A Multi-Compartment Single and Multiple Dose Pharmacokinetic Comparison of Rectally Applied Tenofovir 1% Gel and Oral Tenofovir Disoproxil Fumarate
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{"title"=>"A multi-compartment single and multiple dose pharmacokinetic comparison of rectally applied tenofovir 1% gel and oral tenofovir disoproxil fumarate", "type"=>"journal", "authors"=>[{"first_name"=>"Kuo Hsiung", "last_name"=>"Yang", "scopus_author_id"=>"55908379600"}, {"first_name"=>"Craig", "last_name"=>"Hendrix", "scopus_author_id"=>"7101661990"}, {"first_name"=>"Namandje", "last_name"=>"Bumpus", "scopus_author_id"=>"8345017400"}, {"first_name"=>"Julie", "last_name"=>"Elliott", "scopus_author_id"=>"57193951070"}, {"first_name"=>"Karen", "last_name"=>"Tanner", "scopus_author_id"=>"35911236700"}, {"first_name"=>"Christine", "last_name"=>"Mauck", "scopus_author_id"=>"7003646581"}, {"first_name"=>"Ross", "last_name"=>"Cranston", "scopus_author_id"=>"7004106404"}, {"first_name"=>"Ian", "last_name"=>"McGowan", "scopus_author_id"=>"6701739220"}, {"first_name"=>"Nicola", "last_name"=>"Richardson-Harman", "scopus_author_id"=>"7801573081"}, {"first_name"=>"Peter A.", "last_name"=>"Anton", "scopus_author_id"=>"7006569885"}, {"first_name"=>"Angela D.M.", "last_name"=>"Kashuba", "scopus_author_id"=>"8763134300"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "isbn"=>"1932-6203", "pui"=>"600309302", "sgr"=>"84908592598", "doi"=>"10.1371/journal.pone.0106196", "scopus"=>"2-s2.0-84908592598", "pmid"=>"25350119"}, "id"=>"3cf71b92-2fa5-3b6e-bb85-14f5a65e390e", "abstract"=>"This Phase 1, randomized, two-site (United States), double-blind, placebo-controlled study enrolled 18 sexually abstinent men and women. All received a single 300-mg dose of oral tenofovir disoproxil fumarate (TDF) and were then randomized 2:1 to receive single and then seven daily rectal exposures of vaginally-formulated tenofovir (TFV) 1% gel or a hydroxyethyl cellulose (HEC) placebo gel. Blood, colonic biopsies and rectal and vaginal mucosal fluids were collected after the single oral TDF, the single topical TFV gel dose, and after 7 days of topical TFV gel dosing for extracellular analysis of TFV and intracellular analysis of the active metabolite tenofovir diphosphate (TFVdp) in peripheral blood mononuclear cells (PBMCs) and isolated mucosal mononuclear cells (MMC), including CD4+ and CD4- cell subsets. With a single rectal dose, TFV plasma concentrations were 24-33 fold lower and half-life was 5 h shorter compared to a single oral dose (p = 0.02). TFVdp concentrations were also undetectable in PBMCs with rectal dosing. Rectal tissue exposure to both TFV and TFVdp was 2 to 4-log10 higher after a single rectal dose compared to a single oral dose, and after 7 daily doses, TFVdp accumulated 4.5 fold in tissue. TFVdp in rectal tissue homogenate was predictive (residual standard error, RSE = 0.47) of tissue MMC intracellular TFVdp concentration, with the CD4+ cells having a 2-fold higher TFVdp concentration than CD4- cells. TFV concentrations from rectal sponges was a modest surrogate indicator for both rectal tissue TFV and TFVdp (RSE = 0.67, 0.66, respectively) and plasma TFV (RSE = 0.38). TFV penetrates into the vaginal cavity after oral and rectal dosing, with rectal dosing leading to higher vaginal TFV concentrations (p<0.01). Trial registration: ClinicalTrials.gov NCT00984971.", "link"=>"http://www.mendeley.com/research/multicompartment-single-multiple-dose-pharmacokinetic-comparison-rectally-applied-tenofovir-1-gel-or", "reader_count"=>14, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>2, "Researcher"=>3, "Student > Ph. D. Student"=>3, "Other"=>2, "Student > Master"=>2, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>2, "Researcher"=>3, "Student > Ph. D. Student"=>3, "Other"=>2, "Student > Master"=>2, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Environmental Science"=>1, "Biochemistry, Genetics and Molecular Biology"=>2, "Medicine and Dentistry"=>5, "Agricultural and Biological Sciences"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Social Sciences"=>1, "Computer Science"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>5}, "Social Sciences"=>{"Social Sciences"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Computer Science"=>{"Computer Science"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>2}, "Unspecified"=>{"Unspecified"=>2}, "Environmental Science"=>{"Environmental