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1. Costs and acceptability of simplified monitoring in HIV-suppressed patients switching to dual therapy: the SIMPL’HIV open-label, factorial randomised controlled trial

Author

Annalisa Marinosci, Delphine Sculier, Gilles Wandeler, Sabine Yerly, Marcel Stoeckle, Enos Bernasconi, Dominique L. Braun, Pietro Vernazza, Matthias Cavassini, Marta Buzzi, Karin J. Metzner, Laurent Decosterd, Huldrych F. Günthard, Patrick Schmid, Andreas Limacher, Mattia Branca, and Alexandra Calmy

Subjects
Medicine
Abstract

BACKGROUND: Clinical and laboratory monitoring of patients on antiretroviral therapy is an integral part of HIV care and determines whether treatment needs enhanced adherence or modification of the drug regimen. However, different monitoring and treatment strategies carry different costs and health consequences. MATERIALS AND METHODS: The SIMPL’HIV study was a randomised trial that assessed the non-inferiority of dual maintenance therapy. The co-primary outcome was a comparison of costs over 48 weeks of dual therapy with standard antiretroviral therapy and the costs associated with a simplified HIV care approach (patient-centred monitoring [PCM]) versus standard, tri-monthly routine monitoring. Costs included outpatient medical consultations (HIV/non-HIV consultations), non-medical consultations, antiretroviral therapy, laboratory tests and hospitalisation costs. PCM participants had restricted immunological and blood safety monitoring at weeks 0 and 48, and they were offered the choice to complete their remaining study visits via a telephone call, have medications delivered to a specified address, and to have blood tests performed at a location of their choice. We analysed the costs of both strategies using invoices for medical consultations issued by the hospital where the patient was followed, as well as those obtained from health insurance companies. Secondary outcomes included differences between monitoring arms for renal function, lipids and glucose values, and weight over 48 weeks. Patient satisfaction with treatment and monitoring was also assessed using visual analogue scales. RESULTS: Of 93 participants randomised to dolutegravir plus emtricitabine and 94 individuals to combination antiretroviral therapy (median nadir CD4 count, 246 cells/mm3; median age, 48 years; female, 17%),patient-centred monitoring generated no substantial reductions or increases in total costs (US$ –421 per year [95% CI –2292 to 1451]; p = 0.658). However, dual therapy was significantly less expensive (US$ –2620.4 [95% CI –2864.3 to –2331.4]) compared to standard triple-drug antiretroviral therapy costs. Approximately 50% of participants selected one monitoring option, one-third chose two, and a few opted for three. The preferred option was telephone calls, followed by drug delivery. The number of additional visits outside the study schedule did not differ by type of monitoring. Patient satisfaction related to treatment and monitoring was high at baseline, with no significant increase at week 48. CONCLUSIONS: Patient-centred monitoring did not reduce costs compared to standard monitoring in individuals switching to dual therapy or those continuing combined antiretroviral therapy. In this representative sample of patients with suppressed HIV, antiretroviral therapy was the primary factor driving costs, which may be reduced by using generic drugs to mitigate the high cost of lifelong HIV treatment. Trial registration: ClinicalTrials.gov NCT03160105.

Published
2024
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2. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses

