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Risk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis.

ABSTRACT: Preexposure prophylaxis (PrEP) with emtricitabine plus tenofovir disoproxil fumarate (FTC/TDF) or TDF alone reduces the risk of human immunodeficiency virus (HIV) acquisition. Understanding the risk of antiretroviral resistance selected by PrEP during breakthrough infections is important because of the risk of treatment failure during subsequent antiretroviral use.Within the largest randomized trial of FTC/TDF versus TDF as PrEP, plasma samples were tested for HIV with resistance mutations associated with FTC (K65R and M184IV) and TDF (K65R and K70E), using 454 sequencing.Of 121 HIV seroconverters, 25 received FTC/TDF, 38 received TDF, and 58 received placebo. Plasma drug levels in 26 individuals indicated PrEP use during or after HIV acquisition, of which 5 had virus with resistance mutations associated with their PrEP regimen. Among those with PrEP drug detected during infection, resistance was more frequent in the FTC/TDF arm (4 of 7 [57%]), compared with the TDF arm (1 of 19 [5.3%]; P = .01), owing to the FTC-associated mutation M184IV. Of these cases, 3 had unrecognized acute infection at PrEP randomization, and 2 were HIV negative at enrollment.These results suggest that resistance selected by PrEP is rare but can occur both with PrEP initiation during acute seronegative HIV infection and in PrEP breakthrough infections and that FTC is associated with a greater frequency of resistance mutations than TDF.

SUBMITTER: Lehman DA

PROVIDER: S-EPMC4402339 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Risk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis.

Lehman Dara A DA Baeten Jared M JM McCoy Connor O CO Weis Julie F JF Peterson Dylan D Mbara Gerald G Donnell Deborah D Thomas Katherine K KK Hendrix Craig W CW Marzinke Mark A MA Frenkel Lisa L Ndase Patrick P Mugo Nelly R NR Celum Connie C Overbaugh Julie J Matsen Frederick A FA

The Journal of infectious diseases 20150113 8

<h4>Background</h4>Preexposure prophylaxis (PrEP) with emtricitabine plus tenofovir disoproxil fumarate (FTC/TDF) or TDF alone reduces the risk of human immunodeficiency virus (HIV) acquisition. Understanding the risk of antiretroviral resistance selected by PrEP during breakthrough infections is important because of the risk of treatment failure during subsequent antiretroviral use.<h4>Methods</h4>Within the largest randomized trial of FTC/TDF versus TDF as PrEP, plasma samples were tested for ...[more]

PMID: 25587020

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Project description:ImportanceAlthough HIV preexposure prophylaxis (PrEP) implementation among persons who inject drugs has been inadequate, national HIV monitoring programs do not include data on PrEP, and specific trends in PrEP use are not well understood.ObjectiveTo estimate HIV PrEP uptake among commercially insured persons with opioid or stimulant use disorder by injection drug use (IDU) status.Design, setting, and participantsThis cross-sectional study used deidentified data from the MarketScan Commercial Claims and Encounters Database to identify a sample of 547 709 commercially insured persons without HIV but with opioid and/or stimulant use disorder, including 110 592 with evidence of IDU between January 1, 2010, and December 31, 2019. Data were analyzed from November 1, 2020, to July 1, 2021.ExposuresPersons with opioid and/or stimulant use disorder and evidence of IDU were identified through claims data.Main outcomes and measuresThe outcome was receipt of tenofovir disoproxil fumarate and emtricitabine for PrEP as identified from filled pharmacy claims. Multivariable logistic regression was used to assess the association of demographic and clinical characteristics with receipt of PrEP.ResultsThe study cohort included 211 609 (28.6%) females and 336 100 (61.4%) males with a combined mean (SD) age of 34.8 (13.1) years, including 110 592 individuals with evidence of IDU. During the study period, 508 (0.09%) persons with opioid and/or stimulant use disorder, including 170 (0.15%) with evidence of IDU, received PrEP. Receipt of PrEP increased from 0.001 to 0.243 per 100 person-years from 2010 through 2019 among the entire cohort and from 0.000 to 0.295 per 100 person-years among those with IDU. In multivariable analysis, PrEP use was more likely among males (adjusted odds ratio [aOR] 8.72; 95% CI, 6.39-11.89), persons with evidence of IDU (aOR, 1.47; 95% CI, 1.21-1.79), and persons with evidence of sexual risk indications for PrEP (aOR, 23.68; 95% CI, 19.57-28.66).Conclusions and relevanceIn this cross-sectional study of commercially insured persons with opioid and/or stimulant use disorder, HIV PrEP delivery remained low, including among those with evidence of IDU. PrEP should be consistently offered alongside substance use disorder treatment and other harm reduction and HIV prevention services.

Dataset Information

Risk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis.

Publications

Risk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis.

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