Science"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "group_count"=>0}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1768587", "https://ndownloader.figshare.com/files/1768588"], "description"=>"<div><p>This Phase 1, randomized, two-site (United States), double-blind, placebo-controlled study enrolled 18 sexually abstinent men and women. All received a single 300-mg dose of oral tenofovir disoproxil fumarate (TDF) and were then randomized 2∶1 to receive single and then seven daily rectal exposures of vaginally-formulated tenofovir (TFV) 1% gel or a hydroxyethyl cellulose (HEC) placebo gel. Blood, colonic biopsies and rectal and vaginal mucosal fluids were collected after the single oral TDF, the single topical TFV gel dose, and after 7 days of topical TFV gel dosing for extracellular analysis of TFV and intracellular analysis of the active metabolite tenofovir diphosphate (TFVdp) in peripheral blood mononuclear cells (PBMCs) and isolated mucosal mononuclear cells (MMC), including CD4+ and CD4- cell subsets. With a single rectal dose, TFV plasma concentrations were 24–33 fold lower and half-life was 5 h shorter compared to a single oral dose (p = 0.02). TFVdp concentrations were also undetectable in PBMCs with rectal dosing. Rectal tissue exposure to both TFV and TFVdp was 2 to 4-log<sub>10</sub> higher after a single rectal dose compared to a single oral dose, and after 7 daily doses, TFVdp accumulated 4.5 fold in tissue. TFVdp in rectal tissue homogenate was predictive (residual standard error, RSE  = 0.47) of tissue MMC intracellular TFVdp concentration, with the CD4+ cells having a 2-fold higher TFVdp concentration than CD4- cells. TFV concentrations from rectal sponges was a modest surrogate indicator for both rectal tissue TFV and TFVdp (RSE  = 0.67, 0.66, respectively) and plasma TFV (RSE  = 0.38). TFV penetrates into the vaginal cavity after oral and rectal dosing, with rectal dosing leading to higher vaginal TFV concentrations (p<0.01).</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct2/show/NCT00984971?term=NCT00984971%26rank=1\" target=\"_blank\">NCT00984971</a></p></div>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221124, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0106196.s001", "https://dx.doi.org/10.1371/journal.pone.0106196.s002"], "stats"=>{"downloads"=>13, "page_views"=>17, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_A_Multi_Compartment_Single_and_Multiple_Dose_Pharmacokinetic_Comparison_of_Rectally_Applied_Tenofovir_1_Gel_and_Oral_Tenofovir_Disoproxil_Fumarate_/1221124", "title"=>"A Multi-Compartment Single and Multiple Dose Pharmacokinetic Comparison of Rectally Applied Tenofovir 1% Gel and Oral Tenofovir Disoproxil Fumarate", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768526"], "description"=>"<p>Study Design.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221095, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g001", "stats"=>{"downloads"=>0, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_Design_/1221095", "title"=>"Study Design.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768530"], "description"=>"<p>All 18 trial participants received a single oral dose of 300 mg TDF followed by intensive 24 h PK. After ∼2 week resting period, 12 subjects were randomized to receive a single rectal gel dose of 1% TFV gel with intensive 24 h PK followed, after ∼2 week resting period, by 6 sequential, daily, self-administered rectal 1% TFV gel doses with the 7th dose administered in-clinic with subsequent 24 h intensive PK.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221097, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g002", "stats"=>{"downloads"=>2, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sample_Collection_/1221097", "title"=>"Sample Collection.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768534"], "description"=>"<p>Plasma concentration-time profile is shown (median and interquartile range). Nominal time for single rectal dose was shifted right by 0.250 h and multiple rectal dose by 0.500 h for clarity. N = 18 for oral dose, 12 single rectal dose, 12 multiple rectal dose. (BLQ values are imputed as 0.01.)</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221099, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g003", "stats"=>{"downloads"=>2, "page_views"=>21, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_TFV_Plasma_Half_life_is_shorter_p_8202_8202_0_02_during_rectal_administration_/1221099", "title"=>"TFV Plasma Half-life is shorter (p = 0.02) during rectal administration.