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273 results on '"Luetkemeyer, Anne F."'

1. Hepatitis C Elimination During a Global Pandemic: A Case Study of Resilience in Action

Author

Facente, Shelley N, Grinstein, Rachel, Broussard, Janessa, Shost, Jessica, Azari, Soraya, Siruno, Jennifer, Jimenez, Jose A, Luetkemeyer, Anne F, and Burk, Katie

Subjects
Health Services and Systems, Health Sciences, Digestive Diseases, Hepatitis, Infectious Diseases, Chronic Liver Disease and Cirrhosis, Emerging Infectious Diseases, Health Services, Clinical Research, Liver Disease, Hepatitis - C, Infection, Good Health and Well Being, COVID-19, Hepacivirus, Hepatitis C, Hepatitis C Antibodies, Humans, Pandemics, hepatitis C, HCV, elimination, screening, treatment, pandemic, resilience, Nursing, Public Health and Health Services, Policy and Administration, Public Health, Health services and systems, Public health, Policy and administration
Abstract

Until the COVID-19 pandemic, San Francisco's hepatitis C virus (HCV) elimination initiative, End Hep C SF, was expanding and refining HCV testing and treatment strategies citywide, making progress toward local HCV elimination goals. Although a shelter-in-place health order issued in March 2020 categorized HCV testing as an "essential service," most HCV testing and treatment immediately stopped until COVID-19-safe protocols could be implemented. During the 14 months of pandemic-related organizational closures, End Hep C SF transitioned to a 100% virtual model, maintaining regularly scheduled meetings. Community-based HCV antibody testing decreased 80% from February to April 2020, and HCV treatment initiation also decreased, although both services started to rebound in mid-to-late 2020, partially as a result of End Hep C SF collaborations. End Hep C SF service providers, clinicians, and advocates reported that the continuous communication and common agenda of End Hep C SF-2 principles of the collective impact initiative-served as a familiar touchpoint and helpful source of information during this isolating and uncertain time. Ultimately, End Hep C SF allowed us to continue HCV elimination strategies through 6 lessons learned: maintaining HCV treatment access through telehealth and mobile services; leveraging research studies that provided HCV testing and treatment; offering HCV screening and linkage to care in tandem with COVID-19-related initiatives; being flexible and inventive, such as administering HCV treatment to residents of shelter-in-place hotels; establishing a data dashboard to track HCV testing and treatment; and relying on partnerships to solve problems and avoid burnout.

Published
2022

2. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial

Author

Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C. S., Kamidani, Satoshi, Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Telu, Kalyani, Mu, Jinjian, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Montefiori, David C., Makowski, Mat, Smith, Derek J., Nayak, Seema U., Roberts, Paul C., and Beigel, John H.

Published
2023
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3. Optimal hepatitis C treatment adherence patterns and sustained virologic response among people who inject drugs: The HERO study

Author

Litwin, Alain H., Heo, Moonseong, Pericot-Valverde, Irene, Walker, Hagan, Coleman, Ashley, Mehta, Shruti H., Borsuk, Courtney, Dickerson, Brian, Falade-Nwulia, Oluwaseun, Fingerhood, Michael, Haselhuhn, Taryn, Mason, Angela, Moon, Juhi, Olsen, Yngvild, Walters, Vickie, Kim, Arthur Y., Roche, Jillian M., Schmitt, William, Lijewski, Virginia, Pitts, Anita, Raji, Syeda, Silva, Taniya, Evans, Fiona, Koene, Hope, Brown, Joelle, Norton, Brianna, Agyemang, Linda, Arnsten, Julia, Karasz, Alison, Meissner, Paul, Lora, Kiara, Hidalgo, Jennifer, Soloway, Irene, Jefferson, Karen, Wong, Joyce, Kermack, Andrea, Stein, Melissa, Joseph, Gilian, London, Karyn, Allen, Lincoln, Marte, Venecia, Vera, Tatiana, Alvarez, Romy, Mckee, M. Diane, Lum, Paula J., Stein, Ellen S., Luetkemeyer, Anne F., Cullen, Caycee, Gill, Gurjot, Tierney, Hannah, Shapiro, Scott, Azari, Soraya, Eveland, Joanna, Berrner, Daniel, Grey, Pauli, Akerley, Jordan, Page, Kimberly, Wagner, Katherine, Davis, Herbert, Murray-Krezan, Cristina, Jacobsohn, Vanessa, Anderson, Jessica, Taylor, Lynn E., Tashima, Karen, Sprecht-Walsh, Sophie, Thomas, Aurielle, Hordes, Melissa, McGregor, Danielle, Duryea, Patrick, Weenig, Kathryn, Tsui, Judith I., Blalock, Kendra L., Kim, Hyang Nina, Ramchandani, Meena S., James, Jocelyn R., Peavy, K. Michelle, Grekin, Paul, Ninburg, Michael, Feinberg, Judith, Wilkinson, Samuel, Thomas, Danielle, Kelley, Lacey, Calkins, Andrea, Henry, Gabrielle, Ashler, Alice, Teshale, Eyasu, Seiguer, Sebastian, Brown, Lauren, Rios, Katrina, Spellman, James, Raymond, Daniel, Beane, Susan, Marks, Ronni, Swan, Tracy, Walworth, Chuck, Lie, Yolanda, Reeves, Jackie, Ginter, Walter P., Devin, Jules, Clary, Ryan, Broder, Tina, Davila, Bekeela, Johnson, Nirah, Khatun, Umaima, Flanigan, Colleen, Ahmed, Ray, Polluck, Bob, Mastrianni, Serene, Morton, James, Baldwin, Emily, Pesano, Rick, Fotinos, Charissa, Fish, Douglas, Becker, James, Ward, John W., Parrino, Mark, Maxwell, Carleen, Norton, Brianna L., and Arnsten, Julia H.

Published
2024
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4. Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trials

