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1. Feasibility, safety, efficacy and potential scaling-up of sofosbuvir-based HCV treatment in Central and West Africa: (TAC ANRS 12311 trial)

Author

Lacombe, Karine, Moh, Raoul, Chazallon, Corine, Lemoine, Maud, Sylla, Babacar, Fadiga, Fatoumata, Le Carrou, Jerôme, Marcellin, Fabienne, Kouanfack, Charles, Ciaffi, Laura, Sartre, Michelle Tagni, Sida, Magloire Biwole, Diallo, Alpha, Gozlan, Joel, Seydi, Moussa, Cissé, Viviane, Danel, Christine, Girard, Pierre Marie, Toni, Thomas d’Aquin, Minga, Albert, Boyer, Sylvie, Carrieri, Patrizia, and Attia, Alain

Published
2024
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2. Efficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial

Author

Anglaret, Xavier, Assoumou, Lambert, Bado, Guillaume, Bissagnene, Emmanuel, Bonnet, Fabrice, Britto, Carlos, Brun Vezinet, Françoise, Charpentier, Charlotte, Chazallon, Corine, Chenal, Henri, Chêne, Geneviève, Chenier, Remy, Clouet, Gwenaelle, Colin, Géraldine, Collin, Gilles, Conte, Valérie, Danel, Christine, De Monteynard, Laure-Amélie, Dembele, Fassery, Diallo, Zelica, Diallo, Illah, Dohoun, Lambert, Drabo, Youssouf Joseph, Eholié, Serge Paul, Ekouevi, Didier Koumavi, Fadiga, Fatoumata, Gabillard, Delphine, Girard, Pierre Marie, Gottlieb, Geoffrey S., Hawerlander, Denise, Karcher, Sophie, Kariyiare, Benjamin, Koita Fall, Mame Basty, Konan, Romuald, Kouame, Antoine, Kouley, Serge-Olivier, Laborde Bolen, Gabriele, Landman, Roland, Le Carrou, Jérome, Marcelain, Anne Geneviève, Matheron, Sophie, Mensah, Ephrem, Mercier, Noémie, Messou, Assoua, Messou, Eugène, Minga, Albert, N'dour, Cheick Tidiane, N'chot, Celestin, Ndiaye, Bara, Ngom Gueye, Ndeye Fatou, N'guessan-Koffi, Larissa, Ouattara, Eric, Ouédraogo, Abdoul-Salam, Palokinam Pitche, Vincent, Peytavin, Gilles, Plantier, Jean Christophe, Poda, Armel, Prince-David, Mireille, Raffali, Yasmine, Rekacewicz, Claire, Rouzioux, Christine, Salou, Mounerou, Sangare, Lassana, Sawadogo, Adrien Bruno, Seydi, Moussa, Somé, Désiré, Tamegnon, Séphora, Tchabert-Guié, Annick, Tchounga, Boris, Toni, Thomas d'Aquin, Toure Kane, Coumba, Touret, Pierre, Traoré, Jean-Richard, Vitoria de Avila, Marco Antonio, Yaméogo, Seydou, Yao Yapi, Cyrille, Zoungrana, Jacques, Eholie, Serge P, Ekouevi, Didier K, Toni, Thomas-d'Aquin, and Brun-Vezinet, Françoise

Published
2024
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4. Intensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial

Author

Maitre, Thomas, Bonnet, Maryline, Calmy, Alexandra, Raberahona, Mihaja, Rakotoarivelo, Rivonirina Andry, Rakotosamimanana, Niaina, Ambrosioni, Juan, Miró, José M., Debeaudrap, Pierre, Muzoora, Conrad, Davis, Angharad, Meintjes, Graeme, Wasserman, Sean, Wilkinson, Robert, Eholié, Serge, Nogbou, Frédéric Ello, Calvo-Cortes, Maria-Camilla, Chazallon, Corine, Machault, Vanessa, Anglaret, Xavier, and Bonnet, Fabrice

Published
2022
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5. Efficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial

Author

Eholie, Serge P, primary, Ekouevi, Didier K, additional, Chazallon, Corine, additional, Charpentier, Charlotte, additional, Messou, Eugène, additional, Diallo, Zelica, additional, Zoungrana, Jacques, additional, Minga, Albert, additional, Ngom Gueye, Ndeye Fatou, additional, Hawerlander, Denise, additional, Dembele, Fassery, additional, Colin, Géraldine, additional, Tchounga, Boris, additional, Karcher, Sophie, additional, Le Carrou, Jérome, additional, Tchabert-Guié, Annick, additional, Toni, Thomas-d'Aquin, additional, Ouédraogo, Abdoul-Salam, additional, Bado, Guillaume, additional, Toure Kane, Coumba, additional, Seydi, Moussa, additional, Poda, Armel, additional, Mensah, Ephrem, additional, Diallo, Illah, additional, Drabo, Youssouf Joseph, additional, Anglaret, Xavier, additional, Brun-Vezinet, Françoise, additional, Assoumou, Lambert, additional, Bissagnene, Emmanuel, additional, Bonnet, Fabrice, additional, Britto, Carlos, additional, Brun Vezinet, Françoise, additional, Chenal, Henri, additional, Chêne, Geneviève, additional, Chenier, Remy, additional, Clouet, Gwenaelle, additional, Collin, Gilles, additional, Conte, Valérie, additional, Danel, Christine, additional, De Monteynard, Laure-Amélie, additional, Dohoun, Lambert, additional, Eholié, Serge Paul, additional, Ekouevi, Didier Koumavi, additional, Fadiga, Fatoumata, additional, Gabillard, Delphine, additional, Girard, Pierre Marie, additional, Gottlieb, Geoffrey S., additional, Kariyiare, Benjamin, additional, Koita Fall, Mame Basty, additional, Konan, Romuald, additional, Kouame, Antoine, additional, Kouley, Serge-Olivier, additional, Laborde Bolen, Gabriele, additional, Landman, Roland, additional, Marcelain, Anne Geneviève, additional, Matheron, Sophie, additional, Mercier, Noémie, additional, Messou, Assoua, additional, N'dour, Cheick Tidiane, additional, N'chot, Celestin, additional, Ndiaye, Bara, additional, N'guessan-Koffi, Larissa, additional, Ouattara, Eric, additional, Palokinam Pitche, Vincent, additional, Peytavin, Gilles, additional, Plantier, Jean Christophe, additional, Prince-David, Mireille, additional, Raffali, Yasmine, additional, Rekacewicz, Claire, additional, Rouzioux, Christine, additional, Salou, Mounerou, additional, Sangare, Lassana, additional, Sawadogo, Adrien Bruno, additional, Somé, Désiré, additional, Tamegnon, Séphora, additional, Toni, Thomas d'Aquin, additional, Touret, Pierre, additional, Traoré, Jean-Richard, additional, Vitoria de Avila, Marco Antonio, additional, Yaméogo, Seydou, additional, and Yao Yapi, Cyrille, additional

Published
2024
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6. Standard dose raltegravir or efavirenz-based antiretroviral treatment for patients co-infected with HIV and tuberculosis (ANRS 12 300 Reflate TB 2): an open-label, non-inferiority, randomised, phase 3 trial

