Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and Women
Background: Controlled pharmacokinetic (PK) studies in United States populations have defined categories of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) for various pre-exposure prophylaxis (PrEP) adherence targets. It is unknown how these categories perform in other populations. Theref...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2019-04-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fphar.2019.00401/full |
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| author | Maria Pyra Maria Pyra Pete Anderson Jessica E. Haberer Jessica E. Haberer Renee Heffron Renee Heffron Connie Celum Connie Celum Connie Celum Stephen Asiimwe Elly Katabira Nelly R. Mugo Nelly R. Mugo Elizabeth A. Bukusi Elizabeth A. Bukusi Elizabeth A. Bukusi Jared M. Baeten Jared M. Baeten Jared M. Baeten |
| author_facet | Maria Pyra Maria Pyra Pete Anderson Jessica E. Haberer Jessica E. Haberer Renee Heffron Renee Heffron Connie Celum Connie Celum Connie Celum Stephen Asiimwe Elly Katabira Nelly R. Mugo Nelly R. Mugo Elizabeth A. Bukusi Elizabeth A. Bukusi Elizabeth A. Bukusi Jared M. Baeten Jared M. Baeten Jared M. Baeten |
| author_sort | Maria Pyra |
| collection | DOAJ |
| description | Background: Controlled pharmacokinetic (PK) studies in United States populations have defined categories of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) for various pre-exposure prophylaxis (PrEP) adherence targets. It is unknown how these categories perform in other populations. Therefore, we evaluated the sensitivity and specificity of these PK-derived categories compared to daily medication electronic adherence monitoring (MEMS) data among East African men and women using daily PrEP.Methods: Participants were enrolled as members of HIV serodiscordant couples as part of an open-label PrEP study in Kenya and Uganda. Blood samples were taken at quarterly visits and stored as DBS, which were analyzed for TFV-DP concentrations.Results: Among 150 samples from 103 participants, MEMs data indicated that 87 (58%) took ≥4 doses and 62 (41%) took ≥6 per week consistently over the 4 weeks prior to sample collection. Sensitivities of DBS TFV-DP levels were 62% for the ≥4 doses/week category (≥700 fmol/punch TFV-DP) and 44% for the ≥6 doses/week category (≥1050 fmol/punch TFV-DP); specificities were 86 and 94%, respectively. There were no statistically significant differences in these sensitivities and specificities by gender.Conclusion: In this sample of East African PrEP users, categories of TFV-DP concentrations developed from directly observed PrEP use among United States populations had high specificity but lower than expected sensitivity. Sensitivity was lowest when MEMS data indicated high adherence (i.e., ≥6 doses/week). PrEP studies and implementation programs should carefully consider the sensitivity and specificity of the TFV-DP levels used for adherence feedback. |
| first_indexed | 2024-12-11T20:03:29Z |
| format | Article |
| id | doaj.art-5c94e97654884d329d40de6da1e1516b |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-11T20:03:29Z |
| publishDate | 2019-04-01 |
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| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-5c94e97654884d329d40de6da1e1516b2022-12-22T00:52:28ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122019-04-011010.3389/fphar.2019.00401388752Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and WomenMaria Pyra0Maria Pyra1Pete Anderson2Jessica E. Haberer3Jessica E. Haberer4Renee Heffron5Renee Heffron6Connie Celum7Connie Celum8Connie Celum9Stephen Asiimwe10Elly Katabira11Nelly R. Mugo12Nelly R. Mugo13Elizabeth A. Bukusi14Elizabeth A. Bukusi15Elizabeth A. Bukusi16Jared M. Baeten17Jared M. Baeten18Jared M. Baeten19Department of Epidemiology, University of Washington, Seattle, WA, United StatesDepartment of Global Health, University of Washington, Seattle, WA, United StatesDepartment of Pharmaceutical Sciences, University of Colorado, Aurora, Aurora, CO, United StatesMassachusetts General Hospital Global Health, Boston, MA, United StatesDepartment of Medicine, Harvard Medical School, Boston, MA, United