Browsing by Author "Jorge Pinto"

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    The epidemiology of adolescents living with perinatally acquired HIV: A cross-region global cohort analysis
    (2018-03-01) Amy L. Slogrove; Michael Schomaker; Mary Ann Davies; Paige Williams; Suna Balkan; Jihane Ben-Farhat; Nancy Calles; Kulkanya Chokephaibulkit; Charlotte Duff; Tanoh François Eboua; Adeodata Kekitiinwa-Rukyalekere; Nicola Maxwell; Jorge Pinto; George Seage; Chloe A. Teasdale; Sebastian Wanless; Josiane Warszawski; Kara Wools-Kaloustian; Marcel Yotebieng; Venessa Timmerman; Intira J. Collins; Ruth Goodall; Colette Smith; Kunjal Patel; Mary Paul; Diana Gibb; Rachel Vreeman; Elaine J. Abrams; Rohan Hazra; Russell Van Dyke; Linda Gail Bekker; Lynne Mofenson; Marissa Vicari; Shaffiq Essajee; Martina Penazzato; Gabriel Anabwani; Edith Q. Mohapi; Peter N. Kazembe; Makhosazana Hlatshwayo; Mwita Lumumba; Tessa Goetghebuer; Claire Thorne; Luisa Galli; Annemarie van Rossum; Carlo Giaquinto; Magdalena Marczynska; Laura Marques; Filipa Prata; Luminita Ene; Liubov Okhonskaia; Pablo Rojo; Claudia Fortuny; Lars Naver; Christoph Rudin; Sophie Le Coeur; Alla Volokha; Vanessa Rouzier; Regina Succi; Annette Sohn; Azar Kariminia; Andrew Edmonds; Patricia Lelo; Samuel Ayaya; Patricia Ongwen; Laura F. Jefferys; Sam Phiri; Mwangelwa Mubiana-Mbewe; Shobna Sawry; Lorna Renner; Mariam Sylla; Mark J. Abzug; Myron Levin; James Oleske; Miriam Chernoff; Shirley Traite; Murli Purswani; Ellen G. Chadwick; Ali Judd; Valériane Leroy; Elizabeth Glaser Pediatric AIDS Foundation; Academic Model Providing Access to Healthcare; Shupyk National Medical Academy of Postgraduate Education; Centre for Infectious Disease Research in Zambia; Medical University of Warsaw; INED Institut National d' Études Démographiques; Harvard School of Public Health; Universidade Federal de Minas Gerais; Centre Hospitalier Universitaire Saint Pierre, Brussels; University of Colorado School of Medicine; Columbia University Medical Center; Baragwanath Hospital; Organisation Mondiale de la Santé; Kirby Institute; The University of North Carolina at Chapel Hill; Indiana University School of Medicine Indianapolis; Università degli Studi di Firenze; Santa Maria Hospital, Lisbon; Karolinska University Hospital; University of Ghana; National Institute of Child Health and Human Development; Tulane University; University of Witwatersrand; Sophia Kinderziekenhuis; Universidade Federal de Sao Paulo; Northwestern University Feinberg School of Medicine; Icahn School of Medicine at Mount Sinai; Victor Babes National Institute; UCL Institute of Child Health; Faculty of Medicine, Siriraj Hospital, Mahidol University; UNAIDS; Texas Children's Hospital Houston; UNICEF; Medecins Sans Frontieres; Universitäts-Kinderspital beider Basel; Rutgers New Jersey Medical School; Hospital Universitario 12 de Octubre; Ohio State University; MRC Clinical Trials Unit; Universitat de Barcelona; Inserm; Chiang Mai University; University of Cape Town; Family AIDS Care and Education Services Medical Research Institute; Baylor International Pediatric AIDS Initiative; Baylor International Pediatric AIDS Initiative; Baylor International Pediatric AIDS Initiative; Baylor International Pediatrics AIDS Initiative; PENTA Foundation; SolidarMed Lesotho; CHU Gabriel Touré; Centro Hospitalar do Porto; Baylor International Pediatric AIDS Initiative; Baylor Pediatric International AIDS Initiative; Lighthouse Trust; TREAT Asia/amfAR-The Foundation for AIDS Research; Republican Hospital of Infectious Diseases; Pediatric Hospital Kalembe Lembe; GHESKIO Centers; Yopougon University Hospital