Author

Pan, Hongchao, Peto, Richard, Henao Restrepo, Ana Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Karim, Quarraisha Abdool, Alejandria, Marissa, Hernàndez García, César, Kieny, Marie-Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K. Srinath, Periago, Mirta Roses, Hanna, Pierre Abi, Abutidze, Akaki, Ader, Florence, Al-Bader, Abdullah, Alhasawi, Almonther, Allum, Emma, Al Mawali, Adhra, Alotaibi, Athari, Alvarez- Moreno, Carlos, Appadoo, Sheila, Arts, Derk, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Genetu Bayih, Abebe, Beaumont, Helena, Bellani, Samir, Benassi, Virginia, Bhargava, Balram, Branca, Mattia, Cappel-Porter, Heike, Cerrato, Nery, Cheick Haidara, Fadima, Chow, Ting Soo, Como, Nadia, Eustace, Joe, Gabunia, Tamar, García, Patricia, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Hassan, Mariam, Hassany, Mohamed, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Khamis, Faryal, Kirwan, Jana, Kumar, Suresh, Lennon, Peter, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Manevska, Suzana, Manuel, Oriol, McGinty, Sybil, Medina, Marco, Mesa Rubio, Maria Lucia, Miranda Montoya, Maria Consuelo, Nel, Jeremy, Nunes, Estevao, Perola, Markus, Portoles, Antonio, Rasmin, Menaldi, Raza, Aun, Rees, Helen, Reges, Paula, Rogers, Chris, Salami, Kolawole, Salvadori, Marina, Sauermann, Mamatha, Sinani, Narvina, Sow, Samba, Sterne, Jonathan AC, Stevanovikj, Milena, Tacconelli, Evelina, Tavares Maltez, Fernando Manuel, Teferi, Mekonnen, Tikkinen, Kari, Trelle, Sven, Tsertsvadze, Tengiz, Zaid, Hala, Røttingen, John-Arne, Swaminathan, Soumya, Ryan, Michael, Gjermeni, Nevila, Meta, Esmeralda, Aguila, Damian, Alonso, Ignacio, Altamirano, Marcos, Alvarez, María, Alzola, Rodrigo, Arce, Veronica, Arribillaga, Patricia, Avila, Rafael, Balbuena, Juan, Barcelona, Laura, Barletta, José, Benedetti, María, Berdiñas, Verónica, Burgui, Julieta, Caimi, Sabrina, Carrillo, Juan, Carrizo, Juan, Castelli, Juan, Cazaux, Alexis, Cervellino, Flavia, Chalco, Angelo, Chediack, Viviana, Cunto, Eleonora, D'Amico, Nicolàs, de Vedia, Lautaro, Delgado, Carolina, Di Pilla, Debora, Díaz, Miguel, Díaz Aguiar, Pablo, Domínguez, Cecilia, Ellero, Leonor, Farina, Javier, Fernàndez, José, Ferreyra, Roxana, Filippi, María, Fogar, Carolina, Frare, Pablo, Giudiche, Celeste, Golikow, Mariana, Gomez, Maria Georgina, Hermida, Laura, Hurtado, Mariano, Jacobo, Mariela, Jaume, Martin, Laplume, Diego, Lescano, María, Lista, Nicolàs, Loiacono, Flavia, López, Ana Belen, Losso, Marcelo, Luna, Cecilia, Lupo, Sergio, Marianelli, Leonardo, Martin, Anabella, Masciottra, Florencia, Mykietiuk, Analía, Orellano, Lorena, Pachioli, Valeria, Padilla, María José, Pallavicini, Cecilia, Patroso, Jazmin, Perez Blanco, Luz, Presas, Jose Louis, Provenzano, Matias, Lavera, Lorena, Reichert, Viviana, Riveros, Florencia, Rodríguez, Alejandra, Rolon, María José, Salvay, Carolina, Simonetta, María, Sisto, Alicia, Themines, Sandra, Tito, Fernando, Toibaro, Javier, Torales, Graciela, Verón, Luciano, Vizzotti, Carla, Egle, Alexander, Greil, Richard, Joannidis, Michael, Altdorfer, Antoine, Belkhir, Leila, Fraipont, Vincent, Hites, Maya, Arruda, Erico, Breda, Giovanni, Colussi, Arthur, Corradi, Miran, Croda, Julio, Duani, Helena, João, Esaú, Machado, Elizabeth, Mello, Fernanda, Miranda Filho, Demócrito, Monteiro, Poliana, Nunes, Ceuci, Pereira Junior, Luiz Carlos, Pinto, Gustavo, Raboni, Sonia, Ramos, Marcelo, Ruffing, Leonardo, Santos, Valdilea, Souza, Tamara, Medeiros, Melissa, Schwarzbold, Alexandre, Ali, Karim, Azher, Tanweer, Bellemare, David, Binnie, Alexandra, Borgia, Sergio, Cavayas, Yiorgos Alexandros, Chagnon, Nicholas, Cheng, Matthew, Cloutier, Eve, Conly, John, Costiniuk, Cecilia, Daneman, Nick, Douglas, James, Downey, Catarina, Duan, Erick, Durand, Medeline, English, Shane, Farjou, George, Fera, Evadiki, Fontela, Patricia, Fowler, Rob, Fralick, Mike, Gamble, David Gregory, Geagea, Anna, Grant, Jennifer, Harrison, Luke, Havey, Thomas, Hoang, Holly, Kelly, Lauren, Keynan, Yoav, Khwaja, Kosar, Klein, Marina, Kolan, Christophe, Kronfli, Nadine, Lamontagne, Francois, Lee, Nelson, Lee, Todd, Lim, Rachel, Lostun, Alexandra, MacIntyre, Erika, Malhamé, Isabelle, Martin-Carrier, Francois, McGuinty, Marlee, Munan, Matthew, O'Neil, Conar, Ovakim, Daniel, Papenburg, Jesse, Parhar, Ken, Parvathy, SeemaNair, Perez-Patrigeon, Santiago, Rishu, Asgar, Rushton, Moira, Scherr, Kim, Schwartz, Kevin, Semret, Makeda, Silverman, Micahel, Singh, Ameeta, Sligl, Wendy, Smith, Stephanie, Somayaji, Ranjani, Tan, Darrell, Tran, Tuong-Vi, Tremblay, Alain, Tsang, Jennifer, Turgeon, Alexis, Vakil, Erik, Weatherald, Jason, Yansouni, Cedric, Zarychanski, Ryan, Aristizabal, Claudia, Bravo, Juan, Caicedo, Monica, Chacón, Julio, Garzón, Diego, Guevara, Fredy, Lozano-Gonzàlez, Silvia, Macareno, Hugo, Montañez-Ayala, Anita, Oñate, Jose, Rojas-Gambasica, Jose, Rosso, Fernando, Saavedra, Carlos, Valderrama, Sandra, Vàquiro-Herrera, Eliana, Varón-Vega, Fabio, Zuluaga, Ivan, Abdel Baki, Amin, Abdelbary, Akram, Abdel-Razek, Wael, Amin, Wagdi, Asem, Noha, Elassal, Gehan, Elshesheny, Marwa, Fathy, Mohamed, Fathy, Naglaa, Fayed, Notaila, Hammam, Ahmed, Hassany, Sahar, Ibrahim, Hamdy, Kamal, Ehab, Masoud, Hossam, Mohamed, Maryam, Mohamed Gouda, Abdullah, Moustafa, Ehab, Okasha, Shaimaa, Rafik, Ahmed, Said, Ahmed, Sedky, Asmaa, Solyman Kabil, Mohamed, Tarek, Sara, Tharwat, Ahmed, Zaky, Samy, Abegaz, Emawayish Tesema, Bekele, Zelalem Mekonnen, Asfaw, Filmona Mekuria, Tegegne, Netsanet Aragaw, Teklemariam, Miheret Fikre, Nigusse, Frehiwot Tamiru, Achalu, Daniel Legesse, Weldegergs, Shewit Tesfagabr, Huluka, Dawit Kebede, Tereda, Addisu Birhanu, Ala-Kokko, Tero, Delany, Jutta, Ekroos, Heikki, Hankkio, Riina, Haukipää, Mia, Hetemäki, Iivo, Holma, Pia, Holmberg, Ville, Horstia, Saana, Jalkanen, Ville, Jämsänen, Toni, Järventie, Juuso, Järvinen, Petrus, Kalliala, Ilkka, Kauma, Heikki, Kilpeläinen, Tuomas, Kreivi, Hanna-Riikka, Kuitunen, Ilari, Lamminmäki, Satu, Mäkinen, Laura, Mäntylä, Jarkko, Mattila, Tiina, Myllärniemi, Marjukka, Niskanen, Joni, Nykänen, Taina, Nyqvist, Miro, Paajanen, Juuso, Partanen, Terhi, Patovirta, Riitta-Liisa, Paukkeri, Erja-Leena, Puusti, Emmi, Renner, Andreas, Reponen, Emma, Risku, Sari, Rosberg, Tuomas, Rutanen, Jarno, Säilä, Petrus, Salonen, Päivi, Sinisalo, Marjatta, Sivenius, Katariina, Tuominen, Susanna, Aboab, Jerone, Alfaiate, Toni, Andrejak, Claire, Andreu, Pascal, Belhadi, Drifa, Benezit, Francois, Botelho-Nevers, Elisabeth, Bouadma, Lila, Bougon, David, Bouiller, Kevin, Bounes, Fanny, Boyer, Alexandre, Bruel, Cédric, Buffet, Alexandre, Burdet, Charles, Cazanave, Charles, Chabertier, Cyrille, Clere-Jehl, Rapahel, Costagliola, Dominique, Courjon, Johan-Victor, Crockett, Flora, Danion, Francois, Dechanet, Aline, Dellamonica, Jean, Delmas, Christelle, Diallo, Alpha, Djossou, Felix, Dubost, Clement, Dupont, Axelle, Epaulard, Olivier, Faure, Emmmanuel, Faure, Karine, Fayol, Antoine, Figueiredo, Samy, Fougerou, Claire, Gaborit, Benjamin, Gaci, Rostane, Gagneux-Brunon, Amandine, Gallien, Sebastien, Garot, D, Goehringer, Francois, Gruson, Didier, Hinschberger, Olivier, Hulot, Jean-Sebastien, Jaureguiberry, Stephane, Jean-Michel, Vanessa, Kerneis, Solen, Kimmoun, Antoine, Klouche, Kada, Lachatre, Marie, Lacombe, Karine, Laine, Fabrice, Lanoix, Jean Philippe, Laribi, Samira, Launay, Odile, Laviolle, Bruno, Le Moing, Vincent, Le Pavec, Jerome, Lebeaux, David, Leroy, Sylvie, Lescure, Xavier, Livrozet, Marine, Makinson, Alain, Malvy, Denis, Marquette, Charles-Hugo, Martin-Blondel, Guillaume, Mayaux, Julien, Mekontso Dessap, Armand, Mentre, France, Mercier, Noemie, Meziani, Ferhat, Molina, Jean Michel, Mootien, Yoganaden, Mourvillier, Bruno, Navellou, Jean Christoph, Noret, M, Peiffer- Smadja, Nathan, Peytavin, Gilles, Pialoux, Gilles, Pilmis, Benoît, Piroth, Lionel, Poindron, Vincent, Poissy, Julien, Pourcher, Valerie, Quenot, Jean Pierre, Raffi, Francois, Reignier, Jean, Richard, Jean Christoph, Robert, Céline, Saillard, Juliette, Sayre, Naomi, Senneville, Eric, Stefan, Francois, Tellier, Marie Capucine, Terzi, Nicolas, Textoris, Julien, Thiery, Guillame, Timsit, Jean Francois, Tolsma, Violaine, Tubiana, Sarah, Wallet, Florent, Yazdanpanah, Yazdan, Zerbib, Yoann, Aguilar, Carlos, Erazo, Laura, Fiallos, Angel, Figueroa, Rosbinda, Flores, Juan Jose, Melendez, Lesddyy, Moncada, Wendy, Abraham, Ooriapadickal Cherian, Acharya, Chetankumar, Aedula, Vinaya Sekhar, Aggarwal, Richa, Agrawal, Nishant, Agrawal, Umang, Agrawal, Abhishekh, Ahmad, Mohammad, Atal, Shubham, Babu, Avinash, Baidya, Dalim Kumar, Balachandran, Amith, Bangar, Rakhee, Bhadade, Rakesh, Bhandari, Sudhir, Bhapal, Meghavi, Bhardwaj, Pankaj, Bhati, Gaurav, Bhatia, Pradeep, Bhatt, Krishnakant, Bingi, Thrilok Chander, Borse, Rohidas, Buch, Vyom, Chand, Dipti, Chandwani, Ashish, Charan, Jaykaran, Chaudhari, Mayur, Chaudhari, Kirti, Chaudhary, Vipul, Chauhan, Nishant, Chikara, Gaurav, Daswani, Bharti, de Souza, Rosemarie, Desai, Chetna, Divakar, Balusamy, Divhare, Sujeet, Dorairajan, Suresh Kumar, Dutt, Naveen, Ethirajan, Therani Rajan, Gamit, Amit, Gamit, Sweta, Garg, Mahendra, Goenka, Ajay, Goenka, Aniket, Guleria, Randeep, Gupta, Paras, Gupta, Nivedita, Gupta, Madhur, Harde, Minal, Ingle, Vaibhav, Iyer, Shivkumar, Jamalapuram, Vaishnavi, Jayanthi, Rangarajan, Joshi, Rajnish, Kadam, Abhijeet, Kalakuntla, Hemanth, Kalikar, Mrunalini, Kalme, Sayali, Kamble, Suchit, Kant, Ravi, Kantharia, Bansari, Kashikar, Arundhati, Kavishvar, Abhay, Kayina, Choro Athipro, Kerkar, Pranali, Khadanga, Sagar, Khandare, Sagar, Kokate, Pranjali, Komathi, Jayavelu, Krishnan, Vijay, Krishnan, Jayasree, Krishnan, Sumitra, Kulur Mukhyaprana, Sudha, Kumarasamy, N, Mahavar, Sunil, Maitra, Souvik, Majumdar, Falguni, Malhotra, Supriya, Mamulwar, Megha, Malini, Padma, Marwah, Vikas, Maurya, Akhilesh, Mehta, Kedar, Mesipogu, Rajarao, Misra, Shobha, Mitra, Sajal, Mittal, Ankit, Mohan, Bharathi, Momin, Mohmmedirfan, Nag, Vijaya, Nagarajan, Ramakrishnan, Nagmani, Kammili, Narlawar, Uday, Natarajan, Gopalakrishnan, Nischal, Neeraj, Ogale, Dhananjay, Palat, Paltial, Panda, Prasan, Panda, Samiran, Pandya, Amee, Parate, Rohit, Paritekar, Arunita, Patel, Parvati, Patel, Chetna, Patel, Sunaina, Patel, Vitan, Patel, Deep, Patel, Harshad, Patil, Girish, Peter, Deepu, Prasad, Durga, Purohit, Vimlesh, Rabindrarajan, Ebenezer, Ranganathan, Lakshmiarasimhan, Rao, Tushara, Rao, Chakradhara, Rathod, Chirag, Raval, Devang, Ray, Avik, Reddy, Kamini, Rege, Sujata, Revathi, Ayyasamy, Roy, Dhara, Saigal, Saurabh, Sane, Suvarna, Sangale, Shashi, Seetharaman, Krishnamoorthy, Selvamuthu, Poongulali, Seshaiah, Kurada Venkata, Shadrach, Benhur, Shah, Jignesh, Shah, Sonal, Sharma, Swati, Sharma, Raman, Sharma, Shrikant, Singh, Krishna, Singh, Anil, Singh, Arjeet, Singhai, Abhishek, Soneja, Manish, Soni, Kapil Dev, Subhan, Thasneem banu, Subramaniam, Sudharshini, Sudarsanam, Thambu David, Sudarsi, Ravindra Kumar, Suleman, Dawood, Suthar, Nilay, Talati, Shriraj, Tambe, Murlidhar, Tejomurtula, Tilak, Tirupakuzhi Vijayaraghavan, Bharatkumar, Trikha, Anjan, Trivedi, Aarti, Udwadia, Zarir, Upadhyay, Kamlesh, Vasava, Ashwin, Vasudevan, Damodaran, Velayudham, Rajendran, Venkatasubramanian, Ramasubramanian, Verma, Mamta, Waghmare, Rakesh, Waikar, Anushka, Wig, Naveet, Afrilia, Annisa Rizky, Amin, Muhammad, Arlinda, Dona, Avrina, Rossa, Bang, Lois, Djaharuddin, Irawaty, Djojo, Aryan, Driyah, Sri Laning, Erastuti, Mila, Fajarwati, Tetra, Harsini, Harsini, Hartantri, Yovita, Herman, Deddy, Isbaniah, Fathiyah, Karyana, Muhammad, Kusuma, Indra, Mahmudji, Harli