Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen

Monica Gandhi, Pamela M. Murnane, Peter Bacchetti, Richard Elion, Michael A Kolber, Stephanie E. Cohen, Howard Horng, Alexander Louie, Karen Kuncze, Catherine A. Koss, Peter L. Anderson, Susan Buchbinder, Albert Liu

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Objective: The US preexposure prophylaxis (PrEP) Demonstration Project (U.S. Demo) evaluated MSM on PrEP postmarketing and found low seroconversion rates. The objective of this study is to examine hair levels as an adherence measure to PrEP. Design: Using an 'opt-in' design, participants of PrEP Demo were invited to enroll into a substudy where hair was collected quarterly. Methods: Tenofovir concentrations were measured in hair by liquid chromatography/tandem mass spectrometry. Hair levels consistent with ≥4 doses/week (protective in other studies) defined adequate adherence. Mixed effects multivariate logistic regression models examined factors associated with ≥4 doses/week. Separate mixed effects models evaluated the relationship between hair PrEP levels and changes in creatinine clearance (CrCl) over time. Results: Overall, 58% of U.S. Demo participants enrolled into this opt-in study; reasons for nonparticipation included insufficient hair (61%) and concerns about hairstyle (27%). Hair and dried blood spots levels consistent with ≥4 doses/week were highly concordant (84%). Hair levels showed adequate adherence in 87% of 875 person-visits (among 280 participants). Factors associated with adequate adherence in multivariate models were amphetamine use [adjusted odds ratio (aOR) 2.59 (0.97-6.9, P 0.06)], condomless receptive anal sex [aOR 2.28 (1.19-4.40, P 0.01)], and stable housing [aOR 2.63 (1.03-6.67), P 0.04]. Hair levels of tenofovir showed a monotonic relationship with decline in CrCl (P 0.01 for trend). Conclusion: In this substudy of the U.S. PrEP demonstration project, hair and dried blood spots levels were highly concordant and hair concentrations demonstrated adequate adherence 87% of the time, with stable housing and high-risk behavior associated with higher adherence. Daily PrEP drug taking is associated with modest declines in CrCl.

Original languageEnglish (US)
Pages (from-to)2245-2251
Number of pages7
JournalAIDS
Volume31
Issue number16
DOIs
StatePublished - Oct 23 2017

Fingerprint

Hair
Kidney
Pharmaceutical Preparations
Tenofovir
Creatinine
Odds Ratio
Logistic Models
Amphetamine
Risk-Taking
Tandem Mass Spectrometry
Liquid Chromatography
Sexual Behavior

Keywords

  • creatinine clearance
  • enhancing preexposure prophylaxis in community
  • hair concentrations
  • HIV prevention
  • pharmacologic measures
  • preexposure prophylaxis
  • preexposure prophylaxis US Demo project
  • tenofovir/emtricitabine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

Cite this

Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen. / Gandhi, Monica; Murnane, Pamela M.; Bacchetti, Peter; Elion, Richard; Kolber, Michael A; Cohen, Stephanie E.; Horng, Howard; Louie, Alexander; Kuncze, Karen; Koss, Catherine A.; Anderson, Peter L.; Buchbinder, Susan; Liu, Albert.

In: AIDS, Vol. 31, No. 16, 23.10.2017, p. 2245-2251.

Research output: Contribution to journalArticle

Gandhi, M, Murnane, PM, Bacchetti, P, Elion, R, Kolber, MA, Cohen, SE, Horng, H, Louie, A, Kuncze, K, Koss, CA, Anderson, PL, Buchbinder, S & Liu, A 2017, 'Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen', AIDS, vol. 31, no. 16, pp. 2245-2251. https://doi.org/10.1097/QAD.0000000000001615
Gandhi, Monica ; Murnane, Pamela M. ; Bacchetti, Peter ; Elion, Richard ; Kolber, Michael A ; Cohen, Stephanie E. ; Horng, Howard ; Louie, Alexander ; Kuncze, Karen ; Koss, Catherine A. ; Anderson, Peter L. ; Buchbinder, Susan ; Liu, Albert. / Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen. In: AIDS. 2017 ; Vol. 31, No. 16. pp. 2245-2251.
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title = "Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen",
abstract = "Objective: The US preexposure prophylaxis (PrEP) Demonstration Project (U.S. Demo) evaluated MSM on PrEP postmarketing and found low seroconversion rates. The objective of this study is to examine hair levels as an adherence measure to PrEP. Design: Using an 'opt-in' design, participants of PrEP Demo were invited to enroll into a substudy where hair was collected quarterly. Methods: Tenofovir concentrations were measured in hair by liquid chromatography/tandem mass spectrometry. Hair levels consistent with ≥4 doses/week (protective in other studies) defined adequate adherence. Mixed effects multivariate logistic regression models examined factors associated with ≥4 doses/week. Separate mixed effects models evaluated the relationship between hair PrEP levels and changes in creatinine clearance (CrCl) over time. Results: Overall, 58{\%} of U.S. Demo participants enrolled into this opt-in study; reasons for nonparticipation included insufficient hair (61{\%}) and concerns about hairstyle (27{\%}). Hair and dried blood spots levels consistent with ≥4 doses/week were highly concordant (84{\%}). Hair levels showed adequate adherence in 87{\%} of 875 person-visits (among 280 participants). Factors associated with adequate adherence in multivariate models were amphetamine use [adjusted odds ratio (aOR) 2.59 (0.97-6.9, P 0.06)], condomless receptive anal sex [aOR 2.28 (1.19-4.40, P 0.01)], and stable housing [aOR 2.63 (1.03-6.67), P 0.04]. Hair levels of tenofovir showed a monotonic relationship with decline in CrCl (P 0.01 for trend). Conclusion: In this substudy of the U.S. PrEP demonstration project, hair and dried blood spots levels were highly concordant and hair concentrations demonstrated adequate adherence 87{\%} of the time, with stable housing and high-risk behavior associated with higher adherence. Daily PrEP drug taking is associated with modest declines in CrCl.",
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author = "Monica Gandhi and Murnane, {Pamela M.} and Peter Bacchetti and Richard Elion and Kolber, {Michael A} and Cohen, {Stephanie E.} and Howard Horng and Alexander Louie and Karen Kuncze and Koss, {Catherine A.} and Anderson, {Peter L.} and Susan Buchbinder and Albert Liu",
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T1 - Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen

AU - Gandhi, Monica

AU - Murnane, Pamela M.

AU - Bacchetti, Peter

AU - Elion, Richard

AU - Kolber, Michael A

AU - Cohen, Stephanie E.

AU - Horng, Howard

AU - Louie, Alexander

AU - Kuncze, Karen

AU - Koss, Catherine A.

AU - Anderson, Peter L.

AU - Buchbinder, Susan

AU - Liu, Albert

PY - 2017/10/23

Y1 - 2017/10/23

N2 - Objective: The US preexposure prophylaxis (PrEP) Demonstration Project (U.S. Demo) evaluated MSM on PrEP postmarketing and found low seroconversion rates. The objective of this study is to examine hair levels as an adherence measure to PrEP. Design: Using an 'opt-in' design, participants of PrEP Demo were invited to enroll into a substudy where hair was collected quarterly. Methods: Tenofovir concentrations were measured in hair by liquid chromatography/tandem mass spectrometry. Hair levels consistent with ≥4 doses/week (protective in other studies) defined adequate adherence. Mixed effects multivariate logistic regression models examined factors associated with ≥4 doses/week. Separate mixed effects models evaluated the relationship between hair PrEP levels and changes in creatinine clearance (CrCl) over time. Results: Overall, 58% of U.S. Demo participants enrolled into this opt-in study; reasons for nonparticipation included insufficient hair (61%) and concerns about hairstyle (27%). Hair and dried blood spots levels consistent with ≥4 doses/week were highly concordant (84%). Hair levels showed adequate adherence in 87% of 875 person-visits (among 280 participants). Factors associated with adequate adherence in multivariate models were amphetamine use [adjusted odds ratio (aOR) 2.59 (0.97-6.9, P 0.06)], condomless receptive anal sex [aOR 2.28 (1.19-4.40, P 0.01)], and stable housing [aOR 2.63 (1.03-6.67), P 0.04]. Hair levels of tenofovir showed a monotonic relationship with decline in CrCl (P 0.01 for trend). Conclusion: In this substudy of the U.S. PrEP demonstration project, hair and dried blood spots levels were highly concordant and hair concentrations demonstrated adequate adherence 87% of the time, with stable housing and high-risk behavior associated with higher adherence. Daily PrEP drug taking is associated with modest declines in CrCl.

AB - Objective: The US preexposure prophylaxis (PrEP) Demonstration Project (U.S. Demo) evaluated MSM on PrEP postmarketing and found low seroconversion rates. The objective of this study is to examine hair levels as an adherence measure to PrEP. Design: Using an 'opt-in' design, participants of PrEP Demo were invited to enroll into a substudy where hair was collected quarterly. Methods: Tenofovir concentrations were measured in hair by liquid chromatography/tandem mass spectrometry. Hair levels consistent with ≥4 doses/week (protective in other studies) defined adequate adherence. Mixed effects multivariate logistic regression models examined factors associated with ≥4 doses/week. Separate mixed effects models evaluated the relationship between hair PrEP levels and changes in creatinine clearance (CrCl) over time. Results: Overall, 58% of U.S. Demo participants enrolled into this opt-in study; reasons for nonparticipation included insufficient hair (61%) and concerns about hairstyle (27%). Hair and dried blood spots levels consistent with ≥4 doses/week were highly concordant (84%). Hair levels showed adequate adherence in 87% of 875 person-visits (among 280 participants). Factors associated with adequate adherence in multivariate models were amphetamine use [adjusted odds ratio (aOR) 2.59 (0.97-6.9, P 0.06)], condomless receptive anal sex [aOR 2.28 (1.19-4.40, P 0.01)], and stable housing [aOR 2.63 (1.03-6.67), P 0.04]. Hair levels of tenofovir showed a monotonic relationship with decline in CrCl (P 0.01 for trend). Conclusion: In this substudy of the U.S. PrEP demonstration project, hair and dried blood spots levels were highly concordant and hair concentrations demonstrated adequate adherence 87% of the time, with stable housing and high-risk behavior associated with higher adherence. Daily PrEP drug taking is associated with modest declines in CrCl.

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KW - enhancing preexposure prophylaxis in community

KW - hair concentrations

KW - HIV prevention

KW - pharmacologic measures

KW - preexposure prophylaxis

KW - preexposure prophylaxis US Demo project

KW - tenofovir/emtricitabine

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