Author

Irmine, Ahyi, Kakou, Aka, Ana cláudia, Alves, Jacqueline, Amani, Bonzou, Amoakon, Xavier, Anglaret, Amani, Anzian, Khalide, Azam, Débora Faber, Barreto, Rui, Bastos dos Santos, Aurélie, Beuscart, Nilesh, Bhatt, Antoine, Bi, Maryline, Bonnet, Kim Nhung, Bui thi, Luiz, Camacho, Tung khanh, Cao, Corine, Chazallon, Lara, Coelho, Mai Luong, Cong thi, Robson Pierre, Da SILVA, Minh Há, Dang thi, Lehi Florence, Dano, Nathalie, De castro, Marie, De Solère, Constance, Delaugerre, Alpha, Diallo, Thanh, Dinh phuong, Donald, Diomandé, Giang, Do cha, Trang, Do ha thanh, Anaïs, Domergue, Trang Quynh Nhu, Dong bui vu hoang, Fulgence, Eboumou, Serge, Eholie, Frederick, Ello, Arlette, Emieme, Rodrigo, Escada, Etienne, Etilé, Salimata, Fanny, Ana cristina, Ferreira, Robert, Gbey, Joachim, Gnokoro, Tatiane, Gomes, Maura lassance, Gonzales, Beatriz, Grinsztejn, Frederique, Guiroy, Thanh Trang Do, Ha, Brenda, Hoagland, Anh Phuong, Huynh, Khanh thu, Huynh hoang, Marcelin, Irié, Jean-claude, Kacou, Samuel, Kan, Sophie, Karcher, Mc, Kassy, Celso, Khosa, Lambert, Konan, Romuald, Konan, Fatoumata, Koné, Suzanne, Kouadio, Martin, Kouamé, Tânia, Krsitic, Georgette, Labibi, Didier, Laureillard, Jérôme, Le Carrou, Khanh, Le Guoc, Ngoc bich, Le Thi, Flávia, Lessa, Van Duong, Long, Anh Que, Luong, Huyen Thi Thu, Mai, Thu Huyen Nguyet, Mai, Emelva, Manhiça, Olivier, Marcy, Luana, Marins, Lectícia, Matsinhe, Hervé, Menan, Eugène, Messou, Jean-michel, Molina, Alice, Montoyo, Ronaldo ismerio, Moreira, Jean-baptiste, N'takpé, Sandro, Nazer, Cao van thi, Nguyen, Nuoi THI, Nguyen, Bang, Nguyen duc, Lân, Nguyen huu, Lan, Nguyen ngoc, Viet, Nguyen nhu, Hong, Nguyen thi, Dilário, Nhumaio, Hang THU, Pham, Anh THI QUYNH, Pham, Diane, Ponscarme, Miresta, Previllon, Cyprien, Rabe, Delphine, Rapoud, Daniel, Rebelo, Claire, Rekacewicz, Valéria rita, Ribeiro, Jorge, Ribeiro, Lucimar, Salgado, Soraia, Santana de MOURA, Desiree, Santos, Yamissa, Siloue, Bertine, Siloue, Nádia, Sitoe, Anne-marie, Taburet, Isabel cristina, Tavares, Ezio, Tavora dos Santos Filho, Cecile, Tchehy, Isabel, Timana, Thomas-d'aquin, Toni, Thiago, Torres, Thao PHAM PHUONG, Tran, Loc HUU, Tran, Quy Thi Kim, Tran, Tien Thi Thuy, Tran, Ton, Tran, Thi Hieu Nhi, Tran, Thi-Hai Ly, Tran, Valdilea, Veloso, Arlindo, Vilanculo, Xuan Thinh, Vu, Adolfo, Vubil, Sandra, Wagner, Alcina, Zitha, Astrid, De Castro, Nathalie, Marcy, Olivier, Chazallon, Corine, Messou, Eugène, Eholié, Serge, N'takpe, Jean-Baptiste, Bhatt, Nilesh, Khosa, Celso, Timana Massango, Isabel, Laureillard, Didier, Chau, Giang Do, Domergue, Anaïs, Veloso, Valdilea, Escada, Rodrigo, Wagner Cardoso, Sandra, Delaugerre, Constance, Anglaret, Xavier, Molina, Jean-Michel, and Grinsztejn, Beatriz

Published
2021
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7. Incidence and Predictors of Tuberculosis-associated IRIS in People With HIV Treated for Tuberculosis: Findings From Reflate TB2 Randomized Trial

Author

Coelho, Lara E, primary, Chazallon, Corine, additional, Laureillard, Didier, additional, Escada, Rodrigo, additional, N’takpe, Jean-Baptiste, additional, Timana, Isabelle, additional, Messou, Eugène, additional, Eholie, Serge, additional, Khosa, Celso, additional, Chau, Giang D, additional, Cardoso, Sandra Wagner, additional, Veloso, Valdiléa G, additional, Delaugerre, Constance, additional, Molina, Jean-Michel, additional, Grinsztejn, Beatriz, additional, Marcy, Olivier, additional, and De Castro, Nathalie, additional

Published
2024
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8. Feasability and effectiveness of scaling up hepatitis-C treatment in West and Central Africa: the TAC ANRS 12311 clinical trial

Author

Lacombe, Karine, primary, Moh, Raoul, additional, Chazallon, Corine, additional, Lemoine, Maud, additional, Sylla, Babacar, additional, Fadiga, Fatoumata, additional, Carrou, Jerôme Le, additional, Marcellin, Fabienne, additional, Kouanfack, Charles, additional, Ciaffi, Laura, additional, Sartre, Michelle Tagni, additional, Sida, Magloire Biwole, additional, Diallo, Alpha, additional, Gozlan, Joel, additional, Seydi, Moussa, additional, Cissé, Viviane, additional, Danel, Christine, additional, Girard, Pierre Marie, additional, Toni, Thomas, additional, Minga, Albert, additional, Boyer, Sylvie, additional, Carrieri, Patrizia, additional, and Attia, Alain, additional