Amir, Medison, Irvan, Nugroho, Agung, Nurhayati, Nurhayati, Opitasari, Cicih, Pitoyo, Ceva Wicaksono, Pradana, Antonius Arditya, Raharjo, Sofyan Budi, Rahmaini, Ade, Risniati, Yenni, Riyanto, Bambang Sigit, Sajinadiyasa, I Gede Ketut, Sari, Flora Eka, Sitompul, Pompini Agustina, Soedarsono, Soedarsono, Somia, I Ketut Agus, Sugiri, Yani Jane, Sugiyono, Retna Indah, Susanto, Nugroho Harry, Syarif, Armaji Kamaludi, Yulianto, Aris, Afsharian, Mandana, Akhavi Mirab, Atefehsadat, Amini, Fatemeh, Amini, Mahnaz, Ansarin, Khalil, Baba Mahmoodi, Farhang, Baghaei, Parvaneh, Barazandeh, Fateme, Bayani, Masomeh, Dastan, Farzaneh, Ebrahimpour, Soheil, Eghtesad, Sareh, Fallahi, Mohammad Javad, Fallahpoor Golmaee, Fatemeh, Foroghi Ghomi, Seyed Yaser, Ghadir, Mohammad Reza, Gheitani, Mina, Ghiasvand, Fereshteh, Hafizi Lotfabadi, Saied, Hakamifard, Atousa, Hashemi Madani, Shima Sadat, Hormati, Ahmad, Hosseini, Hamed, Janbakhsh, Alireza, Javanian, Mostafa, Joukar, Farahnaz, Kamali, Alireza, Karampour, Amin, Khajavirad, Nasim, Khodabakhshi, Behnaz, Khodadadi, Javad, Khodashahi, Rozita, Kiani Majd, Somaieh, Mahfoozi, Lida, Mahmoodiyeh, Behnam, Mansour-Ghanaei, Fariborz, Mansouri, Feizollah, Mesgarpour, Bita, Mesri, Mehdi, Mikaeili, Haleh, Miladi, Ronak, Moghadami, Mohsen, Mohamadi, Payam, Mohraz, Minoo, Mohseni Afshar, Zeinab, Moogahi, Sasan, Mousavi Anari, Seyed Alireza, Mozaffar, Seyyed Hassan, Mozdourian, Mahnaz, Najafipour, Reza, Najari, Hamidreza, Nazemiyeh, Masoud, Norouzi, Alireza, Pourkazemi, Aydin, Poustchi, Hossein, Saberhosseini, Seyedeh Naeimeh, Saberi, Marzieh, Saber-Moghaddam, Niloufar, Sadeghi, Anahita, Sadeghi Haddad Zavareh, Mahmoud, Sahraian, Mohammad Ali, Salahi, Mehrdad, Salehi, Mohammad Reza, Sarmadian, Hossein, Sayad, Babak, Shirani, Kiana, Shirvani, Maria, Shojaei, Daryanaz, Shokri, Mehran, Siami, Zeinab, Sima, Ali Reza, Soleimani, Alireza, Soltanmohammad, Saedeh, Tabarsi, Payam, Taghizadieh, Ali, Tavassoli, Samaneh, Varnasseri, Mehran, Vaziri, Siavash, Yadyad, Mohammad Jaafar, Yaghoubi, Shoeleh, Yazdanpanah, Yalda, Yousefi, Farid, Zamanian, Mohammad Hossein, Zand, Farid, Zare Hoseinzade, Elham, Bergin, Colm, Cotter, Aoife, de Barra, Eoghan, Jackson, Arthur, Laffey, John, McCarthy, Cormac, Muldoon, Eavan, Sadlier, Corinna, Maguire, Teresa, Angheben, Andrea, Bai, Francesca, Bandera, Alessandra, Barchiesi, Francesco, Bassetti, Matteo, Bisi, Luca, Bonfanti, Paolo, Calò, Federica, Campoli, Caterina, Canovari, Benedetta, Capetti, Amedeo, Castelli, Francesco, Cauda, Roberto, Cingolani, Antonella, Cocco, Nicolò, Coppola, Nicola, Corcione, Silvia, Cremonini, Eleonora, d'Arminio Monforte, Antonella, de Gaetano Donati, Katleen, De Nardo, Pasquale, De Rosa, Francesco Giuseppe, Degioanni, Maria, Della Siega, Paola, Di Bella, Stefano, Drera, Bruno, Focà, Emanuele, Fornabaio, Chiara, Galli, Massimo, Giacomazzi, Donatella, Gori, Andrea, Gustinetti, Giulia, Iannuzzi, Francesca, Kertusha, Blerta, Lamonica, Silvia, Lichtner, Miriam, Lupia, Tommaso, Luzzati, Roberto, Macera, Margherita, Menatti, Elisabetta, Merelli, Maria, Merlini, Esther, Monari, Caterina, Pan, Angelo, Pecori, Davide, Pezzani, Diletta, Riccardi, Niccolò, Rodari, Paola, Roldan, Eugenia, Rovere, Pierangelo, Rusconi, Stefano, Scabini, Silvia, Tascini, Carlo, Viale, Pierluigi, Vincenzi, Marcello, Zuccalà, Paola, Zucchi, Patrizia, Al-Roomi, Moudhi, Al-Sabah, Salman, Schrapp, Kelly, Hassoun, Mahmoud, Matar, Madonna, Dbouni, Oussaima, Yared, Nadine, Saliba, Michele, Farra, Anna, Riachi, Moussa, Zablockiene, Birute, Reuter, Jean, Staub, Therese, Ab Wahab, Suhaila, Chew, Chun Keat, Chua, Hock Hin, Goh, Pik Pin, Lee, Heng Gee, Leong, Chee Loon, Low, Lee Lee, Mak, Wen Yao, Mohamed Gani, Yasmin, Muhamad, Dzawani, Zaidan, Nor Zaila, Ducker, Camilla, Demiri, Ilir, Aballi, Saad, Berg, Åse, Blomberg, Bjørn, Dalgard, Olav, Dyrhol-Riise, Anne Ma, Eiken, Ragnhild, Ernst, Gernot, Hannula, Ranula, Haugli, Metter, Heggelund, Lars, Hoel, Hedda, Hoff, Dag Arne Lihaug, Holten, Aleksander Rygh, Johannessen, Asgeir, Kåsine, Trine, Kildal, Anders Benjamin, Kittang, Bård Reikvam, Nezvalova-Henriksen, Katerina, Olsen, Inge Christoffer, Olsen, Roy Bjørkolt, Skei, Nina Vibeche, Skudal, Hilde, Tholin, Birgitte, Thoresen, Lars, Trøseid, Marius, Tveita, Anders, Vinge, Leif, Ystrøm, Carl Magnus, Al Jahdhami, Issa, AlNaamani, Khalid, Al Balushi, Zakariya, Pandak, Nenad, Abbas, Salma, Akhtar, Nasim, Azam, Sumeyya, Begum, Dilshad, Hassan, Sadia, Herekar, Fivzia, Khan, Shahzaib, Khan, Ejaz Ahmed, Mahmood, Syed Faisal, Nasir, Nosheen, Rahim, Anum, Sarfaraz, Samreen, Shaikh, Qurat-ul-Ain, Sultan, Faisal, Walayat, Usman, Agurto-Lescano, Erika Cecilia, Alcantara-Díaz, Andrés Martín, Alva-Correa, Ana María, Alvarado-Moreno, José Gustavo, Ángeles-Padilla, Bethsabé, Arbañil-Huamàn, Hugo César, Ávila-Reyes, Pool Christopher, Azañero-Haro, Johan Alexander, Barreto-Rocchetti, Luis Guillermo, Benitez-Peche, Jorge Marko A., Bernal-Màlaga, Karla Hortencia, Cabrera-Portillo, Liliana Norma, Carazas-Chavarry, Reynaldo Javier, Càrcamo, Paloma Mariana, Casimiro-Porras, Indira Catalina, Castillo-Espinoza, Jhuliana, Chacaltana-Huarcaya, Jesús Norberto, Cornejo-Valdivia, Carla Raquel, Cruz-Chereque, Augusto, Del-Aguila-Torres, Keith Cayetano Marcelino, Díaz-Chipana, Erika, Flores-Valdez, Neil, Franco-Vàsquez, Rosanna Andrea, Gallegos-López, Roxana Consuelo, Gastiaburú-Rodriguez, Dauma Yesenia, Gianella-Malca, Gonzalo Ernesto, Gomero-Lopez, Andrés Alonso, Hercilla-Vàsquez, Luis Enrique, Hueda-Zavaleta, Miguel Ángel, Ibarcena-Llerena, Claudia Vanessa, Iberico-Barrera, Carlos Alberto, Inquilla-Castillo, Miguel Angel, Juàrez-Eyzaguirre, Jesus Alberto, Laca-Barrera, Manuel, León-Jiménez, Franco, Luna-Wilson, Carla Vanessa, Màlaga, German, Marin, Ricardo, Mejía-Cordero, Fernando, Mendoza-Laredo, Juan Arturo, Meregildo-Rodríguez, Edinson Dante, Miranda-Manrique, Gonzalo Francisco, Olivera-Chaupis, Marco, Ortega-Monasterios, Fatima Josefina, Otazú-Ybàñez, Jimmy Pedro, Paredes-Moreno, María Angélica, Peña-Mayorga, Claudia Ximena, Peña-Vàsquez, Olivia del Carmen, Peña-Villalobos, Alejandro, Ponce, Oscar J, Ponte-Fernandez, Katherin Estefania, Pro, Jose, Quispe-Nolazco, César Miguel, Ramos-Samanez, Manuel Efrain, Rojas-Murrugarra, Kory Mirtha, Samanez-Pérez, Jorge Mauro, Sànchez-Carrillo, Halbert Chrostian, Sànchez-Garavito, Epifanio, Sànchez-Sevillano, Ricardo Manuel, Sandoval-Manrique, Hernan, Santos-Revilla, Gabriela, Silva-Ramos, Julio Antonio, Solano-Ico, Manuel Alberto, Soto, Alonso, Sotomayor-Woolcott, Giannilu Michelle, Tapia-Orihuela, Ruben Kevin Arnold, Terrazas-Obregón, Carmen Sara, Terrones-Levano, Victor Francisco, Ticona-Huaroto, Cesar Eduardo, Torres-Ninapayta, Walter, Torres-Ruiz, Oscar Martin, Ugarte-Mercado, Dario, Vargas-Anahua, Orlando José, Vàsquez-Becerra, Ruben Dario, Vàsquez-Cerro, José Gabriel, Villegas-Chiroque, Miguel, Williams, Anna Larson, Yauri-Lazo, Randi Mauricio, Abad, Cybele Lara, Andales-Bacolcol, Silverose Ann, Arcegono, Marlon, Arches, Jamie, Astudillo, Mary Grace, Aventura, Emily, Awing, Arlyn, Bala, Mishelle Vonnabie, Bello, Jia An, Blanco, Peter, Benedicto, Jubert, Buno, Susana, Cabrera, Justine, Cajulao, Thea Pamela, Caoili, Janice, Casiple-Amsua, Lina, Catambing, Victor, Chin, Inofel, Chua, Ma. Bernadette, Chua, Mitzi Marie, Climacosa, Fresthel Monica, David-Wang, Aileen, De los Reyes, Virginia, Europa, Gilly May, Fernandez, Lenora, Francisco, Jorge, Garcia, Gerard, Garcia, Jemelyn, Gler, Maria Tarcela, Isidro, Marie Grace Dawn, Javier, Rozelle Jade, Kwek, Marion, Lansang, Mary Ann, Lee, Aileen, Li, Kingbherly, Llanes, Mark Ramon Victor, Llorin, Ryan, Macadato, Omar Khayyam, Malundo, Anna Flor, Mercado, Maria Elizabeth, Mujeres, Mercedes, Nepomuceno, Marisse, Ngo-Sanchez, Katha, Orden, Mary Claire, Pablo-Villamor, Maria Philina, Paez, Ruel Dionisio, Palmes, Patricio, Panaligan, Marion, Quinivista-Yoon, Jenny Mae, Ramos, Mary Shiela Ariola, Ramos -Penalosa, Christine, Reyes, Sheila Marie, Roa, Kathryn, Roman, Arthur Dessi, Rosario, Minette Claire, Roxas, Evalyn, Santos, Lourdes Ella Gonzales, Soldevilla, Helmar, Solante, Rontgene, Suaco, Jane, Tagarda, Daisy, Tang, Issa Rufina, Te, Bob, Teo, Dennis, Tibayan, Christopher John, Villalobos, Ralph Elvi, Ymbong, Duane Richard, Zabat, Gelza Mae, Batkova, Stepanka, Cardoso, Orlando, Garrote, Ana-Raquel, Lino, Sara, Manata, Maria-José, Pinheiro, Helder, Póvoas, Diana, Ramirez, Freddy, Seixas, Diana, Naji, Assem, Al Gethamy, M Al, AL-Mulaify, Mohammed Sami, Al Maghraby, Reem, Alrajhi, A, Al Sharidi, Aynaa, Alotaibi, Naif, AlShaharani, F, Barry, Mazin, Ghonem, Leen, Khalel, Anas, Kharaba, Ayman Mohammed, Alabdan, Lulwah, AlAbdullah, Mohammed Sharaf, Al Shabib, Abdullah, Bengu, Simangele, Bennet, Jacklyn, Dubula, Thozama, Howell, Pauline, Janse van Vuuren, Cloete, Kalla, Ismail, Lifson, Aimee, Maasdorp, Shaun, Magua, Nombulelo, Maluleke, Vongani, Mbhele, Nokuphiwa, Mdladla, Nathi, Mendelson, Mark, Menezes, Colin, Mwelase, Thando, Nchabeleng, Maphoshane, Palanee-Phillips, Thesla, Parker, Victoria, Rassool, Mohammed, Reeder, Paul, Sossen, Bianca, Steyn, Dewald, Tsitsi, Merika, van Blydenstein, Sarah Alex, Venter, Michelle, Van Vuuren, Janse, Venturas, Jacquie, Abad Pérez, Daniel, Abenza, Maria José, Alarcón-Payer, Carolina, Armero Garrigos, Eva, Arribas, Jose Ramon, Ascaso, Ana, Berenguer, Juan, Cabello-Clotet, Noemí, Chamorro Tojeiro, Sandra, Cuenca-Acevedo, Rafael, de la Calle, Fernando, Del Toro, Maria Dolores, Díaz Pollàn, Beatriz, Diez, Cristina, Esquillor-Rodrigo, María José, Estrada, Vicente, Fanciulli, Chiara, Fanjul, Francisco, Fernàndez de Orueta, Lucía, Ferre, Adrian, Ferreira Pasos, Eva Maria, Gainzarain-Arana, Juan-Carlos, Garcia, Felipe, García Deltoro, Miguel, Goikoetxea Agirre, Ane Josune, Gómez Barquero, Julia, Gomez-Huelgas, Ricardo, Gonzàlez Moraleja, Julio, Guijarro, Carlos, Gutierrez, Felix, Guzmàn, Jesús, Ibarguren, Maialen, Iribarren, Jose Antonio, Jerusalem, Koen, Juan Arribas, Arturo, Lalueza, A, Leone, Antonio, Lopez Azkarreta, Iñigo, Lozano-Martin, Daniel, Lucendo, Alfredo J, Luengo López, Mariella, Martín Oterino, JA, Masa, JF, Merino, Esperanza, Monge-Maillo, Begoña, Moran-Rodríguez, Miguel-Angel, Muñez Rubio, Elena, Muñoz Sanchez, Josefa, Nuñez Orantos, Maria Jose, Nuño, Enrique, Ortiz-De-Zarate-Ibarra, Zuriñe, Pagàn-Muñoz, Bàrbara, Paño-Pardo, José Ramón, Peñaranda, Maria, Pérez Chica, Gerardo, Pérez Fernàndez, AM, Pérez-López, Carmen, Polo San Ricardo, Victor, Portu-Zapirain, Joseba, Puchades, Francesco, Rivas Paterna, Ana Belen, Rodríguez Vidigal, Francisco F, Rodríguez-Baño, Jesus, Ruiz-Seco, Pilar, Ryan, Pablo, Saez-De-Adana, Ester, Salas, Rosario, Salavert Lletí, Miguel, Sandoval, Raquel, Toyas-Miazza, Carla, Valencia, Jorge, Vargas, Emilio, Velasco, Maria, Von Wichmann, Miguel Angel, Bosshard, Andreas, Calmy, Alexandra, Castro, Tiago, Cavassini, Matthias, Clerc, Olivier, Conen, Anna, Desbaillets, Nicolas, Desgranges, Florian, Duss, Francois, Emonet, Stephane, Erard, Veronique, Eyer, Myriam, Fayet-Mello, Aurélie, Flammer, Yvonne, Friedl, Andrée, Fulchini, Rosamaria, Furrer, Hansjakob, Garin, Nicolas, Gastberger, Salome, Greiner, Michael, Haefliger, David, Haubitz, Sebastian, Hoffmann, Matthias, Isenring, Egon, Jakopp, Barbara, Lampert, Markus, Marinosci, Annalisa, Martin, Yvonne, Petignat, Pierre-Auguste, Piso, Rein Jan, Prendki, Virginie, Rutishauser, Jonas, Schaefer, Elisabeth, Schmiedel, Yvonne, Schwery, Stefan, Stavropoulou, Elisavet, Stoeckle, Marcel, Suttels, Veronique, Thurnher, Maria Christine, van den Bogaart, Lorena, West, Emily, Wiegand, Jan, and Wiggli, Benedikt

