Please use this identifier to cite or link to this item: http://cmuir.cmu.ac.th/jspui/handle/6653943832/56254
Title: Safety of darunavir and atazanavir in HIV-infected children in Europe and Thailand
Authors: Heather Bailey
Intira Jeannie Collins
Tristan Childs
Anna Tostevin
Tessa Goetghebuer
Niels Valerius
Christoph Königs
Luisa Galli
Magda Marczynska
Laura Marques
Luminita Ene
Evgeny Voronin
Liubov Okhonskaia
Antoni Noguera-Julian
Pablo Rojo
Jose Tomas Ramos Amador
Lars Naver
Christoph Rudin
Gonzague Jourdain
Pat Tookey
Carlo Giaquinto
Ali Judd
Keywords: Medicine
Pharmacology, Toxicology and Pharmaceutics
Issue Date: 1-Jan-2016
Abstract: ©2016 International Medical Press. Background: Surveillance for mid- and long-term antiretroviral therapy (ART) toxicity in children is important for informing treatment guidelines. We assessed the safety of darunavir (DRV) and atazanavir (ATV), commonly used as second-line protease inhibitors following lopinavir/ritonavir, in Europe and Thailand. Methods: Cohorts contributed individual patient data on adverse events (AE) in those aged <18 years taking DRV and ATV, respectively, to 02/2014. Rates of Division of AIDS (DAIDS) grade ≥3 laboratory AEs were calculated. Results: Of 431 patients on DRV and 372 on ATV, 317 (74%) and 301 (81%), respectively, had weight and dose data available, of whom 56 (18%) and 33 (9%) took the drugs at a non-approved age or dose. Median age at DRV and ATV start was 14.8 years (IQR 12.8-16.1) and 13.5 years (11.4-15.2); 43% and 26% had received ≥8 ART drugs previously. Overall rates of grade ≥3 AEs for absolute neutrophils, total cholesterol, triglycerides, pancreatic amylase, lipase and alanine aminotransferase (ALT) were ≤3/100 person-years (PY) on approved doses of both drugs, but 66/100 PY (95% CI 52, 84) for bilirubin after <12 months on ATV declining to 32/100 PY (95% CI 23, 44) after >24 months. Five serious drug-related clinical AEs were reported in four patients on ATV (one discontinued) and three in three patients on DRV (all discontinued), and did not substantially differ in those on approved compared to non-approved doses. Proportions on the drugs at last follow-up were 89% (383/431) for DRV and 81% (301/372) for ATV (including 73/92 with grade ≥3 hyperbilirubinaemia). Conclusions: AEs were few in number and comparable for the two drugs, with the exception of high rates of hyperbilirubinaemia for ATV; few patients discontinued due to toxicity.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84984677356&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/56254
ISSN: 20402058
13596535
Appears in Collections:CMUL: Journal Articles

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