Author

Hermine, Olivier, Mariette, Xavier, Ravaud, Philippe, Bureau, Serge, Dougados, Maxime, Resche-Rigon, Matthieu, Tharaux, Pierre-Louis, Tibi, Annick, Azoulay, Elie, Cadranel, Jacques, Emmerich, Joseph, Fartoukh, Muriel, Guidet, Bertrand, Humbert, Marc, Lacombe, Karine, Mahevas, Matthieu, Pene, Frédéric, Porcher, Raphaël, Pourchet-Martinez, Valerie, Schlemmer, Frédéric, Yazdanpanah, Yazdan, Baron, Gabriel, Perrodeau, Elodie, Vanhoye, Damien, Kedzia, Cécile, Demerville, Lauren, Gysembergh-Houal, Anne, Bourgoin, Alexandre, Raked, Nabil, Mameri, Lakhdar, Montlahuc, Claire, Biard, Lucie, Alary, St.phanie, Hamiria, Samir, Bariz, Thinhinane, Semri, Hala, Hai, Dhiaa Meriem, Benafla, Moustafa, Belloul, Mohamed, Vauboin, Pernelle, Flamand, Saskia, Pacheco, Claire, Walter-Petrich, Anouk, Stan, Emilia, Benarab, Souad, Nyanou, Corine, Charreteur, Robin, Dupre, Céline, Cardet, Kévin, Lehmann, Blandine, Baghli, Kamyl, Madelaine, Claire, D'Ortenzio, Eric, Puéchal, Oriane, Semaille, Caroline, Savale, Laurent, Harrois, Anatole, Figueiredo, Samy, Duranteau, Jacques, Anguel, Nadia, Pavot, Arthur, Monnet, Xavier, Richard, Christian, Teboul, Jean-Louis, Durand, Philippe, Tissieres, Pierre, Jevnikar, Mitja, Montani, David, Pavy, Stephan, Nocturne, Gaétane, Bitoun, Samuel, Noel, Nicolas, Lambotte, Olivier, Escaut, Lelia, Jauréguiberry, Stephane, Baudry, Elodie, Verny, Christiane, Lefevre, Edouard, Zaidan, Mohamad, Molinari, Domitille, Leprun, Gaël, Fourreau, Alain, Cylly, Laurent, Grimaldi, Lamiae, Virlouvet, Myriam, Meftali, Ramdane, Fabre, Soléne, Licois, Marion, Mamoune, Asmaa, Boudali, Yacine, Le Tiec, Clotilde, Verstuyft, Céline, Roques, Anne-Marie, Georgin-Lavialle, Sophie, Senet, Patricia, Pialoux, Gilles, Soria, Angele, Parrot, Antoine, François, Helene, Rozensztajn, Nathalie, Blin, Emmanuelle, Choinier, Pascaline, Camuset, Juliette, Rech, Jean-Simon, Canellas, Antony, Rolland-Debord, Camille, Lemarié, Nadege, Belaube, Nicolas, Nadal, Marine, Siguier, Martin, Petit-Hoang, Camille, Chas, Julie, Drouet, Elodie, Lemoine, Matthieu, Phibel, Audrey, Aunay, Lucie, Bertrand, Eliane, Ravato, Sylviane, Vayssettes, Marie, Adda, Anne, Wilpotte, Celine, Thibaut, Pélagie, Fillon, Julie, Debrix, Isabelle, Fellahi, Soraya, Bastard, Jean-Philippe, Lefévre, Guillaume, Gottenberg, Jacques-Eric, Hansmann, Yves, Blanc, Frédéric, Ohlmann-Caillard, Sophie, Castelain, Vincent, Chatelus, Emmanuel, Chatron, Eva, Collange, Olivier, Danion, François, De Blay, Frédéric, Diemunsch, Pierre, Diemunsch, Sophie, Felten, Renaud, Goichot, Bernard, Greigert, Valentin, Guffroy, Aurelien, Heger, Bob, Kaeuffer, Charlotte, Kassegne, Loic, Korganow, Anne Sophie, Le Borgne, Pierrick, Lefebvre, Nicolas, Mertes, Paul-Michel, Noll, Eric, Oberlin, Mathieu, Poindron, Vincent, Pottecher, Julien, Ruch, Yvon, Weill, François, Meyer, Nicolas, Andres, Emmanuel, Demonsant, Eric, Tayebi, Hakim, Nisand, Gabriel, Brin, Stéphane, Sublon, Cédric, Becker, Guillaume, Hutt, Anne, Martin, Tristan, Bayer, Sophie, Metzger, Catherine, Mekinian, Arsene, Abisror, Noémie, Adedjouma, Amir, Bollens, Diane, Bonneton, Marion, Bourcicaux, Nathalie, Bourrier, Anne, Thibault Chiarabiani, Maria Chauchard, Chopin, Doroth.e, Cohen, Jonathan, Devred, Ines, Donadille, Bruno, Fain, Olivier, Hariri, Geoffrey, Jachiet, Vincent, Ingliz, Patrick, Garnier, Marc, Gatfosse, Marc, Ghrenassia, Etienne, Gobert, Delphine, Krause le Garrec, Jessica, Landman, Cecilia, Lavillegrand, Jean Remy, Lefebvre, Benedicte, Mahevas, Thibault, Mazerand, Sandie, Meynard, Jean Luc, Morgand, Marjolaine, Ouaz.ne, Zineb, Pacanowski, Jerome, Riviere, S.bastien, Seksik, Philippe, Sokol, Harry, Soliman, Heithem, Valin, Nadia, Urbina, Thomas, McAvoy, Chloé, Miranda, Maria Pereira, Aratus, Gladys, Berard, Laurence, Simon, Tabassome, Nguyen, Anne Daguenel, Girault, Elise, Mayala-Kanda, Cl.mentine, Antignac, Marie, Leplay, Céline, Arlet, Jean-Benoit, Diehl, Jean-Luc, Bellenfant, Florence, Blanchard, Anne, Buffet, Alexandre, Cholley, Bernard, Fayol, Antoine, Flamarion, Edouard, Godier, Anne, Gorget, Thomas, Hamada, Sophie-Rym, Hauw-Berlemont, Caroline, Hulot, Jean-Sébastien, Lebeaux, David, Livrozet, Marine, Michon, Adrien, Neuschwander, Arthur, Pennet, Marie-Aude, Planquette, Benjamin, Ranque, Brigitte, Sanchez, Olivier, Volle, Geoffroy, Briois, Sandrine, Cornic, Mathias, Elisee, Virginie, Denis, Jesuthasan, Djadi-Prat, Juliette, Jouany, Pauline, Junquera, Ramon, Henriques, Mickael, Kebir, Amina, Lehir, Isabelle, Meunier, Jeanne, Patin, Florence, Paquet, Val.rie, Tréhan, Anne, Vigna, Véronique, Sabatier, Brigitte, Bergerot, Damien, Jouve, Charléne, Knosp, Camille, Lenoir, Olivia, Mahtal, Nassim, Resmini, Léa, Lescure, Xavier, Ghosn, Jade, Bachelard, Antoine, Rachline, Anne, Isernia, Valentina, Bao-chau, Phung, Vallois, Dorothée, Sautereau, Aurelie, Neukrich, Catherine, Dossier, Antoine, Borie, Raphaël, Crestani, Bruno, Ducrocq, Gregory, Steg, Philippe Gabriel, Dieude, Philippe, Papo, Thomas, Marcault, Estelle, Chaudhry, Marhaba, Da Silveira, Charléne, Metois, Annabelle, Mahenni, Ismahan, Meziani, Meriam, Nilusmas, Cyndie, Le Gac, Sylvie, Ndiaye, Awa, Louni, Fran.oise, Chansombat, Malikhone, Julia, Zelie, Chalal, Solaya, Chalal, Lynda, Kramer, Laura, Le Grand, Jeniffer, Ouifiya, Kafif, Piquard, Valentine, Tubiana, Sarah, Nguyen, Yann, Honsel, Vasco, Weiss, Emmanuel, Codorniu, Anais, Zarrouk, Virginie, de Lastours, Victoire, Uzzan, Matthieu, Gamany, Naura, Claveirole, Agathe, Navid, Alexandre, Fouque, Tiffanie, Cohen, Yonathan, Lupo, Maya, Gilles, Constance, Rahli, Roza, Louis, Zeina, Boutboul, David, Galicier, Lionel, Amara, Yaël, Archer, Gabrielle, Benattia, Amira, Bergeron, Anne, Bondeelle, Louise, de Castro, Nathalie, Clément, Melissa, Darmon, Michaël, Denis, Blandine, Dupin, Clairelyne, Feredj, Elsa, Feyeux, Delphine, Joseph, Adrien, Lenglin, Etienne, Le Guen, Pierre, Liégeon, Geoffroy, Lorillon, Gwenaël, Mabrouki, Asma, Mariotte, Eric, Martin de Frémont, Grégoire, Mirouse, Adrien, Molina, Jean-Michel, Peffault de Latour, Régis, Oksenhendler, Eric, Saussereau, Julien, Tazi, Abdellatif, Tudesq, Jean-Jacques, Zafrani, Lara, Brindele, Isabelle, Bugnet, Emmanuelle, Lebras, Karine Celli, Chabert, Julien, Djaghout, Lamia, Fauvaux, Catherine, Jegu, Anne Lise, Kozakiewicz, Ewa, Meunier, Martine, Tremorin, Marie-Thérèse, Davoine, Claire, Madelaine, Isabelle, Caillat-Zucman, Sophie, Delaugerre, Constance, Morin, Florence, Sène, Damien, Burlacu, Ruxandra, Chousterman, Benjamin, Mégarbanne, Bruno, Richette, Pascal, Riveline, Jean-Pierre, Frazier, Aline, Vicaut, Eric, Berton, Laure, Hadjam, Tassadit, Vazquez-Ibarra, Miguel Alejandro, Jourdaine, Clément, Tran, Olivia, Jouis, Véronique, Jacob, Aude, Smati, Julie, Renaud, Stéphane, Pernin, Claire, Suarez, Lydia, Semerano, Luca, Abad, Sébastien, nainous, Ruben B., Bonnet, Nicolas, Comparon, Celine, Cohen, Yves, Cordel, Hugues, Dhote, Robin, Dournon, Nathalie, Duchemann, Boris, Ebstein, Nathan, Gille, Thomas, Giroux-Leprieur, Benedicte, Goupil de Bouille, Jeanne, Nunes, Hilario, Oziel, Johanna, Roulot, Dominique, Sese, Lucile, ClaireTantet, Uzunhan, Yurdagul, Bloch-Queyrat, Coralie, Levy, Vincent, Messani, Fadhila, Rahaoui, Mohammed, Petit, Myléne, Brahmi, Sabrina, Rathoin, Vanessa, Rigal, Marthe, Costedoat-Chalumeau, Nathalie, Luong, Liem Binh, Hamou, Zakaria Ait, Benghanem, Sarah, Blanche, Philippe, Carlier, Nicolas, Chaigne, Benjamin, Gauzit, Remy, Joumaa, Hassan, Jozwiak, Mathieu, Lachétre, Marie, Lafoeste, Hélène, Launay, Odie, Legendre, Paul, Marey, Jonathan, Morbieu, Caroline, Palmieri, Lola-Jade, Szwebel, Tali-Anne, Abdoul, Hendy, Bruneau, Alexandra, Beclin-Clabaux, Audrey, Larrieu, Charly, Montanari, Pierre, Dufour, Eric, Clarke, Ada, Le Bourlout, Catherine, Marin, Nathalie, Menage, Nathalie, Saleh-Mghir, Samira, Cisse, Mamadou Salif, Cheref, Kahina, Guerin, Corinne, Zerbit, Jérémie, Michel, Marc, Gallien, Sébastien, Crickx, Etienne, Le Vavasseur, Benjamin, Kempf, Emmanuelle, Jaffal, Karim, Vindrios, William, Oniszczuk, Julie, Guillaud, Constance, Lim, Pascal, Fois, Elena, Melica, Giovanna, Matignon, Marie, Jalabert, Maud, Lelièvre, Jean-Daniel, Schmitz, David, Bourhis, Marion, Belazouz, Sylia, Languille, Laetitia, Boucle, Caroline, Cita, Nelly, Didier, Agnés, Froura, Fahem, Ledudal, Katia, Sadaoui, Thiziri, Thiemele, Alaki, Le Febvre De Bailly, Delphine, Verlinde, Muriel Carvhalo, Mayaux, Julien, Cacoub, Patrice, Saadoun, David, Vautier, Mathieu, Bugaut, Héléne, Benveniste, Olivier, Allenbach, Yves, Leroux, Gaëlle, Rigolet, Aude, Guillaume-Jugnot, Perrine, Domont, Fanny, Desbois, Anne Claire, Comarmond, Chloé, Champtiaux, Nicolas, Toquet, Segolene, Ghembaza, Amine, Vieira, Matheus, Maalouf, Georgina, Boleto, Goncalo, Ferfar, Yasmina, Corvol, Jean-Christophe, Louapre, C.line, Sambin, Sara, Mariani, Louise-Laure, Karachi, Carine, Tubach, Florence, Estellat, Candice, Gimeno, Linda, Martin, Karine, Bah, Aicha, Keo, Vixra, Ouamri, Sabrine, Messaoudi, Yasmine, Yelles, Nessima, Faye, Pierre, Cavelot, Sebastien, Larcheveque, Cecile, Annonay, Laurence, Benhida, Jaouad, Zahrate-Ghoul, Aida, Hammal, Soumeya, Belilita, Ridha, Charbonnier, Fanny, Aguilar, Claire, Alby-Laurent, Fanny, Burger, Carole, Campos-Vega, Clara, Chavarot, Nathalie, Fournier, Benjamin, Rouzaud, Claire, Vimpére, Damien, Elie, Caroline, Bakouboula, Prissile, Choupeaux, Laure, Granville, Sophie, Issorat, Elodie, Broissand, Christine, Alyanakian, Marie-Alexandra, Geri, Guillaume, Derridj, Nawal, Sguiouar, Naima, Meddah, Hakim, Djadel, Mourad, Chambrin-Lauvray, Héléne, Duclos-vallée, Jean-Charles, Saliba, Faouzi, Sacleux, Sophie-Caroline, Kounis, Ilias, Tamazirt, Sonia, Rudant, Eric, Michot, Jean-Marie, Stoclin, Annabelle, Colomba, Emeline, Pommeret, Fanny, Willekens, Christophe, Da Silva, Rosa, Dejean, Valérie, Mekid, Yasmina, Ben-Mabrouk, Ines, Netzer, Florence, Pradon, Caroline, Drouard, Laurence, Camara-Clayette, Valérie, Morel, Alexandre, Garcia, Gilles, Mohebbi, Abolfazl, Berbour, Férial, Dehais, Mélanie, Pouliquen, Anne-Lise, Klasen, Alison, Soyez-Herkert, Loren, London, Jonathan, Keroumi, Younes, Guillot, Emmanuelle, Grailles, Guillaume, El amine, Younes, Defrancq, Fanny, Fodil, Hanane, Bouras, Chaouki, Dautel, Dominique, Gambier, Nicolas, Dieye, Thierno, Bienvenu, Boris, Lancon, Victor, Lecomte, Laurence, Beziriganyan, Kristina, Asselate, Belkacem, Allanic, Laure, Kiouris, Elena, Legros, Marie-Héléne, Lemagner, Christine, Martel, Pascal, Provitolo, Vincent, Ackermann, Félix, Le Marchand, Mathilde, Chan Hew Wai, Aurélie, Fremont, Dimitri, Coupez, Elisabeth, Adda, Mireille, Duée, Frédéric, Bernard, Lise, Gros, Antoine, Henry, Estelle, Courtin, Claire, Pattyn, Anne, Guinot, Pierre-Grégoire, Bardou, Marc, Maurer, Agnes, Jambon, Julie, Cransac, Amélie, Pernot, Corinne, Mourvillier, Bruno, Marquis, Eric, Benoit, Philippe, Roux, Damien, Gernez, Coralie, Yelnik, Cécile, Poissy, Julien, Nizard, Mandy, Denies, Fanette, Gros, Helene, Mourad, Jean-Jacques, Sacco, Emmanuelle, Renet, Sophie, Ader, F., Yazdanpanah, Y., Mentre, F., Peiffer-Smadja, N., Lescure, F.X., Poissy, J., Bouadma, L., Timsit, J.F., Lina, B., Morfin-Sherpa, F., Bouscambert, M., Gaymard, A., Peytavin, G., Abel, L., Guedj, J., Andrejak, C., Burdet, C., Laouenan, C., Belhadi, D., Dupont, A., Alfaiate, T., Basli, B., Chair, A., Laribi, S., Level, J., Schneider, M., Tellier, M.C., Dechanet, A., Costagliola, D., Terrier, B., Ohana, M., Couffin-Cadiergues, S., Esperou, H., Delmas, C., Saillard, J., Fougerou, C., Moinot, L., Wittkop, L., Cagnot, C., Le Mestre, S., Lebrasseur-Longuet, D., Petrov-Sanchez, V., Diallo, A., Mercier, N., Icard, V., Leveau, B., Tubiana, S., Hamze, B., Gelley, A., Noret, M., D’Ortenzio, E., Puechal, O., Semaille, C., Welte, T., Paiva, J.A., Halanova, M., Kieny, M.P., Balssa, E., Birkle, C., Gibowski, S., Landry, E., Le Goff, A., Moachon, L., Moins, C., Wadouachi, L., Paul, C., Levier, A., Bougon, D., Djossou, F., Epelboin, L., Dellamonica, J., Marquette, C.H., Robert, C., Gibot, S., Senneville, E., Jean-Michel, V., Zerbib, Y., Chirouze, C., Boyer, A., Cazanave, C., Gruson, D., Malvy, D., Andreu, P., Quenot, J.P., Terzi, N., Faure, K., Chabartier, C., Le Moing, V., Klouche, K., Ferry, T., F, Valour, Gaborit, B., Canet, E., Le Turnier, P., Boutoille, D., Bani-Sadr, F., Benezit, F., Revest, M., Cameli, C., Caro, A., Um Tegue, MJ Ngo, Le Tulzo, Y., Laviolle, B., Laine, F., Thiery, G., Meziani, F., Hansmann, Y., Oulehri, W., Tacquard, C., Vardon-Bounes, F., Riu-Poulenc, B., Murris-Espin, M., Bernard, L., Garot, D., Hinschberger, O., Martinot, M., Bruel, C., Pilmis, B., Bouchaud, O., Loubet, P., Roger, C., Monnet, X., Figueiredo, S., Godard, V., Mira, J.P., Lachatre, M., Kerneis, S., Aboab, J., Sayre, N., Crockett, F., Lebeaux, D., Buffet, A., Diehl, J.L., Fayol, A., Hulot, J.S., Livrozet, M., Dessap, A Mekontso, Ficko, C., Stefan, F., Le Pavec, J., Mayaux, J., Ait-Oufella, H., Molina, J.M., Pialoux, G., Fartoukh, M., Textoris, J., Brossard, M., Essat, A., Netzer, E., Riault, Y., Ghislain, M., Beniguel, L., Genin, M., Gouichiche, L., Betard, C., Belkhir, L., Altdorfer, A., Centro, V Fraipont, Braz, S., Ribeiro, JM Ferreira, Alburqueque, R Roncon, Berna, M., Alexandre, M., Lamprecht, B., Egle, A., Greil, R., Joannidis, M., Patterson, Thomas F., Ponce, Philip O., Taylor, Barbara S., Patterson, Jan E., Bowling, Jason E., Javeri, Heta, Kalil, Andre C., Larson, LuAnn, Hewlett, Angela, Mehta, Aneesh K., Rouphael, Nadine G., Saklawi, Youssef, Scanlon, Nicholas, Traenkner, Jessica J., Trible, Ronald P., Jr., Walter, Emmanuel B., Ivey, Noel, Holland, Thomas L., Ruiz-Palacios, Guillermo M., Ponce de León, Alfredo, Rajme, Sandra, Hsieh, Lanny, Amin, Alpesh N., Watanabe, Miki, Lee, Helen S., Kline, Susan, Billings, Joanne, Noren, Brooke, Kim, Hyun, Bold, Tyler D., Tapson, Victor, Grein, Jonathan, Sutterwala, Fayyaz, Iovine, Nicole, Beattie, Lars K., Wakeman, Rebecca Murray, Shaw, Matthew, Jain, Mamta K., Mocherla, Satish, Meisner, Jessica, Luque, Amneris, Sweeney, Daniel A., Benson, Constance A., Ali, Farhana, Atmar, Robert L., El Sahly, Hana M., Whitaker, Jennifer, Falsey, Ann R., Branche, Angela R., Rozario, Cheryl, Pineda, Justino Regalado, Martinez-Orozco, José Arturo, Lye, David Chien, Ong, Sean WX., Chia, Po Ying, Young, Barnaby E., Sandkovsky, Uriel, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Cantos, Valeria D., Kelley, Colleen F., Rebolledo Esteinou, Paulina A., Kandiah, Sheetal, Doernberg, Sarah B., Crouch, Pierre-Cedric B., Jang, Hannah, Luetkemeyer, Anne F., Dwyer, Jay, Cohen, Stuart H., Thompson, George R., 3rd, Nguyen, Hien H., Finberg, Robert W., Wang, Jennifer P., Perez-Velazquez, Juan, Wessolossky, Mireya, Jackson, Patrick E.H., Bell, Taison D., West, Miranda J., Taiwo, Babafemi, Krueger, Karen, Perez, Johnny, Pearson, Triniece, Paules, Catharine I., Julian, Kathleen G., Ahmad, Danish, Hajduczok, Alexander G., Arguinchona, Henry, Arguinchona, Christa, Erdmann, Nathaniel, Goepfert, Paul, Ahuja, Neera, Frank, Maria G., Wyles, David, Young, Heather, Oh, Myoung-don, Park, Wan Beom, Kang, Chang Kyung, Marconi, Vincent, Moanna, Abeer, Cribbs, Sushma, Harrison, Telisha, Kim, Eu Suk, Jung, Jongtak, Song, Kyoung-Ho, Kim, Hong Bin, Tan, Seow Yen, Shafi, Humaira, Chien, Jaime, Fong, Raymond KC., Murray, Daniel D., Lundgren, Jens, Nielsen, Henrik, Jensen, Tomas, Zingman, Barry S., Grossberg, Robert, Riska, Paul F., Yang, Otto O., Ahn, Jenny, Arias, Rubi, Rapaka, Rekha R., Hauser, Naomi, Campbell, James D., Short, William R., Tebas, Pablo, Baron, Jillian T., McLellan, Susan L.F., Blanton, Lucas S., Seashore, Justin B., Creech, C. Buddy, Rice, Todd W., Walker, Shannon, Thomsen, Isaac P., Lopez de Castilla, Diego, Van Winkle, Jason W., Riedo, Francis X., Pada, Surinder Kaur, Wang, Alvin DY., Lin, Li, Harkins, Michelle, Mertz, Gregory, Sosa, Nestor, Ann Chai, Louis Yi, Tambyah, Paul Anantharajah, Tham, Sai Meng, Archuleta, Sophia, Yan, Gabriel, Lindholm, David A., Markelz, Ana Elizabeth, Mende, Katrin, Mularski, Richard, Hohmann, Elizabeth, Torres-Soto, Mariam, Jilg, Nikolaus, Maves, Ryan C., Utz, Gregory C., George, Sarah L., Hoft, Daniel F., Brien, James D., Paredes, Roger, Mateu, Lourdes, Loste, Cora, Kumar, Princy, Thornton, Sarah, Mohanraj, Sharmila, Hynes, Noreen A., Sauer, Lauren M., Colombo, Christopher J., Schofield, Christina, Colombo, Rhonda E., Chambers, Susan E., Novak, Richard M., Wendrow, Andrea, Gupta, Samir K., Lee, Tida, Lalani, Tahaniyat, Holodniy, Mark, Chary, Aarthi, Huprikar, Nikhil, Ganesan, Anuradha, Ohmagari, Norio, Mikami, Ayako, Price, D. Ashley, Duncan, Christopher J.A., Dierberg, Kerry, Neumann, Henry J., Taylor, Stephanie N., Lacour, Alisha, Masri, Najy, Swiatlo, Edwin, Widmer, Kyle, Neaton, James D., Bessesen, Mary, Stephens, David S., Burgess, Timothy H., Uyeki, Timothy M., Walker, Robert, Marks, G. Lynn, Osinusi, Anu, Cao, Huyen, Cardoso, Anabela, de Bono, Stephanie, Schlichting, Douglas E., Chung, Kevin K., Ferreira, Jennifer L., Green, Michelle, Makowski, Mat, Wierzbicki, Michael R., Conrad, Tom M., El-Khorazaty, Jill Ann, Hill, Heather, Bonnett, Tyler, Gettinger, Nikki, Engel, Theresa, Lewis, Teri, Wang, Jing, Beigel, John H., Tomashek, Kay M., Ghazaryan, Varduhi, Beresnev, Tatiana, Nayak, Seema, Dodd, Lori E., Dempsey, Walla, Nomicos, Effie, Lee, Marina, Pikaart-Tautges, Rhonda, Elsafy, Mohamed, Jurao, Robert, Koo, Hyung, Proschan, Michael, Yokum, Tammy, Arega, Janice, Florese, Ruth, Voell, Jocelyn D., Davey, Richard, Serrano, Ruth C., Wiley, Zanthia, Phadke, Varun K., Goepfert, Paul A., Gomez, Carlos A., Sofarelli, Theresa A., Certain, Laura, Imlay, Hannah N., Wolfe, Cameron R., Ko, Emily R., Engemann, John J., Felix, Nora Bautista, Wan, Claire R., Elmor, Sammy T., Bristow, Laurel R., Harkins, Michelle S., Iovine, Nicole M., Elie-Turenne, Marie-Carmelle, Tapson, Victor F., Choe, Pyoeng Gyun, Mularski, Richard A., Rhie, Kevin S., Hussein, Rezhan H., Ince, Dilek, Winokur, Patricia L., Takasaki, Jin, Saito, Sho, McConnell, Kimberly, Wyles, David L., Sarcone, Ellen, Grimes, Kevin A., Perez, Katherine, Janak, Charles, Whitaker, Jennifer A., Rebolledo, Paulina A., Gharbin, John, Lambert, Allison A., Zea, Diego F., Bainbridge, Emma, Hostler, David C., Hostler, Jordanna M., Shahan, Brian T., Ling, Evelyn, Go, Minjoung, Hubbard, Fleesie A., Chakrabarty, Melony, Laguio-Vila, Maryrose, Walsh, Edward E., Guirgis, Faheem, Marconi, Vincent C., Madar, Christian, Borgetti, Scott A., Levine, Corri, Nock, Joy, Candiotti, Keith, Rozman, Julia, Dangond, Fernando, Hyvert, Yann, Seitzinger, Andrea, Cross, Kaitlyn, Pettibone, Stephanie, Nayak, Seema U., Deye, Gregory A., Siempos, Ilias I., Belhadi, Drifa, Veiga, Viviane Cordeiro, Cavalcanti, Alexandre Biasi, Branch-Elliman, Westyn, Papoutsi, Eleni, Gkirgkiris, Konstantinos, Xixi, Nikoleta A., and Kotanidou, Anastasia

