current Severe Acute Respiratory Syndrome Coronavirus 2 Variant Climate?

Author

Werbel, William A, Weld, Ethel D, Advani, Sonali D, Patel, Payal K, Sundaram, Maria E, and Phadke, Varun K

Subjects
*THERAPEUTIC use of monoclonal antibodies, *COVID-19, *IMMUNIZATION, *ANTIVIRAL agents, *RISK assessment, *TREATMENT effectiveness, *MEDICAL protocols, *INFECTION control, *RITONAVIR, *HOSPITAL care
Abstract

Mutations accumulated by novel Severe Acute Respiratory Syndrome Coronavirus 2 Omicron sublineages contribute to evasion of previously effective monoclonal antibodies for treatment or prevention of Coronavirus Disease 2019 (COVID-19). Other authorized or approved antiviral drugs such as nirmatrelvir/ritonavir, remdesivir, and molnupiravir are, however, predicted to maintain activity against these sublineages and are key tools to reduce severe COVID-19 outcomes in vulnerable populations. A stepwise approach may be taken to target the appropriate antiviral drug to the appropriate patient, beginning with identifying whether a patient is at high risk for hospitalization or other complications of COVID-19. Among higher risk individuals, patient profile (including factors such as age, organ function, and comedications) and antiviral drug access inform suitable antiviral drug selection. When applied in targeted fashion, these therapies serve as a complement to vital ongoing nonpharmaceutical interventions and vaccination strategies that reduce morbidity and maximize protection against COVID-19. [ABSTRACT FROM AUTHOR]

Published
2023
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16. Realizing the Promise of Long-Acting Antiretroviral Treatment Strategies for Individuals with HIV and Adherence Challenges: An Illustrative Case Series

Author

Kilcrease, Christin, primary, Yusuf, Hasiya, additional, Park, Joan, additional, Powell, Aaron, additional, James, Leon, additional, Oates, Jacob, additional, Davis, Brittany, additional, Weld, Ethel D., additional, Dooley, Kelly, additional, Arrington-Sanders, Renata, additional, and Agwu, Allison, additional

Published
2022
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19. Preferences of Persons With or at Risk for Hepatitis C for Long-Acting Treatments

Author

Weld, Ethel D, primary, Astemborski, Jacqueline, additional, Kirk, Gregory D, additional, Sulkowski, Mark S, additional, Katz, Stephanie, additional, Rothman, Richard, additional, Solomon, Sunil S, additional, Matthews, Gail V, additional, Hsieh, Yu Hsiang, additional, Verma, Malvika, additional, Traverso, Giovanni, additional, Swindells, Susan, additional, Owen, Andrew, additional, Feld, Jordan, additional, Flexner, Charles, additional, Mehta, Shruti H, additional, and Thomas, David L, additional

Published
2021
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21. Multiparametric magnetic resonance imaging to characterize cabotegravir long‐acting formulation depot kinetics in healthy adult volunteers

Author

Jucker, Beat M., primary, Fuchs, Edward J., additional, Lee, Sarah, additional, Damian, Valeriu, additional, Galette, Paul, additional, Janiczek, Robert, additional, Macura, Katarzyna J., additional, Jacobs, Michael A., additional, Weld, Ethel D., additional, Solaiyappan, Meiyappan, additional, D'Amico, Ronald, additional, Shaik, Jafar Sadik, additional, Bakshi, Kalpana, additional, Han, Kelong, additional, Ford, Susan, additional, Margolis, David, additional, Spreen, William, additional, Gupta, Manish K., additional, Hendrix, Craig W., additional, and Patel, Parul, additional

Published
2021
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22. Multicompartmental pharmacokinetic evaluation of long‐acting cabotegravir in healthy adults for HIV preexposure prophylaxis

Author

Shaik, Jafar Sadik, primary, Weld, Ethel D., additional, Edick, Stacey, additional, Fuchs, Edward, additional, Riddler, Sharon, additional, Marzinke, Mark A., additional, D'Amico, Ronald, additional, Bakshi, Kalpana, additional, Lou, Yu, additional, Hendrix, Craig, additional, Han, Kelong, additional, Ford, Susan L., additional, Margolis, David, additional, Spreen, William, additional, and Patel, Parul, additional

Published
2021
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23. Examining the Safety, Pharmacokinetics, and Pharmacodynamics of a Rectally Administered IQP-0528 Gel for HIV Pre-Exposure Prophylaxis: A First-In-Human Study

Author

Al-Khouja, Amer, primary, Shieh, Eugenie, additional, Fuchs, Edward J., additional, Marzinke, Mark A., additional, Bakshi, Rahul P., additional, Hummert, Pamela, additional, Ham, Anthony S., additional, Buckheit, Karen W., additional, Breakey, Jennifer, additional, Weld, Ethel D., additional, Chen, Huan, additional, Caffo, Brian S., additional, Buckheit, Robert W., additional, and Hendrix, Craig W., additional

Published
2021
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26. Preferences of Persons With or at Risk for Hepatitis C for Long-Acting Treatments.

Author

Weld, Ethel D, Astemborski, Jacqueline, Kirk, Gregory D, Sulkowski, Mark S, Katz, Stephanie, Rothman, Richard, Solomon, Sunil S, Matthews, Gail V, Hsieh, Yu Hsiang, Verma, Malvika, Traverso, Giovanni, Swindells, Susan, Owen, Andrew, Feld, Jordan, Flexner, Charles, Mehta, Shruti H, and Thomas, David L

Subjects
*HEPATITIS C treatment, *HEPATITIS C risk factors, *DRUG delivery systems, *CROSS-sectional method, *PATIENTS' attitudes, *DESCRIPTIVE statistics
Abstract

Background Whereas safe, curative treatments for hepatitis C virus (HCV) have been available since 2015, there are still 58 million infected persons worldwide, and global elimination may require new paradigms. We sought to understand the acceptability of approaches to long-acting HCV treatment. Methods A cross-sectional, 43-question survey was administered to 1457 individuals with or at risk of HCV at 28 sites in 9 countries to assess comparative interest in a variety of long-acting strategies in comparison with oral pills. Results Among HCV-positive participants, 37.7% most preferred an injection, 5.6% an implant, and 6% a gastric residence device, as compared with 50.8% who stated they would most prefer taking 1–3 pills per day. When compared directly to taking pills, differences were observed in the relative preference for an injection based on age (P <.001), location (P <.001), and prior receipt of HCV treatment (P =.005) but not sex. When an implant was compared with pills, greater preference was represented by women (P =.01) and adults of younger ages (P =.01 per 5 years). Among participants without HCV, 49.5% believed that injections are stronger than pills and 34.7% preferred taking injections to pills. Among those at-risk participants who had received injectable medications in the past, 123 of 137 (89.8%) expressed willingness to receive one in the future. Conclusions These data point to high acceptability of long-acting treatments, which for a substantial minority might even be preferred to pills for the treatment of HCV infection. Long-acting treatments for HCV infection might contribute to global efforts to eliminate hepatitis C. [ABSTRACT FROM AUTHOR]

Published
2022
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27. Multicompartmental pharmacokinetic evaluation of long‐acting cabotegravir in healthy adults for HIV preexposure prophylaxis.