Published
2023
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9. Lancet Infect Dis

Author

Valdilea G. Veloso, Domergue Anaïs, De Solère Marie, Do cha Giang, Le Thi Ngoc bich, Timana Isabel, Mai Thu Huyen Nguyet, Nguyen Nuoi Thi, Nilesh Bhatt, Nguyen Cao van thi, Amani Jacqueline, Serge Eholié, Isabel Timana Massango, Kan Samuel, Moreira Ronaldo ismerio, Beuscart Aurélie, Siloue Yamissa, Siloue Bertine, Dano Lehi Florence, Azam Khalide, Koné Fatoumata, Khosa Celso, Da Silva Robson Pierre, Nazer Sandro, Huynh Anh Phuong, Chazallon Corine, Sandra W. Cardoso, Previllon Miresta, Santana de Moura Soraia, Aka Kakou, Lessa Flávia, Tran Thi Hieu Nhi, Tran Thi-Hai Ly, Mai Huyen Thi Thu, Barreto Débora Faber, Celso Khosa, Jean-Baptiste N'takpe, Molina Jean-michel, Tran Quy Thi Kim, Krsitic Tânia, Fanny Salimata, Montoyo Alice, Nguyen thi Hong, Anais Domergue, Tran Tien Thi Thuy, Grinsztejn Beatriz, Camacho Luiz, Kacou Jean-claude, Gonzales Maura lassance, Tavora dos Santos Filho Ezio, Corine Chazallon, Ahyi Irmine, Nguyen duc Bang, Laureillard Didier, Guiroy Frederique, Luong Anh Que, Vu Xuan Thinh, Tran Ton, Didier Laureillard, Dinh phuong Thanh, Dang thi Minh Há, Gomes Tatiane, Menan Hervé, Bastos dos Santos Rui, Rapoud Delphine, Anzian Amani, De castro Nathalie, Eholie Serge, Pham Anh Thi Quynh, Amoakon Bonzou, Konan Lambert, Coelho Lara, Matsinhe Lectícia, Xavier Anglaret, Rodrigo Escada, Ha Thanh Trang Do, Ponscarme Diane, Gbey Robert, Dong bui vu hoang Trang Quynh Nhu, Konan Romuald, Beatriz Grinsztejn, Eugène Messou, Nguyen ngoc Lan, Cao Tung khanh, Bonnet Maryline, Nathalie De Castro, Etilé Etienne, Taburet Anne-marie, Tavares Isabel cristina, Torres Thiago, Nguyen nhu Viet, Kouamé Martin, Rebelo Daniel, N'takpé Jean-baptiste, Emieme Arlette, Diomandé Donald, Veloso Valdilea, Kassy Mc, Manhiça Emelva, Tran Thao Pham Phuong, Karcher Sophie, Santos Desiree, Salgado Lucimar, Cong thi Mai Luong, Rekacewicz Claire, Pham Hang Thu, Tran Loc Huu, Bhatt Nilesh, Toni Thomas-d'aquin, Wagner Sandra, Marins Luana, Vubil Adolfo, Sitoe Nádia, Huynh hoang Khanh thu, Kouadio Suzanne, Jean-Michel Molina, Irié Marcelin, Olivier Marcy, Labibi Georgette, Tchehy Cecile, Nguyen huu Lân, Messou Eugène, Marcy Olivier, Rabe Cyprien, Escada Rodrigo, Anglaret Xavier, Ribeiro Jorge, Bui thi Kim Nhung, Alves Ana cláudia, Zitha Alcina, Giang Do Chau, Ribeiro Valéria rita, Eboumou Fulgence, Ello Frederick, Le Guoc Khanh, Long Van Duong, Delaugerre Constance, Bi Antoine, Hoagland Brenda, Gnokoro Joachim, Diallo Alpha, Constance Delaugerre, Do ha thanh Trang, Astrid, Ferreira Ana cristina, Vilanculo Arlindo, Nhumaio Dilário, Le Carrou Jérôme, Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Cyclopropanes, Male, 0301 basic medicine, HIV Infections, chemistry.chemical_compound, 0302 clinical medicine, Drug Dosage Calculations, 030212 general & internal medicine, Mozambique, Aged, 80 and over, education.field_of_study, Coinfection, virus diseases, Lamivudine, Middle Aged, 3. Good health, Treatment Outcome, Infectious Diseases, Vietnam, Alkynes, Female, France, Brazil, medicine.drug, Adult, medicine.medical_specialty, Efavirenz, Tuberculosis, Anti-HIV Agents, Population, Young Adult, 03 medical and health sciences, Acquired immunodeficiency syndrome (AIDS), Raltegravir Potassium, Internal medicine, medicine, Humans, education, Adverse effect, Aged, business.industry, medicine.disease, Raltegravir, 030112 virology, Benzoxazines, Cote d'Ivoire, chemistry, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Rifampicin
Abstract