Published
2024
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5. Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial

Author

Kalil, Andre C, Mehta, Aneesh K, Patterson, Thomas F, Erdmann, Nathaniel, Gomez, Carlos A, Jain, Mamta K, Wolfe, Cameron R, Ruiz-Palacios, Guillermo M, Kline, Susan, Pineda, Justino Regalado, Luetkemeyer, Anne F, Harkins, Michelle S, Jackson, Patrick EH, Iovine, Nicole M, Tapson, Victor F, Oh, Myoung-don, Whitaker, Jennifer A, Mularski, Richard A, Paules, Catharine I, Ince, Dilek, Takasaki, Jin, Sweeney, Daniel A, Sandkovsky, Uriel, Wyles, David L, Hohmann, Elizabeth, Grimes, Kevin A, Grossberg, Robert, Laguio-Vila, Maryrose, Lambert, Allison A, de Castilla, Diego Lopez, Kim, EuSuk, Larson, LuAnn, Wan, Claire R, Traenkner, Jessica J, Ponce, Philip O, Patterson, Jan E, Goepfert, Paul A, Sofarelli, Theresa A, Mocherla, Satish, Ko, Emily R, de Leon, Alfredo Ponce, Doernberg, Sarah B, Atmar, Robert L, Maves, Ryan C, Dangond, Fernando, Ferreira, Jennifer, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori, Tomashek, Kay M, Beigel, John H, members, ACTT-3 study group, Hewlett, Angela, Taylor, Barbara S, Bowling, Jason E, Serrano, Ruth C, Rouphael, Nadine G, Wiley, Zanthia, Phadke, Varun K, Certain, Laura, Imlay, Hannah N, Engemann, John J, Walter, Emmanuel B, Meisner, Jessica, Rajme, Sandra, Billings, Joanne, Kim, Hyun, Martinez-Orozco, Jose A, Felix, Nora Bautista, Elmor, Sammy T, Bristow, Laurel R, Mertz, Gregory, Sosa, Nestor, Bell, Taison D, West, Miranda J, Elie-Turenne, Marie-Carmelle, Grein, Jonathan, Sutterwala, Fayyaz, Choe, Pyoeng Gyun, Kang, Chang Kyung, Sahly, Hana M El, Rhie, Kevin S, Hussein, Rezhan H, Winokur, Patricia L, Mikami, Ayako, Saito, Sho, Benson, Constance A, McConnell, Kimberly, Berhe, Mezgebe, Dishner, Emma, Frank, Maria G, Sarcone, Ellen, Crouch, Pierre-Cedric B, Jang, Hannah, and Jilg, Nikolaus

Subjects
Rehabilitation, Clinical Trials and Supportive Activities, Lung, Clinical Research, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Adenosine Monophosphate, Adult, Aged, Alanine, Antiviral Agents, Double-Blind Method, Female, Humans, Interferon beta-1a, Japan, Male, Mexico, Middle Aged, Oxygen, Oxygen Saturation, Republic of Korea, SARS-CoV-2, Singapore, Treatment Outcome, United States, COVID-19 Drug Treatment, ACTT-3 study group members, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

BackgroundFunctional impairment of interferon, a natural antiviral component of the immune system, is associated with the pathogenesis and severity of COVID-19. We aimed to compare the efficacy of interferon beta-1a in combination with remdesivir compared with remdesivir alone in hospitalised patients with COVID-19.MethodsWe did a double-blind, randomised, placebo-controlled trial at 63 hospitals across five countries (Japan, Mexico, Singapore, South Korea, and the USA). Eligible patients were hospitalised adults (aged ≥18 years) with SARS-CoV-2 infection, as confirmed by a positive RT-PCR test, and who met one of the following criteria suggestive of lower respiratory tract infection: the presence of radiographic infiltrates on imaging, a peripheral oxygen saturation on room air of 94% or less, or requiring supplemental oxygen. Patients were excluded if they had either an alanine aminotransferase or an aspartate aminotransferase concentration more than five times the upper limit of normal; had impaired renal function; were allergic to the study product; were pregnant or breast feeding; were already on mechanical ventilation; or were anticipating discharge from the hospital or transfer to another hospital within 72 h of enrolment. Patients were randomly assigned (1:1) to receive intravenous remdesivir as a 200 mg loading dose on day 1 followed by a 100 mg maintenance dose administered daily for up to 9 days and up to four doses of either 44 μg interferon beta-1a (interferon beta-1a group plus remdesivir group) or placebo (placebo plus remdesivir group) administered subcutaneously every other day. Randomisation was stratified by study site and disease severity at enrolment. Patients, investigators, and site staff were masked to interferon beta-1a and placebo treatment; remdesivir treatment was given to all patients without masking. The primary outcome was time to recovery, defined as the first day that a patient attained a category 1, 2, or 3 score on the eight-category ordinal scale within 28 days, assessed in the modified intention-to-treat population, defined as all randomised patients who were classified according to actual clinical severity. Safety was assessed in the as-treated population, defined as all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04492475.FindingsBetween Aug 5, 2020, and Nov 11, 2020, 969 patients were enrolled and randomly assigned to the interferon beta-1a plus remdesivir group (n=487) or to the placebo plus remdesivir group (n=482). The mean duration of symptoms before enrolment was 8·7 days (SD 4·4) in the interferon beta-1a plus remdesivir group and 8·5 days (SD 4·3) days in the placebo plus remdesivir group. Patients in both groups had a time to recovery of 5 days (95% CI not estimable) (rate ratio of interferon beta-1a plus remdesivir group vs placebo plus remdesivir 0·99 [95% CI 0·87-1·13]; p=0·88). The Kaplan-Meier estimate of mortality at 28 days was 5% (95% CI 3-7%) in the interferon beta-1a plus remdesivir group and 3% (2-6%) in the placebo plus remdesivir group (hazard ratio 1·33 [95% CI 0·69-2·55]; p=0·39). Patients who did not require high-flow oxygen at baseline were more likely to have at least one related adverse event in the interferon beta-1a plus remdesivir group (33 [7%] of 442 patients) than in the placebo plus remdesivir group (15 [3%] of 435). In patients who required high-flow oxygen at baseline, 24 (69%) of 35 had an adverse event and 21 (60%) had a serious adverse event in the interferon beta-1a plus remdesivir group compared with 13 (39%) of 33 who had an adverse event and eight (24%) who had a serious adverse event in the placebo plus remdesivir group.InterpretationInterferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalised patients with COVID-19 pneumonia. Patients who required high-flow oxygen at baseline had worse outcomes after treatment with interferon beta-1a compared with those given placebo.FundingThe National Institute of Allergy and Infectious Diseases (USA).

Published
2021

6. Characteristics of High-Titer Convalescent Plasma and Antibody Dynamics After Administration in Patients With Severe Coronavirus Disease 2019

Author

Bainbridge, Emma D, Hsue, Priscilla Y, Esensten, Jonathan H, Lynch, Kara L, Hendrickson, Carolyn M, Doernberg, Sarah B, Fung, Monica, Chin-Hong, Peter, Di Germanio, Clara, Norris, Philip J, Simmons, Graham, Glidden, David V, and Luetkemeyer, Anne F

Subjects
Good Health and Well Being, antibody avidity, convalescent plasma, COVID-19, neutralizing antibody, SARS-CoV-2
Abstract

We characterized the antibody composition of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) and the immunologic responses of hospitalized COVID-19 patients after receiving CCP or nonimmune fresh frozen plasma. Despite selection of CCP with significantly higher total immunoglobulin G than recipients, neutralizing antibody levels did not differ between donor plasma and CCP recipients.

Published
2021

7. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

Author

Kalil, Andre C, Patterson, Thomas F, Mehta, Aneesh K, Tomashek, Kay M, Wolfe, Cameron R, Ghazaryan, Varduhi, Marconi, Vincent C, Ruiz-Palacios, Guillermo M, Hsieh, Lanny, Kline, Susan, Tapson, Victor, Iovine, Nicole M, Jain, Mamta K, Sweeney, Daniel A, El Sahly, Hana M, Branche, Angela R, Regalado Pineda, Justino, Lye, David C, Sandkovsky, Uriel, Luetkemeyer, Anne F, Cohen, Stuart H, Finberg, Robert W, Jackson, Patrick EH, Taiwo, Babafemi, Paules, Catharine I, Arguinchona, Henry, Erdmann, Nathaniel, Ahuja, Neera, Frank, Maria, Oh, Myoung-Don, Kim, Eu-Suk, Tan, Seow Y, Mularski, Richard A, Nielsen, Henrik, Ponce, Philip O, Taylor, Barbara S, Larson, LuAnn, Rouphael, Nadine G, Saklawi, Youssef, Cantos, Valeria D, Ko, Emily R, Engemann, John J, Amin, Alpesh N, Watanabe, Miki, Billings, Joanne, Elie, Marie-Carmelle, Davey, Richard T, Burgess, Timothy H, Ferreira, Jennifer, Green, Michelle, Makowski, Mat, Cardoso, Anabela, de Bono, Stephanie, Bonnett, Tyler, Proschan, Michael, Deye, Gregory A, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, and Beigel, John H

Subjects
Rehabilitation, Clinical Trials and Supportive Activities, Lung, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adenosine Monophosphate, Adult, Aged, Alanine, Antiviral Agents, Azetidines, COVID-19, Double-Blind Method, Drug Therapy, Combination, Female, Hospital Mortality, Hospitalization, Humans, Janus Kinase Inhibitors, Male, Middle Aged, Oxygen Inhalation Therapy, Purines, Pyrazoles, Respiration, Artificial, Sulfonamides, Treatment Outcome, COVID-19 Drug Treatment, ACTT-2 Study Group Members, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundSevere coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known.MethodsWe conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15.ResultsA total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003).ConclusionsBaricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).

Published
2021

8. Hepatic steatosis and nonalcoholic fatty liver disease are common and associated with cardiometabolic risk in a primary prevention cohort of people with HIV

Author

Lake, Jordan E., Taron, Jana, Ribaudo, Heather J., Leon-Cruz, Jorge, Utay, Netanya S., Swaminathan, Shobha, Fitch, Kathleen V., Kileel, Emma M., Paradis, Kayla, Fulda, Evelynne S., Ho, Ken S., Luetkemeyer, Anne F., Johnston, Carrie D., Zanni, Markella V., Douglas, Pamela S., Grinspoon, Steven K., Lu, Michael T., and Fichtenbaum, Carl J.