Author

Shaik, Jafar Sadik, Weld, Ethel D., Edick, Stacey, Fuchs, Edward, Riddler, Sharon, Marzinke, Mark A., D'Amico, Ronald, Bakshi, Kalpana, Lou, Yu, Hendrix, Craig, Han, Kelong, Ford, Susan L., Margolis, David, Spreen, William, and Patel, Parul

Subjects
*HIV, *PHARMACOKINETICS, *PREVENTIVE medicine, *ADULTS, *FLUIDS
Abstract

Aims: Cabotegravir is an integrase strand transfer inhibitor in clinical development as long‐acting (LA) injectable HIV preexposure prophylaxis. Methods: This phase I study assessed pharmacokinetics of cabotegravir in plasma and anatomical sites associated with sexual HIV‐1 transmission after repeated oral and single intramuscular (IM) LA dosing in healthy adults. Following a 28‐day oral lead‐in period of cabotegravir 30 mg and a washout period of 14–42 days, participants were administered a single ultrasound‐guided gluteal IM cabotegravir LA 600‐mg injection. The study objective was to characterize cabotegravir concentrations in plasma, cervical, vaginal and rectal tissues, and cervicovaginal and rectal fluids and up to Week 12 after IM injection. Results: Nineteen participants enrolled and 16 completed the study through Week 52. Cabotegravir was detected in plasma and all tissues and fluids. Median plasma cabotegravir concentrations exceeded the in vitro protein‐adjusted 90% maximal inhibitory concentration through Week 12. Median tissue‐ and fluid‐to‐plasma cabotegravir concentration ratios across all visits were 0.32 for rectal fluid and 0.08–0.16 for other tissues and fluids. Adjusted R2 coefficients between cabotegravir concentrations in plasma and cervical, vaginal and rectal tissues were 0.78, 0.79 and 0.90, respectively. Injection‐site reactions were common (88% of participants) and were mostly grade 1 in intensity (82%). Two participants reported 11 non–drug‐related serious adverse events. Conclusion: Concentrations of cabotegravir in tissues and fluids were proportional to plasma over time, with strong correlations between tissue and plasma concentrations. Cabotegravir LA tissue‐to‐plasma ratios may be important for understanding its use as preexposure prophylaxis. [ABSTRACT FROM AUTHOR]

Published
2022
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28. Multiparametric magnetic resonance imaging to characterize cabotegravir long‐acting formulation depot kinetics in healthy adult volunteers.

Author

Jucker, Beat M., Fuchs, Edward J., Lee, Sarah, Damian, Valeriu, Galette, Paul, Janiczek, Robert, Macura, Katarzyna J., Jacobs, Michael A., Weld, Ethel D., Solaiyappan, Meiyappan, D'Amico, Ronald, Shaik, Jafar Sadik, Bakshi, Kalpana, Han, Kelong, Ford, Susan, Margolis, David, Spreen, William, Gupta, Manish K., Hendrix, Craig W., and Patel, Parul

Subjects
MAGNETIC resonance imaging, VOLUNTEERS, GLUTEAL muscles, VOLUNTEER service, ADIPOSE tissues, REGRESSION analysis
Abstract

Aim: Cabotegravir long‐acting (LA) intramuscular (IM) injection is being investigated for HIV preexposure prophylaxis due to its potent antiretroviral activity and infrequent dosing requirement. A subset of healthy adult volunteers participating in a Phase I study assessing cabotegravir tissue pharmacokinetics underwent serial magnetic resonance imaging (MRI) to assess drug depot localization and kinetics following a single cabotegravir LA IM targeted injection. Methods: Eight participants (four men, four women) were administered cabotegravir LA 600 mg under ultrasonographic‐guided injection targeting the gluteal muscles. MRI was performed to determine injection‐site location in gluteal muscle (IM), subcutaneous (SC) adipose tissue and combined IM/SC compartments, and to quantify drug depot characteristics, including volume and surface area, on Days 1 (≤2 hours postinjection), 3 and 8. Linear regression analysis examined correlations between MRI‐derived parameters and plasma cabotegravir exposure metrics, including maximum observed concentration (Cmax) and partial area under the concentration–time curve (AUC) through Weeks 4 and 8. Results: Cabotegravir LA depot locations varied by participant and were identified in the IM compartment (n = 2), combined IM/SC compartments (n = 4), SC compartment (n = 1) and retroperitoneal cavity (n = 1). Although several MRI parameter and exposure metric correlations were determined, total depot surface area on Day 1 strongly correlated with plasma cabotegravir concentration at Days 3 and 8, Cmax and partial AUC through Weeks 4 and 8. Conclusion: MRI clearly delineated cabotegravir LA injection‐site location and depot kinetics in healthy adults. Although injection‐site variability was observed, drug depot surface area correlated with both plasma Cmax and partial AUC independently of anatomical distribution. [ABSTRACT FROM AUTHOR]

Published
2022
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29. Contributors