BACKGROUND: In patients co-infected with HIV and tuberculosis, antiretroviral therapy options are limited due to drug—drug interactions with rifampicin. A previous phase 2 trial indicated that raltegravir 400 mg twice a day or efavirenz 600 mg once a day might have similar virological efficacy in patients given rifampicin. In this phase 3 trial, we assessed the non-inferiority of raltegravir to efavirenz. METHODS: We did a multicentre, open-label, non-inferiority, randomised, phase 3 trial at six sites in Côte d'Ivoire, Brazil, France, Mozambique, and Vietnam. We included antiretroviral therapy (ART)-naive adults (aged ≥18 years) with confirmed HIV-1 infection and bacteriologically confirmed or clinically diagnosed tuberculosis who had initiated rifampicin-containing tuberculosis treatment within the past 8 weeks. Using computerised random numbers, we randomly assigned participants (1:1; stratified by country) to receive raltegravir 400 mg twice daily or efavirenz 600 mg once daily, both in combination with tenofovir and lamivudine. The primary outcome was the proportion of patients with virological suppression at week 48 (defined as plasma HIV RNA concentration

Published
2021
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10. Additional file 1 of Intensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial

Author

Maitre, Thomas, Bonnet, Maryline, Calmy, Alexandra, Raberahona, Mihaja, Rakotoarivelo, Rivonirina Andry, Rakotosamimanana, Niaina, Ambrosioni, Juan, Miró, José M., Debeaudrap, Pierre, Muzoora, Conrad, Davis, Angharad, Meintjes, Graeme, Wasserman, Sean, Wilkinson, Robert, Eholié, Serge, Nogbou, Frédéric Ello, Calvo-Cortes, Maria-Camilla, Chazallon, Corine, Machault, Vanessa, Anglaret, Xavier, and Bonnet, Fabrice

Abstract

Additional file 1. Modified MARAIS Score (modified from Marais et al. [27]).

Published
2022
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11. Current management of late onset neonatal bacterial sepsis in five European countries

Author

Lutsar, Irja, Chazallon, Corine, Carducci, Francesca Ippolita Calò, Trafojer, Ursula, Abdelkader, Ben, de Cabre, Vincent Meiffredy, Esposito, Susanna, Giaquinto, Carlo, Heath, Paul T., Ilmoja, Mari-Liis, Katragkou, Aspasia, Lascoux, Carine, Metsvaht, Tuuli, Mitsiakos, George, Netzer, Emmanuelle, Pugni, Lorenza, Roilides, Emmanuel, Saidi, Yacine, Sarafidis, Kosmas, Sharland, Mike, Usonis, Vytautas, Aboulker, Jean-Pierre, and NeoMero Consortium

Published
2014
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12. Determinants of Antiretroviral Treatment Success and Adherence in People With Human Immunodeficiency Virus Treated for Tuberculosis.

Author

Castro, Nathalie De, Chazallon, Corine, N'takpe, Jean-Baptiste, Timana, Isabel, Escada, Rodrigo, Wagner, Sandra, Messou, Eugène, Eholie, Serge, Bhatt, Nilesh, Khosa, Celso, Laureillard, Didier, Chau, Giang Do, Veloso, Valdilea G, Delaugerre, Constance, Anglaret, Xavier, Molina, Jean-Michel, Grinsztejn, Beatriz, Marcy, Olivier, and Group, for the ANRS 12300 Reflate TB2 Study

Subjects
*HIV, *DIRECTLY observed therapy, *PATIENT compliance, *ANTIRETROVIRAL agents, *TUBERCULOSIS, *RNA
Abstract