    © 2018 The Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Global Cohort Collaboration et al. Background: Globally, the population of adolescents living with perinatally acquired HIV (APHs) continues to expand. In this study, we pooled data from observational pediatric HIV cohorts and cohort networks, allowing comparisons of adolescents with perinatally acquired HIV in “real-life” settings across multiple regions. We describe the geographic and temporal characteristics and mortality outcomes of APHs across multiple regions, including South America and the Caribbean, North America, Europe, sub-Saharan Africa, and South and Southeast Asia. Methods and findings: Through the Collaborative Initiative for Paediatric HIV Education and Research (CIPHER), individual retrospective longitudinal data from 12 cohort networks were pooled. All children infected with HIV who entered care before age 10 years, were not known to have horizontally acquired HIV, and were followed up beyond age 10 years were included in this analysis conducted from May 2016 to January 2017. Our primary analysis describes patient and treatment characteristics of APHs at key time points, including first HIV-associated clinic visit, antiretroviral therapy (ART) start, age 10 years, and last visit, and compares these characteristics by geographic region, country income group (CIG), and birth period. Our secondary analysis describes mortality, transfer out, and lost to follow-up (LTFU) as outcomes at age 15 years, using competing risk analysis. Among the 38,187 APHs included, 51% were female, 79% were from sub-Saharan Africa and 65% lived in low-income countries. APHs from 51 countries were included (Europe: 14 countries and 3,054 APHs; North America: 1 country and 1,032 APHs; South America and the Caribbean: 4 countries and 903 APHs; South and Southeast Asia: 7 countries and 2,902 APHs; sub-Saharan Africa, 25 countries and 30,296 APHs). Observation started as early as 1982 in Europe and 1996 in sub-Saharan Africa, and continued until at least 2014 in all regions. The median (interquartile range [IQR]) duration of adolescent follow-up was 3.1 (1.5–5.2) years for the total cohort and 6.4 (3.6–8.0) years in Europe, 3.7 (2.0–5.4) years in North America, 2.5 (1.2–4.4) years in South and Southeast Asia, 5.0 (2.7–7.5) years in South America and the Caribbean, and 2.1 (0.9–3.8) years in sub-Saharan Africa. Median (IQR) age at first visit differed substantially by region, ranging from 0.7 (0.3–2.1) years in North America to 7.1 (5.3–8.6) years in sub-Saharan Africa. The median age at ART start varied from 0.9 (0.4–2.6) years in North America to 7.9 (6.0–9.3) years in sub-Saharan Africa. The cumulative incidence estimates (95% confidence interval [CI]) at age 15 years for mortality, transfers out, and LTFU for all APHs were 2.6% (2.4%–2.8%), 15.6% (15.1%–16.0%), and 11.3% (10.9%–11.8%), respectively. Mortality was lowest in Europe (0.8% [0.5%–1.1%]) and highest in South America and the Caribbean (4.4% [3.1%–6.1%]). However, LTFU was lowest in South America and the Caribbean (4.8% [3.4%–6.7%]) and highest in sub-Saharan Africa (13.2% [12.6%–13.7%]). Study limitations include the high LTFU rate in sub-Saharan Africa, which could have affected the comparison of mortality across regions; inclusion of data only for APHs receiving ART from some countries; and unavailability of data from high-burden countries such as Nigeria. Conclusion: To our knowledge, our study represents the largest multiregional epidemiological analysis of APHs. Despite probable under-ascertained mortality, mortality in APHs remains substantially higher in sub-Saharan Africa, South and Southeast Asia, and South America and the Caribbean than in Europe. Collaborations such as CIPHER enable us to monitor current global temporal trends in outcomes over time to inform appropriate policy responses.