Author

Abcarian, Ariane M., Abcarian, Herand, Abdulhai, Mohamad A., Abularrage, Christopher J., AbuRahma, Ali F., AbuRahma, Zachary T., Adams, David B., Adams, Laura M., Adams, Reid B., Adekeye, Adeseye, Adrales, Gina L., Ahrendt, Gillian M., Ahrendt, Steven A., Ahuja, Nita, Akshintala, Venkata S., Efishat, Mohammad Al, Alam, Hasan B., Albaugh, Vance L., Albutt, Katherine, Alimi, Yewande, Alobuia, Wilson M., Alsaad, Ranim, Alvarenga, Emanuela Silva, Alverdy, John C., Amin, Avani, Andolfi, Ciro, Antognoli, Lauren, Aravind, Pathik, Arnold, Margaret W., Professor, Associate, Atallah, Chady, Axtell, Andrea L., Azad, Nilofer, Azizad, Omaira, Bales, Alison M., Barbul, Adrian, Barie, Philip S., Barnes, Emilie C., Barnes, Stephen L., Barnett, Erica, Basho, Reva, Bass, Gary A., Battafarano, Richard J., Bayard, Solange, Bedine, Marshall S., Behrns, Kevin E., Beliveau, Lauren, Benjamin, Elizabeth R., Berger, David, III, James H. Black, Blair, Alex B., Bomman, Shivanand, Bonds, Morgan, Boutros, Marylise, Brilliant, Justin, Britt, L.D., Broccard, Sacha P., Brock, Malcolm V., Broderick, Ryan C., Broderick, Stephen R., Brown, Lawrence B., Buckley, Jill C., Bunn, Corinne, Burke, Mark S., Burkhart, Richard A., Burnim, Michael S., Burns, William Reece, Bush, Errol L., Busuttil, Ronald W., Buyske, Jo, Calhoun, Kristine E., Calotta, Nicholas A., Cambria, Richard P., Camp, Melissa S., Cao, Yilin (Linda), Carp, Ned Z., Casciani, Fabio, Chaikof, Elliot L., Chatila, Ahmed, Chen, Sophia Y., Chi, Albert, Chilton, Timothy D., Cholewczynski, Walter, Choti, Michael A., Christensen, Joani, Christopher, Adrienne N., Chudnovets, Anna, Cintron, Jose R., Clary, Bryan M., Cloyd, Jordan M., Cocanour, Christine S., Coimbra, Raul, Colakoglu, Salih, Conyers, Julie A., III, Edward E. Cornwell, Coté, Gregory A., Cribari, Chris, Cronin, Patricia A., Crosby, Patrick, Cross, Alisa, Cunningham, Steven C., Dani, Hasan, Dardik, Alan, Darrach, Halley, Davidson, Whitney A., deAngeli, Katherine, Deery, Sarah E., Delitto, Daniel J., DeMeester, Tom R., Dempsey, Daniel T., Dennahy, Isabel S., Dent, Daniel L., DePeralta, Danielle K., Desai, Niraj M., DeSouza, Melissa Louise, DeStefano, Lauren M., Diggs, Laurence P., Dillon, Conor, DiNorcia, Joseph, Doherty, Gerard M., Donahue, James M., Done, Joy Zhou, Doucet, Jay J., Duh, Quan-Yang, Duncan, Mark D., Eckardt, Mark A., Edil, Barish H., Efron, David T., Efron, Jonathan E., Ehlers, Anne P., Eisenson, Daniel L., Haddi, S. James El, Moheb, Mohamad El, El-Diwany, Ramy, Elsey, James K., Elterman, Joel, Enumah, Zachary Obinna, Euhus, David M., Evans, Douglas B., C, Donald, Fadoul, Mikael A., Fagenholz, Peter J., Famularo, Marissa, Fang, Sandy Hwang, Farber, Alik, Fasano, Genevieve, Feliciano, David V., Feller-Kopman, MD, FACP, David J., Fergus, Kirkpatrick Beekman, Fernandez, Carlos, Fichera, Alessandro, Fischer, John P., Fish, Adam, Fisichella, P. Marco, Jr., James W. Fleshman, Florecki, Katherine L., Fong, Yuman, Fong, Zhi Ven, Fransman, Ryan B., Freischlag, Julie A., Frost, Christopher, Gabre-Kidan, Alodia, Gahtan, Vivian, Jr, Edward Hines, Galandiuk, Susan, Jr, Hiram C. Polk, Jr., Samuel M. Galvagno, Gao, Raisa, Garibaldi, Brian T., Garrido, Danon E., Gearhart, Susan L., Gemignani, Mary L., Georgiades, Christos, German, Zachary, Gewertz, Bruce L., Ghanem, Omar M., Giglia, Joseph S., Giuliano, Armando E., Glebova, Natalia O., Gleisner, Ana, Goeddel, Lee A., Goldberg, Eric M., Gonzalez, Reyna, Gore, Amy V., Goverman, Jeremy, Grandhi, Miral Sadaria, Grant, Michael D., Gray, Richard J., Greer, Jonathan B., Grewal, Mahip, Grimes, Chassidy, Grucz, Traci M., Grunwald, Matthew D., Guillem, Jose G., Gunter, Rebecca L., Gupta, NavYash, Habib, Joseph R., Habibi, Mehran, Hagen, Edward R., Haghshenas, Jafar, Halandras, Pegge M., Hamilton, James P., Hammami, Muhammad, Han, Britta Jean, Han, Misop, Handley, Guy, Harmon, John W., Harris, Andrew, Jr, James E. Harris, Harrison, Jon M., Haugen, Christine, Haut, Elliott R., Hayden, Dana, He, Jin, Herbella, Fernando A.M., Herman, Joseph M., Hickey, Sean, Hicks, Caitlin W., Hindin, David, Hines, O. Joe, Ho, Jessie, Hodin, Richard A., Houng, Abraham P., House, Michael G., Hoyt, David B., Hu, Yinin, Ijaz, Nadia, Inaba, Kenji, Ivey, Gabriel D., Jacobs, Lisa K., Janssen, Claire, Javed, Ammar A., John, Amballur David, Johnson, Eric K., Johnson, Wali Rashad, Johnston, Fabian M., Jones, Ronald C., Joseph, Bellal, Joshi, Girish P., Kaafarani, Haytham, Kalloo, Anthony N., Kaplan, Lewis J., Karzai, Shkala, Kashyap, Vikram S., Katlic, Mark, Kattah, Michael G., Kaups, Krista L., Kavousi, Yasaman, Kawaji, Qingwen, Kebaish, Khaled M., Kebebew, Electron, Kelley, Scott R., Kennard, Kaitlyn, Kent, Alistair J., Khadaroo, Rachel G., Khalifeh, Ali H., MD, Maria Abou Khalil, Khan, Hamza, Khan, Maryam Ali, Khan, Sameer, Khashab, Mouen A., Khodorskiy, Dmitriy O., Khreiss, Mohammad R., Kim, Jina, Kim, Joseph, Kim, Karen M., King, Elizabeth Gherardi, Kinny-Köster, Benedict, Klimberg, V. Suzanne, Koganti, Deepika, Kokosis, George, Kolarich, Andrew R., Kozarek, Richard, Krepline, Ashley, Kulkarni, Swati