Published
2023
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9. Optimizing Hydroxychloroquine Dosing for Patients With COVID‐19: An Integrative Modeling Approach for Effective Drug Repurposing

Author

Garcia‐Cremades, Maria, Solans, Belen P, Hughes, Emma, Ernest, Jacqueline P, Wallender, Erika, Aweeka, Francesca, Luetkemeyer, Anne F, and Savic, Radojka M

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Emerging Infectious Diseases, Infectious Diseases, Coronaviruses, Coronaviruses Therapeutics and Interventions, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Antiviral Agents, Betacoronavirus, Coronavirus Infections, Drug Repositioning, Humans, Hydroxychloroquine, Models, Biological, Reproducibility of Results, Severe acute respiratory syndrome-related coronavirus, SARS-CoV-2, Translational Research, Biomedical, Viral Load, Virus Replication, COVID-19 Drug Treatment, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

Hydroxychloroquine (HCQ) is a promising candidate for Coronavirus disease of 2019 (COVID-19) treatment. The optimal dosing of HCQ is unknown. Our goal was to integrate historic and emerging pharmacological and toxicity data to understand safe and efficacious HCQ dosing strategies for COVID-19 treatment. The data sources included were (i) longitudinal clinical, pharmacokinetic (PK), and virologic data from patients with severe acute respiratory syndrome-2 (SARS-CoV-2) infection who received HCQ with or without azithromycin (n = 116), (ii) in vitro viral replication data and SARS-CoV-2 viral load inhibition by HCQ, (iii) a population PK model of HCQ, and (iv) a model relating chloroquine PKs to corrected QT (QTc) prolongation. A mechanistic PK/virologic/QTc model for HCQ was developed and externally validated to predict SARS-CoV-2 rate of viral decline and QTc prolongation. SARS-CoV-2 viral decline was associated with HCQ PKs (P  400 mg b.i.d. for ≥5 days were predicted to rapidly decrease viral loads, reduce the proportion of patients with detectable SARS-CoV-2 infection, and shorten treatment courses, compared with lower dose (≤ 400 mg daily) regimens. However, HCQ doses > 600 mg b.i.d. were also predicted to prolong QTc intervals. This prolongation may have clinical implications warranting further safety assessment. Due to COVID-19's variable natural history, lower dose HCQ regimens may be indistinguishable from controls. Evaluation of higher HCQ doses is needed to ensure adequate safety and efficacy.

Published
2020

10. HCV treatment barriers among HIV/HCV co-infected patients in the US: a qualitative study to understand low uptake among marginalized populations in the DAA era

Author

Nápoles, Tessa M, Batchelder, Abigail W, Lin, Ada, Moran, Lissa, Johnson, Mallory O, Shumway, Martha, Luetkemeyer, Anne F, Peters, Marion G, Eagen, Kellene V, and Riley, Elise D

Subjects
Health Services and Systems, Health Sciences, Chronic Liver Disease and Cirrhosis, Liver Disease, Behavioral and Social Science, Hepatitis - C, Digestive Diseases, Hepatitis, Substance Misuse, HIV/AIDS, Infectious Diseases, Basic Behavioral and Social Science, Drug Abuse (NIDA only), Emerging Infectious Diseases, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Management of diseases and conditions, 7.1 Individual care needs, Infection, Good Health and Well Being, No Poverty, Antiviral Agents, Coinfection, Female, HIV Infections, Health Services Accessibility, Hepatitis C, Humans, Interviews as Topic, Male, Middle Aged, Qualitative Research, Safety-net Providers, United States, comorbidity, direct-acting antiviral treatment, HIV/HCV coinfected, poverty, safety net, substance use, Public Health and Health Services, Public Health, Epidemiology, Health services and systems, Public health
Abstract

BackgroundWell-tolerated, highly effective HCV treatment, known as direct-acting antivirals (DAAs), is now recommended for all people living with HCV, providing the tools for HCV elimination. We sought to understand treatment barriers among low-income HIV/HCV coinfected patients and providers with the goal of increasing uptake.MethodsIn 2014, we conducted 26 interviews with HIV/HCV co-infected patients and providers from a San Francisco clinic serving underinsured and publically-insured persons to explore barriers impacting treatment engagement and completion. Interview transcripts were coded, and a thematic analysis was conducted to identify emerging patterns.ResultsConditions of poverty-specifically, meeting basic needs for food, shelter, and safety-undermined patient perceptions of self-efficacy to successfully complete HCV treatment programs. While patient participants expressed interest in HCV treatment, the perceived burden of taking daily medications without strong social support was an added challenge. This need for support contradicted provider assumptions that, due to the shorter-course regimens, support is unnecessary in the DAA era.ConclusionsInterferon-free treatments alone are not sufficient to overcome social-structural barriers to HCV treatment and care among low-income HIV/HCV co-infected patients. Support for patients with unmet social needs may facilitate treatment initiation and completion, particularly among those in challenging socioeconomic situations.

Published
2019

11. Direct-acting antiviral treatment for HIV/HCV patients in safety net settings: patient and provider preferences

Author

Shumway, Martha, Luetkemeyer, Anne F, Peters, Marion G, Johnson, Mallory O, Napoles, Tessa M, and Riley, Elise D

Subjects
Clinical and Health Psychology, Health Sciences, Public Health, Human Society, Psychology, Sociology, Emerging Infectious Diseases, Liver Disease, Clinical Research, Hepatitis, Behavioral and Social Science, HIV/AIDS, Health Services, Infectious Diseases, Chronic Liver Disease and Cirrhosis, Digestive Diseases, Hepatitis - C, Infection, Good Health and Well Being, Adult, Antiviral Agents, Female, HIV Infections, Hepatitis C, Chronic, Humans, Male, Middle Aged, Patient Preference, Physician-Patient Relations, San Francisco, Treatment Outcome, HIV, hepatitis C, coinfection, direct-acting antivirals, preferences, vulnerable populations, Public Health and Health Services, Public health, Clinical and health psychology
Abstract

HIV/HCV coinfected patients are a priority for direct acting antiretroviral (DAA) treatment, yet barriers to treating vulnerable patients persist. This study surveyed safety net clinic patients and providers to quantify their preferences for DAA treatment and prioritize modifiable barriers. Preferences were assessed using best-worst scaling. General linear mixed models were used to determine whether attributes differed in importance and whether patients and providers valued attributes differently. 158 HIV/HCV coinfected patients and 49 providers participated. Patients and providers had strong preferences for treatment within the medical homes where patients receive HIV care. Support such as reminders and advice numbers were also important, but were more important to providers than patients. Providers identified lack of insurance coverage for DAA as the most significant barrier. Providers rated HIV primary care providers as best suited to deliver DAA to HIV+ patients. Addressing structural barriers is essential for increasing DAA treatment in safety net settings.

Published
2019

12. Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial

Author

Litwin, Alain H, Lum, Paula J, Taylor, Lynn E, Mehta, Shruti H, Tsui, Judith I, Feinberg, Judith, Kim, Arthur Y, Norton, Brianna L, Heo, Moonseong, Arnsten, Julia, Meissner, Paul, Karasz, Alison, Mckee, M Diane, Ward, John W, Johnson, Nirah, Pericot-Valverde, Irene, Agyemang, Linda, Stein, Ellen S, Thomas, Aurielle, Borsuk, Courtney, Blalock, Kendra L, Wilkinson, Samuel, Wagner, Katherine, Roche, Jillian, Murray-Krezan, Cristina, Anderson, Jessica, Jacobsohn, Vanessa, Luetkemeyer, Anne F, Falade-Nwulia, Oluwaseun, and Page, Kimberly

Published
2022
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13. Association of Rapid Molecular Testing With Duration of Respiratory Isolation for Patients With Possible Tuberculosis in a US Hospital

Author

Chaisson, Lelia H, Duong, David, Cattamanchi, Adithya, Roemer, Marguerite, Handley, Margaret A, Schillinger, Dean, Sur, Matthew, Pham, Phong, Lin, Mary Ann, Goldman, L Elizabeth, Quan, Judy, Perez, Saida, Healy, Michael, Higashi, Julie, Winston, Lisa, Haller, Barbara, Luetkemeyer, Anne F, and Davis, J Lucian

Subjects
Rare Diseases, Infectious Diseases, Clinical Research, Lung, Tuberculosis, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Infection, Good Health and Well Being, Adult, Aged, Algorithms, Female, Humans, Infection Control, Male, Middle Aged, Mycobacterium tuberculosis, Patient Isolation, Prospective Studies, Sensitivity and Specificity, United States, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services
Abstract

ImportanceNew guidelines recommend that molecular testing replace sputum-smear microscopy to guide discontinuation of respiratory isolation in patients undergoing evaluation for active tuberculosis (TB) in health care settings.ObjectiveTo evaluate the implementation and impact of a molecular testing strategy to guide discontinuation of isolation.Design, setting, and participantsProspective cohort study with a pragmatic, before-and-after-implementation design of 621 consecutive patients hospitalized at Zuckerberg San Francisco General Hospital and Trauma Center who were undergoing sputum examination for evaluation for active pulmonary TB from January 2014 to January 2016.InterventionsImplementation of a sputum molecular testing algorithm using GeneXpert MTB/RIF (Xpert; Cepheid) to guide discontinuation of isolation.Main outcomes and measuresWe measured the proportion of patients with molecular testing ordered and completed; the accuracy of the molecular testing algorithm in reference to mycobacterial culture; the duration of each component of the testing and isolation processes; length of stay; mean days in isolation and in hospital; and mean cost. We extracted data from hospital records and compared measures before and after implementation.ResultsClinicians ordered sputum testing for TB for 621 patients at ZSFG during the 2-year study period. Of 301 patients in the preimplementation period with at least 1 sputum microscopy and culture ordered, clinicians completed the rapid TB testing evaluation process for 233 (77%).Among 320 patients evaluated in the postimplementation period, clinicians ordered molecular testing for 234 (73%) patients and received results for 295 of 302 (98%) tests ordered. Median age was 54 years (interquartile range, 44-63 years), and 161 (26%) were women. The molecular testing algorithm accurately diagnosed all 7 patients with culture-confirmed TB and excluded TB in all 251 patients with Mycobacterium tuberculosis (MTB) culture-negative results. Compared with the preimplementation period, there were significant decreases in median times to final rapid test result (39.1 vs 22.4 hours, P

Published
2018

14. Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial

Author

Wahid, Lana, Walter, Emmanuel B., Belur, Akhila G., Dreyer, Grace, Patterson, Jan E., Bowling, Jason E., Dixon, Danielle O., Hewlett, Angela, Odrobina, Robert, Pupaibool, Jakrapun, Mocherla, Satish, Lazarte, Suzana, Cayabyab, Meilani, Hussein, Rezhan H., Golamari, Reshma R., Krill, Kaleigh L., Rajme, Sandra, Riska, Paul F., Zingman, Barry S., Mertz, Gregory, Sosa, Nestor, Goepfert, Paul A., Berhe, Mezgebe, Dishner, Emma, Fayed, Mohamed, Hubel, Kinsley, Martinez-Orozco, José Arturo, Bautista Felix, Nora, Elmor, Sammy T., Bechnak, Amer Ryan, Saklawi, Youssef, Van Winkle, Jason W., Zea, Diego F., Laguio-Vila, Maryrose, Walsh, Edward E., Falsey, Ann R., Carvajal, Karen, Hyzy, Robert C., Hanna, Sinan, Olbrich, Norman, Traenkner, Jessica J., Kraft, Colleen S., Tebas, Pablo, Baron, Jillian T, Levine, Corri, Nock, Joy, Billings, Joanne, Kim, Hyun, Elie-Turenne, Marie-Carmelle, Whitaker, Jennifer A., Luetkemeyer, Anne F., Dwyer, Jay, Bainbridge, Emma, Gyun Choe, Pyoeng, Kyung Kang, Chang, Jilg, Nikolaus, Cantos, Valeria D, Bhamidipati, Divya R., Nithin Gopalsamy, Srinivasa, Chary, Aarthi, Jung, Jongtak, Song, Kyoung-Ho, Kim, Hong Bin, Benson, Constance A., McConnell, Kimberly, Wang, Jennifer P., Wessolossky, Mireya, Perez, Katherine, Eubank, Taryn A, Berjohn, Catherine, Utz, Gregory C., Jackson, Patrick E.H., Bell, Taison D., Haughey, Heather M., Moanna, Abeer, Cribbs, Sushma, Harrison, Telisha, Colombo, Christopher J., Schofield, Christina, Colombo, Rhonda E., Tapson, Victor F., Grein, Jonathan, Sutterwala, Fayyaz, Ince, Dilek, Winokur, Patricia L., Fung, Monica, Jang, Hannah, Wyles, David, Frank, Maria G., Sarcone, Ellen, Neumann, Henry, Viswanathan, Anand, Hochman, Sarah, Mulligan, Mark, Eckhardt, Benjamin, Carmody, Ellie, Ahuja, Neera, Nadeau, Kari, Svec, David, Macaraeg, Jeffrey C., Morrow, Lee, Quimby, Dave, Bessesen, Mary, Nicholson, Lindsay, Adams, Jill, Kumar, Princy, Lambert, Allison A., Arguinchona, Henry, Alicic, Radica Z., Saito, Sho, Ohmagari, Norio, Mikami, Ayako, Chien Lye, David, Hong Lee, Tau, Ying Chia, Po, Hsieh, Lanny, Amin, Alpesh N., Watanabe, Miki, Candiotti, Keith A., Castro, Jose G., Antor, Maria A., Lee, Tida, Lalani, Tahaniyat, Novak, Richard M., Wendrow, Andrea, Borgetti, Scott A., George, Sarah L., Hoft, Daniel F., Brien, James D., Cohen, Stuart H., Thompson, George R., 3rd, Chakrabarty, Melony, Guirgis, Faheem, Davey, Richard T., Voell, Jocelyn, Strich, Jeffrey R., Lindholm, David A., Mende, Katrin, Wellington, Trevor R., Rapaka, Rekha R., Husson, Jennifer S., Levine, Andrea R., Yen Tan, Seow, Shafi, Humaira, Chien, Jaime M F, Hostler, David C., Hostler, Jordanna M., Shahan, Brian T., Adams, David H., Osinusi, Anu, Cao, Huyen, Burgess, Timothy H., Rozman, Julia, Chung, Kevin K., Nieuwoudt, Christina, El-Khorazaty, Jill A., Hill, Heather, Pettibone, Stephanie, Gettinger, Nikki, Engel, Theresa, Lewis, Teri, Wang, Jing, Deye, Gregory A., Nomicos, Effie, Pikaart-Tautges, Rhonda, Elsafy, Mohamed, Jurao, Robert, Koo, Hyung, Proschan, Michael, Yokum, Tammy, Arega, Janice, Florese, Ruth, Wolfe, Cameron R, Tomashek, Kay M, Patterson, Thomas F, Gomez, Carlos A, Marconi, Vincent C, Jain, Mamta K, Yang, Otto O, Paules, Catharine I, Palacios, Guillermo M Ruiz, Grossberg, Robert, Harkins, Michelle S, Mularski, Richard A, Erdmann, Nathaniel, Sandkovsky, Uriel, Almasri, Eyad, Pineda, Justino Regalado, Dretler, Alexandra W, de Castilla, Diego Lopez, Branche, Angela R, Park, Pauline K, Mehta, Aneesh K, Short, William R, McLellan, Susan L F, Kline, Susan, Iovine, Nicole M, El Sahly, Hana M, Doernberg, Sarah B, Oh, Myoung-don, Huprikar, Nikhil, Hohmann, Elizabeth, Kelley, Colleen F, Holodniy, Mark, Kim, Eu Suk, Sweeney, Daniel A, Finberg, Robert W, Grimes, Kevin A, Maves, Ryan C, Ko, Emily R, Engemann, John J, Taylor, Barbara S, Ponce, Philip O, Larson, LuAnn, Melendez, Dante Paolo, Seibert, Allan M, Rouphael, Nadine G, Strebe, Joslyn, Clark, Jesse L, Julian, Kathleen G, de Leon, Alfredo Ponce, Cardoso, Anabela, de Bono, Stephanie, Atmar, Robert L, Ganesan, Anuradha, Ferreira, Jennifer L, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, Beigel, John H, and Kalil, Andre C

Published
2022
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15. Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir-experienced, NS5A treatment-naïve patients: Findings from two randomized trials.