Published
2022
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3. Efficacy and Safety of Dolutegravir Plus Emtricitabine vs Combined Antiretroviral Therapy for the Maintenance of HIV Suppression: Results Through Week 144 of the SIMPL'HIV Trial.

Author

Marinosci, Annalisa, Sculier, Delphine, Wandeler, Gilles, Yerly, Sabine, Stoeckle, Marcel, Bernasconi, Enos, Braun, Dominique L, Vernazza, Pietro, Cavassini, Matthias, Decosterd, Laurent, Günthard, Huldrych F, Schmid, Patrick, Limacher, Andreas, Branca, Mattia, Calmy, Alexandra, and Study, the Swiss HIV Cohort

Subjects
*PATIENT satisfaction, *ANTIRETROVIRAL agents, *DOLUTEGRAVIR, *EMTRICITABINE, *QUALITY of life
Abstract

The SIMPL'HIV study investigated whether switching to dolutegravir (DTG) + emtricitabine (FTC) was noninferior to continuing combined antiretroviral therapy for maintaining HIV-1 suppression at 144 weeks. The study demonstrated that viral suppression, CD4 gains, adverse events, quality of life, and patient satisfaction were comparable between groups, confirming DTG + FTC's safety and efficacy for long-term management of HIV-1 infection. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Post-exposure Lopinavir-Ritonavir Prophylaxis versus Surveillance for Individuals Exposed to SARS-CoV-2: The COPEP Pragmatic Open-Label, Cluster Randomized Trial

Author

Labhardt, Niklaus D, Smit, Mikaela, Petignat, Ianis, Perneger, Thomas, Marinosci, Annalisa, Ustero, Pilar, Diniz Ribeiro, Maria Pia, Ragozzino, Silvio, Nicoletti, Giovanni Jacopo, Faré, Pietro Benedetto, Andrey, Diego O, Jacquerioz, Frederique, Lebowitz, Dan, Agoritsas, Thomas, Meyer, Benjamin, Spechbach, Hervé, Salamun, Julien, Guessous, Idris, Chappuis, François, Kaiser, Laurent, Decosterd, Laurent Arthur, Grinsztejn, Beatriz, Bernasconi, Enos, Cardoso, Sandra Wagner, Calmy, Alexandra, and Team, for the COPEP Study

Published
2021
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6. Role of the HIV-1 Reservoir to Maintain Viral Suppression in a Simplified Strategy for the Long-Term Management of HIV-1 Infection (The SIMPL’HIV Trial)

Author

Mattia Branca, Annalisa Marinosci, Delphine Sculier, Gilles Wandeler, Sabine Yerly, Marcel Stoeckle, Enos Bernasconi, Dominique L. Braun, Kathrin Neumann, Pietro Vernazza, Matthias Cavassini, Marta Buzzi, Laurent A. Decosterd, Patrick Schmid, Andreas Limacher, Huldrych F. Günthard, Karin J. Metzner, and Alexandra Calmy

Subjects
HIV-1 reservoir, dolutegravir+emtricitabine, dual therapy, cART, HIV-1 RNA, Microbiology, QR1-502
Abstract

HIV-1 reservoir size and dynamics are promising parameters to ensure the safe prescription of simplified maintenance antiretroviral therapy in chronically HIV-1 infected patients. In the SIMPL’HIV trial, HIV-1 DNA was quantified in peripheral blood mononuclear cells obtained at baseline and week 48 to investigate changes over time and evidence of a predictive relationship to maintain HIV-1 RNA

Published
2022
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7. Costs and acceptability of simplified monitoring in HIV-suppressed patients switching to dual therapy: the SIMPL’HIV open-label, factorial randomised controlled trial