A., Kumbhari, Vivek, Kunisaki, Shaun M., Kwakye, Gifty, Ladd, Mitchell R., Lafaro, Kelly J., Laheru, Daniel A., Lancaster, William P., Lange, Julie R., Ledgerwood, Anna M., Lee, Christina, Lee, Eliza J., Lee, Grace C., Lee, Hanjoo, Levin, Adam S., Liddell, Robert P., Lillemoe, Heather A., Lillemoe, Keith D., Lipsett, Pamela A., Liveris, Anna, Livingston, David H., Loiacono, Laurie Anne, Lombardi, Joseph V., Low, Gregory K., Lowenfeld, Lea, Lucas, Charles E., Lum, Ying Wei, Lumati, Juliet Siena, Lyons, Gray R., MacGillivray, Thomas E., Magnuson, Thomas H., Mahdi, Elaa, Makary, Martin A., Malas, Mahmoud B., Mallon, William C., Manahan, Michele Ann, Manson, Paul N., Mansour, M. Ashraf, Mantilla, Nathalie, Manukyan, Mariuxi C., Markmann, James F., Maroun, Christopher A., Martin, Matthew J., Martin, Niels D., Martyak, Michael, Matar, Regina, Mathisen, Douglas J., Mathur, Aarti, Matsushima, Kazuhide, Mawn, J. Greg, McCarthy, Mary C., McCarthy, Patrick M., McDermott, Katherine, McFadden, David W., McGuire, Sean P., McHenry, Christopher R., McIntosh, Erin E., Melton-Meaux, Genevieve B., Meneshian, Avedis, Menon, Raman, Metkus Jr, Thomas S., Michelassi, Fabrizio, Mony, Shruti, Morgan, Katherine A., Morgan, Ryan B., Morris, Carol D., Morse, Christopher R., Muniappan, Ashok, II, Peter Muscarella, Mutch, Matthew, Muñoz-Largacha, Juan A., Nam, Arthur J., Narang, Amol Kumar, Nasr, Isam W., Nawalaniec, James T., Nehs, Matthew A., Nelson, Adam, Nettles, Brenda S., Newman, Lisa Ann, Nezami, Nariman, Nguyen, Dennis C., Nguyen, Hien T., Nicholson, Jake A., Nizam, Wasay, Novitsky, Yuri W., Oelschlager, Brant K., Ogilvie, Jennifer B., Jr., John A. Olson, Olson, Kristofor A., O’Mara, Charles S., Oseni, Tawakalitu O., Osgood, Greg M., Ostrosky-Zeichner, Luis, Ottmann, Shane, Pappas, Theodore N., Paranjape, Charudutt, Park, Adrian E., Park, Pauline K., Pastoriza, Jessica M., Patel, Purvi P., Patel, Shirali T., Patti, Marco G., Pawlik, Timothy M., Pearl, Gregory J., Jr., Walter Pegoli, Perler, Bruce A., Perrier, Nancy D., Philosophe, Benjamin, Pitt, Henry A., Plichta, Jennifer K., Podolsky, Dina, Politano, Amani D., Port, Elisa, Postol, Carolyn R., Prabhu, Ajita S., Preiss, Joshua E., Prescott, Jason D., Price, Leigh Ann, Price, Matthew D., Prushik, Scott G., Pugh, Carla M., Qaqish, T. Robert, Qasim, Zaffer, Quick, Jacob A., Radisic, Amanda, Radomski, Shannon N., Rasmussen, Todd E., Reddy, Abhinav V., Reed, Christopher R., Regelsberger-Alvarez, Christina Maria, Reifsnyder, Thomas, Reilly, Linda M., Riall, Taylor S., Ricci, John Peter, Robles, Anamaria J., Rodgers, Douglas, Roginsky, Alexandra B., Rojas-Khalil, Yesenia, Rokosh, Rae S., Rosati, Riccardo, Rose, J. Bart, Rosenberger, Laura H., Ross, Robert C., Rosson, Gedge D., Roy, Rishi A., Rozycki, Grace S., Ryan, Colleen M., Sachdeva, Uma M., Sacks, Bethany C., Sacks, Justin M., Sahli, Zeyad T., Sakran, Joseph V., Sanders, David, Sarr, Michael G., Sawyer, Robert G., Sbayi, Samer, Scalea, Thomas M., Schauer, Philip R., Scheurlen, Katharina M., Schimpf, Dennis K., Schlachter, Todd R., Schonefeld, Sally, Schulick, Andrew, Schulick, Richard D., Schweitzer, Michael A., Sell, Naomi M., Senagore, Anthony J., Shah, Aamir S., Shah, Adil A., Shames, Brian D., Sharma, Ashwyn K., Sheridan, Robert, Shirali, Aditya S., Shmelev, Artem, Shoham, Shmuel, Shores, Jaimie T., Sicklick, Jason K., Sieber, Frederick, Simmons, Justin M., Sims, Sarah S., Singh, Vikesh K., Smeds, Matthew R., Nikolhaus Smith, John, Smith, Thomas J., Jr., Thomas W. Smith, Sorrentino, Anthony, Sosa, Julie Ann, Spaniolas, Konstantinos, Sperry, Jason, Steele, Scott R., Stem, Jonathan M., Stevens, Jane, Stevens, Kent Allen, Stonko, David P., Streiff, Michael B., Stringfield, Sarah, Strosberg, David S., Su, Amanda, Subramanian, Madhu, Suresh, Visakha, Susarla, Srinivas M., Sutton, Whitney, Swanstrom, Lee L., Talamini, Mark A., Tam, Vernissia, Tamburini, Nicola, Tan, Li Ting, Tanabe, Kenneth K., Tang, Rebecca, Tchou, Julia, Teixeira, Pedro G., Thiboutot, Jeffrey, Thompson, Jon S., Thornblade, Lucas W., Thorsen, Amy J., Torres, Crisanto M., Tsai, Susan, Tsitsiou, Yvonne, Tsung, Eric, Tufaro, Anthony, Tulla, Kiara A., Tunder, Kelly H., Udelsman, Brooks V., Vane, Marissa, Velmahos, George, Vernamonti, Jack P., Vollmer, Charles M., Jr., Vora, Halley, Vosler, Peter S., Walsh, Christi M., Wang, Xuanji, Warshaw, Andrew L., Wasicek, Philip J., Weeks, Sharon R., Weiser, Roi, Weiss, Clifford R., Weiss, Eric G., Weiss, Matthew J., Weld, Ethel D., Weller, Jennine H., Weltz, Adam S., Wesson, Russel N., Wexner, Steven D., Whitman, Glenn J.R., Whittaker, David R., Wick, Elizabeth C., Wilder, Fatima G., Williams, Austin D., Williams, Timothy K., Wiseman, James E., Witthaus, Michael W., Wogsland, Aric, Wolfgang, Christopher L., Wong, Daniel J., Wong, Virginia L., Wood, Douglas E., Wright, Cameron D., Wu, Clement, Wu, Lawrence W., Yang, Stephen C., Ye, Linda, Yeo, Heather L., Young, Stephanie, Zaydfudim, Victor M., Zeiger, Martha A., Zenilman, Michael E., Zhu, Jay, Zuberi, Maaz K., and Zyromski, Nicholas J.