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    Etravirine in treatment-experienced, HIV-1-infected children and adolescents: 48-week safety, efficacy and resistance analysis of the phase II PIANO study
    (2014-01-01) Gareth Tudor-Williams; Pedro Cahn; Kulkanya Chokephaibulkit; Jan Fourie; Chris Karatzios; S. Dincq; M. Opsomer; T. N. Kakuda; S. Nijs; L. Tambuyzer; F. L. Tomaka; Rosa Bologna; Esaú João; José Henrique Pilotto; Marisa Mussi-Pinhata; Jorge Pinto; Normand Lapointe; Albert Faye; Kamila Kebaili; Steven Welch; Stefania Bernardi; Luisa Galli; Carlo Giaquinto; Nicola Principi; Gian Vincenzo Zuccotti; Henriette J. Scherpbier; Laura Marques; Isabel Soares; Margarida Tavares; Midnela Acevedo; Dan Duiculescu; Sorin Rugina; Gulam H. Latiff; Claudia Fortuny; Juan Antonio Leon Leal; Marissa Navarro; Jose T. Ramos; Tawee Chotpitayasunondh; Pope Kosalaraksa; Kiat Ruxrungtham; Jacobo Abadi; Tess Barton; William Borkowsy; Janet Chen; Joseph Church; Patricia Flynn; Sohail Rana; Richard Rutstein; Leonard Weiner; Imperial College London; Fundacion Huesped; Mahidol University; Dr Jan Fourie Medical Practice; Centre universitaire de sante McGill; Janssen Infectious Diseases BVBA; Janssen
    © 2014 British HIV Association 15 9 October 2014 10.1111/hiv.12141 Original research Original research. © 2014 British HIV Association. Objectives: PIANO (Paediatric study of Intelence As an NNRTI Option; TMC125-C213; NCT00665847) assessed the safety/tolerability, antiviral activity and pharmacokinetics of etravirine plus an optimized background regimen (OBR) in treatment-experienced, HIV-1-infected children (≥6 to <12 years) and adolescents (≥12 to <18 years) over 48 weeks. Methods: In a phase II, open-label, single-arm study, 101 treatment-experienced patients (41 children; 60 adolescents) with screening viral load (VL) ≥500 HIV-1 RNA copies/mL received etravirine 5.2mg/kg (maximum dose 200mg) twice a day (bid) plus OBR. Results: Sixty-seven per cent of patients had previously used efavirenz or nevirapine. At week 48, the most common treatment-related grade ≥2 adverse event (AE) was rash (13%); 12% experienced grade 3 AEs. Only two grade 4 AEs occurred (both thrombocytopaenia, not etravirine related). At week 48, 56% of patients (68% children; 48% adolescents) achieved a virological response (VL<50copies/mL; intent-to-treat, noncompleter=failure). Factors predictive of response were adherence >95%, male sex, low baseline etravirine weighted genotypic score and high etravirine trough concentration (C0h). Seventy-six patients (75%) completed the trial; most discontinuations occurred because of protocol noncompliance or AEs (8% each). Sixty-five per cent of patients were >95% adherent by questionnaire and 39% by pill count. Forty-one patients experienced virological failure (VF; time-to-loss-of-virological-response non-VF-censored algorithm) (29 nonresponders; 12 rebounders). Of 30 patients with VF with paired baseline/endpoint genotypes, 18 (60%) developed nonnucleoside reverse transcriptase inhibitor (NNRTI) mutations, most commonly Y181C. Mean etravirine area under the plasma concentration-time curve over 12h (AUC0-12h; 5216ng h/mL) and C0h (346ng/mL) were comparable to adult target values. Conclusions: Results with etravirine 5.2mg/kg bid (with OBR) in this treatment-experienced paediatric population and etravirine 200mg bid in treatment-experienced adults were comparable. Etravirine is an NNRTI option for treatment-experienced paediatric patients. Copyright.