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1. Early inflammation as a footprint of increased mortality risk in infants living with HIV from three African countries

Author

Morrocchi, Elena, Pascucci, Giuseppe R., Cotugno, Nicola, Pighi, Chiara, Dominguez-Rodriguez, Sara, Petrara, Maria Raffaella, Tagarro, Alfredo, Kuhn, Louise, Cotton, Mark F., Otwombe, Kennedy, Lain, Maria G., Vaz, Paula, Barnabas, Shaun L., Spyer, Moira J., Lopez, Elisa, Fernández-Luis, Sheila, Nhampossa, Tacilta, Maiga, Almoustapha I., Dolo, Oumar, De Rossi, Anita, Rojo, Pablo, Giaquinto, Carlo, Lichterfeld, Mathias, Violari, Avy, Smit, Theresa, Behuhuma, Osee, Klein, Nigel, De Armas, Lesley, Pahwa, Savita, Rossi, Paolo, and Palma, Paolo

Published
2024
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3. CONTRIBUTORS

Author

Abahuje, Egide, primary, Abrahim, Orit, additional, Adetifa, Ifedayo M.O., additional, Ajjampur, Sitara S.R., additional, Alexander, Suceena, additional, PhD, Chiara Altare,, additional, Alves, Fabiana, additional, Andrianaivoarimanana, Voahangy, additional, Angelakis, Emmanouil, additional, Aronson, Jeffrey K., additional, Atukorala, Inoshi G., additional, Baily, Guy, additional, Baker, Stephen, additional, Barrett, Alan D.T., additional, Basnyat, Buddha, additional, Bastawrous, Andrew, additional, Bates, Imelda, additional, Bausch, Daniel G., additional, Baxter, Cheryl, additional, Beare, Nicholas A.V., additional, Beeching, Nick J., additional, Bekker, Linda-Gail, additional, Berlin, Anita, additional, FRS, Zulfiqar A. Bhutta, additional, Bloom, David E., additional, Blumberg, Lucille, additional, Boelaert, Marleen, additional, Brett-Major, David, additional, Brooker, Simon J., additional, Brouwer, Matthijs C., additional, Brunetti, Enrico, additional, Bull, Susan, additional, Bundy, Donald A.P., additional, Burri, Christian, additional, Bustinduy, Amaya L., additional, Caillet, Céline, additional, Chai, Jong Yil, additional, Chang, Thashi, additional, Chappuis, François, additional, Chibi, Buyisile, additional, Chiodini, Peter L., additional, Chowdhury, Rajiv, additional, Chowdhury, Sudipta Dhar, additional, Clemens, John D., additional, Cooke, Graham S., additional, Cotton, Mark F., additional, Currie, Bart J., additional, Cusack, Tomas-Paul, additional, Dance, David A.B., additional, Davis, Emily H., additional, Day, Nicholas P.J., additional, Deen, Jacqueline, additional, Dondorp, Arjen M., additional, Dünser, Martin W., additional, Eitzen, Edward, additional, Chebib, Hassan El, additional, Enria, Delia, additional, Faust, Christina, additional, Fekadu, Abebaw, additional, Fink, Günther, additional, Fischer, Peter U., additional, Fletcher, Tom, additional, Franco-Paredes, Carlos, additional, French, Neil, additional, Frumkin, Howard, additional, Garcia, Hector H., additional, Gerada, Alessandro, additional, Glass, Roger I., additional, Gordon, Stephen B., additional, Gottstein, Bruno, additional, Goyal, Alpesh, additional, Grey, Jonathan, additional, Gupta, Yashdeep, additional, Haines, Andy, additional, Hampson, Katie, additional, Hanlon, Charlotte, additional, Harrison, Mark, additional, Haswell, Melissa R., additional, Hawkesworth, Sophie, additional, Hay, Roderick J., additional, Heckmann, Jeannine M., additional, Heimesaat, Markus M., additional, Henao-Martínez, Andrés F., additional, Hien, Tran Tinh, additional, Hoerauf, Achim, additional, Irfan, Omar, additional, PhD, Euzebiusz Jamrozik, additional, Jobe, Modou, additional, John, George T., additional, Jones, Nick K., additional, Jones, Malcolm K., additional, Junghanss, Thomas, additional, Kaewkes, Sasithorn, additional, Karim, Quarraisha