Published
2023
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33. Twice neglected? Neglected diseases in neglected populations.

Author

Weld, Ethel D., Waitt, Catriona, Barnes, Karen, and Garcia Bournissen, Facundo

Subjects
*NEGLECTED diseases, *CLINICAL pharmacology, *PREGNANT women
Abstract

It is unfortunately true that clinicians lack the necessary evidence to know how to use medications properly in large sections of the population and do not have optimal treatments to use for many neglected tropical diseases (NTDs). NTDs often disproportionately affect neglected populations that are left out of research efforts, such as children and pregnant women. As reliable access to safe, effective preventives and treatments can break the cycle of poverty, illness, and ensuing debility that further perpetuates poverty, it is of paramount importance to investigate and develop new medicines for neglected populations suffering from NTDs. Furthermore, there is not only a need to develop and evaluate novel therapies, but also to ensure that these are affordable, available, and adapted to the communities who need them. The NIH has proposed a "4 C's" framework which is relevant for neglected diseases and populations and should be leveraged for the study of the Twice Neglected: Consider inclusion; Collect data from neglected populations with neglected conditions; Characterize differences through meaningful analysis; Communicate findings pertaining to neglected diseases and populations. With this editorial, the British Journal of Clinical Pharmacology hereby launches a call for high‐quality articles focusing on NTDs in special populations, to facilitate and encourage the reversal of this dual neglect. [ABSTRACT FROM AUTHOR]

Published
2022
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34. Ethical issues in therapeutic use and research in pregnant and breastfeeding women.

Author

Weld, Ethel D., Bailey, Theodore C., and Waitt, Catriona

Subjects
*PREGNANT women, *NEW trials, *DECISION making, *CLINICAL trials, *FETUS
Abstract

Pregnant or potentially pregnant women have historically been excluded from clinical trials of new medications. However, it is increasingly recognised that it is imperative to generate evidence from the population in whom the drugs are likely to be used to inform safe, evidence‐based shared clinical decision making. Reluctance by researchers and regulators to perform such studies often relates to concerns about risk, particularly to the foetus. However, this must be offset against the risk of untreated disease or using a drug in pregnancy where safety, efficacy and dosing information are not known. This review summarises the historical perspective, and the ethical and legal frameworks that inform the conduct of such research, then highlights examples of innovative practice that have enabled high quality, ethical research to proceed to inform the evidence‐based use of medication in pregnancy. [ABSTRACT FROM AUTHOR]

Published
2022
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35. Strategic use of salvage long-acting antiretrovirals in the setting of resistance.

Author

Kilcrease, Christin, Agwu, Allison, and Weld, Ethel D

Subjects
*DIAGNOSIS of HIV infections, *RILPIVIRINE, *PATIENT compliance, *HIV, *ANTIRETROVIRAL agents, *HIV-positive persons, *HIV infections, *TREATMENT effectiveness, *ANTIVIRAL agents, *HIGHLY active antiretroviral therapy, *VIREMIA, *ANTI-HIV agents, *DRUGS, *SUBCUTANEOUS injections
Abstract

Purpose Long-acting cabotegravir/rilpivirine (LA-CAB/RPV) was approved for use in virally suppressed patients with human immunodeficiency virus (HIV) in January 2021. While this was a paradigm shift for many patients living with HIV, as LA-CAB/RPV was the first injectable complete regimen for the treatment of HIV, several patient populations, including those lacking virologic suppression, have not been able to easily access this advance in science and care. Summary In this article, we provide an update on 2 patients from our previous report and describe one further patient who experienced treatment failure following initiation of LA-CAB/RPV. Additionally, we review reports published to date of the clinical outcomes of patients with viremia who have accessed LA-CAB/RPV in the setting of baseline resistance-associated mutations (RAMs) to either component and any resulting RAMs at virologic failure. On the basis of this evidence, we recommend that hybrid or all-injectable regimens be considered for patients who have struggled with adherence to oral antiretroviral therapy or have partial or full resistance to one component of LA-CAB/RPV. Conclusion The case series reported here adds to literature supporting the notion that LA-CAB/RPV can be successfully used in patients who are viremic. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Conceptual Design of a Universal Donor Screening Approach for Vaginal Microbiota Transplant

Author

DeLong, Kevin, primary, Bensouda, Sabrine, additional, Zulfiqar, Fareeha, additional, Zierden, Hannah C., additional, Hoang, Thuy M., additional, Abraham, Alison G., additional, Coleman, Jenell S., additional, Cone, Richard A., additional, Gravitt, Patti E., additional, Hendrix, Craig W., additional, Fuchs, Edward J., additional, Gaydos, Charlotte A., additional, Weld, Ethel D., additional, and Ensign, Laura M., additional

Published
2019
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37. Colaboradores