Author

Tam, Edward, Luetkemeyer, Anne F, Mantry, Parvez S, Satapathy, Sanjaya K, Ghali, Peter, Kang, Minhee, Haubrich, Richard, Shen, Xianlin, Ni, Liyun, Camus, Gregory, Copans, Amanda, Rossaro, Lorenzo, Guyer, Bill, Brown, Robert S, and RESCUE and ACTG A5348 study investigators

Subjects
RESCUE and ACTG A5348 study investigators, Humans, Hepacivirus, Hepatitis C, Chronic, HIV Infections, Liver Cirrhosis, Headache, Fatigue, Benzimidazoles, Fluorenes, Ribavirin, Uridine Monophosphate, Antiviral Agents, Pregnancy, Adult, Aged, Middle Aged, Female, Male, Coinfection, Sofosbuvir, Sustained Virologic Response, HCV, HIV, ledipasvir, sofosbuvir, treatment-experienced, Gastroenterology & Hepatology, Clinical Sciences
Abstract

Background & aimsWe report data from two similarly designed studies that evaluated the efficacy, safety, and optimal duration of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) for retreatment of chronic hepatitis C virus (HCV) in individuals who failed to achieve sustained virological response (SVR) with prior SOF-based, non-NS5A inhibitor-containing regimens.MethodsThe RESCUE study enrolled HCV mono-infected adults with genotype (GT) 1 or 4. Non-cirrhotic participants were randomized to 12 weeks of LDV/SOF or LDV/SOF + RBV. Compensated cirrhotic participants were randomized to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). The AIDS Clinical Trials Group A5348 study randomized genotype 1 adults with HCV/HIV co-infection to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). Both studies used SVR at 12 weeks post-treatment (SVR12) as the primary endpoint.ResultsIn the RESCUE study, 82 participants were randomized and treated, and all completed treatment. Overall, SVR12 was 88% (72/82); 81-100% in non-cirrhotic participants treated with LDV/SOF or LDV/SOF + RBV for 12 weeks and 80-92% in cirrhotic participants treated with LDV/SOF + RBV for 12 weeks or LDV/SOF for 24 weeks. Adverse events (AEs), mostly mild-to-moderate in severity, were experienced by 78% of participants, with headache and fatigue most frequently reported. One serious AE, not related to treatment, was observed. No premature discontinuations of study drug, or deaths occurred. In the A5348 study, seven participants were randomized (cirrhotic n = 1; GT1a n = 5) and all attained SVR12, with no serious AEs or premature discontinuations.ConclusionsIn this SOF-experienced, NS5A inhibitor-naïve population, which included participants with cirrhosis or HCV/HIV co-infection, high SVR12 rates were achieved.

Published
2018

16. Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Hewlett, Angela, Taylor, Barbara S, Bowling, Jason E, Serrano, Ruth C, Rouphael, Nadine G, Wiley, Zanthia, Phadke, Varun K, Certain, Laura, Imlay, Hannah N, Engemann, John J, Walter, Emmanuel B, Meisner, Jessica, Rajme, Sandra, Billings, Joanne, Kim, Hyun, Martinez-Orozco, Jose A, Bautista Felix, Nora, Elmor, Sammy T, Bristow, Laurel R, Mertz, Gregory, Sosa, Nestor, Bell, Taison D, West, Miranda J, Elie-Turenne, Marie-Carmelle, Grein, Jonathan, Sutterwala, Fayyaz, Gyun Choe, Pyoeng, Kyung Kang, Chang, El Sahly, Hana M, Rhie, Kevin S, Hussein, Rezhan H, Winokur, Patricia L, Mikami, Ayako, Saito, Sho, Benson, Constance A, McConnell, Kimberly, Berhe, Mezgebe, Dishner, Emma, Frank, Maria G, Sarcone, Ellen, Crouch, Pierre-Cedric B, Jang, Hannah, Jilg, Nikolaus, Perez, Katherine, Janak, Charles, Cantos, Valeria D, Rebolledo, Paulina A, Gharbin, John, Zingman, Barry S, Riska, Paul F, Falsey, Ann R, Walsh, Edward E, Branche, Angela R, Arguinchona, Henry, Arguinchona, Christa, Van Winkle, Jason W, Zea, Diego F, Jung, Jongtak, Song, Kyoung-Ho, Kim, Hong Bin, Dwyer, Jay, Bainbridge, Emma, Hostler, David C, Hostler, Jordanna M, Shahan, Brian T, Hsieh, Lanny, Amin, Alpesh N, Watanabe, Miki, Short, William R, Tebas, Pablo, Baron, Jillian T, Ahuja, Neera, Ling, Evelyn, Go, Minjoung, Yang, Otto O, Ahn, Jenny, Arias, Rubi, Rapaka, Rekha R, Hubbard, Fleesie A, Campbell, James D, Cohen, Stuart H, Thompson, George R, 3rd, Chakrabarty, Melony, Taylor, Stephanie N, Masri, Najy, Lacour, Alisha, Lee, Tida, Lalani, Tahaniyat, Lindholm, David A, Markelz, Ana Elizabeth, Mende, Katrin, Colombo, Christopher J, Schofield, Christina, Colombo, Rhonda E, Guirgis, Faheem, Holodniy, Mark, Chary, Aarthi, Bessesen, Mary, Hynes, Noreen A, Sauer, Lauren M, Marconi, Vincent C, Moanna, Abeer, Harrison, Telisha, Lye, David C, Ong, Sean W X, Ying Chia, Po, Huprikar, Nikhil, Ganesan, Anuradha, Madar, Christian, Novak, Richard M, Wendrow, Andrea, Borgetti, Scott A, George, Sarah L, Hoft, Daniel F, Brien, James D, McLellan, Susan L F, Levine, Corri, Nock, Joy, Yen Tan, Seow, Shafi, Humaira, Chien, Jaime M F, Candiotti, Keith, Finberg, Robert W, Wang, Jennifer P, Wessolossky, Mireya, Utz, Gregory C, Chambers, Susan E, Stephens, David S, Burgess, Timothy H, Rozman, Julia, Hyvert, Yann, Seitzinger, Andrea, Osinusi, Anu, Cao, Huyen, Chung, Kevin K, Conrad, Tom M, Cross, Kaitlyn, El-Khorazaty, Jill A, Hill, Heather, Pettibone, Stephanie, Wierzbicki, Michael R, Gettinger, Nikki, Engel, Theresa, Lewis, Teri, Wang, Jing, Deye, Gregory A, Nomicos, Effie, Pikaart-Tautges, Rhonda, Elsafy, Mohamed, Jurao, Robert, Koo, Hyung, Proschan, Michael, Davey, Richard, Yokum, Tammy, Arega, Janice, Florese, Ruth, Kalil, Andre C, Mehta, Aneesh K, Patterson, Thomas F, Erdmann, Nathaniel, Gomez, Carlos A, Jain, Mamta K, Wolfe, Cameron R, Ruiz-Palacios, Guillermo M, Kline, Susan, Regalado Pineda, Justino, Luetkemeyer, Anne F, Harkins, Michelle S, Jackson, Patrick E H, Iovine, Nicole M, Tapson, Victor F, Oh, Myoung-don, Whitaker, Jennifer A, Mularski, Richard A, Paules, Catharine I, Ince, Dilek, Takasaki, Jin, Sweeney, Daniel A, Sandkovsky, Uriel, Wyles, David L, Hohmann, Elizabeth, Grimes, Kevin A, Grossberg, Robert, Laguio-Vila, Maryrose, Lambert, Allison A, Lopez de Castilla, Diego, Kim, EuSuk, Larson, LuAnn, Wan, Claire R, Traenkner, Jessica J, Ponce, Philip O, Patterson, Jan E, Goepfert, Paul A, Sofarelli, Theresa A, Mocherla, Satish, Ko, Emily R, Ponce de Leon, Alfredo, Doernberg, Sarah B, Atmar, Robert L, Maves, Ryan C, Dangond, Fernando, Ferreira, Jennifer, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori, Tomashek, Kay M, and Beigel, John H

Published
2021
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18. Optimal hepatitis C treatment adherence patterns and sustained virologic response among people who inject drugs: The HERO study

Author

Heo, Moonseong, primary, Norton, Brianna L., additional, Pericot-Valverde, Irene, additional, Mehta, Shruti H., additional, Tsui, Judith I., additional, Taylor, Lynn E., additional, Lum, Paula J., additional, Feinberg, Judith, additional, Kim, Arthur Y., additional, Arnsten, Julia H., additional, Sprecht-Walsh, Sophie, additional, Page, Kimberly, additional, Murray-Krezan, Cristina, additional, Anderson, Jessica, additional, Litwin, Alain H., additional, Heo, Moonseong, additional, Walker, Hagan, additional, Coleman, Ashley, additional, Borsuk, Courtney, additional, Dickerson, Brian, additional, Falade-Nwulia, Oluwaseun, additional, Fingerhood, Michael, additional, Haselhuhn, Taryn, additional, Mason, Angela, additional, Moon, Juhi, additional, Olsen, Yngvild, additional, Walters, Vickie, additional, Roche, Jillian M., additional, Schmitt, William, additional, Lijewski, Virginia, additional, Pitts, Anita, additional, Raji, Syeda, additional, Silva, Taniya, additional, Evans, Fiona, additional, Koene, Hope, additional, Brown, Joelle, additional, Norton, Brianna, additional, Agyemang, Linda, additional, Arnsten, Julia, additional, Karasz, Alison, additional, Meissner, Paul, additional, Lora, Kiara, additional, Hidalgo, Jennifer, additional, Soloway, Irene, additional, Jefferson, Karen, additional, Wong, Joyce, additional, Kermack, Andrea, additional, Stein, Melissa, additional, Joseph, Gilian, additional, London, Karyn, additional, Allen, Lincoln, additional, Marte, Venecia, additional, Vera, Tatiana, additional, Alvarez, Romy, additional, Mckee, M. Diane, additional, Stein, Ellen S., additional, Luetkemeyer, Anne F., additional, Cullen, Caycee, additional, Gill, Gurjot, additional, Tierney, Hannah, additional, Shapiro, Scott, additional, Azari, Soraya, additional, Eveland, Joanna, additional, Berrner, Daniel, additional, Grey, Pauli, additional, Akerley, Jordan, additional, Wagner, Katherine, additional, Davis, Herbert, additional, Jacobsohn, Vanessa, additional, Tashima, Karen, additional, Thomas, Aurielle, additional, Hordes, Melissa, additional, McGregor, Danielle, additional, Duryea, Patrick, additional, Weenig, Kathryn, additional, Blalock, Kendra L., additional, Kim, Hyang Nina, additional, Ramchandani, Meena S., additional, James, Jocelyn R., additional, Peavy, K. Michelle, additional, Grekin, Paul, additional, Ninburg, Michael, additional, Wilkinson, Samuel, additional, Thomas, Danielle, additional, Kelley, Lacey, additional, Calkins, Andrea, additional, Henry, Gabrielle, additional, Ashler, Alice, additional, Teshale, Eyasu, additional, Seiguer, Sebastian, additional, Brown, Lauren, additional, Rios, Katrina, additional, Spellman, James, additional, Raymond, Daniel, additional, Beane, Susan, additional, Marks, Ronni, additional, Swan, Tracy, additional, Walworth, Chuck, additional, Lie, Yolanda, additional, Reeves, Jackie, additional, Ginter, Walter P., additional, Devin, Jules, additional, Clary, Ryan, additional, Broder, Tina, additional, Davila, Bekeela, additional, Johnson, Nirah, additional, Khatun, Umaima, additional, Flanigan, Colleen, additional, Ahmed, Ray, additional, Polluck, Bob, additional, Mastrianni, Serene, additional, Morton, James, additional, Baldwin, Emily, additional, Pesano, Rick, additional, Fotinos, Charissa, additional, Fish, Douglas, additional, Becker, James, additional, Ward, John W., additional, Parrino, Mark, additional, and Maxwell, Carleen, additional

Published
2024
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19. Retrospective-prospective study of safety and efficacy of sofosbuvir-based direct-acting antivirals in HIV/HCV-coinfected participants with decompensated liver disease pre– or post–liver transplant

Author

Peters, Marion G., Kottilil, Shyam, Terrault, Norah, Amara, Dominic, Husson, Jennifer, Huprikar, Shirish, Florman, Sander, Sulkowski, Mark S., Durand, Christine M., Luetkemeyer, Anne F., Rogers, Rodney, Grab, Joshua, Haydel, Brandy, Blumberg, Emily, Dove, Lorna, Emond, Jean, Olthoff, Kim, Smith, Coleman, Fishbein, Thomas, Masur, Henry, and Stock, Peter G.

Published
2021
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20. Doxycycline as Postsexual Exposure Prophylaxis: Use, Acceptability, and Associated Sexual Health Behaviors Among a Multi-Site Sample of Clinical Trial Participants.