Background In people with human immunodeficiency virus [HIV] presenting with advanced disease, rates of virologic success may be lower than expected. The Reflate TB2 trial did not show non-inferiority of raltegravir versus efavirenz in people with HIV (PWH) treated for tuberculosis. We aimed to identify factors associated with virologic success and higher adherence in the trial. Methods In this analysis, we included participants enrolled in the Reflate TB2 trial with adherence data available. The primary outcome was virologic success (HIV-1 ribonucleic acid [RNA] <50 copies/mL) at week 48, and the secondary outcome was adherence as assessed by the pill count adherence ratio. We used logistic regression to study determinants of virologic success and optimal adherence in 2 separate analyses. Results Four hundred forty-four participants were included in the present analysis. Over the 48-week follow-up period, 290 of 444 (65%) participants had a pill count adherence ratio ≥95%. At week 48, 288 of 444 (65%) participants were in virologic success. In the multivariate analysis, female sex (adjusted odds ratio [aOR], 1.77; 95% confidence interval [CI], 1.16–2.72; P =.0084), lower baseline HIV-1 RNA levels (<100 000; aOR, 2.29; 95% CI, 1.33–3.96; P =.0087), and pill count adherence ratio ≥95% (aOR, 2.38; 95% CI, 1.56–3.62; P <.0001) were independently associated with virologic success. Antiretroviral pill burden was the only factor associated with pill count adherence ratio ≥95% (OR, 0.81; 95% CI,.71–.92; P =.0018). Conclusions In PWH with tuberculosis receiving raltegravir or efavirenz-based regimens, female sex, optimal adherence, and baseline HIV-1 RNA <100 000 copies/mL were associated with virologic success, and the number of antiretroviral tablets taken daily was a strong predictor of adherence. [ABSTRACT FROM AUTHOR]

Published
2022
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13. Lancet Infect Dis

Author

DE CASTRO, Nathalie, MARCY, Olivier, CHAZALLON, Corine, MESSOU, Eugene, EHOLIE, Serge Paul, N'TAKPE, Jean-Baptiste, BHATT, Nilesh, KHOSA, Celso, TIMANA MASSANGO, Isabel, LAUREILLARD, Didier, CHAU, Giang Do, DOMERGUE, Anais, VELOSO, Valdilea, ESCADA, Rodrigo, WAGNER CARDOSO, Sandra, DELAUGERRE, Constance, ANGLARET, Xavier, MOLINA, Jean-Michel, GRINSZTEJN, Beatriz, and GROUP, Anrs Reflate TB2 Study

Published
2021

20. Plasma and CSF pharmacokinetics of meropenem in neonates and young infants: Results from the NeoMero studies

Author

Germovsek, Eva, Lutsar, Irja, Kipper, Karin, Karlsson, Mats O, Planche, Tim, Chazallon, Corine, Meyer, Laurence, Trafojer, Ursula M. T., Metsvaht, Tuuli, Fournier, Isabelle, Sharland, Mike, Heath, Paul, and Standing, Joseph F.

Subjects
Pediatrik, Pediatrics
Abstract

Background: Sepsis and bacterial meningitis are major causes of mortality and morbidity in neonates and infants. Meropenem, a broad-spectrum antibiotic, is not licensed for use in neonates and infants below 3 months of age and sufficient information on its plasma and CSF disposition and dosing in neonates and infants is lacking. Objectives: To determine plasma and CSF pharmacokinetics of meropenem in neonates and young infants and the link between pharmacokinetics and clinical outcomes in babies with late-onset sepsis (LOS). Methods: Data were collected in two recently conducted studies, i.e. NeoMero-1 (neonatal LOS) and NeoMero-2 (neonatal meningitis). Optimally timed plasma samples (n = 401) from 167 patients and opportunistic CSF samples (n = 78) from 56 patients were analysed. Results: A one-compartment model with allometric scaling and fixed maturation gave adequate fit to both plasma and CSF data; the CL and volume (standardized to 70 kg) were 16.7 (95% CI 14.7, 18.9) L/h and 38.6 (95% CI 34.9, 43.4) L, respectively. CSF penetration was low (8%), but rose with increasing CSF protein, with 40% penetration predicted at a protein concentration of 6 g/L. Increased infusion time improved plasma target attainment, but lowered CSF concentrations. For 24 patients with culture-proven Gram-negative LOS, pharmacodynamic target attainment was similar regardless of the test-of-cure visit outcome. Conclusions: Simulations showed that longer infusions increase plasma PTA but decrease CSF PTA. CSF penetration is worsened with long infusions so increasing dose frequency to achieve therapeutic targets should be considered.

Published
2018

21. Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): A randomised controlled trial.