Author

Abbas, Maher A., Abularrage, Christopher J., AbuRahma, Ali F., AbuRahma, Zachary T., Adams, Charles A., Jr., Adams, David B., Adams, Reid B., Adrales, Gina L., Agarwal, Suresh K., Agarwalla, Anant, Ahrendt, Steven A., Aleassa, Essa M., Efishat, Mohammad Al, Ali, Aamna, Alverdy, John C., Amajoyi, Robert, Amankwah, Kwame S., Aminian, Ali, Andolfi, Ciro, Anthone, Gary, Arnold, Maggie, Arrington, Amanda K., Asare, Elliot A., Assi, Roland, Auchincloss, Hugh G., Azagury, Dan E., Azar, Faris K., Azizzadeh, Ali, Banerjee, Sudeep, Barie, Philip S., Barth, Richard J., Jr., Battafarano, Richard J., Baumgartner, Joel M., Beaulieu, Robert J., Benlice, Cigdem, Bernstein, Mitchell A., Berry, Cherisse, Bhattacharya, Saveri, Black, James H., III, Blair, Alex B., Bland, Kirby I., Blas, Joseph-Vincent V., Bogert, James N., Boughey, Judy C., Boyle, Kelly A., Brem, Rachel F., Brenner, Megan, Brewer, J. Michael, Gutierrez, Olaya I. Brewer, Breyer, Benjamin N., Brigode, William M., Britt, L.D., Brock, Malcolm V., Brown, Carlos V.R., Brunicardi, F. Charles, Buesing, Keely L., Bukur, Marko, Bulat, Robert, Burkhart, Richard A., Busuttil, Ronald W., Cain, Christian, Callcut, Rachael A., Calotta, Nicholas A., Cambria, Richard P., Cameron, Andrew M., Camp, Melissa S., Capek, Karel D., Cardella, Jonathan A., Cartwright, Paul, Chaar, Cassius Iyad Ochoa, Chaikof, Elliot L., Chawla, Akhil, Chen, Po-Hung, Cherry-Bukowiec, Jill R., Choron, Rachel L., Choti, Michael A., Chuquin, Kathryn Ely Pierce, Cintron, Jose R., Cioffi, William G., Clary, Bryan, Cloyd, Jordan M., Coan, Kathryn E., Cody, Hiram S., III, Cogbill, Thomas H., Cohen, Andrew J., Coimbra, Raul, Cologne, Kyle G., Colombani, Paul M., Cools-Lartigue, Jonathan, Cooney, Robert N., Coté, Gregory A., Cotton, Bryan A., Croce, Martin A., Cross, Alisa, Croteau, Alfred, Crowl, Gabriel, Cunningham, Steven C., Dageforde, Leigh Anne, Danielson, Paul D., Dardik, Alan, Darling, R. Clement, III, Darrach, Halley, Dempsey, Daniel T., Denoya, Paula, Deune, E. Gene, Dhillon, Navpreet K., DiBrito, Sandra R., Dillavou, Ellen, Dillhoff, Mary E., DiNorcia, Joseph, Doherty, Gerard M., Doucet, Jay, Dubose, Joseph, Duh, Quan-Yang, Duncan, Mark D., Dunn, Geoffrey P., Ecker, Brett L., Efron, David T., Efron, Jonathan, Ehlers, Anne P., Ejaz, Aslam, Elias, Alexandra W., Lakis, Mustapha El, Ellison, E. Christopher, Elmously, Adham, Englesbe, Michael J., Erstad, Derek J., Espinosa, Jairo A., Etchill, Eric W., Euhus, David, Evans, Cory R., Evans, Douglas B., Evans, Heather L., Fabian, Timothy C., Fackche, Nadege T., Fagenholz, Peter J., Famularo, Marissa, Fang, Sandy H., Farber, Alik, Feliciano, David V., Castillo, Carlos Fernandez-del, Ferrada, Paula, Ferrara, Marco, Ferrone, Cristina R., Fichera, Alessandro, Filicori, Filippo, Filtes, John, Finnerty, Celeste C., Fischer, Josef E., Fishbein, Thomas M., Fisichella, Marco P., Fitzgerald, Michael, Fitzgibbons, Robert J., Jr., Fleshman, James, Foncerrada, Guillermo, Fong, Yuman, Fong, Zhi Ven, Foster, Deshka S., Frangos, Spiros G., Francone, Todd D., Franklin, Adam, Fransman, Ryan B., Friedstat, Jonathan, Freischlag, Julie A., Frost, Christopher, Futchko, John, Gabre-Kidan, Alodia, Gadd, Michele A., Gage, Michele M., Galandiuk, Susan, Galvagno, Samuel M., Jr., Garner, Matthew, Garrido, Danon E., Gearhart, Susan L., Genuit, Thomas, Georgiades, Christos, Gewertz, Bruce L., Giglia, Joseph S., Gilmore, Richard C., Giuliano, Armando E., Glebova, Natalia, Glorioso, Jaime M., Goussous, Naeem, Goverman, Jeremy, Grant, Michael D., Grant, Michael P., Grimsley, Lauren, Gronchi, Alessandro, Guillem, José G., Gupta, Aakanksha, Gupta, NavYash, Harmon, John W., Habibi, Mehran, Hackam, David J., Haider, Adil H., Haines, Krista L., Halabi, Wissam J., Hallemeier, Christopher L., Hanks, John B., Harris, Andrew, Hartwell, Jennifer L., Hatton, Gabrielle E., Haut, Elliott R., Hawksworth, Jason S., He, Jin, Henry, Sharon, Herman, Joseph M., Herndon, David N., Hicks, Caitlin W., Hines, O. Joe, Holihan, Julie L., Holscher, Courtenay M., Hong, Kelvin, House, Michael G., Hsu, Cary, Huang, Renee, Hughes, Kevin, Hull, Travis, Huppe, Ashley I., Hutcheon, David F., Ibrahim-zada, Irada, Itani, Kamal M.F., Ito, Tomoaki, Jackson, Anee Sophia, Jacob, Brian, Jacobs, Lisa K., Jacobson, Richard A., Javed, Ammar A., Johnston, Fabian, Jones, Douglas W., Jones, Ronald C., Joseph, Kimberly, Kalloo, Anthony N., Kaiser, Andreas M., Kandagatla, Pridvi, Kao, Lillian S., Kashyap, Vikram S., Katlic, Mark, Kebaish, Khaled M., Kebebew, Electron, Kelley, Matthew P., Kelley, Scott R., Kelly, Kaitlyn J., Kemp, Kevin, Khan, Aadil A., Khan, Uzer, Kiguchi, Misaki, Kisat, Mehreen T., Klein, Andrew, Kokosis, George, Komak, Spogmai, Kosari, Kambiz, Kovler, Mark L., Krepline, Ashley N., Krontiras, Helen, Kupstas, Amanda, Lafaro, Kelly J., Ladd, Mitchell Ryan, Lambright, Eric, LaMuraglia, Glenn M., Lancaster, Rachael B., Lancaster, William P., Landmann, Ron G., Lange, Julie R., Langenfeld, Sean J., Lazar, Melissa, Ledgerwood, Anna M., Lee, Candice Y., Lee, Jong O., Lee, Sang W., Lee, Yann-Leei Larry, Leeds, Ira L., Lei, Ji, Le Leannec, Isabelle C., Levine, Rebecca, Ley, Eric J., Liang, Mike K., Liang, Yu, Liddell, Robert P., Lidor, Anne O., Lillemoe, Keith D., Lipham, John C., Lipman, Jeremy M., Lipsett, Pamela A., Lipsitz, Evan C., Liveris, Anna, Locham, Satinderjit S., Lombardi, Joseph V., Lonze, Bonnie E., Louie, Brian E., Low, Gregory K., Lowy, Andrew M., Lucas, Charles E., Lum, Ying Wei, Magovern, George J., Jr., Makary, Martin A., Malas, Mahmoud B., Manson, Paul N., Mantilla, Nathalie, Marcinkowski, Peter, Markmann, James F., Markowiak, Stephen F., Martin, Allison N., Martin, Daniel, Martin, Matthew J., Martyak, Michael, Massoumi, Roxanne L., Mathisen, Douglas J., Mawn, J. Greg, Mazer, Laura M., McCarthy, Mary, McColl, Michael, McFadden, David W., Meagher, Ashley D., Mezina, Anya, Michelassi, Fabrizio, Milia, David J., Miller, Barbra S., Miraflor, Emily J., Mitchell, Erica L., Molena, Daniela, Molina, George, Monson, John R.T., Montgomery, John R., Moore, Derek T., Moraca, Robert J., Moran, Benjamin, Morse, Christopher R., Muscarella, Peter, II, Narang, Amol, Narang, Rahul, Narayan, Mayur, Nash, Nicholas A., Nason, Katie S., Nasseri, Yosef, Nassiri, Naiem, Needham, Victoria, Nehs, Matthew A., Newman, Lisa A., Nguyen, Quang, Nishtala, Madhuri V., Nissen, Nicholas, Niu, Bolin, Noren, Erik R., Norton, Jeffrey A., Nukala, Melanie, Nwaogu, Iheoma Y., Obokhare, Izi, Oelschlager, Brant K., O’Keeffe, Terence, O’Mara, Charles S., O’Neal, Patrick B., Ong, Cecilia T., Orloff, Mark S., Oseni, Tawakalitu O., Osgood, Greg M., Ottmann, Shane E., Overton, Heidi N., Oyetunji, Shakirat, Pachter, H. Leon, Pagacnik, Javier Salgado, Palmer, Barnard J.A., Panda, Nikhil, Pappas, Theodore N., Park, Lisa, Pasricha, Pankaj Jay, Peitzman, Andrew B., Patti, Marco G., Pawlik, Timothy M., Perler, Bruce A., Pettke, Erica, Pitt, Henry A., Politano, Amani D., Prescott, Jason D., Price, Leigh Ann, Propper, Brandon W., Prushik, Scott G., Puzio, Thaddeus J., Qaqish, T. Robert, Ramdon, Andre R., Ramirez, Christine, Ramirez, Daniel E., Ramshaw, Bruce, Raut, Chandrajit P., Reames, Bradley N., Reed, Christopher R., Reifsnyder, Thomas, Riall, Taylor S., Richardson, J. David, Rickert, Charles G., Rizvi, Addi Z., Robinson, Thomas N., Roddy, Sean P., Rogers, Andrew P., Rojas-Khalil, Yesenia, Romanelli, John R., Rosenthal, Ronnie A., Rosson, Gedge D., Rozycki, Grace S., Rueda, Mario, Russell, Jonathon O., Ryan, Colleen M., Sacks, Bethany C., Sacks, Justin M., Safar, Bashar, Sahli, Zeyad T., Sakran, Joseph V., Santa-Maria, Cesar A., Sarmiento, Samuel, Sawyer, Robert, Scalea, Joseph R., Scalea, Thomas M., Schauer, Philip R., Schechtman, David W., Schlottmann, Francisco, Schulick, Andrew, Schulick, Richard D., Schwartz, Samuel I., Scully, Rebecca, Seegmiller, Colby J., Sell, Naomi M., Semon, Gregory, Senter, Katherine, Shah, Samir Kaushik, Shake, Jay G., Sham, Jonathan G., Shank, Jessica B., Shehebar, Josef A., Shibata, David, Shoham, Shmuel, Sicklick, Jason K., Sims, Carrie A., Singh, Vikesh K., Smeds, Matthew R., Smith, Barbara L., Smith, Philip W., Soliman, Mark, Solsky, Ian, Sooppan, Renganaden, Sorber, Rebecca, Sosa, Julie Ann, Sriram, Krishnan, Steele, Scott R., Stein, Deborah, Steinberg, Toby B., Stevens, Kent A., Strasberg, Steven M., Swanström, Lee L., Talamini, Mark A., Tan, Winson Jianhong, Tanabe, Kenneth K., Tatum, James M., Tavakkoli, Ali, Taylor, James, Taylor, John R., III, Taylor, Spence M., Teal, Christine B., Tecos, Maria E., Tesoriero, Ronald, Thompson, Alastair M., Tieszen, Myles, Tsai, Susan, Tsao, Miriam W., Tsangaris, Theodore N., Tufaro, Anthony P., Tufano, Ralph P., Tung, Lily, Udelsman, Robert, Vallabhajosyula, Prashanth, van den Berg, Fons, Vane, Marissa, Vaught, Arthur Jason, Veerapong, Jula, Velez-Rosborough, Ana M., Velmahos, George, Vollmer, Charles M., Jr., Wahlgren, Carl M., Walsh, Christi, Wang, Tracy S., Warshaw, Andrew L., Webb, Travis P., Weeks, Sharon R., Weiss, Clifford R., Weiss, Matthew J., Weld, Ethel D., Wells, Katarina, Wessells, Hunter, Wexner, Steven D., Whelan, Richard L., Wick, Elizabeth, Williams, Timothy K., Wiseman, Douglas, Witten, Meredith O., Wolfgang, Christopher L., Wong, Daniel J., Wood, Douglas E., Woreta, Tinsay, Wright, Cameron D., Yang, Stephen C., Yap, Raymond, Yellinek, Shlomo, Yeo, Heather L., Zarzaur, Ben L., Zaydfudim, Victor M., Zeb, Sarah, Zeiger, Martha A., Zenilman, Michael, Zhan, Luke X., Zhu, Ruoyan, and Zyromski, Nicholas J.