Abdool, additional, Keiser, Jennifer, additional, Kelly, Paul, additional, Khan, Amira M., additional, King, Charles H., additional, Kishore, Sandeep P., additional, Lang, Trudie, additional, Le, Thuy, additional, Liesenfeld, Oliver, additional, Lockwood, Diana N.J., additional, Mabey, David C.W., additional, Madkour, M. Monir, additional, Manesh, Abi, additional, Masekela, Refiloe, additional, Mäser, Pascal, additional, Mayaud, Philippe, additional, Mbanya, Dora, additional, McCarthy, James S., additional, McCartney, Daniel J., additional, McGready, Rose, additional, McKee, Martin, additional, Mc, Namara, Paul S., additional, Meara, John G., additional, Meintjes, Graeme, additional, Merson, Laura, additional, Mola, Glen, additional, Morassutti, Alessandra L., additional, Morris-Jones, Rachael, additional, Mortimer, Kevin J., additional, Muliyil, Divya Elizabeth, additional, Mumcuoglu, Kosta Y., additional, Munoz, Flor M., additional, Murphy, Adrianna, additional, Mutabingwa, Theonest, additional, Nawa, Yukifumi, additional, Newton, Paul N., additional, Nightingale, Sam, additional, Nokes, D. James, additional, Nosten, François H., additional, O’Hea, Jennifer, additional, Olliaro, Piero, additional, Ong, Jason J., additional, Oommen, Anu Mary, additional, Parashar, Umesh D., additional, Paris, Daniel H., additional, Parker, Michael, additional, Pluschke, Gerd, additional, Preidis, Geoffrey A., additional, Prentice, Andrew M., additional, Quail, Geoffrey, additional, Quinn, Thomas C., additional, Rabie, Helena, additional, Rajashekharaiah, Harsha, additional, Rajerison, Minoarisoa, additional, Ranganathan, Kannan, additional, Raoult, Didier, additional, Rassi,, Anis, additional, Ravi, Vasanthapuram, additional, Reddy, K. Srinath, additional, Rees, Claire, additional, Reynolds, Steven J., additional, Richter, Joachim, additional, Rijken, Marcus J., additional, Riviello, Robert, additional, Robinson, Janet, additional, Salazar, Juan C., additional, Schultz, Marcus J., additional, Schwarz, Dan, additional, Sendagire, Ibrahim, additional, Sharma, Savitri, additional, Shawon, Shajedur Rahman, additional, Singh, Bhagteshwar, additional, Sithithaworn, Paiboon, additional, Siwila, Joyce, additional, Solomon, Tom, additional, Spiegel, Paul, additional, Sridhar, Devi, additional, Sripa, Banchob, additional, Srour, M. Leila, additional, Stojković, Marija, additional, Strader, Christopher, additional, Suárez, Jose A., additional, Sundar, Shyam, additional, Tamarozzi, Francesca, additional, Tandon, Nikhil, additional, Tate, Jacqueline E., additional, Thachil, Jecko, additional, Thomson, Madeleine C., additional, Thwaites, Guy, additional, Thwaites, C. Louise, additional, van Daalen, Kim R., additional, Beek, Diederik van de, additional, van Doorn, H. Rogier, additional, Vega-Lopez, Francisco, additional, von Seidlein, MD, PhD, Lorenz, additional, Wakeham, Katie, additional, Walker, Stephen L., additional, Wallace, Ryan M., additional, Ward, Honorine, additional, Warrell, David A., additional, Weber, Tim Frederik, additional, Weil, Gary J., additional, White, Nicholas J., additional, White, MB Ch, B, Graham B., additional, Wong, Vanessa, additional, Wood, Robin, additional, Wood, Georgina, additional, Wyllie, Sarah, additional, Yacoub, Sophie, additional, Yen, Lam Minh, additional, Young, Paul R., additional, and Zafren, Ken, additional

Published
2024
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4. Pharmacokinetics and safety of coformulated bictegravir, emtricitabine, and tenofovir alafenamide in children aged 2 years and older with virologically suppressed HIV: a phase 2/3, open-label, single-arm study

