eprintid: 10072714
rev_number: 25
eprint_status: archive
userid: 608
dir: disk0/10/07/27/14
datestamp: 2019-04-26 11:44:41
lastmod: 2021-12-13 03:19:07
status_changed: 2019-04-29 10:35:14
type: article
metadata_visibility: show
creators_name: Chiappini, E
creators_name: Ene, L
creators_name: Galli, L
creators_name: Giaquinto, C
creators_name: Goetghebuer, T
creators_name: Judd, A
creators_name: Malyuta, R
creators_name: Noguera-Julian, A
creators_name: Ramos Amador, JT
creators_name: Rojo-Conejo, P
creators_name: Rudin, C
creators_name: Tookey, P
creators_name: Lisi, C
creators_name: Thorne, C
title: Severe haematologic toxicity is rare in high risk HIV-exposed infants receiving combination neonatal prophylaxis
ispublished: pub
divisions: UCL
divisions: B02
divisions: D65
divisions: J38
divisions: D13
divisions: G25
keywords: children; antiretroviral therapy; adverse event
note: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
abstract: Objectives
Combination neonatal prophylaxis (CNP) is recommended in high‐risk situations for the prevention of mother‐to‐child HIV transmission, although data on its safety are limited. The aim of the study was to identify whether neonatal prophylaxis (NP) type is associated with the risk of severe anaemia or neutropaenia.

Methods
An individual patient data meta‐analysis was conducted within six European cohorts, in infants at high risk for acquiring HIV infection. Adjusted logistic regression models were used to assess the risk of National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) grade 3–4 anaemia/neutropaenia at ages 0–6 months. Mixture models of haemoglobin (Hb) level and log10‐transformed neutrophil count (NC) were used to explore associations with NP type at ages 0–18 months.

Results
Of 1836 infants, 25% were preterm, 1149 (63%) had antenatal combination antiretroviral therapy (cART) exposure and 395 (22%) received NP (125 received CNP with three drugs). Overall, 117 (6.7%) infants had grade 3–4 anaemia at age 0–6 months and 140 (9.1%) had grade 3–4 neutropaenia. The presence of grade 3–4 anaemia or neutropaenia was not associated with NP type [adjusted odds ratio (aOR) 1.04 for one‐drug NP and 1.60 for three‐drug NP versus two‐drug NP (P = 0.879 and P = 0.277, respectively) for anaemia; aOR 1.33 for one‐drug NP and 1.98 for three‐drug NP versus two‐drug NP (P = 0.330 and P = 0.113, respectively) for neutropaenia], but was associated with preterm delivery. Overall, 7746 Hb and NC results were available for 1836 infants up to age 18 months; no significant differences in predicted Hb level or NC were apparent by NP type.

Conclusions
A small proportion of infants experienced grade 3–4 haematological adverse events; risk of anaemia or netropenia was not associated with type of NP.
date: 2019-05
date_type: published
official_url: https://doi.org/10.1111/hiv.12696
oa_status: green
full_text_type: other
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1643347
doi: 10.1111/hiv.12696
lyricists_name: Judd, Ali
lyricists_name: Thorne, Claire
lyricists_id: AJUDD59
lyricists_id: CNTHO93
actors_name: Thorne, Claire
actors_id: CNTHO93
actors_role: owner
full_text_status: public
publication: HIV Medicine
volume: 20
number: 5
pagerange: 291-307
issn: 1468-1293
citation:        Chiappini, E;    Ene, L;    Galli, L;    Giaquinto, C;    Goetghebuer, T;    Judd, A;    Malyuta, R;                             ... Thorne, C; + view all <#>        Chiappini, E;  Ene, L;  Galli, L;  Giaquinto, C;  Goetghebuer, T;  Judd, A;  Malyuta, R;  Noguera-Julian, A;  Ramos Amador, JT;  Rojo-Conejo, P;  Rudin, C;  Tookey, P;  Lisi, C;  Thorne, C;   - view fewer <#>    (2019)    Severe haematologic toxicity is rare in high risk HIV-exposed infants receiving combination neonatal prophylaxis.                   HIV Medicine , 20  (5)   pp. 291-307.    10.1111/hiv.12696 <https://doi.org/10.1111/hiv.12696>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10072714/1/haem%20toxicity%20paper%20for%20RPS%20upload.pdf