StatesDepartment of Epidemiology, University of Washington, Seattle, WA, United StatesDepartment of Global Health, University of Washington, Seattle, WA, United StatesDepartment of Epidemiology, University of Washington, Seattle, WA, United StatesDepartment of Global Health, University of Washington, Seattle, WA, United StatesDepartment of Medicine, University of Washington, Seattle, WA, United StatesKabwohe Clinical Research Center, Kabwohe, UgandaInfectious Diseases Institute, Makerere University, Makerere, UgandaDepartment of Global Health, University of Washington, Seattle, WA, United StatesKenya Medical Research Institute, Nairobi, KenyaDepartment of Global Health, University of Washington, Seattle, WA, United StatesKenya Medical Research Institute, Nairobi, Kenya0Department of Obstetrics & Gynecology, University of Washington, Seattle, WA, United StatesDepartment of Epidemiology, University of Washington, Seattle, WA, United StatesDepartment of Global Health, University of Washington, Seattle, WA, United StatesDepartment of Medicine, University of Washington, Seattle, WA, United StatesBackground: Controlled pharmacokinetic (PK) studies in United States populations have defined categories of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) for various pre-exposure prophylaxis (PrEP) adherence targets. It is unknown how these categories perform in other populations. Therefore, we evaluated the sensitivity and specificity of these PK-derived categories compared to daily medication electronic adherence monitoring (MEMS) data among East African men and women using daily PrEP.Methods: Participants were enrolled as members of HIV serodiscordant couples as part of an open-label PrEP study in Kenya and Uganda. Blood samples were taken at quarterly visits and stored as DBS, which were analyzed for TFV-DP concentrations.Results: Among 150 samples from 103 participants, MEMs data indicated that 87 (58%) took ≥4 doses and 62 (41%) took ≥6 per week consistently over the 4 weeks prior to sample collection. Sensitivities of DBS TFV-DP levels were 62% for the ≥4 doses/week category (≥700 fmol/punch TFV-DP) and 44% for the ≥6 doses/week category (≥1050 fmol/punch TFV-DP); specificities were 86 and 94%, respectively. There were no statistically significant differences in these sensitivities and specificities by gender.Conclusion: In this sample of East African PrEP users, categories of TFV-DP concentrations developed from directly observed PrEP use among United States populations had high specificity but lower than expected sensitivity. Sensitivity was lowest when MEMS data indicated high adherence (i.e., ≥6 doses/week). PrEP studies and implementation programs should carefully consider the sensitivity and specificity of the TFV-DP levels used for adherence feedback.https://www.frontiersin.org/article/10.3389/fphar.2019.00401/fulltenofovir-diphosphateadherencepre-exposure prophylaxiswomenAfricaHIV |
| spellingShingle | Maria Pyra Maria Pyra Pete Anderson Jessica E. Haberer Jessica E. Haberer Renee Heffron Renee Heffron Connie Celum Connie Celum Connie Celum Stephen Asiimwe Elly Katabira Nelly R. Mugo Nelly R. Mugo Elizabeth A. Bukusi Elizabeth A. Bukusi Elizabeth A. Bukusi Jared M. Baeten Jared M. Baeten Jared M. Baeten Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and Women Frontiers in Pharmacology tenofovir-diphosphate adherence pre-exposure prophylaxis women Africa HIV |
| title | Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and Women |
| title_full | Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and Women |
| title_fullStr | Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and Women |
| title_full_unstemmed | Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and Women |
| title_short | Tenofovir-Diphosphate as a Marker of HIV Pre-exposure Prophylaxis Use Among East African Men and Women |
| title_sort | tenofovir diphosphate as a marker of hiv pre exposure prophylaxis use among east african men and women |
| topic | tenofovir-diphosphate adherence pre-exposure prophylaxis women Africa HIV |
| url | https://www.frontiersin.org/article/10.3389/fphar.2019.00401/full |
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