Author

Rodriguez, Carina A, Natukunda, Eva, Strehlau, Renate, Venter, Esme L, Rungmaitree, Supattra, Cunningham, Coleen K, Lalloo, Umesh, Kosalaraksa, Pope, HellstrÖm, Elizabeth, Liberty, Afaaf, McGrath, Eric J, Kaur, Meenu, Leisegang, Rory, Hindman, Jason T, Vieira, Vinicius A, Kersey, Kathryn, Cotton, Mark F, Rakhmanina, Natella, and Gaur, Aditya H

Published
2024
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6. Paediatric abacavir–lamivudine fixed-dose dispersible tablets and ritonavir-boosted lopinavir granules in neonates exposed to HIV (PETITE study): an open-label, two-stage, single-arm, phase 1/2, pharmacokinetic and safety trial

Author

Bekker, Adrie, Salvadori, Nicolas, Rabie, Helena, du Toit, Samantha, Than-in-at, Kanchana, Groenewald, Marisa, Cressey, Ratchada, Nielsen, James, Capparelli, Edmund V, Lallemant, Marc, Cotton, Mark F, and Cressey, Tim R

Published
2024
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7. HIV-1 reservoir size after neonatal antiretroviral therapy and the potential to evaluate antiretroviral-therapy-free remission (IMPAACT P1115): a phase 1/2 proof-of-concept study

Author

Persaud, Deborah, Bryson, Yvonne, Nelson, Bryan S, Tierney, Camlin, Cotton, Mark F, Coletti, Anne, Jao, Jennifer, Spector, Stephen A, Mirochnick, Mark, Capparelli, Edmund V, Costello, Diane, Szewczyk, Joseph, Nicodimus, Nicol, Stranix-Chibanda, Lynda, Kekitiinwa, Adeodata R, Korutaro, Violet, Reding, Christina, Carrington, Mary N, Majji, Sai, Yin, Dwight E, Jean-Philippe, Patrick, and Chadwick, Ellen G

Published
2024
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9. Study APV20002: Safety and Efficacy Results Through Week 684 for Pediatric Participants Living with HIV-1 Treated with Ritonavir-Boosted Fosamprenavir Oral Solution–Based Antiretroviral Therapy.

Author

Ross, Lisa L., Cotton, Mark F., Cassim, Haseena, Garges, Harmony P., van Dijkman, Sven C., Morarji, Kishen, Karthika, Supriya, Danehower, Susan, Radford, Jacob, and Butcher, David

Abstract

APV20002 was a multicenter, international, open-label study that began in 2003 investigating the pharmacokinetics, efficacy, and safety of ritonavir-boosted fosamprenavir (FPV/r) oral solution (OS) in combination with nucleoside reverse transcriptase inhibitor-based antiretroviral therapy (ART) in participants living with HIV-1 aged 4 weeks to <2 years with a primary endpoint at Week 48 (48W). Participants in APV20002 could continue in the study post-48W until FPV OS was locally available in their countries. Children were required to discontinue after reaching >39 kg or if FPV OS had no clinical benefit. Fifty-nine participants were enrolled; 5/59 received a single FPV OS visit for pharmacokinetic determinations. Most (38/54; 70%) were antiretroviral experienced; 39/59 participants had >48 weeks on treatment, 4/39 of whom discontinued after 48 weeks due to an adverse event (AE). At 48W, 88% of participants had HIV-1 RNA <400 copies/mL by Observed analysis; the proportion with HIV-1 RNA <400 copies/mL remained high (84%−100%) through Week 684. The median CD4+ cell count was 1,235 cells/mm3 [n = 51] at baseline, 1,690 cells/mm3 (n = 41) at Week 48, and 1,280 cells/mm3 (n = 21) at Week 180. From baseline to Week 684, 54/59 (92%) participants had ≥1 treatment-emergent AE regardless of causality; 42/59 (71%) had a treatment-emergent grade 2–4 AE, predominantly maximum toxicity: grade 2; 21/59 (36%) and 21/59 (36%) had severe or grade 3/4 AEs. From baseline to Week 684, 14/54 (26%) participants met virologic failure (VF) criteria, 9/14 before 48W. HIV from 1/9 VFs through 48W developed treatment-emergent reduced susceptibility to FPV and 1/9 to lamivudine/emtricitabine. Post-48W, 4/5 participants with VF had phenotype results; all were still susceptible to all study drugs at VF. In conclusion, FPV OS-based ART was efficacious and generally well tolerated in this long-running pediatric study through 684 weeks of treatment, with a safety profile consistent with experience in adults and older children. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Lamivudine dosing for preterm infants exposed to HIV: a population pharmacokinetic modelling and simulation study.