Author

Fredericksen, Rob J., Perkins, Rodney, Brown, Clare E., Cannon, Chase, Lopez, Carolina, Cohee, Alison, Dombrowski, Julia Cook, Cohen, Stephanie, Malinski, Cheryl, Powell, Minh, Luetkemeyer, Anne F., Celum, Connie, and Christopoulos, Katerina

Subjects
PREVENTION of sexually transmitted diseases, ANXIETY prevention, HIV prevention, SEXUAL partners, HEALTH attitudes, MENTAL health, CONTROL (Psychology), RESEARCH funding, INTERVIEWING, HISPANIC Americans, HIV-positive persons, CLINICAL trials, DOXYCYCLINE, TREATMENT effectiveness, WHITE people, DESCRIPTIVE statistics, PRE-exposure prophylaxis, MEN who have sex with men, THEMATIC analysis, BLACK people, HEALTH behavior, RESEARCH methodology, QUALITY of life, TRANS women, INFECTIOUS disease transmission, COMPARATIVE studies, HEALTH education, SEXUAL health, PATIENTS' attitudes
Abstract

Doxycycline postexposure prophylaxis (doxy-PEP) reduces sexually transmitted infections (STIs) in men who have sex with men (MSM) and transgender women (TGW). In a clinical trial of doxy-PEP, we sought to assess acceptability, impact, and meaning of doxy-PEP use among MSM/TGW. We conducted semistructured, in-depth 1:1 interviews with MSM and TGW enrolled in the intervention arm of the Doxy-PEP study. We queried motivations for and meaning of use, attitudes, beliefs, adherence, effect on sexual behaviors, and partner, community, and structural factors related to use. We coded interview transcripts into content areas, followed by thematic analysis. We interviewed 44 participants (median age 38), 2% were TGW, 17% Black, 61% White, 30% Hispanic, and 45% persons with HIV. We identified three overarching themes. First, participants found doxy-PEP acceptable, and believed it was effective based on their history of STIs, easy to adhere to, and acceptable to sex partners. Second, doxy-PEP benefited their quality of life and mental health, offering "peace of mind" by reducing their anxiety about acquisition or unwitting transmission of STIs. Participants reported feeling more "in control" of preventing STIs, and positive about supporting their personal, partner, and community health. Third, impact on sexual behavior was variable, with most reporting no change or a brief initial change. Participants in a multi-site clinical trial of doxycycline for STI prevention perceived it to be efficacious, and that it provided quality-of-life benefits, including reduced anxiety and sense of control over sexual health. Doxy-PEP had limited impact on sexual behavior. Clinicaltrials.gov: NCT03980223. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Evaluation of Xpert MTB/RIF Versus AFB Smear and Culture to Identify Pulmonary Tuberculosis in Patients With Suspected Tuberculosis From Low and Higher Prevalence Settings

Author

Luetkemeyer, Anne F, Firnhaber, Cynthia, Kendall, Michelle A, Wu, Xingye, Mazurek, Gerald H, Benator, Debra A, Arduino, Roberto, Fernandez, Michel, Guy, Elizabeth, Johnson, Pamela, Metchock, Beverly, Sattler, Fred, Telzak, Edward, Wang, Yun F, Weiner, Marc, Swindells, Susan, Sanne, Ian M, Havlir, Diane V, Grinsztejn, Beatriz, and Alland, David

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Lung, Rare Diseases, Prevention, Biodefense, HIV/AIDS, Clinical Research, Vaccine Related, Infectious Diseases, Tuberculosis, Emerging Infectious Diseases, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Infection, Good Health and Well Being, Adult, Antibiotics, Antitubercular, Brazil, DNA, Bacterial, Drug Resistance, Bacterial, Female, Humans, Male, Middle Aged, Mutation, Mycobacterium tuberculosis, Nucleic Acid Amplification Techniques, Prevalence, Rifampin, Sensitivity and Specificity, South Africa, Sputum, Tuberculosis, Pulmonary, United States, Xpert MTB/RIF, tuberculosis diagnosis, respiratory isolation, nontuberculous mycobacteria, HIV/tuberculosis coinfection, AIDS Clinical Trials Group A5295 and Tuberculosis Trials Consortium Study 34 Teams, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundThe Xpert MTB/RIF (Xpert) assay is a rapid nucleic acid amplification test widely used in settings of high tuberculosis prevalence to detect tuberculosis as well asrpoBmutations associated with rifampin resistance. Data are needed on the diagnostic performance of Xpert in lower-prevalence settings to inform appropriate use for both tuberculosis detection and the need for respiratory isolation.MethodsXpert was compared to 2 sputum samples, each evaluated with acid-fast bacilli (AFB) smear and mycobacterial culture using liquid and solid culture media, from participants with suspected pulmonary tuberculosis from the United States, Brazil, and South Africa.ResultsOf 992 participants enrolled with evaluable results, 22% had culture-confirmed tuberculosis. In 638 (64%) US participants, 1 Xpert result demonstrated sensitivity of 85.2% (96.7% in participants with AFB smear-positive [AFB(+)] sputum, 59.3% with AFB smear-negative [AFB(-)] sputum), specificity of 99.2%, negative predictive value (NPV) of 97.6%, and positive predictive value of 94.9%. Results did not differ between higher- and low-prevalence settings. A second Xpert assay increased overall sensitivity to 91.1% (100% if AFB(+), 71.4% if AFB(-)), with specificity of 98.9%. In US participants, a single negative Xpert result predicted the absence of AFB(+)/culture-positive tuberculosis with an NPV of 99.7%; NPV of 2 Xpert assays was 100%, suggesting a role in removing patients from airborne infection isolation. Xpert detected tuberculosis DNA and mutations associated with rifampin resistance in 5 of 7 participants with rifampin-resistant, culture-positive tuberculosis. Specificity for rifampin resistance was 99.5% and NPV was 98.9%.ConclusionsIn the United States, Xpert testing performed comparably to 2 higher-tuberculosis-prevalence settings. These data support the use of Xpert in the initial evaluation of tuberculosis suspects and in algorithms assessing need for respiratory isolation.

Published
2016

22. Tuberculosis Infection in Early Childhood and the Association with HIV-exposure in HIV-uninfected Children in Rural Uganda

Author

Marquez, Carina, Chamie, Gabriel, Achan, Jane, Luetkemeyer, Anne F, Kyohere, Mary, Okiring, Jaffer, Dorsey, Grant, Kamya, Moses R, Charlebois, Edwin D, and Havlir, Diane V

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Pediatric, Prevention, Rare Diseases, HIV/AIDS, Pediatric AIDS, Sexually Transmitted Infections, Infectious Diseases, Clinical Research, Emerging Infectious Diseases, Tuberculosis, 2.2 Factors relating to the physical environment, Aetiology, Infection, Good Health and Well Being, Adult, Child, Preschool, Cross-Sectional Studies, Environmental Exposure, Female, HIV Infections, Humans, Infant, Interferon-gamma Release Tests, Male, Pregnancy, Prevalence, Risk Assessment, Rural Population, Tuberculin Test, Uganda, Young Adult, childhood TB infection, latent TB infection, HIV-exposed children, Paediatrics and Reproductive Medicine, Public Health and Health Services, Pediatrics, Clinical sciences, Paediatrics
Abstract

BackgroundIn high tuberculosis (TB) burden countries, a significant proportion of the latent TB reservoir is established by the age 5 years. There are critical knowledge gaps in our understanding of the age-specific prevalence of TB infection and the influence of HIV exposure on TB infection in the first 5 years of life among HIV-uninfected children in sub-Saharan Africa.MethodsWe measured TB infection with the Quantiferon Gold-in-Tube (QFT) and tuberculin skin tests (TST) in 447 children ≤60 months and their 284 HIV-infected and IV-uninfected mothers in rural Uganda.ResultsThe overall prevalence of TB infection in children ≤60 months by TST was 24% (95% confidence intervals [CI]: 19.9-27.9). The prevalence of TST positivity was highest among children in their first year of life (36%; 95% CI: 26.0-45.9) and declined with age to 19% at 36-60 months of age, χ test for trend P = 0.014. In contrast, 4% (95% CI: 1.9-5.87%) of children had a positive QFT, and there was no trend detected with age, P = 0.576. QFT positivity was detected as early as 5 months. HIV-exposed uninfected children had significantly higher odds of TB infection by QFT (odds ratio [OR]: 21.2; P = 0.008; 95% CI: 2.2-204.7) or positive TST or QFT (OR, 2.4; P = 0.020; 95% CI: 1.2-5.1) compared with HIV-unexposed uninfected children, adjusting for age, BCG vaccination and a positive maternal TST or QFT.ConclusionsAn appreciable prevalence of TB infection was detected in early childhood. HIV-exposed uninfected children have a higher risk for TB infection compared with children born to HIV-uninfected mothers.

Published
2016

23. Ethical Considerations in Implementing Doxycycline Post-Exposure Prophylaxis for the Prevention of Bacterial Sexually Transmitted Infections

Author

Sugarman, Jeremy, primary, Taylor, Holly A., additional, Bachmann, Laura H., additional, Barbee, Lindley A., additional, Cahill, Sean, additional, Celum, Connie, additional, Luetkemeyer, Anne F., additional, Mayer, Kenneth H., additional, Mena, Leandro, additional, Mermin, Jonathan, additional, Upshur, Ross, additional, and Aral, Sevgi, additional

Published
2023
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25. Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1 : The EXPEDITION-2 Study

Author

Rockstroh, Jürgen K., Lacombe, Karine, Viani, Rolando M., Orkin, Chloe, Wyles, David, Luetkemeyer, Anne F., Soto-Malave, Ruth, Flisiak, Robert, Bhagani, Sanjay, Sherman, Kenneth E., Shimonova, Tatiana, Ruane, Peter, Sasadeusz, Joseph, Slim, Jihad, Zhang, Zhenzhen, Samanta, Suvajit, Ng, Teresa I., Gulati, Abhishek, Kosloski, Matthew P., Shulman, Nancy S., Trinh, Roger, and Sulkowski, Mark

Published
2018

26. Bartonella quintana Aortitis in a Man with AIDS, Diagnosed by Needle Biopsy and 16S rRNA Gene Amplification

Author

Lee, Sulggi A, Plett, Sara K, Luetkemeyer, Anne F, Borgo, Gina M, Ohliger, Michael A, Conrad, Miles B, Cookson, Brad T, Sengupta, Dhruba J, and Koehler, Jane E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Vector-Borne Diseases, Pain Research, Acquired Immunodeficiency Syndrome, Anti-Bacterial Agents, Antibodies, Bacterial, Aortitis, Bartonella quintana, Biopsy, Needle, Cluster Analysis, DNA, Bacterial, DNA, Ribosomal, Doxycycline, Genes, rRNA, Histocytochemistry, Humans, Male, Microscopy, Middle Aged, Molecular Sequence Data, Phylogeny, RNA, Ribosomal, 16S, Rifabutin, Sequence Analysis, DNA, Tomography, X-Ray Computed, Treatment Outcome, Trench Fever, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Microbiology, Clinical sciences, Medical microbiology
Abstract

A man with newly diagnosed AIDS presented with months of back pain and fever. Computed tomography (CT) results demonstrated aortitis with periaortic tissue thickening. DNA amplification of biopsy tissue revealed Bartonella quintana, and Bartonella serologies were subsequently noted to be positive. The patient improved with prolonged doxycycline and rifabutin treatment. This case illustrates how molecular techniques are increasingly important in diagnosing Bartonella infections.

Published
2015

27. Combined Effect of CYP2B6 and NAT2 Genotype on Plasma Efavirenz Exposure During Rifampin-based Antituberculosis Therapy in the STRIDE Study

Author

Luetkemeyer, Anne F, Rosenkranz, Susan L, Lu, Darlene, Grinsztejn, Beatriz, Sanchez, Jorge, Ssemmanda, Michael, Sanne, Ian, McIlleron, Helen, Havlir, Diane V, and Haas, David W

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Genetics, Good Health and Well Being, Alkynes, Antitubercular Agents, Arylamine N-Acetyltransferase, Benzoxazines, Cyclopropanes, Cytochrome P-450 CYP2B6, Female, Genotype, HIV Infections, Humans, Male, Peru, Pharmacogenetics, Rifampin, South Africa, Tuberculosis, Uganda, HIV/AIDS, tuberculosis, efavirenz, rifampin, pharmacogenetic, Adult AIDS Clinical Trials Group A5221 and A5243 Study Teams, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

In STRIDE, slow metabolizer CYP2B6 and NAT2 genotypes were each associated with increased plasma efavirenz concentrations during antituberculosis therapy. Concentrations were greater on therapy than off therapy in 58% with CYP2B6 and 93% with NAT2 slow metabolizer genotypes. Individuals with slow metabolizer genotypes in both genes had markedly elevated concentrations.

Published
2015

28. Phase I Safety, Pharmacokinetics, and Pharmacogenetics Study of the Antituberculosis Drug PA-824 with Concomitant Lopinavir-Ritonavir, Efavirenz, or Rifampin

Author

Dooley, Kelly E, Luetkemeyer, Anne F, Park, Jeong-Gun, Allen, Reena, Cramer, Yoninah, Murray, Stephen, Sutherland, Deborah, Aweeka, Francesca, Koletar, Susan L, Marzan, Florence, Bao, Jing, Savic, Rada, and Haas, David W

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Alkynes, Antitubercular Agents, Antiviral Agents, Benzoxazines, Cyclopropanes, Drug Combinations, Drug Therapy, Combination, Female, Humans, Lopinavir, Male, Middle Aged, Nitroimidazoles, Pharmacogenetics, Rifampin, Ritonavir, Young Adult, AIDS Clinical Trials Group A5306 Study Team, Microbiology, Medical Microbiology, Pharmacology and Pharmaceutical Sciences, Medical microbiology, Pharmacology and pharmaceutical sciences
Abstract

There is an urgent need for new antituberculosis (anti-TB) drugs, including agents that are safe and effective with concomitant antiretrovirals (ARV) and first-line TB drugs. PA-824 is a novel antituberculosis nitroimidazole in late-phase clinical development. Cytochrome P450 (CYP) 3A, which can be induced or inhibited by ARV and antituberculosis drugs, is a minor (∼20%) metabolic pathway for PA-824. In a phase I clinical trial, we characterized interactions between PA-824 and efavirenz (arm 1), lopinavir/ritonavir (arm 2), and rifampin (arm 3) in healthy, HIV-uninfected volunteers without TB disease. Participants in arms 1 and 2 were randomized to receive drugs via sequence 1 (PA-824 alone, washout, ARV, and ARV plus PA-824) or sequence 2 (ARV, ARV with PA-824, washout, and PA-824 alone). In arm 3, participants received PA-824 and then rifampin and then both. Pharmacokinetic sampling occurred at the end of each dosing period. Fifty-two individuals participated. Compared to PA-824 alone, plasma PA-824 values (based on geometric mean ratios) for maximum concentration (Cmax), area under the concentration-time curve from 0 to 24 h (AUC0-24), and trough concentration (Cmin) were reduced 28%, 35%, and 46% with efavirenz, 13%, 17%, and 21% with lopinavir-ritonavir (lopinavir/r) and 53%, 66%, and 85% with rifampin, respectively. Medications were well tolerated. In conclusion, lopinavir/r had minimal effect on PA-824 exposures, supporting PA-824 use with lopinavir/r without dose adjustment. PA-824 exposures, though, were reduced more than expected when given with efavirenz or rifampin. The clinical implications of these reductions will depend upon data from current clinical trials defining PA-824 concentration-effect relationships. (This study has been registered at ClinicalTrials.gov under registration no. NCT01571414.).