Author

Marinosci, Annalisa; https://orcid.org/0000-0002-8054-0044, Sculier, Delphine; https://orcid.org/0000-0002-6741-9813, Wandeler, Gilles; https://orcid.org/0000-0002-5278-8763, Yerly, Sabine; https://orcid.org/0000-0003-1668-696X, Stoeckle, Marcel; https://orcid.org/0000-0002-0088-5078, Bernasconi, Enos; https://orcid.org/0000-0002-9724-8373, Braun, Dominique L; https://orcid.org/0000-0003-4036-1030, Vernazza, Pietro; https://orcid.org/0000-0002-6849-6941, Cavassini, Matthias; https://orcid.org/0000-0003-0933-7833, Buzzi, Marta, Metzner, Karin J; https://orcid.org/0000-0003-4862-1503, Decosterd, Laurent, Günthard, Huldrych F; https://orcid.org/0000-0002-1142-6723, Schmid, Patrick, Limacher, Andreas; https://orcid.org/0000-0002-9094-9476, Branca, Mattia; https://orcid.org/0000-0002-8063-7882, Calmy, Alexandra; https://orcid.org/0000-0002-1137-6826, Marinosci, Annalisa; https://orcid.org/0000-0002-8054-0044, Sculier, Delphine; https://orcid.org/0000-0002-6741-9813, Wandeler, Gilles; https://orcid.org/0000-0002-5278-8763, Yerly, Sabine; https://orcid.org/0000-0003-1668-696X, Stoeckle, Marcel; https://orcid.org/0000-0002-0088-5078, Bernasconi, Enos; https://orcid.org/0000-0002-9724-8373, Braun, Dominique L; https://orcid.org/0000-0003-4036-1030, Vernazza, Pietro; https://orcid.org/0000-0002-6849-6941, Cavassini, Matthias; https://orcid.org/0000-0003-0933-7833, Buzzi, Marta, Metzner, Karin J; https://orcid.org/0000-0003-4862-1503, Decosterd, Laurent, Günthard, Huldrych F; https://orcid.org/0000-0002-1142-6723, Schmid, Patrick, Limacher, Andreas; https://orcid.org/0000-0002-9094-9476, Branca, Mattia; https://orcid.org/0000-0002-8063-7882, and Calmy, Alexandra; https://orcid.org/0000-0002-1137-6826

Abstract

BACKGROUND: Clinical and laboratory monitoring of patients on antiretroviral therapy is an integral part of HIV care and determines whether treatment needs enhanced adherence or modification of the drug regimen. However, different monitoring and treatment strategies carry different costs and health consequences. MATERIALS AND METHODS: The SIMPL’HIV study was a randomised trial that assessed the non-inferiority of dual maintenance therapy. The co-primary outcome was a comparison of costs over 48 weeks of dual therapy with standard antiretroviral therapy and the costs associated with a simplified HIV care approach (patient-centred monitoring [PCM]) versus standard, tri-monthly routine monitoring. Costs included outpatient medical consultations (HIV/non-HIV consultations), non-medical consultations, antiretroviral therapy, laboratory tests and hospitalisation costs. PCM participants had restricted immunological and blood safety monitoring at weeks 0 and 48, and they were offered the choice to complete their remaining study visits via a telephone call, have medications delivered to a specified address, and to have blood tests performed at a location of their choice. We analysed the costs of both strategies using invoices for medical consultations issued by the hospital where the patient was followed, as well as those obtained from health insurance companies. Secondary outcomes included differences between monitoring arms for renal function, lipids and glucose values, and weight over 48 weeks. Patient satisfaction with treatment and monitoring was also assessed using visual analogue scales. RESULTS: Of 93 participants randomised to dolutegravir plus emtricitabine and 94 individuals to combination antiretroviral therapy (median nadir CD4 count, 246 cells/mm3; median age, 48 years; female, 17%),patient-centred monitoring generated no substantial reductions or increases in total costs (US$ –421 per year [95% CI –2292 to 1451]; p = 0.658). However, dual therapy was significa

Published
2024

9. Viral Infections and Cutaneous Drug-Related Eruptions

Author

Eleonora Anci, Camille Braun, Annalisa Marinosci, Frédérique Rodieux, Elise Midun, Maria-Jose Torres, and Jean-Christoph Caubet

Subjects
drug, hypersensitivity, allergy, virus, mechanism, Therapeutics. Pharmacology, RM1-950
Abstract

In the general population, up to 10% of children treated by antibiotics have cutaneous adverse drug reaction, but allergy is confirmed in less than 20% of patients. Most of the non-allergic reactions are probably due to virus, such as enterovirus acute infection or Ebstein-Barr Virus (EBV) acute infection or reactivation. Especially in children, viruses have the propensity to induce skin lesions (maculopapular rash, urticaria) due to their skin infiltration or immunologic response. In drug-related skin eruptions, a virus can participate by activating an immune predisposition. The culprit antibiotic is then the trigger for reacting. Even in severe drug-induced reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, viruses take part in immune phenomena, especially herpes viruses. Understanding the mechanisms of both virus- and drug-induced skin reaction is important to develop our clinical reflection and give an adaptive care to the patient. Our aim is to review current knowledge on the different aspects and potential roles of viruses in the different type of drug hypersensitivity reactions (DHR). Although major advances have been made those past year, further studies are needed for a better understanding of the link between viruses and DHR, to improve management of those patients.

Published
2021
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11. Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial.

Author

Delphine Sculier, Gilles Wandeler, Sabine Yerly, Annalisa Marinosci, Marcel Stoeckle, Enos Bernasconi, Dominique L Braun, Pietro Vernazza, Matthias Cavassini, Marta Buzzi, Karin J Metzner, Laurent A Decosterd, Huldrych F Günthard, Patrick Schmid, Andreas Limacher, Matthias Egger, Alexandra Calmy, and Swiss HIV Cohort Study (SHCS)

Subjects
Medicine
Abstract

BackgroundDolutegravir (DTG)-based dual therapy is becoming a new paradigm for both the initiation and maintenance of HIV treatment. The SIMPL'HIV study investigated the outcomes of virologically suppressed patients on standard combination antiretroviral therapy (cART) switching to DTG + emtricitabine (FTC). We present the 48-week efficacy and safety data on DTG + FTC versus cART.Methods and findingsSIMPL'HIV was a multicenter, open-label, non-inferiority randomized trial with a factorial design among treatment-experienced people with HIV in Switzerland. Participants were enrolled between 12 May 2017 and 30 May 2018. Patients virologically suppressed for at least 24 weeks on standard cART were randomized 1:1 to switching to DTG + FTC or to continuing cART, and 1:1 to simplified patient-centered monitoring versus standard monitoring. The primary endpoint was the proportion of patients virologically suppressed with ConclusionsIn this study, DTG + FTC as maintenance therapy was non-inferior to cART in terms of efficacy, with a similar safety profile and a greater improvement in quality of life, thus expanding the offer of 2-drug simplification options among virologically suppressed individuals.Trial registrationClinicalTrials.gov NCT03160105.

Published
2020
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12. Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial

Author

François Chappuis, Idris Guessous, Thomas Perneger, Manuel Battegay, Laurent Kaiser, Mikaela Smit, Frederique Jacquerioz, Annalisa Marinosci, Giovanni Jacopo Nicoletti, Silvio Ragozzino, Diego O Andrey, Dan Lebowitz, Benjamin Meyer, Herve Spechbach, Julien Salamun, Moritz Back, Carla Schaubhut, Simon Fuchs, Laurent Decosterd, and Niklaus D Labhardt

Subjects
Medicine
Abstract

Introduction Lopinavir/ritonavir (LPV/r) has been proposed as repurposed drugs for pre-exposure and postexposure prophylaxis as well as therapy of COVID-19. Coronavirus postexposure prophylaxis (COPEP) trial aims at assessing their efficacy as postexposure ring-prophylaxis among adults exposed to SARS-CoV-2.Methods and analysis COPEP is a two-arm open-label cluster-randomised trial conducted in three cantons of Switzerland. Asymptomatic contacts (≥16 years) of individuals diagnosed with COVID-19 will be randomised (2:1) to either LPV/r (400 mg/100 mg two times per day) for 5 days, or a standard of care arm (no treatment). Asymptomatic individuals may be either SARS-CoV-2 positive or negative. Contacts living in the single household will form a cluster and will be randomised into the same arm. All participants will be followed-up for 21 days and undergo daily monitoring for COVID-19 symptoms. The primary endpoint is 21-day incidence of laboratory-confirmed COVID-19 with ≥1 compatible symptom, analysed in an intention-to-treat (ITT) analysis. The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology at baseline. Assuming a 21-day incidence for COVID-19 of 20% among contacts without postexposure chemoprophylaxis, to detect a relative risk reduction of 60% (ie, translating in an absolute reduction from 20% to 8%), with a power of 80%, an alpha of 5%. Accounting for design effect of cluster design of circa 1.1, we plan to enrol 200 participants to the LPV/r arm and 100 to the standard of care arm, 300 participants in total.Ethics and dissemination Ethics approval has been granted by the Commission Cantonale d’Ethique de la Recherche, Ethikkommission Nordwest- und Zentralschweiz and Comitato Etico Cantonale (ref 2020-00864) and Swissmedic (2020DR3056). Results from this trial will be disseminated via journal articles and presentations at national and international conferences.Trial registration number Clinicaltrials.gov Registry (NCT04364022); Swiss National Clinical Trial Portal Registry (SNCTP 000003732).Registered report identifier CCER 2020-0864.

Published
2020
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17. Role of the HIV-1 Reservoir to Maintain Viral Suppression in a Simplified Strategy for the Long-Term Management of HIV-1 Infection (The SIMPL’HIV Trial)

Author

Branca, Mattia, primary, Marinosci, Annalisa, additional, Sculier, Delphine, additional, Wandeler, Gilles, additional, Yerly, Sabine, additional, Stoeckle, Marcel, additional, Bernasconi, Enos, additional, Braun, Dominique L., additional, Neumann, Kathrin, additional, Vernazza, Pietro, additional, Cavassini, Matthias, additional, Buzzi, Marta, additional, Decosterd, Laurent A., additional, Schmid, Patrick, additional, Limacher, Andreas, additional, Günthard, Huldrych F., additional, Metzner, Karin J., additional, and Calmy, Alexandra, additional

Published
2022
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18. Role of the HIV-1 Reservoir to Maintain Viral Suppression in a Simplified Strategy for the Long-Term Management of HIV-1 Infection (The SIMPL’HIV Trial)

Author

Branca, Mattia, Marinosci, Annalisa, Sculier, Delphine, Wandeler, Gilles, Yerly, Sabine, Stoeckle, Marcel, Bernasconi, Enos, Braun, Dominique L, Neumann, Kathrin, Vernazza, Pietro, Cavassini, Matthias, Buzzi, Marta, Decosterd, Laurent A, Schmid, Patrick, Limacher, Andreas, Günthard, Huldrych F, Metzner, Karin J, Calmy, Alexandra, Branca, Mattia, Marinosci, Annalisa, Sculier, Delphine, Wandeler, Gilles, Yerly, Sabine, Stoeckle, Marcel, Bernasconi, Enos, Braun, Dominique L, Neumann, Kathrin, Vernazza, Pietro, Cavassini, Matthias, Buzzi, Marta, Decosterd, Laurent A, Schmid, Patrick, Limacher, Andreas, Günthard, Huldrych F, Metzner, Karin J, and Calmy, Alexandra

Abstract

HIV-1 reservoir size and dynamics are promising parameters to ensure the safe prescription of simplified maintenance antiretroviral therapy in chronically HIV-1 infected patients. In the SIMPL’HIV trial, HIV-1 DNA was quantified in peripheral blood mononuclear cells obtained at baseline and week 48 to investigate changes over time and evidence of a predictive relationship to maintain HIV-1 RNA <20 copies/ml. Measurements were available for 175 patients, with no differences observed between treatment strategies. Findings showed that baseline HIV-1 DNA was lower in those with durable HIV-1 RNA <20 copies/ml compared with patients with incomplete viral suppression over 48 weeks.