Author

Bekker, Adrie, Capparelli, Edmund V, Mirochnick, Mark, Clarke, Diana F, Cotton, Mark F, Shapiro, Roger, McCarthy, Katie, Moye, Jack, Violari, Avy, Chokephaibulkit, Kulkanya, Abrams, Elaine, Penazzato, Martina, Ruel, Theodore D, and Cressey, Tim R

Subjects
NEWBORN infants, PREMATURE infants, LAMIVUDINE, GESTATIONAL age, INFANTS
Abstract

Objectives To develop a pragmatic twice daily lamivudine dosing strategy for preterm infants from 24 to 37 completed weeks of gestation. Methods Data were combined from eight pharmacokinetic studies in neonates and infants receiving lamivudine oral solution. A population pharmacokinetic model was developed using non-linear mixed effects regression. Different lamivudine dosing strategies, stratified by gestational age at birth (GA) bands, were simulated in a virtual population of preterm infants, aimed at maintaining lamivudine drug exposures (AUC0-12) within a reference target range of 2.95 to 13.25 µg·h/mL, prior to switching to WHO-weight band doses when ≥4 weeks of age and weighing ≥3 kg. Results A total of 154 infants (59% female) contributed 858 lamivudine plasma concentrations. Median (range) GA at birth was 38 (27–41) weeks. At the time of first pharmacokinetic sampling infants were older with median postnatal age (PNA) of 6.3 (0.52–26.6) weeks. Lamivudine concentrations were described by a one-compartment model, with CL/F and V /F allometrically scaled to weight. Maturation of CL/F was described using an Emax model based on PNA. CL/F was also adjusted on GA to allow extrapolation for extreme prematurity. Simulations predicted an optimal lamivudine dosing for infants GA ≥24 to <30 weeks of 2 mg/kg twice daily from birth until weighing 3 kg; and for GA ≥30 to <37 weeks, 2 mg/kg twice daily for the first 4 weeks of life, followed by 4 mg/kg twice daily until weighing 3 kg. Conclusions Model-based predictions support twice daily pragmatic GA band dosing of lamivudine for preterm infants, but clinical validation is warranted. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Early Proteomic and Innate Immunity Profiles: A Footprint of Increased Mortality Risk In Infants Living with Hiv From Three African Countries

Author

Morrocchi, Elena, primary, Pascucci, Giuseppe Rubens, additional, Cotugno, Nicola, additional, Pighi, Chiara, additional, Domínguez-Rodríguez, Sara, additional, Petrara, Maria Raffaella, additional, Tagarro, Alfredo, additional, Kuhn, Louise, additional, Cotton, Mark F., additional, Otwombe, Kennedy, additional, Lain, Maria Grazia, additional, Vaz, Paula, additional, Barnabas, Shaun L., additional, Spyer, Moira J., additional, Lopez Varela, Elisa, additional, Fernandez-Luis, Sheila, additional, Nhampossa, Tacilta, additional, Maiga, Almoustapha Issiaka, additional, Dolo, Oumar, additional, De Rossi, Anita, additional, Rojo, Pablo, additional, Giaquinto, Carlo, additional, Lichterfeld, Matthias, additional, Violari, Avy, additional, Smit, Theresa, additional, Behuhuma, Osee, additional, Klein, Nigel, additional, De Armas, Lesley, additional, Pahwa, Savita, additional, Rossi, Paolo, additional, Palma, Paolo, additional, and Consortium, EPIICAL, additional

Published
2024
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14. Impact of a care bundle on short peripheral catheter-associated complications in a resource-limited neonatal unit

Author

Dramowski, Angela, Erasmus, Louisa, Fataar, Aaqilah, Cotton, Mark F, Whitelaw, Andrew C, Coffin, Susan, and Bekker, Adrie