Published
2014

29. Sofosbuvir and Ribavirin for Hepatitis C in Patients With HIV Coinfection

Author

Sulkowski, Mark S, Naggie, Susanna, Lalezari, Jacob, Fessel, Walford Jeffrey, Mounzer, Karam, Shuhart, Margaret, Luetkemeyer, Anne F, Asmuth, David, Gaggar, Anuj, Ni, Liyun, Svarovskaia, Evguenia, Brainard, Diana M, Symonds, William T, Subramanian, G Mani, McHutchison, John G, Rodriguez-Torres, Maribel, and Dieterich, Douglas

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Emerging Infectious Diseases, Liver Disease, Clinical Research, Digestive Diseases, Hepatitis - C, Genetics, Clinical Trials and Supportive Activities, HIV/AIDS, Infectious Diseases, Hepatitis, Chronic Liver Disease and Cirrhosis, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Administration, Oral, Adult, Aged, Antiviral Agents, Coinfection, Drug Administration Schedule, Drug Therapy, Combination, Female, Genotype, HIV Infections, Hepacivirus, Hepatitis C, Humans, Male, Middle Aged, RNA, Viral, Ribavirin, Sofosbuvir, Treatment Outcome, Uridine Monophosphate, Viral Load, Young Adult, PHOTON-1 Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ImportanceTreatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.ObjectiveTo determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.Design, setting, and participantsOpen-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants.InterventionsTreatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks.Main outcomes and measuresThe primary study outcome was the proportion of patients with SVR (serum HCV

Published
2014

30. CROI 2014: Viral hepatitis and complications of HIV disease and antiretroviral therapy.

Author

Luetkemeyer, Anne F, Havlir, Diane V, and Currier, Judith S

Subjects
Humans, Tuberculosis, Hepatitis C, Chronic, HIV Infections, Antitubercular Agents, Antiviral Agents, Treatment Outcome, Drug Interactions, HIV/AIDS, Clinical Research, Chronic Liver Disease and Cirrhosis, Hepatitis, Emerging Infectious Diseases, Infectious Diseases, Orphan Drug, Liver Disease, Digestive Diseases, Rare Diseases, Hepatitis - C, 5.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Infection, Good Health and Well Being
Abstract

The remarkable advances in interferon-sparing, all-oral hepatitis C virus (HCV) treatment were a highlight of the 2014 Conference on Retroviruses and Opportunistic Infections (CROI). The backbone of the nucleotide inhibitor sofosbuvir and the nonstructural protein 5A (NS5A) inhibitor ledipasvir with an additional third agent (HCV protease inhibitor or HCV nonnucleoside reverse transcriptase inhibitor) led to a sustained virologic response (SVR) rate 12 weeks after cessation of treatment of 95% to 100% after only 6 weeks of treatment. These results demonstrate the potential of combination directacting antiviral (DAA) therapy for abbreviated, well-tolerated, and highly effective HCV treatment. Two triple-drug regimens that comprised 12 weeks of an NS5A inhibitor, an HCV protease inhibitor, and a nonnucleoside inhibitor also resulted in SVRs of more than 90% in patients with HCV genotype 1. HIV coinfection does not appear to negatively impact response to DAA-based HCV therapy, as evidenced by similar response rates in HIV/HCV-coinfected patients compared with HCV-monoinfected patients receiving interferonsparing or -containing regimens. There was continued emphasis at CROI 2014 on non-AIDS complications of HIV infection, specifically cardiovascular disease, renal insufficiency, and bone and endocrine disorders that persist among patients with treated HIV disease and contribute to morbidity and mortality. Finally, new data on novel drugs and combinations for treatment of tuberculosis (TB), patient outcomes using new rapid TB diagnostics, and a short-course TB prevention strategy were presented.

Published
2014

31. Evaluation of Two Line Probe Assays for Rapid Detection of Mycobacterium tuberculosis, Tuberculosis (TB) Drug Resistance, and Non-TB Mycobacteria in HIV-Infected Individuals with Suspected TB

Author

Luetkemeyer, Anne F, Kendall, Michelle A, Wu, Xingye, Lourenço, Maria Cristina, Jentsch, Ute, Swindells, Susan, Qasba, Sarojini S, Sanchez, Jorge, Havlir, Diane V, Grinsztejn, Beatriz, Sanne, Ian M, and Firnhaber, Cynthia

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Lung, Emerging Infectious Diseases, Antimicrobial Resistance, Orphan Drug, Clinical Research, Infectious Diseases, Rare Diseases, Sexually Transmitted Infections, Tuberculosis, Biodefense, HIV/AIDS, Infection, Good Health and Well Being, Adult, Africa, Southern, Bacteriological Techniques, Drug Resistance, Bacterial, Female, HIV Infections, Humans, Male, Molecular Diagnostic Techniques, Mycobacterium, Mycobacterium Infections, Nontuberculous, Sensitivity and Specificity, South America, Sputum, Adult AIDS Clinical Trials Group A5255 Study Team, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Microbiology, Clinical sciences, Medical microbiology
Abstract

Limited performance data from line probe assays (LPAs), nucleic acid tests used for the rapid diagnosis of tuberculosis (TB), nontuberculosis mycobacteria (NTM), and Mycobacterium tuberculosis drug resistance are available for HIV-infected individuals, in whom paucibacillary TB is common. In this study, the strategy of testing sputum with GenoType MTBDRplus (MTBDR-Plus) and GenoType Direct LPA (Direct LPA) was compared to a gold standard of one mycobacterial growth indicator tube (MGIT) liquid culture. HIV-positive (HIV(+)) individuals with suspected TB from southern Africa and South America with

Published
2014

32. Tuberculosis Immune Reconstitution Inflammatory Syndrome in A5221 STRIDE

Author

Luetkemeyer, Anne F, Kendall, Michelle A, Nyirenda, Mulinda, Wu, Xingye, Ive, Prudence, Benson, Constance A, Andersen, Janet W, Swindells, Susan, Sanne, Ian M, Havlir, Diane V, and Kumwenda, Johnstone

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Rare Diseases, Lung, Tuberculosis, HIV/AIDS, Orphan Drug, Sexually Transmitted Infections, Emerging Infectious Diseases, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Adult, Anti-Retroviral Agents, CD4 Lymphocyte Count, Female, HIV Infections, Humans, Immune Reconstitution Inflammatory Syndrome, Male, Severity of Illness Index, Time Factors, HIV, AIDS, tuberculosis, immune reconstitution inflammatory syndrome, paradoxical reaction, Adult AIDS Clinical Trials Group A5221 Study Team, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

Rationale and objectivesEarlier initiation of antiretroviral therapy (ART) in HIV-tuberculosis (TB) is associated with increased immune reconstitution inflammatory syndrome (IRIS). The severity, frequency, and complications of TB IRIS were evaluated in A5221, a randomized trial of earlier ART (within 2 weeks after TB treatment initiation) vs. later ART (8-12 weeks after TB treatment) in HIV-infected patients starting TB treatment.Methods and measurementsIn 806 participants, TB IRIS was defined using published clinical criteria. Cases were classified as severe (hospitalization/death), moderate (corticosteroid use/invasive procedure), or mild (no hospitalization/procedures/steroids). Fisher exact, Wilcoxon, and log-rank tests were used for comparisons.Main resultsTB IRIS occurred in 61 (7.6%) patients: 10.4% in earlier vs. 4.7% in later ART, 11.5% with CD4

Published
2014

35. Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial

Author

Rouphael, Nadine G, primary, Branche, Angela R, additional, Diemert, David J, additional, Falsey, Ann R, additional, Losada, Cecilia, additional, Baden, Lindsey R, additional, Frey, Sharon E, additional, Whitaker, Jennifer A, additional, Little, Susan J, additional, Kamidani, Satoshi, additional, Walter, Emmanuel B, additional, Novak, Richard M, additional, Rupp, Richard, additional, Jackson, Lisa A, additional, Babu, Tara M, additional, Kottkamp, Angelica C, additional, Luetkemeyer, Anne F, additional, Immergluck, Lilly C, additional, Presti, Rachel M, additional, Bäcker, Martín, additional, Winokur, Patricia L, additional, Mahgoub, Siham M, additional, Goepfert, Paul A, additional, Fusco, Dahlene N, additional, Atmar, Robert L, additional, Posavad, Christine M, additional, Netzl, Antonia, additional, Smith, Derek J, additional, Telu, Kalyani, additional, Mu, Jinjian, additional, McQuarrie, Lisa J, additional, Makowski, Mat, additional, Makhene, Mamodikoe K, additional, Crandon, Sonja, additional, Montefiori, David C, additional, Roberts, Paul C, additional, and Beigel, John H, additional

Published
2023
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36. Relationship Between Weight, Efavirenz Exposure, and Virologic Suppression in HIV-Infected Patients on Rifampin-Based Tuberculosis Treatment in the AIDS Clinical Trials Group A5221 STRIDE Study

Author

Luetkemeyer, Anne F, Rosenkranz, Susan L, Lu, Darlene, Marzan, Florence, Ive, Prudence, Hogg, Evelyn, Swindells, Susan, Benson, Constance A, Grinsztejn, Beatriz, Sanne, Ian M, Havlir, Diane V, Aweeka, Francesca, and Team, for the Adult AIDS Clinical Trials Group A5221 Study

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Clinical Research, Clinical Trials and Supportive Activities, HIV/AIDS, Sexually Transmitted Infections, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Alkynes, Anti-HIV Agents, Antitubercular Agents, Benzoxazines, Body Weight, Cyclopropanes, Drug Interactions, Female, HIV Infections, Humans, Male, Rifampin, Treatment Outcome, Tuberculosis, Viral Load, tuberculosis, efavirenz, rifampin, pharmacokinetics, Adult AIDS Clinical Trials Group A5221 Study Team, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundRifampin (RIF) upregulates CYP 450 isoenzymes, potentially lowering efavirenz (EFV) exposure. The US EFV package insert recommends an EFV dose increase for patients on RIF weighing ≥50 kg. We conducted a pharmacokinetic study to evaluate EFV trough concentrations (Cmin) and human immunodeficiency virus (HIV) virologic suppression in patients on EFV (600 mg) and RIF-based tuberculosis treatment in the multicenter randomized trial (ACTG A5221).MethodsEFV Cmin was measured 20-28 hours post-EFV dose at weeks 4, 8, 16, 24 on-RIF and weeks 4, 8 off-RIF. Results were evaluated with 2-sided Wilcoxon rank-sum, χ(2), Fisher exact tests and logistic regression (5% type I error rate).ResultsSeven hundred eighty patients received EFV; 543 provided ≥1 EFV Cmin. Median weight was 52.8 kg (interquartile range [IQR], 48.0-59.5), body mass index 19.4 kg/m(2) (IQR, 17.5-21.6), and age 34 years (IQR, 29-41); 63% were male, 74% black. Median Cmin was 1.96 µg/mL on-RIF versus 1.80 off-RIF (P = .067). Cmin were significantly higher on-RIF versus off-RIF in blacks (2.08 vs 1.75, P = .005). Weight ≥60 kg on-RIF, compared to

Published
2013

37. CROI 2013: Complications of HIV disease, viral hepatitis, and antiretroviral therapy.

Author

Luetkemeyer, Anne F, Havlir, Diane V, and Currier, Judith S

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Immunology, HIV/AIDS, Hepatitis - C, Liver Disease, Emerging Infectious Diseases, Clinical Research, Chronic Liver Disease and Cirrhosis, Hepatitis, Digestive Diseases, Infectious Diseases, Evaluation of treatments and therapeutic interventions, Aetiology, 5.1 Pharmaceuticals, 2.2 Factors relating to the physical environment, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, AIDS-Related Opportunistic Infections, Antiretroviral Therapy, Highly Active, Antiviral Agents, Drug Interactions, HIV Infections, Hepatitis C, Chronic, Humans, Neoplasms, Treatment Outcome, Vitamin D Deficiency
Abstract

Studies with direct-acting antivirals (DAAs) for hepatitis C virus (HCV) monoinfection and HIV coinfection were highlighted at the 2013 Conference on Retroviruses and Opportunistic Infections (CROI). In HCV monoinfected patients, several interferon alfa-sparing, all-oral regimens demonstrated cure rates of greater than 90% with 12 weeks of treatment, including for hard-to-treat patients. Cure rates of 75% were attained in HIV/HCV coinfected patients with the addition of the investigational HCV protease inhibitor (PI) simeprevir to peginterferon alfa and ribavirin. Drug-drug interaction data to inform safe coadminstration of antiretroviral therapy with DAA-based HCV treatment were presented. There was continued emphasis on pathogenesis, management, and prevention of the long-term complications of HIV disease and its therapies, including cardiovascular disease, renal disease, alterations in bone metabolism, and vitamin D deficiency, along with a growing focus on biomarkers to predict development of end-organ disease. Understanding the elevated risk for non-AIDS-defining malignancies in the HIV-infected population and optimal management was a focal point of this year's data. Finally, the conference provided important information on tuberculosis coinfection and cryptococcal meningitis.

Published
2013

38. Complications of HIV disease and antiretroviral therapy.

Author

Luetkemeyer, Anne F, Havlir, Diane V, and Currier, Judith S

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Emerging Infectious Diseases, HIV/AIDS, Clinical Research, Hepatitis, Chronic Liver Disease and Cirrhosis, Digestive Diseases, Prevention, Liver Disease, Infectious Diseases, Hepatitis - C, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Infection, Good Health and Well Being, Antiretroviral Therapy, Highly Active, Antiviral Agents, Drug Interactions, HIV Infections, Hepatitis C, Chronic, Humans, Interferons, Ribavirin
Abstract

Studies on the efficacy of and drug interactions with the hepatitis C virus (HCV) direct-acting antivirals (DAAs) in HCV/ HIV coinfection were a highlight of the 2012 Conference on Retroviruses and Opportunistic Infections. The addition of an HCV protease inhibitor (PI) to pegylated interferon alfa/ribavirin increased HCV cure rates by 30% to 35% in HCV genotype 1 treatment-naive HIV-coinfected patients, an increase similar to that observed in HIV-uninfected HCV-infected patients. Drug interactions with antiretrovirals can be complex, and DAAs are recommended for use only with antiretroviral drugs for which pharmacokinetic data are available. Further drug interaction and clinical data are needed to ensure the safe coadminstration of DAAs with antiretroviral therapy. The conference placed continued emphasis on pathogenesis, management, and prevention of the long-term complications of HIV disease and its therapies, including cardiovascular disease, lipodystrophy, renal disease, alterations in bone metabolism, and vitamin D deficiency, along with a growing focus on biomarkers to predict development of end-organ disease. HIV has increasingly been recognized as a disease of accelerated aging, manifested by increased progression of vascular disease, cellular markers of aging, and a heightened risk of certain non-AIDS-defining malignancies. This year's conference also highlighted data on diagnosis, prevention, and complications of tuberculosis coinfection as well as the treatment and prevention of coinfections that are common with HIV, including cryptococcal meningitis, influenza, and varicella zoster.

