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2024 ; 14
(7
): e079292
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Rates of adverse events of antiretroviral therapy in women living with HIV/AIDS:
a systematic review and meta-analysis
#MMPMID39089716
de Oliveira JC
; Alves MR
; Lopes LPN
; Motter FR
; Iwami RS
; Bergamaschi CC
; Silva MT
; Scalco DL
; Lucio DS
; Mazzei LG
; Derech RD
; Itria A
; Barreto JOM
; Lopes LC
BMJ Open
2024[Jul]; 14
(7
): e079292
PMID39089716
show ga
OBJECTIVE: There is limited information regarding the incidence of
treatment-related adverse events (AE) following antiretroviral therapy (ART) in
women. So, this review aimed to describe the incidence of AE of ART in women
living with HIV/AIDS. DESIGN: Systematic review and meta-analysis. DATA SOURCES:
Medline, Embase, Cochrane Library, Epistemonikos, Lilacs and Who Index, from
inception to 9 April 2023. ELIGIBILITY CRITERIA: We included randomised
controlled trials with at least 12 weeks of follow-up and evaluated AE of ART in
women at any age living with HIV/AIDS, without restrictions on status, year or
language of publication. We excluded post hoc or secondary analyses and
open-label extensions without comparator, and trials involving pregnant or
breastfeeding women or with a focus on coinfection with tuberculosis, hepatitis B
or C. The primary outcomes were the incidence rate of participants with any
clinical and/or laboratory AE related or not to ART and treatment
discontinuation. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers
extracted data and assessed the risk of bias using Cochrane's risk of bias tool
2. We used Bayesian random-effects meta-analysis to summarise event rates.
Results were presented as event rates per 1000 person-years (95% credibility
intervals, 95% CrI). The pooled incidence rate per 1000 person-years adjusted for
duration and loss to follow-up was estimated. We assessed the certainty of the
evidence using Grading of Recommendations, Assessment, Development and
Evaluation. RESULTS: A total of 24 339 studies were identified for screening, of
which 10 studies (2871 women) met the eligibility criteria, with 11 different
antiretrovirals (ARVs) regimens. Seven studies included exclusively women, while
in the remaining three, the proportion of women ranged from 11% to 46%. Nine
studies received industry funding. The pooled analysis showed a mean incidence
rate of ART-related clinical and laboratory AE of 341.60 events per 1000
person-years (95% CrI 133.60-862.70), treatment discontinuation of 20.78 events
per 1000 person-years (95% CrI 5.58-57.31) and ART-related discontinuation of
4.31 per 1000 person-years (95% CrI 0.13-54.72). Summary estimates were subject
to significant uncertainty due to the limited number of studies and sparse data.
The certainty of the evidence was graded as very low for all outcomes assessed.
CONCLUSION: Existing randomised trials do not provide sufficient evidence on the
incidence rates of safety outcomes from antiretroviral treatment in women living
with HIV/AIDS. Large comparative studies in well-characterised populations are
needed to provide a more comprehensive landscape of the safety profile of these
ARV therapies in women with HIV/AIDS. PROSPERO REGISTRATION NUMBER:
CRD42021251051.