Published
2022

19. Pharmacokinetic parameters and weight change in HIV patients newly switched to dolutegravir-based regimens in SIMPL'HIV clinical trial

Author

Enos Bernasconi, Charlotte Barbieux, Matthias Cavassini, Pietro Vernazza, Dominique L Braun, Delphine Sculier, Alexandra Calmy, Patrick Schmid, Laurent A. Decosterd, Monia Guidi, Perrine Courlet, Marcel Stoeckle, Gilles Wandeler, Huldrych F. Günthard, Mikaela Smit, Andreas Limacher, Susana Alves Saldanha, Annalisa Marinosci, University of Zurich, and Courlet, Perrine

Subjects
10028 Institute of Medical Virology, Oncology, medicine.medical_specialty, Anti-HIV Agents, Pyridones, 610 Medicine & health, HIV Infections, 030226 pharmacology & pharmacy, Piperazines, 10234 Clinic for Infectious Diseases, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacokinetics, Internal medicine, Oxazines, medicine, 2736 Pharmacology (medical), Humans, Pharmacology (medical), 030212 general & internal medicine, HIV Integrase Inhibitors, Pharmacology, Reverse-transcriptase inhibitor, business.industry, Weight change, Confounding, 3. Good health, Clinical trial, Regimen, 3004 Pharmacology, Treatment Outcome, chemistry, Dolutegravir, Female, medicine.symptom, business, Weight gain, Heterocyclic Compounds, 3-Ring, medicine.drug
Abstract

This study aims to evaluate the association between dolutegravir (DTG) pharmacokinetic parameters and weight changes in treatment-experienced people with HIV (PWHIV) from the Simpl'HIV study newly switched to a dual DTG-based regimen. We used multivariable linear regressions to evaluate the association between DTG pharmacokinetic parameters at week 48 (derived using an established model) and weight change between week 0 and week 48. We adjusted our model for potential confounders including CD4 nadir, female sex, African origin, age, weight at week 0 and presence of a non-nucleoside reverse transcriptase inhibitor-based regimen before switch to DTG. The analysis included data from 39 PWHIV. An average significant weight gain of 2.4 kg was observed between baseline and week 48. DTG plasma exposure was not significantly associated with weight gain, even after adjusting for potential confounders (P = .9). We found no significant association between DTG pharmacokinetic parameters and weight gain amongst PWHIV newly switched to a DTG-based dual regimen.

Published
2021

21. Efficacy of Lopinavir-Ritonavir Prophylaxis for Individuals Exposed to SARS-CoV-2: The COPEP Pragmatic Open-Label, Cluster Randomized Trial

Author

Niklaus D. Labhardt, Mikaela Smit, Ianis Petignat, Thomas Perneger, Annalisa Marinosci, Piluca Ustero, Maria Pia Diniz Ribeiro, Silvio Ragozzino, Giovanni Jacopo Nicoletti, Pietro Benedetto Faré, Diego O. Andrey, Frederique Jacquerioz, Dan Lebowitz, Thomas Agoritsas, Benjamin Meyer, Hervé Spechbach, Julien Salamun, Idris Guessous, François Chappuis, Laurent Kaiser, Laurent Arthur Decosterd, Beatriz Grinsztejn, Enos Bernasconi, Sandra Wagner Cardoso, Alexandra Calmy, and The COPEP Study Team

Subjects
medicine.medical_specialty, business.industry, Hazard ratio, Lopinavir/ritonavir, Lopinavir, Clinical trial, Interquartile range, Internal medicine, Clinical endpoint, medicine, Ritonavir, Cluster randomised controlled trial, business, medicine.drug
Abstract

Background: Since the beginning of the COVID-19 pandemic, no direct antiviral treatment is effective as post-exposure prophylaxis (PEP). Lopinavir/ritonavir (LPV/r) was repurposed as a potential PEP agent against COVID-19. Methods: We conducted a pragmatic open-label, parallel, cluster-randomized superiority trial in four sites in Switzerland and Brazil. Clusters were randomized to receive LPV/r PEP (400/100 mg) twice daily for 5 days or no PEP (surveillance). The primary outcome is the occurrence of COVID-19 within 21 days post-enrollment. Findings: Of 318 participants, 157 (49.4%) were women, median age was 39 (interquartile range, 28-50) years. A total of 209 (179 clusters) participants were randomized to LPV/r PEP and 109 (95 clusters) to surveillance. Baseline characteristics were similar, with the exception of baseline SARS-CoV-2 PCR positivity, which was 3-fold more frequent in the LPV/r arm (34/209 [16.3%] vs 6/109 [5.5%], respectively). During 21-day follow-up, 48/318 (15.1%) participants developed COVID-19: 35/209 (16.7%) in the LPV/r group and 13/109 (11.9%) in the surveillance group (unadjusted hazard ratio 1.44; 95% CI, 0.76 to 2.73). In the primary endpoint analysis adjusted for propensity score to receive LPV/r, the hazard ratio for developing COVID-19 in the LPV/r group vs surveillance was 0.53 (95% CI, 0.23 to 1.23, respectively; P =.14). Interpretation: LPV/r role as PEP for COVID-19 remains unanswered. In this trial, LPV/r over 5 days did not significantly reduce incidence of COVID-19 in exposed individuals. We observed a change in directionality of the effect in favor of LPV/r after adjusting for baseline SARS-CoV-2 PCR results, indicating a potential role of antivirals in COVID-19 prevention. Clinical Trial Registration Details: ClinicalTrials.gov (Identifier: NCT04364022); Swiss National Clinical Trial Portal: SNCTP 000003732. Funding Information: Fondation privee des HUG and Swiss National Fund (project number: 33IC30_166819). Declaration of Interests: None reported. Ethics Approval Statement: The protocol and amendments were approved by Swissmedic and local ethics committees in Switzerland and Brazil. Participants provided written informed consent before study entry.

Published
2021
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22. Caring for people living with HIV during the global coronavirus disease 2019 pandemic

Author

Hélène Buvelot, Alexandra Calmy, Mikaela Smit, Annalisa Marinosci, Pablo Valladares, Olivier Nawej Tshikung, Yvonne Flammer, and Thanh Doco Lecompte

Subjects
Aged, 80 and over, Male, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Immunology, Human immunodeficiency virus (HIV), COVID-19, HIV Infections, Middle Aged, medicine.disease_cause, Virology, Infectious Diseases, Pandemic, medicine, Humans, Immunology and Allergy, Female, business, Delivery of Health Care, Pandemics, Aged
Published
2020
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23. Prophylaxis for COVID-19: a systematic review

Author

Annalisa Marinosci, Alexandra Calmy, Mikaela Smit, and Thomas Agoritsas

Subjects
0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 030106 microbiology, Psychological intervention, MEDLINE, Antibodies, Viral, Antiviral Agents, law.invention, 03 medical and health sciences, Antimalarials, 0302 clinical medicine, Study Eligibility Criteria, Randomized controlled trial, systematic review, law, medicine, Animals, Humans, 030212 general & internal medicine, Intensive care medicine, Randomized Controlled Trials as Topic, Vaccines, business.industry, Prophylaxis, SARS-CoV-2, Antibodies, Monoclonal, COVID-19, Hydroxychloroquine, General Medicine, Antibodies, Neutralizing, Clinical trial, Infectious Diseases, Pre-Exposure Prophylaxis, business, Post-Exposure Prophylaxis, medicine.drug
Abstract

Background While the landscape of vaccine and treatment candidates against the novel coronavirus disease 2019 (COVID-19) has been reviewed systematically, prophylactic candidates remain unexplored. Objectives To map pre- and postexposure prophylactic (PrEP and PEP) candidate for COVID-19. Data sources PubMed/Medline, Embase, International Committee of Medical Journal Editors and International Clinical Trials Registry Platform clinical trial registries and medRxiv. Study eligibility criteria and participants All studies in humans or animals and randomized controlled trials (RCTs) in humans reporting primary data on prophylactic candidates against COVID-19, excluding studies focused on key populations. Interventions PrEP and PEP candidate for COVID-19. Methods Systematic review and qualitative synthesis of COVID-19 PrEP and PEP studies and RCTs complemented by search of medRxiv and PubMed and Embase for studies reporting RCT outcomes since systematic review search completion. Results We identified 13 studies (from 2119 database records) and 117 RCTs (from 5565 RCTs listed in the registries) that met the inclusion criteria. Non-RCT studies reported on cross-sectional studies using hydroxychloroquine (HCQ) in humans (n = 2) or reported on animal studies (n = 7), most of which used antibodies. All five completed RCTs focused on the use of HCQ as either PrEP or PEP, and these and the cross-sectional studies reported no prophylactic effect. The majority of ongoing RCTs evaluated HCQ or other existing candidates including non–severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, anti(retro)virals or use of vitamins and supplements. Conclusions The key message from completed studies and RCTs seems to be that HCQ does not work. There is little evidence regarding other compounds, with all RCTs using candidates other than HCQ still ongoing. It remains to be seen if the portfolio of existing molecules being evaluated in RCTs will identify successful prophylaxis against COVID-19 or if there is a need for the development of new candidates.