Author

Lutsar, Irja, Chazallon, Corine, Trafojer, Ursula, de Cabre, Vincent Meiffredy, Auriti, Cinzia, Bertaina, Chiara, Calo Carducci, Francesca Ippolita, Canpolat, Fuat Emre, Esposito, Susanna, Fournier, Isabelle, Hallik, Maarja, Heath, Paul T., Ilmoja, Mari-Liis, Iosifidis, Elias, Kuznetsova, Jelena, Meyer, Laurence, Metsvaht, Tuuli, Mitsiakos, George, Pana, Zoi Dorothea, and Mosca, Fabio

Subjects
*NEONATAL sepsis, *MEROPENEM, *SEPSIS, *TREATMENT effectiveness, *BIOMARKERS, *LOGISTIC regression analysis
Abstract

Background: The early use of broad-spectrum antibiotics remains the cornerstone for the treatment of neonatal late onset sepsis (LOS). However, which antibiotics should be used is still debatable, as relevant studies were conducted more than 20 years ago, recruited in single centres or countries, evaluated antibiotics not in clinical use anymore and had variable inclusion/exclusion criteria and outcome measures. Moreover, antibiotic-resistant bacteria have become a major problem in many countries worldwide. We hypothesized that efficacy of meropenem as a broad-spectrum antibiotic is superior to standard of care regimens (SOC) in empiric treatment of LOS and aimed to compare meropenem to SOC in infants aged <90 days with LOS. Methods and findings: NeoMero-1 was a randomized, open-label, phase III superiority trial conducted in 18 neonatal units in 6 countries. Infants with post-menstrual age (PMA) of ≤44 weeks with positive blood culture and one, or those with negative culture and at least with two predefined clinical and laboratory signs suggestive of LOS, or those with PMA >44 weeks meeting the Goldstein criteria of sepsis, were randomized in a 1:1 ratio to receive meropenem or one of the two SOC regimens (ampicillin+gentamicin or cefotaxime+gentamicin) chosen by each site prior to the start of the study for 8–14 days. The primary outcome was treatment success (survival, no modification of allocated therapy, resolution/improvement of clinical and laboratory markers, no need of additional antibiotics and presumed/confirmed eradication of pathogens) at test-of-cure visit (TOC) in full analysis set. Stool samples were tested at baseline and Day 28 for meropenem-resistant Gram-negative organisms (CRGNO). The primary analysis was performed in all randomised patients and in patients with culture confirmed LOS. Proportions of participants with successful outcome were compared by using a logistic regression model adjusted for the stratification factors. From September 3, 2012 to November 30th 2014, total of 136 patients (instead of planned 275) in each arm were randomized; 140 (52%) were culture positive. Successful outcome at TOC was achieved in 44/136 (32%) in the meropenem arm vs. 31/135 (23%) in the SOC arm (p = 0.087). The respective numbers in patients with positive cultures were 17/63 (27%) vs. 10/77 (13%) (p = 0.022). The main reason of failure was modification of allocated therapy. Treatment emergent adverse events occurred in 72% and serious adverse events in 17% of patients, the Day 28 mortality was 6%. Cumulative acquisition of CRGNO by Day 28 occurred in 4% of patients in the meropenem and 12% in the SOC arm (p = 0.052). Conclusions: Within this study population, we found no evidence that meropenem was superior to SOC in terms of success at TOC, short term hearing disturbances, safety or mortality were similar in both treatment arms but the study was underpowered to detect the planned effect. Meropenem treatment did not select for colonization with CRGNOs. We suggest that meropenem as broad-spectrum antibiotic should be reserved for neonates who are more likely to have Gram-negative LOS, especially in NICUs where microorganisms producing extended spectrum- and AmpC type beta-lactamases are circulating. [ABSTRACT FROM AUTHOR]

Published
2020
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22. Influence of alpha-1 glycoprotein acid concentrations and variants on atazanavir pharmacokinetics in HIV-infected patients included in the ANRS 107 trial

Author

Barrail-Tran, Aurélie, Mentré, France, Cosson, Claudine, Piketty, Christophe, Chazallon, Corine, Gérard, Laurence, Girard, Pierre-Marie, Taburet, Anne-Marie, Service de pharmacie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Service de Biochimie [Bicêtre], Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Service d'immunologie [HEGP, Paris], Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Essais Therapeutiques et Infection Par Le Vih, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), Services des Maladies Infectieuses et Tropicales [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and This study was supported by ANRS (National Agency for AIDS Research), Paris, France