Published
2012

39. Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial

Author

Rouphael, Nadine G., primary, Branche, Angela R., additional, Diemert, David J., additional, Falsey, Ann R., additional, Losada, Cecilia, additional, Baden, Lindsey R., additional, Frey, Sharon E., additional, Whitaker, Jennifer A., additional, Little, Susan J., additional, Kamidani, Satoshi, additional, Walter, Emmanuel B., additional, Novak, Richard M., additional, Rupp, Richard, additional, Jackson, Lisa A., additional, Babu, Tara M., additional, Kottkamp, Angelica C., additional, Luetkemeyer, Anne F., additional, Immergluck, Lilly C., additional, Presti, Rachel M., additional, Bäcker, Martín, additional, Winokur, Patricia L., additional, Mahgoub, Siham M., additional, Goepfert, Paul A., additional, Fusco, Dahlene N., additional, Atmar, Robert L., additional, Posavad, Christine M., additional, Netzl, Antonia, additional, Smith, Derek J., additional, Telu, Kalyani, additional, Mu, Jinjian, additional, Makowski, Mat, additional, Makhene, Mamodikoe K., additional, Crandon, Sonja, additional, Montefiori, David C., additional, Roberts, Paul C., additional, and Beigel, John H., additional

Published
2023
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40. Immunogenicity of the BA.1 and BA.4/BA.5 Severe Acute Respiratory Syndrome Coronavirus 2 Bivalent Boosts: Preliminary Results From the COVAIL Randomized Clinical Trial

Author

Branche, Angela R, primary, Rouphael, Nadine G, additional, Losada, Cecilia, additional, Baden, Lindsey R, additional, Anderson, Evan J, additional, Luetkemeyer, Anne F, additional, Diemert, David J, additional, Winokur, Patricia L, additional, Presti, Rachel M, additional, Kottkamp, Angelica C, additional, Falsey, Ann R, additional, Frey, Sharon E, additional, Rupp, Richard, additional, Bäcker, Martín, additional, Novak, Richard M, additional, Walter, Emmanuel B, additional, Jackson, Lisa A, additional, Little, Susan J, additional, Immergluck, Lilly C, additional, Mahgoub, Siham M, additional, Whitaker, Jennifer A, additional, Babu, Tara M, additional, Goepfert, Paul A, additional, Fusco, Dahlene N, additional, Atmar, Robert L, additional, Posavad, Christine M, additional, Netzl, Antonia, additional, Smith, Derek J, additional, Telu, Kalyani, additional, Mu, Jinjian, additional, Makowski, Mat, additional, Makhene, Mamodikoe K, additional, Crandon, Sonja, additional, Montefiori, David C, additional, Roberts, Paul C, additional, and Beigel, John H, additional

Published
2023
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41. Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections

Author

Luetkemeyer, Anne F., primary, Donnell, Deborah, additional, Dombrowski, Julia C., additional, Cohen, Stephanie, additional, Grabow, Cole, additional, Brown, Clare E., additional, Malinski, Cheryl, additional, Perkins, Rodney, additional, Nasser, Melody, additional, Lopez, Carolina, additional, Vittinghoff, Eric, additional, Buchbinder, Susan P., additional, Scott, Hyman, additional, Charlebois, Edwin D., additional, Havlir, Diane V., additional, Soge, Olusegun O., additional, and Celum, Connie, additional

Published
2023
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42. Immunogenicity of a 2-Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.

Author

Rouphael, Nadine G, Branche, Angela R, Diemert, David J, Falsey, Ann R, Losada, Cecilia, Baden, Lindsey R, Frey, Sharon E, Whitaker, Jennifer A, Little, Susan J, Kamidani, Satoshi, Walter, Emmanuel B, Novak, Richard M, Rupp, Richard, Jackson, Lisa A, Babu, Tara M, Kottkamp, Angelica C, Luetkemeyer, Anne F, Immergluck, Lilly C, Presti, Rachel M, and Bäcker, Martín

Subjects
CLINICAL trials, SARS-CoV-2 Omicron variant, IMMUNE response, VACCINES, MESSENGER RNA
Abstract

We compared the serologic responses of 1 dose versus 2 doses of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults. A 2-dose boosting regimen with a variant vaccine did not increase the magnitude or the durability of the serological responses compared to a single variant vaccine boost. [ABSTRACT FROM AUTHOR]

Published
2023
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43. Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial

Author

Rouphael, Nadine G., Branche, Angela R., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Kamidani, Satoshi, Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Atmar, Robert L., Posavad, Christine M., Netzl, Antonia, Smith, Derek J., Telu, Kalyani, Mu, Jinjian, Makowski, Mat, Makhene, Mamodikoe K., Crandon, Sonja, Montefiori, David C., Roberts, Paul C., and Beigel, John H.

Subjects
Article
Abstract

In this brief report, we compare the magnitude and durability of the serologic response of one versus two doses (separated by 56 days) of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults.

Published
2023

44. Immunogenicity of the BA.1 and BA.4/BA.5 SARS-CoV-2 Bivalent Boosts: Preliminary Results from the COVAIL Randomized Clinical Trial

Author

Branche, Angela R., primary, Rouphael, Nadine G., additional, Losada, Cecilia, additional, Baden, Lindsey R., additional, Anderson, Evan J., additional, Luetkemeyer, Anne F., additional, Diemert, David J., additional, Winokur, Patricia L., additional, Presti, Rachel M., additional, Kottkamp, Angelica C., additional, Falsey, Ann R., additional, Frey, Sharon E., additional, Rupp, Richard, additional, Bäcker, Martín, additional, Novak, Richard M., additional, Walter, Emmanuel B., additional, Jackson, Lisa A., additional, Little, Susan J., additional, Immergluck, Lilly C., additional, Mahgoub, Siham M., additional, Whitaker, Jennifer A., additional, Babu, Tara M., additional, Goepfert, Paul A., additional, Fusco, Dahlene N., additional, Atmar, Robert L., additional, Posavad, Christine M., additional, Netzl, Antonia, additional, Smith, Derek J., additional, Telu, Kalyani, additional, Mu, Jinjian, additional, Makowski, Mat, additional, Makhene, Mamodikoe K., additional, Crandon, Sonja, additional, Montefiori, David C., additional, Roberts, Paul C., additional, and Beigel, John H., additional

Published
2023
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45. Robust humoral and cellular recall responses to AZD1222 attenuate breakthrough SARS-CoV-2 infection compared to unvaccinated

Author

Maaske, Jill, primary, Sproule, Stephanie, additional, Falsey, Ann R., additional, Sobieszczyk, Magdalena E., additional, Luetkemeyer, Anne F., additional, Paulsen, Grant C., additional, Riddler, Sharon A., additional, Robb, Merlin L., additional, Rolle, Charlotte-Paige, additional, Sha, Beverly E., additional, Tong, Tina, additional, Ahani, Bahar, additional, Aksyuk, Anastasia A., additional, Bansal, Himanshu, additional, Egan, Timothy, additional, Jepson, Brett, additional, Padilla, Marcelino, additional, Patel, Nirmeshkumar, additional, Shoemaker, Kathryn, additional, Stanley, Ann Marie, additional, Swanson, Phillip A., additional, Wilkins, Deidre, additional, Villafana, Tonya, additional, Green, Justin A., additional, and Kelly, Elizabeth J., additional

Published
2023
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47. Evaluation of Xpert MTB/RIF Versus AFB Smear and Culture to Identify Pulmonary Tuberculosis in Patients With Suspected Tuberculosis From Low and Higher Prevalence Settings

Author

AIDS Clinical Trials Group A5295 and Tuberculosis Trials Consortium Study 34 Teams, Luetkemeyer, Anne F., Firnhaber, Cynthia, Kendall, Michelle A., Wu, Xingye, Mazurek, Gerald H., Benator, Debra A., Arduino, Roberto, Fernandez, Michel, Guy, Elizabeth, Johnson, Pamela, Metchock, Beverly, Sattler, Fred, Telzak, Edward, Wang, Yun F., Weiner, Marc, Swindells, Susan, Sanne, Ian M., Havlir, Diane V., Grinsztejn, Beatriz, and Alland, David

Published
2016

48. Health-related quality of life in people receiving opioid agonist treatment and treatment for hepatitis C virus infection.

Author

Dalgard, Olav, Litwin, Alain H., Shibolet, Oren, Grebely, Jason, Nahass, Ronald, Altice, Frederick L., Conway, Brian, Gane, Edward J., Luetkemeyer, Anne F., Peng, Cheng-Yuan, Iser, David, Gendrano, Isaias Noel, Kelly, Michelle M., Haber, Barbara A., Platt, Heather, and Puenpatom, Amy

Subjects
NARCOTICS, DRUG addiction, NARCOTIC antagonists, CONFIDENCE intervals, HEPATITIS C, ANTIVIRAL agents, RANDOMIZED controlled trials, QUALITY of life, DESCRIPTIVE statistics, QUESTIONNAIRES, RESEARCH funding, STATISTICAL sampling
Abstract

In people with chronic hepatitis C virus (HCV) infection, viral eradication is associated with improved health-related quality of life (HRQOL). To assess changes in HRQOL among participants receiving opioid agonist therapy undergoing treatment for HCV infection COSTAR (NCT02251990) was a randomized, double-blind, placebo-controlled study. Adults with HCV infection on opioid agonist therapy received elbasvir (50 mg)/grazoprevir (100 mg) or placebo for 12 weeks. HRQOL was evaluated using the Medical Outcomes Study 36-Item Short Form Health Survey version 2 (SF-36v2) Acute Form. Participants remained blinded until 4 weeks after end of treatment. Overall, 201 participants received elbasvir/grazoprevir and 100 participants received placebo. Treatment difference mean change from baseline scores (elbasvir/grazoprevir minus placebo) indicated an improvement in HRQOL at 4 weeks after end of treatment in participants receiving elbasvir/grazoprevir versus those receiving placebo, driven by declining HRQOL in those receiving placebo and improved HRQOL in certain domains among participants receiving elbasvir/grazoprevir. Notable differences in SF-36v2 scores were evident in the general health (mean treatment difference [MTD], 6.00; 95% CI, 1.37–10.63), vitality (MTD, 6.81; 95% CI, 1.88–11.75), and mental health (MTD, 5.17; 95% CI, 0.52–9.82) domains and in the mental component summary score (mean, 2.83; 95% CI, 0.29–5.37). No notable between-treatment differences were evident at treatment weeks 4 or 12. HRQOL in patients receiving medication for opioid dependence was improved following treatment for HCV infection with elbasvir/grazoprevir, suggesting that eradication of HCV infection with direct-acting antivirals is associated with improved HRQOL. ClinicalTrials.gov, NCT02251990 [ABSTRACT FROM AUTHOR]

Published
2023
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49. 1953. Immune responses, viral shedding, and COVID-19 symptom burden from breakthrough SARS-CoV-2 infection in a 2:1 randomized, double-blind, placebo-controlled Phase 3 study of AZD1222 (ChAdOx1 nCoV-19) vaccination

Author

Sobieszczyk, Magdalena E, primary, Falsey, Ann R, additional, Luetkemeyer, Anne F, additional, Paulsen, Grant C, additional, Riddler, Sharon A, additional, Robb, Merlin L, additional, Rolle, Charlotte-Paige M, additional, Sha, Beverly E, additional, Tong, Tina, additional, Ahani, Bahar, additional, Aksyuk, Anastasia A, additional, Bansal, Himanshu, additional, Green, Justin A, additional, Jepson, Brett, additional, Maaske, Jill, additional, Shoemaker, Kathryn, additional, Sproule, Stephanie, additional, Stanley, Ann Marie, additional, Wilkins, Deidre, additional, Villafana, Tonya L, additional, and Kelly, Elizabeth J, additional

Published
2022
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50. SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses

Author

Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C.S., Rostad, Christina A., Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Lee, Marina, Nayak, Seema U., Montefiori, David C., Makowski, Mat, Smith, Derek J., Roberts, Paul C., and Beigel, John H.

Subjects
Article
Abstract

BackgroundProtection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety and immunogenicity of SARS-CoV-2 variant vaccines.MethodsThis phase 2 open-label, randomized trial enrolled healthy adults previously vaccinated with a SARS-CoV-2 primary series and a single boost. Eligible participants were randomized to one of six Moderna COVID19 mRNA vaccine arms (50µg dose): Prototype (mRNA-1273), Omicron BA.1+Beta (1 or 2 doses), Omicron BA.1+Delta, Omicron BA.1 monovalent, and Omicron BA.1+Prototype. Neutralization antibody titers (ID50) were assessed for D614G, Delta, Beta and Omicron BA.1 variants and Omicron BA.2.12.1 and BA.4/BA.5 subvariants 15 days after vaccination.ResultsFrom March 30 to May 6, 2022, 597 participants were randomized and vaccinated. Median age was 53 years, and 20% had a prior SARS-CoV-2 infection. All vaccines were safe and well-tolerated. Day 15 geometric mean titers (GMT) against D614G were similar across arms and ages, and higher with prior infection. For uninfected participants, Day 15 Omicron BA.1 GMTs were similar across Omicron-containing vaccine arms (3724-4561) and higher than Prototype (1,997 [95%CI:1,482-2,692]). The Omicron BA.1 monovalent and Omicron BA.1+Prototype vaccines induced a geometric mean ratio (GMR) to Prototype for Omicron BA.1 of 2.03 (97.5%CI:1.37-3.00) and 1.56 (97.5%CI:1.06-2.31), respectively. A subset of samples from uninfected participants in four arms were also tested in a different laboratory at Day 15 for neutralizing antibody titers to D614G and Omicron subvariants BA.1, BA.2.12.2 and BA.4/BA.5. Omicron BA.4/BA.5 GMTs were approximately one third BA.1 GMTs (Prototype 517 [95%CI:324-826] vs. 1503 [95%CI:949-2381]; Omicron BA.1+Beta 628 [95%CI:367-1,074] vs. 2125 [95%CI:1139-3965]; Omicron BA.1+Delta 765 [95%CI:443-1,322] vs. 2242 [95%CI:1218-4128] and Omicron BA.1+Prototype 635 [95%CI:447-903] vs. 1972 [95%CI:1337-2907).ConclusionsHigher Omicron BA.1 titers were observed with Omicron-containing vaccines compared to Prototype vaccine and titers against Omicron BA.4/BA.5 were lower than against BA.1 for all candidate vaccines.Clinicaltrials.govNCT05289037

Published
2022

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