Published
2020

24. Pharmacokinetic parameters and weight change in HIV patients newly switched to dolutegravir‐based regimens in SIMPL'HIV clinical trial

Author

Courlet, Perrine, primary, Barbieux, Charlotte, additional, Sculier, Delphine, additional, Wandeler, Gilles, additional, Stoeckle, Marcel, additional, Bernasconi, Enos, additional, Braun, Dominique, additional, Vernazza, Pietro, additional, Cavassini, Matthias, additional, Marinosci, Annalisa, additional, Smit, Mikaela, additional, Günthard, Huldrych F., additional, Schmid, Patrick, additional, Limacher, Andreas, additional, Guidi, Monia, additional, Alves Saldanha, Susana, additional, Decosterd, Laurent Arthur, additional, and Calmy, Alexandra, additional

Published
2021
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26. Efficacy of Lopinavir-Ritonavir Prophylaxis for Individuals Exposed to SARS-CoV-2: The COPEP Pragmatic Open-Label, Cluster Randomized Trial

Author

Labhardt, Niklaus D., primary, Smit, Mikaela, additional, Petignat, Ianis, additional, Perneger, Thomas, additional, Marinosci, Annalisa, additional, Ustero, Piluca, additional, Diniz Ribeiro, Maria Pia, additional, Ragozzino, Silvio, additional, Nicoletti, Giovanni Jacopo, additional, Faré, Pietro Benedetto, additional, Andrey, Diego O., additional, Jacquerioz, Frederique, additional, Lebowitz, Dan, additional, Agoritsas, Thomas, additional, Meyer, Benjamin, additional, Spechbach, Hervé, additional, Salamun, Julien, additional, Guessous, Idris, additional, Chappuis, François, additional, Kaiser, Laurent, additional, Decosterd, Laurent Arthur, additional, Grinsztejn, Beatriz, additional, Bernasconi, Enos, additional, Cardoso, Sandra Wagner, additional, Calmy, Alexandra, additional, and Team, The COPEP Study, additional

Published
2021
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28. Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial

Author

Smit, Mikaela, primary, Marinosci, Annalisa, additional, Nicoletti, Giovanni Jacopo, additional, Perneger, Thomas, additional, Ragozzino, Silvio, additional, Andrey, Diego O, additional, Stoeckle, Marcel, additional, Jacquerioz, Frederique, additional, Lebowitz, Dan, additional, Agoritsas, Thomas, additional, Meyer, Benjamin, additional, Spechbach, Herve, additional, Salamun, Julien, additional, Back, Moritz, additional, Schaubhut, Carla, additional, Fuchs, Simon, additional, Decosterd, Laurent, additional, Battegay, Manuel, additional, Guessous, Idris, additional, Chappuis, François, additional, Kaiser, Laurent, additional, Labhardt, Niklaus D, additional, and Calmy, Alexandra, additional

Published
2020
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29. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results

Author

Carlos Guijarro, Farid Zand, Mohamed solyman Kabil, Sven Trelle, Birgitte Tholin, Belén Comeche, Johan Alexander Azañero Haro, Gonzalo Sierra Torres, Quarraisha Abdool Karim, Kari Tikkinen, Jean-michel Molina, Atousa Hakamifard, George M Varghese, Oscar Josue Ponce Ponte, Mazin Barry, Pilar Vizcarra, Niccolo Riccardi, Natalia Pérez-Macias, Aynaa AlSharidi, Nelson Lee, Alexandra Binnie, Firouzé BANI-SADR, Beatriz Díaz-Pollán, Aldo Pietro Maggioni, Ilkka Kalliala, Florian Desgranges, Anders Benjamin Kildal, Katerina Nezvalova-Henriksen, Corinne Merle, Andrés Martín Alcántara, Benjamin Gaborit, Daniel Lozano Martín, Antonio Ramos-Martinez, Miguel Villegas-Chiroque, Fredy Orlando Guevara Pulido, Ana Fernández-Cruz, Cormac McCarthy, Thesla Palanee-Phillips, Annalisa Marinosci, Abdullah Assiri, Florent Wallet, Juan Pablo Balbuena, Avik Ray, Francesc Puchades, Rajarao Mesipogu, Marjatta Sinisalo, Jonathan Sterne, Antonio Portolés, Heike Cappel-Porter, Jussi Mustonen, Jeremy Nel, BRUNO MOURVILLIER, María Consuelo Miranda Montoya, Chiara Fanciulli, L Marjukka Myllärniemi, Edinson Dante Meregildo Rodriguez, Alexy Inciarte, Mohamed Hassany, François Danion, Elena Muñez Rubio, Jean-Pierre QUENOT, Esperanza Merino de Lucas, Sheela Godbole, Luis Guillermo Barreto Rocchetti, Katerina Spasovska, William Connors, Kiana Shirani, Umang Agrawal, Srinivas Murthy, Bjorn Blomberg, Vasee Moorthy, Amith Balachandran, Antonio De Pablo Esteban, Mahnaz Amini, Dag Arne Lihaug Hoff, Zeinab Siami, Guillaume Martin-Blondel, Heng Gee Lee, Thrilok Chander Bingi, Vijay Krishnan, ANA BELEN RIVAS PATERNA, Eric D'Ortenzio, Samy Zaky, Carlos Arturo Alvarez-Moreno, Alonso Soto, VIKAS MARWAH, Marco Tulio Medina, Zaira R. Palacios-Baena, Jean-Sébastien Hulot, Miguel Angel Hueda Zavaleta, Felipe García, Francisco Fanjul, Hospices Civils de Lyon (HCL), INSERM UMR-S 606, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, PRES Sorbonne Paris-Cité, and Université Paris Denis Diderot, Université Paris Diderot - Paris 7 (UPD7), Michel-Avella, Amandine, Pan, H., Peto, R., Henao-Restrepo, A. -M., Preziosi, M. -P., Sathiyamoorthy, V., Karim, Q. A., Alejandria, M. M., Garcia, C. H., Kieny, M. -P., Malekzadeh, R., Murthy, S., Srinath Reddy, K., Periago, M. R., Hanna, P. A., Ader, F., Al-Bader, A. M., Alhasawi, A., Allum, E., Alotaibi, A., Alvarez-Moreno, C. A., Appadoo, S., Asiri, A., Aukrust, P., Barratt-Due, A., Bellani, S., Branca, M., Cappel-Porter, H. B. C., Cerrato, N., Chow, T. S., Como, N., Eustace, J., Garcia, P. J., Godbole, S., Gotuzzo, E., Griskevicius, L., Hamra, R., Hassan, M., Hassany, M., Hutton, D., Irmansyah, I., Jancoriene, L., Kirwan, J., Kumar, S., Lennon, P., Lopardo, G., Lydon, P., Magrini, N., Maguire, T., Manevska, S., Manuel, O., Mcginty, S., Medina, M. T., Mesa Rubio, M. L., Miranda-Montoya, M. C., Nel, J., Nunes, E. P., Perola, M., Portoles, A., Rasmin, M. R., Raza, A., Rees, H., Reges, P. P. S., Rogers, C. A., Salami, K., Salvadori, M. I., Sinani, N., Sterne, J. A. C., Stevanovikj, M., Tacconelli, E., Tikkinen, K. A. O., Trelle, S., Zaid, H., Rottingen, J. -A., Swaminathan S., &amp, Luzzati, R, Di Bella, S, Doctoral Programme in Population Health, Doctoral Programme in Biomedicine, HUS Abdominal Center, Department of Surgery, Urologian yksikkö, South Carelia Social and Health care District Eksote, HUS Heart and Lung Center, Department of Medicine, Clinicum, Department of Obstetrics and Gynecology, HUS Gynecology and Obstetrics, UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, and UCL - (SLuc) Service de médecine interne générale

Subjects
Male, Kaplan Meier method, Intention to Treat Analysi, MESH: Treatment Failure, MESH: Hydroxychloroquine, remdesivir, Rate ratio, MESH: Intention to Treat Analysis, MESH: Length of Stay, law.invention, Lopinavir/*therapeutic use, 0302 clinical medicine, middle aged, Medicine, Hospital Mortality, MESH: Respiration, Artificial, Antiviral Agents/administration & dosage/adverse effects/*therapeutic use, comparative study, beta1a interferon, MESH: Middle Aged, Alanine, Respiration, adult, clinical trial, General Medicine, 3. Good health, Intention to Treat Analysis, [SDV] Life Sciences [q-bio], aged, health care quality, priority journal, drug withdrawal, Artificial, Interferon, Drug Therapy, Combination, medicine.medical_specialty, Initiation of ventilation, Interferon beta-1a/*therapeutic use, World Health Organization, Antiviral Agents, Article, Duration of hospital stay, antiviral drugs, 03 medical and health sciences, Drug Therapy, death, Humans, MESH: Hospital Mortality, human, MESH: Kaplan-Meier Estimate, Aged, MESH: Humans, treatment duration, extracorporeal oxygenation, Hydroxychloroquine, Length of Stay, major clinical study, mortality, Respiration, Artificial, Adenosine Monophosphate/*analogs & derivatives/therapeutic use, multicenter study, Alanine/*analogs & derivatives/therapeutic use, MESH: Interferon beta-1a, randomized controlled trial, MESH: Female, antivirus agent, [SDV]Life Sciences [q-bio], MESH: Hospitalization, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Lopinavir, Adenosine Monophosphate, COVID-19, Female, Hospitalization, Interferon beta-1a, Middle Aged, Treatment Failure, Randomized controlled trial, Interquartile range, law, MESH: COVID-19, MESH: Adenosine Monophosphate, 030212 general & internal medicine, antiviral drugs, Covid-19, MESH: Aged, Hydroxychloroquine/*therapeutic use, MESH: Lopinavir, Covid19, artificial ventilation, drug therapy, ritonavir, hospital patient, female, Combination, medicine.drug, MESH: Antiviral Agents, combination drug therapy, COVID-19/*drug therapy/mortality, Randomization, MESH: Alanine, drug repositioning, drug clearance, adenosine phosphate, coronavirus disease 2019, length of stay, Internal medicine, controlled study, Antiviral Agent, Intention-to-treat analysis, business.industry, MESH: Male, COVID-19 Drug Treatment, purl.org/pe-repo/ocde/ford#3.02.00 [https], MESH: Drug Therapy, Combination, 3121 General medicine, internal medicine and other clinical medicine, business
Abstract

The authors report interim results of the WHO Solidarity trial of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with Covid-19. Effects on overall mortality, initiation of ventilation, and duration of hospital stay are compared. Background World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). Methods We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. Results At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. Conclusions These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ; ClinicalTrials.gov number, .)