Published
2021
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40. Contributors

Author

Abbas, Maher A., Abularrage, Christopher J., AbuRahma, Ali F., AbuRahma, Zachary T., Adams, Charles A., Jr, Adams, David B., Adams, Reid B., Adrales, Gina L., Agarwal, Suresh K., Agarwalla, Anant, Ahrendt, Steven A., Aleassa, Essa M., Al Efishat, Mohammad, Ali, Aamna, Alverdy, John C., Amajoyi, Robert, Amankwah, Kwame S., Aminian, Ali, Andolfi, Ciro, Anthone, Gary, Arnold, Maggie, Arrington, Amanda K., Asare, Elliot A., Assi, Roland, Auchincloss, Hugh G., Azagury, Dan E., Azar, Faris K., Azizzadeh, Ali, Banerjee, Sudeep, Barie, Philip S., Barth, Richard J., Jr, Battafarano, Richard J., Baumgartner, Joel M., Beaulieu, Robert J., Benlice, Cigdem, Bernstein, Mitchell A., Berry, Cherisse, Bhattacharya, Saveri, Black, James H., III, Blair, Alex B., Bland, Kirby I., Blas, Joseph-Vincent V., Bogert, James N., Boughey, Judy C., Boyle, Kelly A., Brem, Rachel F., Brenner, Megan, Brewer, J. Michael, Brewer Gutierrez, Olaya I., Breyer, Benjamin N., Brigode, William M., Britt, L.D., Brock, Malcolm V., Brown, Carlos V.R., Brunicardi, F. Charles, Buesing, Keely L., Bukur, Marko, Bulat, Robert, Burkhart, Richard A., Busuttil, Ronald W., Cain, Christian, Callcut, Rachael A., Calotta, Nicholas A., Cambria, Richard P., Cameron, Andrew M., Camp, Melissa S., Capek, Karel D., Cardella, Jonathan A., Cartwright, Paul, Ochoa Chaar, Cassius Iyad, Chaikof, Elliot L., Chawla, Akhil, Chen, Po-Hung, Cherry-Bukowiec, Jill R., Choron, Rachel L., Choti, Michael A., Pierce Chuquin, Kathryn Ely, Cintron, Jose R., Cioffi, William G., Clary, Bryan, Cloyd, Jordan M., Coan, Kathryn E., Cody, Hiram S., III, Cogbill, Thomas H., Cohen, Andrew J., Coimbra, Raul, Cologne, Kyle G., Colombani, Paul M., Cools-Lartigue, Jonathan, Cooney, Robert N., Coté, Gregory A., Cotton, Bryan A., Croce, Martin A., Cross, Alisa, Croteau, Alfred, Crowl, Gabriel, Cunningham, Steven C., Dageforde, Leigh Anne, Danielson, Paul D., Dardik, Alan, Darling, R. Clement, III, Darrach, Halley, Dempsey, Daniel T., Denoya, Paula, Deune, E. Gene, Dhillon, Navpreet K., DiBrito, Sandra R., Dillavou, Ellen, Dillhoff, Mary E., DiNorcia, Joseph, Doherty, Gerard M., Doucet, Jay, Dubose, Joseph, Duh, Quan-Yang, Duncan, Mark D., Dunn, Geoffrey P., Ecker, Brett L., Efron, David T., Efron, Jonathan, Ehlers, Anne P., Ejaz, Aslam, Elias, Alexandra W., El Lakis, Mustapha, Ellison, E. Christopher, Elmously, Adham, Englesbe, Michael J., Erstad, Derek J., Espinosa, Jairo A., Etchill, Eric W., Euhus, David, Evans, Cory R., Evans, Douglas B., Evans, Heather L., Fabian, Timothy C., Fackche, Nadege T., Fagenholz, Peter J., Famularo, Marissa, Fang, Sandy H., Farber, Alik, Feliciano, David V., Castillo, Carlos Fernandez-del, Ferrada, Paula, Ferrara, Marco, Ferrone, Cristina R., Fichera, Alessandro, Filicori, Filippo, Filtes, John, Finnerty, Celeste C., Fischer, Josef E., Fishbein, Thomas M., Fisichella, Marco P., Fitzgerald, Michael, Fitzgibbons, Robert J., Jr, Fleshman, James, Foncerrada, Guillermo, Fong, Yuman, Fong, Zhi Ven, Foster, Deshka S., Frangos, Spiros G., Francone, Todd D., Franklin, Adam, Fransman, Ryan B., Friedstat, Jonathan, Freischlag, Julie A., Frost, Christopher, Futchko, John, Gabre-Kidan, Alodia, Gadd, Michele A., Gage, Michele M., Galandiuk, Susan, Galvagno, Samuel M., Jr, Garner, Matthew, Garrido, Danon E., Gearhart, Susan L., Genuit, Thomas, Georgiades, Christos, Gewertz, Bruce L., Giglia, Joseph S., Gilmore, Richard C., Giuliano, Armando E., Glebova, Natalia, Glorioso, Jaime M., Goussous, Naeem, Goverman, Jeremy, Grant, Michael D., Grant, Michael P., Grimsley, Laura, Gronchi, Alessandro, Guillem, José G., Gupta, Aakanksha, Gupta, NavYash, Harmon, John W., Habibi, Mehran, Hackam, David J., Haider, Adil H., Haines, Krista L., Halabi, Wissam J., Hallemeier, Christopher L., Hanks, John B., Harris, Andrew, Hartwell, Jennifer L., Hatton, Gabrielle E., Haut, Elliott R., Hawksworth, Jason S., He, Jin, Henry, Sharon, Herman, Joseph M., Herndon, David N., Hicks, Caitlin W., Hines, O. Joe, Holihan, Julie L., Holscher, Courtenay M., Hong, Kelvin, House, Michael G., Hsu, Cary, Huang, Renee, Hughes, Kevin, Hull, Travis, Huppe, Ashley I., Hutcheon, David F., Ibrahim-zada, Irada, Itani, Kamal M.F., Ito, Tomoaki, Jackson, Anee Sophia, Jacob, Brian, Jacobs, Lisa K., Jacobson, Richard A., Javed, Ammar A., Johnston, Fabian, Jones, Douglas W., Jones, Ronald C., Joseph, Kimberly, Kalloo, Anthony N., Kaiser, Andreas M., Kandagatla, Pridvi, Kao, Lillian S., Katlic, Mark, Kashyap, Vikram S., Kebaish, Khaled M., Kebebew, Electron, Kelley, Matthew P., Kelley, Scott R., Kelly, Kaitlyn J., Kemp, Kevin, Khan, Aadil A., Khan, Uzer, Kiguchi, Misaki, Kisat, Mehreen T., Klein, Andrew, Kokosis, George, Komak, Spogmai, Kosari, Kambiz, Kovler, Mark L., Krepline, Ashley N., Krontiras, Helen, Kupstas, Amanda, Lafaro, Kelly J., Ladd, Mitchell Ryan, Lambright, Eric, LaMuraglia, Glenn M., Lancaster, Rachael B., Lancaster, William P., Landmann, Ron G., Lange, Julie R., Langenfeld, Sean J., Lazar, Melissa, Ledgerwood, Anna M., Lee, Candice Y., Lee, Jong O., Lee, Sang W., Larry Lee, Yann-Leei, Leeds, Ira L., Lei, Ji, Le Leannec, Isabelle C., Levine, Rebecca, Ley, Eric J., Liang, Mike K., Liang, Yu, Liddell, Robert P., Lidor, Anne O., Lillemoe, Keith D., Lipham, John C., Lipman, Jeremy M., Lipsett, Pamela A., Lipsitz, Evan C., Liveris, Anna, Locham, Satinderjit S., Lombardi, Joseph V., Lonze, Bonnie E., Louie, Brian E., Low, Gregory K., Lowy, Andrew M., Lucas, Charles E., Lum, Ying Wei, Magovern, George J., Jr, Makary, Martin A., Malas, Mahmoud B., Manson, Paul N., Mantilla, Nathalie, Marcinkowski, Peter, Markmann, James F., Markowiak, Stephen F., Martin, Allison N., Martin, Daniel, Martin, Matthew J., Martyak, Michael, Massoumi, Roxanne L., Mathisen, Douglas J., Mawn, J. Greg, Mazer, Laura M., McCarthy, Mary, McColl, Michael, McFadden, David W., Meagher, Ashley D., Mezina, Anya, Michelassi, Fabrizio, Milia, David J., Miller, Barbra S., Miraflor, Emily J., Mitchell, Erica L., Molena, Daniela, Molina, George, Monson, John R.T., Montgomery, John R., Moore, Derek T., Moraca, Robert J., Moran, Benjamin, Morse, Christopher R., Muscarella, Peter, II, Narang, Amol, Narang, Rahul, Narayan, Mayur, Nash, Nicholas A., Nason, Katie S., Nasseri, Yosef, Nassiri, Naiem, Needham, Victoria, Nehs, Matthew A., Newman, Lisa A., Nguyen, Quang, Nishtala, Madhuri V., Nissen, Nicholas, Niu, Bolin, Noren, Erik R., Norton, Jeffrey A., Nukala, Melanie, Nwaogu, Iheoma Y., Obokhare, Izi, Oelschlager, Brant K., O’Keeffe, Terence, O’Mara, Charles S., O’Neal, Patrick B., Ong, Cecilia T., Orloff, Mark S., Oseni, Tawakalitu O., Osgood, Greg M., Ottmann, Shane E., Overton, Heidi N., Oyetunji, Shakirat, Pachter, H. Leon, Pagacnik, Javier Salgado, Palmer, Barnard J.A., Panda, Nikhil, Pappas, Theodore N., Park, Lisa, Pasricha, Pankaj Jay, Peitzman, Andrew B., Patti, Marco G., Pawlik, Timothy M., Perler, Bruce A., Pettke, Erica, Pitt, Henry A., Politano, Amani D., Prescott, Jason D., Price, Leigh Ann, Propper, Brandon W., Prushik, Scott G., Puzio, Thaddeus J., Qaqish, T. Robert, Ramdon, Andre R., Ramirez, Christine, Ramirez, Daniel E., Ramshaw, Bruce, Raut, Chandrajit P., Reames, Bradley N., Reed, Christopher R., Reifsnyder, Thomas, Riall, Taylor S., Richardson, J. David, Rickert, Charles G., Rizvi, Addi Z., Robinson, Thomas N., Roddy, Sean P., Rogers, Andrew P., Rojas-Khalil, Yesenia, Romanelli, John R., Rosenthal, Ronnie A., Rosson, Gedge D., Rozycki, Grace S., Rueda, Mario, Russell, Jonathon O., Ryan, Colleen M., Sacks, Bethany C., Sacks, Justin M., Safar, Bashar, Sahli, Zeyad T., Sakran, Joseph V., Santa-Maria, Cesar A., Sarmiento, Samuel, Sawyer, Robert, Scalea, Joseph R., Scalea, Thomas M., Schauer, Philip R., Schechtman, David W., Schlottmann, Francisco, Schulick, Andrew, Schulick, Richard D., Schwartz, Samuel I., Scully, Rebecca, Seegmiller, Colby J., Sell, Naomi M., Semon, Gregory, Senter, Katherine, Shah, Samir Kaushik, Shake, Jay G., Sham, Jonathan G., Shank, Jessica B., Shehebar, Josef A., Shibata, David, Shoham, Shmuel, Sicklick, Jason K., Sims, Carrie A., Singh, Vikesh K., Smeds, Matthew R., Smith, Barbara L., Smith, Philip W., Soliman, Mark, Solsky, Ian, Sooppan, Renganaden, Sorber, Rebecca, Sosa, Julie Ann, Sriram, Krishnan, Steele, Scott R., Stein, Deborah, Steinberg, Toby B., Stevens, Kent A., Strasberg, Steven M., Swanström, Lee L., Talamini, Mark A., Tan, Winson Jianhong, Tanabe, Kenneth K., Tatum, James M., Tavakkoli, Ali, Taylor, James, Taylor, John R., III, Taylor, Spence M., Teal, Christine B., Tecos, Maria E., Tesoriero, Ronald, Thompson, Alastair M., Tieszen, Myles, Tsai, Susan, Tsao, Miriam W., Tsangaris, Theodore N., Tufaro, Anthony P., Tufano, Ralph P., Tung, Lily, Udelsman, Robert, Vallabhajosyula, Prashanth, van den Berg, Fons, Vane, Marissa, Vaught, Arthur Jason, Veerapong, Jula, Velez-Rosborough, Ana M., Velmahos, George, Vollmer, Charles M., Jr, Wahlgren, Carl M., Walsh, Christi, Wang, Tracy S., Warshaw, Andrew L., Webb, Travis P., Weeks, Sharon R., Weiss, Clifford R., Weiss, Matthew J., Weld, Ethel D., Wells, Katarina, Wessells, Hunter, Wexner, Steven D., Whelan, Richard L., Wick, Elizabeth, Williams, Timothy K., Wiseman, Douglas, Witten, Meredith O., Wolfgang, Christopher L., Wong, Daniel J., Wood, Douglas E., Woreta, Tinsay, Wright, Cameron D., Yang, Stephen C., Yap, Raymond, Yellinek, Shlomo, Yeo, Heather L., Zarzaur, Ben L., Zaydfudim, Victor M., Zeb, Sarah, Zeiger, Martha A., Zenilman, Michael, Zhan, Luke X., Zhu, Ruoyan, and Zyromski, Nicholas J.