Abstract

Background: Short peripheral catheter (SPC)-associated complications occur frequently in hospitalised neonates. Few studies have reported the use of SPC care bundles in resource-limited neonatal units.Objective: To evaluate the impact of a SPC care bundle on SPC associated complications (infiltration, dislodgement, phlebitis) and catheter dwell time.Methods: We conducted a quasi-experimental study comparing neonatal SPC complications during a 2-month baseline and a 2-month intervention period, where a SPC care bundle was introduced including hand hygiene, insertion site antisepsis, nurse assistance during cannulation, IV insertion carts and IV securement dressings.Results: A total of 459 SPC days were observed in 223 neonates: 111 pre-intervention and 112 post-intervention (after SPC bundle implementation). Most neonates were preterm (208, 93.3%) with very or extremely low birth weight (133, 59.6%). SPC care bundle compliance was 43.8% for five bundle elements and 83.9% for four bundle elements. Most SPCs had unplanned removal within 48 h of insertion owing to infiltration or dislodgement (89/111 pre-intervention (80.2%) vs 90/112 post-intervention (80.4%); 0.974). No phlebitis was documented. The mean SPC dwell time was unchanged following bundle implementation (32.9 vs 34.2 h; p= 0.376).Conclusions: Infiltration and dislodgement occurred frequently necessitating replacement of four of every five SPCs. Despite moderate compliance with the SPC care bundle, the high rates of unplanned SPC removal and short duration of catheter dwell time were unchanged.Contribution: The SPC care bundle did not improve catheter dwell time; further research is needed to identify strategies to reduce unplanned SPC removal and extend catheter dwell time in hospitalised neonates.

Published
2024
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15. Influence of age and co-medication on dolutegravir glucuronidation in paediatric patients.

Author

Jacobs TG, Waalewijn H, Houlden L, Bollen PDJ, Nanduudu A, Nambi E, Cassim H, Lugemwa A, Makumbi S, Monkiewicz LN, Shakeshaft C, Bamford A, Archary M, Musuro G, Chidziva E, Mujuru HA, Bwakura-Dangarembizi M, Chabala C, Turkova A, Gibb DM, Cotton MF, Aarnoutse R, Burger DM, and Colbers A

Subjects
Adolescent, Child, Child, Preschool, Female, Humans, Infant, Male, Age Factors, Area Under Curve, Reverse Transcriptase Inhibitors pharmacokinetics, Reverse Transcriptase Inhibitors therapeutic use, Randomized Controlled Trials as Topic, Drug Interactions, Glucuronides metabolism, Heterocyclic Compounds, 3-Ring pharmacokinetics, Heterocyclic Compounds, 3-Ring therapeutic use, Heterocyclic Compounds, 3-Ring administration & dosage, HIV Infections drug therapy, HIV Integrase Inhibitors pharmacokinetics, HIV Integrase Inhibitors therapeutic use, HIV Integrase Inhibitors administration & dosage, Oxazines pharmacokinetics, Piperazines, Pyridones pharmacokinetics, Rifampin therapeutic use, Rifampin pharmacology, Rifampin pharmacokinetics, Rifampin administration & dosage
Abstract

Dolutegravir (DTG) is primarily metabolized by uridine diphosphate glucuronosyltransferases, forming the pharmacologically inactive DTG glucuronide (DTG-gluc). We described the dolutegravir metabolic ratio (DTG-MR; DTG-gluc AUC 0-24h divided by DTG AUC 0-24h ) in 85 children with HIV aged 3 months to 18 years receiving DTG in the CHAPAS-4 (ISRCTN22964075) and ODYSSEY (NCT02259127) trials. Additionally, we assessed the influence of age, body weight, nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone, rifampicin use and kidney function on DTG-MR. The overall geometric mean (CV%) DTG-MR was 0.054 (52%). Rifampicin use was the only significant factor associated with DTG-MR (P < .001) in multiple linear regression. DTG-MR geometric mean ratio was 1.81 (95% CI: 1.57-2.08) for children while on vs. off rifampicin. This study showed that overall DTG-MR in children was similar to adults, unaffected by age or NRTI backbone, and increased with rifampicin co-administration. These findings support future paediatric pharmacokinetic modelling and extrapolation from adult data., (© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Published
2024
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