Real-world effectiveness of pre-exposure prophylaxis in men at high risk of HIV infection in France: a nested case-control study.
Journal
The Lancet. Public health
ISSN: 2468-2667
Titre abrégé: Lancet Public Health
Pays: England
ID NLM: 101699003
Informations de publication
Date de publication:
06 2022
06 2022
Historique:
received:
23
02
2022
revised:
28
03
2022
accepted:
11
04
2022
entrez:
6
6
2022
pubmed:
7
6
2022
medline:
9
6
2022
Statut:
ppublish
Résumé
Pre-exposure prophylaxis (PrEP) has shown high efficacy in clinical trials, but few observational studies have confirmed its effectiveness when prescribed in real life to users with diverse profiles. This study aimed to assess real-world PrEP effectiveness. We did a matched, nested case-control study among adult men at high risk of HIV infection between Jan 1, 2016, and June 30, 2020, using data from the French national health data system. Men who were newly diagnosed with HIV infection up to Dec 31, 2020, were individually matched with up to five controls for age, socioeconomic status, place of residence, calendar year, and follow-up duration. PrEP use was characterised on the basis of tenofovir disoproxil fumarate plus emtricitabine dispensing over time. Conditional logistic regression was used to calculate the adjusted odds ratios (ORs) of PrEP use associated with HIV infection. PrEP effectiveness (computed as 1-adjusted OR), was estimated overall, by mode of PrEP use, and by individuals' sociodemographic characteristics. Among a total of 46 706 individuals, 256 patients with HIV infection were identified and matched with 1213 controls. PrEP users accounted for 29% of cases and 49% of controls. PrEP effectiveness was 60% (95% CI 46 to 71) overall, reaching 93% (84 to 97) for a high amount of PrEP consumption, and 86% (78 to 92) if excluding periods after PrEP discontinuation. PrEP effectiveness was significantly reduced in people younger than 30 years (26% [-21 to 54]) and in those who were socioeconomically deprived (-64% [-392 to 45]), both of which groups showed low amounts of PrEP consumption and high rates of PrEP discontinuation. PrEP effectiveness appears to be lower in real-world conditions than is reported in clinical trials. Strengthening efforts to improve the monitoring of PrEP compliance will be essential to ensure PrEP effectiveness, especially among young and socioeconomically deprived recipients. None.
Sections du résumé
BACKGROUND
Pre-exposure prophylaxis (PrEP) has shown high efficacy in clinical trials, but few observational studies have confirmed its effectiveness when prescribed in real life to users with diverse profiles. This study aimed to assess real-world PrEP effectiveness.
METHODS
We did a matched, nested case-control study among adult men at high risk of HIV infection between Jan 1, 2016, and June 30, 2020, using data from the French national health data system. Men who were newly diagnosed with HIV infection up to Dec 31, 2020, were individually matched with up to five controls for age, socioeconomic status, place of residence, calendar year, and follow-up duration. PrEP use was characterised on the basis of tenofovir disoproxil fumarate plus emtricitabine dispensing over time. Conditional logistic regression was used to calculate the adjusted odds ratios (ORs) of PrEP use associated with HIV infection. PrEP effectiveness (computed as 1-adjusted OR), was estimated overall, by mode of PrEP use, and by individuals' sociodemographic characteristics.
FINDINGS
Among a total of 46 706 individuals, 256 patients with HIV infection were identified and matched with 1213 controls. PrEP users accounted for 29% of cases and 49% of controls. PrEP effectiveness was 60% (95% CI 46 to 71) overall, reaching 93% (84 to 97) for a high amount of PrEP consumption, and 86% (78 to 92) if excluding periods after PrEP discontinuation. PrEP effectiveness was significantly reduced in people younger than 30 years (26% [-21 to 54]) and in those who were socioeconomically deprived (-64% [-392 to 45]), both of which groups showed low amounts of PrEP consumption and high rates of PrEP discontinuation.
INTERPRETATION
PrEP effectiveness appears to be lower in real-world conditions than is reported in clinical trials. Strengthening efforts to improve the monitoring of PrEP compliance will be essential to ensure PrEP effectiveness, especially among young and socioeconomically deprived recipients.
FUNDING
None.
Identifiants
pubmed: 35660214
pii: S2468-2667(22)00106-2
doi: 10.1016/S2468-2667(22)00106-2
pii:
doi:
Substances chimiques
Anti-HIV Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e529-e536Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests HJ was an employee of AstraZeneca, France from January, 2019 to July, 2020. All other authors declare no competing interests.