Subjects
MESH: Humans, MESH: Middle Aged, MESH: Pyridines, virus diseases, MESH: Serum Albumin, MESH: Adult, MESH: HIV Infections, [SDV.BIBS]Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], MESH: Male, MESH: Orosomucoid, MESH: Oligopeptides, [INFO.INFO-BI]Computer Science [cs]/Bioinformatics [q-bio.QM], MESH: Female, MESH: HIV Protease Inhibitors
Abstract

International audience; Atazanavir is an HIV-1 protease inhibitor with high protein binding in human plasma. The objectives were first to determine the in vitro binding characteristics of atazanavir and second to evaluate whether plasma protein binding to albumin and alpha-1 glycoprotein acid (AAG) influences the pharmacokinetics of atazanavir in HIV-infected patients. For the in vitro study, atazanavir protein binding characteristics were determined in AAG- and albumin-containing purified solutions. Atazanavir was found to bind AAG on a high-affinity saturable site (association constant, 4.61x10(5) liters/mol) and albumin on a low-affinity nonsaturable site. For the in vivo study, blood samples from 51 patients included in trial ANRS 107--Puzzle 2 were drawn prior to drug intake at week 6. For 10 patients included in the pharmacokinetic substudy, five additional blood samples were collected during one dosing interval at week 6. Atazanavir concentrations were assayed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Albumin concentrations, AAG concentrations, and phenotypes were also measured in these patients. Concentrations of atazanavir were modeled using a population approach. A one-compartment model with first-order absorption and elimination best described atazanavir pharmacokinetics. Atazanavir pharmacokinetic parameters and their interindividual variabilities were as follows: absorption rate constant (ka), 0.73 h(-1) (139.3%); apparent clearance (CL/F), 13.3 liters/h (26.7%); and apparent volume of distribution (V/F), 79.7 liters (27.0%). Atazanavir CL/F decreased significantly when alanine aminotransferase and/or AAG levels increased (P

Published
2010
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24. Salvage Therapy with Atazanavir/Ritonavir Combined to Tenofovir in HIV-Infected Patients with Multiple Treatment Failures: Randomized Anrs 107 Trial

Author

Piketty, Christophe, primary, Gérard, Laurence, additional, Chazallon, Corine, additional, Marcelin, Anne-Geneviève, additional, Clavel, François, additional, Taburet, Anne-Marie, additional, Calvez, Vincent, additional, Madelaine-Chambrin, Isabelle, additional, Molina, Jean-Michel, additional, Aboulker, Jean-Pierre, additional, and Girard, Pierre-Marie, additional

Published
2006
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26. Renal Function in Antiretroviral-Experienced Patients treated with Tenofovir Disoproxil Fumarate associated with Atazanavir/ritonavir

Author

Gérard, Laurence, Chazallon, Corine, Taburet, Anne-Marie, Girard, Pierre-Marie, Aboulker, Jean-Pierre, and Piketty, Christophe

Abstract

Objective To determine the evolution of renal function in highly treatment-experienced patients with normal renal function at baseline receiving tenofovir disoproxil fumarate (TDF) as part of a fixed combined antiretroviral regimen and to identify prognostic factors of change in renal function, including tenofovir concentrations.Methods A prospective 48-week open-label trial was carried out, evaluating the safety of TDF, associated with atazanavir/ritonavir, and optimized nucleoside reverse transcriptase inhibitors, in patients with documented failure in previous treatments. Statistical analysis was performed on an intent-to-treat basis.Results Fifty-three patients were included, with a median CD4+T-cell count of 206x106/l and a median HIV RNA level of 5 log10copies/ml. All patients had normal serum creatinine levels and creatinine clearances (CLCr) at baseline, which were stable within the 2 months preceding inclusion. Two patients discontinued TDF as a result of severe renal impairment. Two patients never started TDF. A total of 49 patients without clinical nephrotoxicity were analysed. The median creatinine level increased significantly from baseline to week 48 (+0.04 mg/dl [+5.8%]; P=0.008), and the median CLCrdecreased significantly (-7.8 ml/min [-7.6%]; P=0.005). Trough tenofovir concentration was not associated with change in CLCr(P=0.79). No risk factors, including tenofovir plasma trough levels, were significantly associated with change in CLCrat week 24.Conclusions This study confirms that TDF-related severe nephrotoxicity is an uncommon event. In patients without clinical nephrotoxicity, the use of TDF during a 1-year period was associated with a slight but significant alteration of renal function, which was not associated with increased trough concentration.

Published
2007
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