Published
2020
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41. Lubricant Provides Poor Rectal Mucosal HIV Coverage

Author

Shieh, Eugenie C., primary, Weld, Ethel D., additional, Fuchs, Edward J., additional, Hiruy, Hiwot, additional, Buckheit, Karen W., additional, Buckheit, Robert W., additional, Breakey, Jennifer, additional, and Hendrix, Craig W., additional

Published
2017
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42. A Comparative Pre-Phase I Study of the Impact of Gel Vehicle Volume on Distal Colon Distribution, User Experience, and Acceptability

Author

Weld, Ethel D., primary, Hiruy, Hiwot, additional, Guthrie, Kate Morrow, additional, Fava, Joseph L., additional, Vargas, Sara E., additional, Buckheit, Karen, additional, Buckheit, Robert, additional, Spiegel, Hans, additional, Breakey, Jennifer, additional, Fuchs, Edward J., additional, and Hendrix, Craig W., additional

Published
2017
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45. Mapping Colorectal Distribution of Cell-free and Cell-associated HIV Surrogates Following Simulated Anal Intercourse to Aid Rectal Microbicide Development.

Author

Weld ED, Ogasawara K, Fuchs EJ, Louissaint N, Caffo B, and Hendrix CW

Abstract

Background: Anal sex remains the greatest HIV transmission risk for men who have sex with men and carries substantial population attributable risk among women. Despite a growing array of HIV pre-exposure prophylaxis (PrEP) options, rectal microbicides remain desirable as on demand, non-systemic PrEP. Rectal microbicide product development for PrEP requires understanding the spatiotemporal distribution of HIV infectious elements in the rectosigmoid to optimize formulation development., Setting: Outpatient setting with healthy research participants., Methods: Six healthy men underwent simulated receptive anal sex with an artificial phallus fitted with a triple lumen catheter in the urethral position. To simulate ejaculation of HIV-infected semen, autologous seminal plasma laden with autologous blood lymphocytes from apheresis labeled with 111Indium-oxine (cell-associated) and 99mTechnetium-sulfur colloid (cell-free) as HIV surrogates were injected into the rectal lumen through the phallic urethra. Spatiotemporal distribution of each radioisotope was assessed using SPECT/CT over eight hours. Analysis of radiolabel distribution used a flexible principal curve algorithm to quantitatively estimate rectal lumen distribution., Results: Cell-free and cell-associated HIV surrogates distributed to a maximal distance of 15 and 16 cm, respectively, from the anorectal junction (∼19 and ∼20 cm from the anal verge), with a maximal signal intensity located 6 and 7 cm, respectively. There were no significant differences in any distribution parameters between cell-free and cell-associated HIV surrogate., Conclusions: Cell-free and cell-associated HIV surrogate distribution in the rectosigmoid can be quantified with spatiotemporal pharmacokinetic methods. These results describe the ideal luminal target distribution to guide rectal microbicide development., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2024
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46. Interest of Youth Living With HIV in Long-Acting Antiretrovirals.

Author

Weld ED, Rana MS, Dallas RH, Camacho-Gonzalez AF, Ryscavage P, Gaur AH, Chakraborty R, Swindells S, Flexner C, and Agwu AL

Subjects
Adolescent, Anti-HIV Agents pharmacology, Cross-Sectional Studies, Delayed-Action Preparations pharmacology, Female, HIV Infections epidemiology, HIV Infections psychology, Humans, Male, United States epidemiology, Young Adult, Anti-HIV Agents therapeutic use, Delayed-Action Preparations therapeutic use, HIV Infections drug therapy, Medication Adherence statistics & numerical data, Patient Satisfaction statistics & numerical data, Viral Load drug effects
Abstract

Objectives: This study's primary objective was to characterize attitudes to long-acting antiretrovirals (LAARV), among youth aged 13-24 years living with perinatally acquired HIV and nonperinatally acquired HIV. Secondary objectives included: assessing whether those with detectable HIV RNA PCR viral load had higher enthusiasm for LAARV compared to those with suppressed viral load, and examining characteristics associated with LAARV enthusiasm., Methods: A cross-sectional survey of 303 youth living with HIV (YHIV) followed at 4 pediatric/adolescent HIV clinics in the United States was performed to determine interest in LAARV, using a modified survey instrument previously used in adults. Interest in LAARV across groups was compared. Poisson regression with robust variance was used to determine the impact of various characteristics on interest in LAARV., Findings: Overall, 88% of YHIV reported probable or definite willingness to use LAARV. The enthusiasm level was similar between youth with perinatally acquired HIV and nonperinatally acquired HIV (P = 0.93). Youth with HIV viral load >1000 copies per milliliter had significantly higher interest than youth with suppressed viral load [prevalence ratio 1.12 (95% confidence interval: 1.03 to 1.20); P = 0.005]. Female youth participants who had had past experience with implantable contraceptive methods had a significantly higher interest in LAARV (100% vs. 85.5%; P = 0.002). Proportion of respondents endorsing definite willingness to use was significantly higher with decreased injection frequency compared with increased injection frequency., Interpretation: YHIV at 4 urban US pediatric/adolescent HIV clinics had high levels of enthusiasm for LAARV. LAARV should be given high priority as a potentially viable treatment option to improve clinical outcomes in YHIV.

Published
2019
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47. Transfusion medicine illustrated. The expanding range and severity of babesiosis.

Author

Weld ED, Eimer KM, Saharia K, Orenstein A, and Hess JR

Subjects
Acute Kidney Injury etiology, Acute Kidney Injury therapy, Aged, 80 and over, Anemia, Hemolytic etiology, Animals, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Murine-Derived, Arachnid Vectors parasitology, Babesia microti isolation & purification, Babesiosis complications, Babesiosis epidemiology, Babesiosis parasitology, Babesiosis transmission, Communicable Diseases, Emerging epidemiology, Communicable Diseases, Emerging parasitology, Disease Reservoirs parasitology, Female, Humans, Immunocompromised Host, Lymphoproliferative Disorders complications, Lymphoproliferative Disorders drug therapy, Maryland epidemiology, Renal Dialysis, Rituximab, Rodentia parasitology, Salivary Glands parasitology, Salivary Glands ultrastructure, Babesia microti growth & development, Babesiosis blood, Bites and Stings parasitology, Communicable Diseases, Emerging blood, Erythrocytes parasitology, Ixodidae parasitology, Transfusion Reaction
Published
2010
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