Brief Report: Short-Term Adherence Marker to PrEP Predicts Future Nonretention in a Large PrEP Demo Project: Implications for Point-of-Care Adherence Testing.
Adenine
/ analogs & derivatives
Adult
Anti-HIV Agents
/ blood
Dried Blood Spot Testing
/ methods
Emtricitabine
/ analogs & derivatives
Female
HIV Infections
/ blood
Homosexuality, Male
Humans
Male
Medication Adherence
Organophosphates
/ blood
Point-of-Care Testing
Pre-Exposure Prophylaxis
Proportional Hazards Models
Prospective Studies
Tenofovir
/ blood
Journal
Journal of acquired immune deficiency syndromes (1999)
ISSN: 1944-7884
Titre abrégé: J Acquir Immune Defic Syndr
Pays: United States
ID NLM: 100892005
Informations de publication
Date de publication:
01 06 2019
01 06 2019
Historique:
entrez:
17
5
2019
pubmed:
17
5
2019
medline:
25
2
2020
Statut:
ppublish
Résumé
Objective adherence metrics for tenofovir (TFV) disoproxil fumarate/emtricitabine (FTC)-based pre-exposure prophylaxis (PrEP) were critical for interpretation of efficacy in PrEP clinical trials, and there is increasing interest in using drug levels to tailor interventions for reengagement and adherence. Point-of-care immunoassays for TFV, which examine short-term adherence, are in development. However, the ability of poor short-term and long-term adherence to predict future PrEP nonretention is unknown. Secondary data analysis of a large, prospective multi-site U.S. PrEP demonstration project. An adjusted Cox-proportional hazards model examined the relationship of dried blood spot (DBS) levels of FTC-triphosphate (FTC-TP) or TFV-diphosphate (TFV-DP), measures of short-term and long-term PrEP adherence, respectively, with future study nonretention. Overall, 294 individuals (median age 33 years) contributed drug levels within the U.S. PrEP demonstration project. By the end of study, 27% were lost to follow-up, 25% had at least one undetectable FTC-TP level indicating poor short-term adherence, and 29% had a drug level indicating suboptimal long-term adherence (TFV-DP <700 fmol/punch). The strongest factor associated with future study nonretention using a binary drug-level cut-off was an undetectable DBS FTC-TP level (adjusted hazard ratio 6.3; 95% confidence interval 3.8 to 10.2). The suboptimal long-term adherence based on low DBS TFV-DP levels was also associated with nonretention (adjusted hazard ratio 4.3; 95% confidence interval: 2.4 to 7.6). Both short- and long-term metrics of PrEP adherence are strongly associated with future loss to follow-up in a U.S. demonstration project study. Short-term metrics of adherence, once available at the point-of-care, could be used to direct real-time tailored retention and adherence interventions.
Sections du résumé
BACKGROUND
Objective adherence metrics for tenofovir (TFV) disoproxil fumarate/emtricitabine (FTC)-based pre-exposure prophylaxis (PrEP) were critical for interpretation of efficacy in PrEP clinical trials, and there is increasing interest in using drug levels to tailor interventions for reengagement and adherence. Point-of-care immunoassays for TFV, which examine short-term adherence, are in development. However, the ability of poor short-term and long-term adherence to predict future PrEP nonretention is unknown.
SETTING
Secondary data analysis of a large, prospective multi-site U.S. PrEP demonstration project.
METHODS
An adjusted Cox-proportional hazards model examined the relationship of dried blood spot (DBS) levels of FTC-triphosphate (FTC-TP) or TFV-diphosphate (TFV-DP), measures of short-term and long-term PrEP adherence, respectively, with future study nonretention.
RESULTS
Overall, 294 individuals (median age 33 years) contributed drug levels within the U.S. PrEP demonstration project. By the end of study, 27% were lost to follow-up, 25% had at least one undetectable FTC-TP level indicating poor short-term adherence, and 29% had a drug level indicating suboptimal long-term adherence (TFV-DP <700 fmol/punch). The strongest factor associated with future study nonretention using a binary drug-level cut-off was an undetectable DBS FTC-TP level (adjusted hazard ratio 6.3; 95% confidence interval 3.8 to 10.2). The suboptimal long-term adherence based on low DBS TFV-DP levels was also associated with nonretention (adjusted hazard ratio 4.3; 95% confidence interval: 2.4 to 7.6).
CONCLUSIONS
Both short- and long-term metrics of PrEP adherence are strongly associated with future loss to follow-up in a U.S. demonstration project study. Short-term metrics of adherence, once available at the point-of-care, could be used to direct real-time tailored retention and adherence interventions.
Identifiants
pubmed: 31095005
doi: 10.1097/QAI.0000000000002005
pii: 00126334-201906010-00007
pmc: PMC6530484
mid: NIHMS1521277
doi:
Substances chimiques
Anti-HIV Agents
0
Organophosphates
0
tenofovir diphosphate
0
Tenofovir
99YXE507IL
Emtricitabine
G70B4ETF4S
Adenine
JAC85A2161
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
158-162Subventions
Organisme : NIAID NIH HHS
ID : T32 AI060530
Pays : United States
Organisme : NIAID NIH HHS
ID : R03 AI122908
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI084735
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069451
Pays : United States
Organisme : NIAID NIH HHS
ID : R37 AI098472
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI027763
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI098472
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI143340
Pays : United States
Organisme : NIAID NIH HHS
ID : R03 AI120819
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI106499
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069496
Pays : United States
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