Published
2020
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30. Possible link between anosmia and COVID-19: sniffing out the truth

Author

Alexandra Calmy, Basile Nicolas Landis, and Annalisa Marinosci

Subjects
ddc:616, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), business.industry, General surgery, Anosmia, MEDLINE, General Medicine, ddc:616.8, Otorhinolaryngology, Sniffing, medicine, Head and neck surgery, Neurosurgery, medicine.symptom, business
Published
2020

31. Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL-HIV trial: DATASET

Author

Sculier, Delphine, Wandeler, Gilles, Yerly, Sabine, Marinosci, Annalisa, Stoeckle, Marcel, Bernasconi, Enos, Braun, Dominique L, Vernazza, Pietro, Cavassini, Matthias, Buzzi, Marta, Metzner, Karin J, Decosterd, Laurent, Günthard, Huldrych F, Schmid, Patrick, Limacher, Andreas, Egger, Matthias, Calmy, Alexandra, and Swiss HIV, Cohort Study

Subjects
610 Medicine & health, 360 Social problems & social services
Published
2020
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32. Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial

Author

Sculier, Delphine; https://orcid.org/0000-0002-6741-9813, Wandeler, Gilles, Yerly, Sabine; https://orcid.org/0000-0003-1668-696X, Marinosci, Annalisa; https://orcid.org/0000-0002-8054-0044, Stoeckle, Marcel; https://orcid.org/0000-0002-0088-5078, Bernasconi, Enos; https://orcid.org/0000-0002-9724-8373, Braun, Dominique L, Vernazza, Pietro, Cavassini, Matthias; https://orcid.org/0000-0003-0933-7833, Buzzi, Marta, Metzner, Karin J; https://orcid.org/0000-0003-4862-1503, Decosterd, Laurent A; https://orcid.org/0000-0002-9840-1325, Günthard, Huldrych F; https://orcid.org/0000-0002-1142-6723, Schmid, Patrick, Limacher, Andreas; https://orcid.org/0000-0002-9094-9476, Egger, Matthias; https://orcid.org/0000-0001-7462-5132, Calmy, Alexandra, Sculier, Delphine; https://orcid.org/0000-0002-6741-9813, Wandeler, Gilles, Yerly, Sabine; https://orcid.org/0000-0003-1668-696X, Marinosci, Annalisa; https://orcid.org/0000-0002-8054-0044, Stoeckle, Marcel; https://orcid.org/0000-0002-0088-5078, Bernasconi, Enos; https://orcid.org/0000-0002-9724-8373, Braun, Dominique L, Vernazza, Pietro, Cavassini, Matthias; https://orcid.org/0000-0003-0933-7833, Buzzi, Marta, Metzner, Karin J; https://orcid.org/0000-0003-4862-1503, Decosterd, Laurent A; https://orcid.org/0000-0002-9840-1325, Günthard, Huldrych F; https://orcid.org/0000-0002-1142-6723, Schmid, Patrick, Limacher, Andreas; https://orcid.org/0000-0002-9094-9476, Egger, Matthias; https://orcid.org/0000-0001-7462-5132, and Calmy, Alexandra

Abstract

BACKGROUND Dolutegravir (DTG)-based dual therapy is becoming a new paradigm for both the initiation and maintenance of HIV treatment. The SIMPL'HIV study investigated the outcomes of virologically suppressed patients on standard combination antiretroviral therapy (cART) switching to DTG + emtricitabine (FTC). We present the 48-week efficacy and safety data on DTG + FTC versus cART. METHODS AND FINDINGS SIMPL'HIV was a multicenter, open-label, non-inferiority randomized trial with a factorial design among treatment-experienced people with HIV in Switzerland. Participants were enrolled between 12 May 2017 and 30 May 2018. Patients virologically suppressed for at least 24 weeks on standard cART were randomized 1:1 to switching to DTG + FTC or to continuing cART, and 1:1 to simplified patient-centered monitoring versus standard monitoring. The primary endpoint was the proportion of patients virologically suppressed with <100 copies/ml through 48 weeks. The secondary endpoints included virological suppression at 48 weeks according to the US Food and Drug Administration (FDA) snapshot analysis. Non-inferiority of DTG + FTC versus cART for viral suppression was assessed using a stratified Mantel-Haenszel risk difference, with non-inferiority declared if the lower bound of the 95% confidence interval was greater than -12%. Adverse events were monitored to assess safety. Quality of life was evaluated using the PROQOL-HIV questionnaire. Ninety-three participants were randomized to DTG + FTC, and 94 individuals to cART. Median nadir CD4 count was 246 cells/mm3; median age was 48 years; 17% of participants were female. DTG + FTC was non-inferior to cART. The proportion of patients with viral suppression (<100 copies/ml) through 48 weeks was 93.5% in the DTG + FTC arm and 94.7% in the cART arm in the intention-to-treat population (risk difference -1.2%; 95% CI -7.8% to 5.6%). Per-protocol analysis showed similar results, with viral suppression in 96.5% of patients in both arms (

Published
2020

34. Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial.

Author

Sculier, Delphine, Wandeler, Gilles, Yerly, Sabine, Marinosci, Annalisa, Stoeckle, Marcel, Bernasconi, Enos, Braun, Dominique L., Vernazza, Pietro, Cavassini, Matthias, Buzzi, Marta, Metzner, Karin J., Decosterd, Laurent A., Günthard, Huldrych F., Schmid, Patrick, Limacher, Andreas, Egger, Matthias, Calmy, Alexandra, and the Swiss HIV Cohort Study (SHCS), and Swiss HIV Cohort Study (SHCS)

Subjects
EMTRICITABINE, CLINICAL trials monitoring, HIV-positive persons, VIRAL load, LABEL design, DRUG dosage
Abstract

Background: Dolutegravir (DTG)-based dual therapy is becoming a new paradigm for both the initiation and maintenance of HIV treatment. The SIMPL'HIV study investigated the outcomes of virologically suppressed patients on standard combination antiretroviral therapy (cART) switching to DTG + emtricitabine (FTC). We present the 48-week efficacy and safety data on DTG + FTC versus cART.Methods and Findings: SIMPL'HIV was a multicenter, open-label, non-inferiority randomized trial with a factorial design among treatment-experienced people with HIV in Switzerland. Participants were enrolled between 12 May 2017 and 30 May 2018. Patients virologically suppressed for at least 24 weeks on standard cART were randomized 1:1 to switching to DTG + FTC or to continuing cART, and 1:1 to simplified patient-centered monitoring versus standard monitoring. The primary endpoint was the proportion of patients virologically suppressed with <100 copies/ml through 48 weeks. The secondary endpoints included virological suppression at 48 weeks according to the US Food and Drug Administration (FDA) snapshot analysis. Non-inferiority of DTG + FTC versus cART for viral suppression was assessed using a stratified Mantel-Haenszel risk difference, with non-inferiority declared if the lower bound of the 95% confidence interval was greater than -12%. Adverse events were monitored to assess safety. Quality of life was evaluated using the PROQOL-HIV questionnaire. Ninety-three participants were randomized to DTG + FTC, and 94 individuals to cART. Median nadir CD4 count was 246 cells/mm3; median age was 48 years; 17% of participants were female. DTG + FTC was non-inferior to cART. The proportion of patients with viral suppression (<100 copies/ml) through 48 weeks was 93.5% in the DTG + FTC arm and 94.7% in the cART arm in the intention-to-treat population (risk difference -1.2%; 95% CI -7.8% to 5.6%). Per-protocol analysis showed similar results, with viral suppression in 96.5% of patients in both arms (risk difference 0.0%; 95% CI -5.6% to 5.5%). There was no relevant interaction between the type of treatment and monitoring (interaction ratio 0.98; 95% CI 0.85 to 1.13; p = 0.81). Using the FDA snapshot algorithm, 84/93 (90.3%) participants in the DTG + FTC arm had an HIV-1 RNA viral load of <50 copies/ml compared to 86/94 (91.5%) participants on standard cART (risk difference -1.1%; 95% CI -9.3% to 7.1%; p = 0.791). The overall proportion of patients with adverse events and discontinuations did not differ by randomization arm. The proportion of patients with serious adverse events was higher in the cART arm (16%) compared to the DTG + FTC arm (6.5%) (p = 0.041), but none was considered to be related to the study medication. Quality of life improved more between baseline and week 48 in the DTG + FTC compared to the cART arm (adjusted difference +2.6; 95% CI +0.4 to +4.7). The study's main limitations included a rather small proportion of women included, the open label design, and its short duration.Conclusions: In this study, DTG + FTC as maintenance therapy was non-inferior to cART in terms of efficacy, with a similar safety profile and a greater improvement in quality of life, thus expanding the offer of 2-drug simplification options among virologically suppressed individuals.Trial Registration: ClinicalTrials.gov NCT03160105. [ABSTRACT FROM AUTHOR]

Published
2020
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35. Prenatal features of Noonan syndrome: prevalence and prognostic value

Author

Alessandro Mussa, Elena Banaudi, Giovanni Battista Ferrero, Serena Forzano, Annalisa Marinosci, Anna Dotta, Cesare Rossi, Margherita Silengo, Marco Tartaglia, and Giuseppina Baldassarre

Subjects
Pediatrics, medicine.medical_specialty, Pregnancy, Polyhydramnios, Fetus, medicine.diagnostic_test, Heart disease, business.industry, Genetic counseling, Obstetrics and Gynecology, medicine.disease, Short stature, medicine, Noonan syndrome, medicine.symptom, business, Fetal echocardiography, Genetics (clinical)
Abstract

Objective Noonan syndrome (NS) is a common autosomal dominant developmental disorder, mainly characterized by congenital heart defects, short stature, and a variable degree of developmental delay. We have reviewed the prenatal findings in NS and we have correlated them with genotype and postnatal phenotype. Methods The cohort consisted of 47 patients with molecular diagnosis of NS. Prenatal and postnatal phenotypes were assessed by analysis of medical records, and clinical follow-up. Postnatal clinical phenotype, congenital heart disease, neuropsychomotor development, and growth pattern were arbitrarily scored in terms of severity. Results Mean age at diagnosis of NS was 7 years (ranging from birth to 38 years). Abnormal maternal serum triple screen was present in 36% of cases, nuchal translucency > 2.5 mm in 41%, polyhydramnios in 38% and fetal anomalies at prenatal ultrasonography in 21%. No statistical association was observed between prenatal findings and NS genotype or scores of postnatal clinical phenotype, congenital heart disease, neuropsychomotor development, or short stature. Presence of morphologic fetal anomalies at ultrasonography was associated with developmental delay/intellectual disabilities (p < 0.001) and juvenile myelomonocytic leukaemia (p = 0.006). Conclusions Abnormal prenatal findings are frequent in NS pregnancies, though they are not specific and most are not useful for the prediction of the postnatal phenotype. Copyright © 2011 John Wiley & Sons, Ltd.

Published
2011
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36. Analisi del profilo di trascrizione genetica nella sindrome di Noonan

Author

Picco, Gabriele, Cantarella, D, Baldassarre, Giuseppina, Marinosci, Annalisa, Dotta, Anna, Isella, Claudio, Crescenzo, N, Timeus, F, Chiesa, Nicoletta, Merla, G, Mazzanti, L, Rossi, Claudia, Zampino, G, Tartaglia, M, Cirillo, Margherita, Medico, Enzo, and Ferrero, Giovanni Battista

Published
2010

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