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768536"], "description"=>"<p>There is a linear correlation between rectal tissue homogenate TFVdp and TFV (p = 0.04, robust RSE  = 0.37) with oral dosing only (solid line is mean prediction of TFVdp in rectal tissue from oral dosing). Shaded regions are the 10–90% confidence intervals of the mean predictions from robust linear regression model. There is no correlation during rectal dosing.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221101, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g004", "stats"=>{"downloads"=>3, "page_views"=>26, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Increasing_TFV_in_Rectal_Tissue_Homogenate_results_in_increased_TFVdp_/1221101", "title"=>"Increasing TFV in Rectal Tissue Homogenate results in increased TFVdp.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768540"], "description"=>"<p>Each set of figures documents the 30 min drug quantification in the left-side graph and the 24 hr in the right side graph in rectal tissue biopsy homogenate (5A, 5B) and isolated mucosal mononuclear immune cells (MMC) (5C). Comparisons performed with paired Wilcoxon signed-rank test; only a subset of patients gave both C<sub>30 min</sub> and C<sub>24 h</sub> samples. Figure S5A  =  TFV<sub>Tissue</sub>; Figure S5B  =  TFVdp<sub>Tissue</sub>; Figure S5C  =  TFVdp<sub>MMC</sub>. There is accumulation of TFV and TFVdp from multiple rectal dosing. Critical p for significance was 0.025 after Bonferroni correction.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221104, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g005", "stats"=>{"downloads"=>2, "page_views"=>33, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Rectal_tissue_exposure_to_TFV_and_TFVdp_median_177_IQR_is_higher_during_rectal_dosing_with_multiple_rectal_dosing_resulting_in_accumulation_of_TFVdp_/1221104", "title"=>"Rectal tissue exposure to TFV and TFVdp (median ± IQR) is higher during rectal dosing with multiple rectal dosing, resulting in accumulation of TFVdp.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768552"], "description"=>"<p>Intracellular TFVdp concentration in isolated rectal mucosal mononuclear cells increases linearly as TFVdp concentration in rectal tissue homogenate increases. (p<0.001, robust RSE  = 0.46) There is higher phosphorylation of TFV in CD4+ cells, seen in its higher y-intercept. The lines are the mean rectal tissue MMC TFVdp concentration predictions from robust linear regression model; solid is CD4+, dashed is CD4-. Shaded regions are the 10–90% confidence intervals of the mean prediction.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221107, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g006", "stats"=>{"downloads"=>5, "page_views"=>27, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_TFVdp_in_rectal_tissue_homogenate_is_predictive_of_intracellular_TFVdp_concentration_in_isolated_rectal_mucosal_mononuclear_cells_MMCs_with_higher_levels_of_phosphorylation_in_the_CD4_T_cells_compared_to_CD4_T_cells_/1221107", "title"=>"TFVdp in rectal tissue homogenate is predictive of intracellular TFVdp concentration in isolated rectal mucosal mononuclear cells (MMCs), with higher levels of phosphorylation in the CD4+ T cells compared to CD4- T cells.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768556"], "description"=>"<p>Plasma TFV exposure is correlated linearly with rectal sponge TFV exposure. (p<0.001, robust RSE  = 0.38) The linear correlation is the same regardless of number of rectal doses. Shaded regions are the 10–90% confidence intervals of the mean predictions from robust linear regression model.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221109, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g007", "stats"=>{"downloads"=>1, "page_views"=>22, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_TFV_quantification_from_rectal_sponges_is_predictive_of_plasma_TFV_exposure_during_rectal_dosing_/1221109", "title"=>"TFV quantification from rectal sponges is predictive of plasma TFV exposure during rectal dosing.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768558"], "description"=>"<p>(p<0.001, robust RSE<sub>TFV</sub>  = 0.67, RSE<sub>TFVdp</sub>  = 0.66) Shaded regions are the 10–90% confidence intervals of the mean predictions from robust linear regression model. The correlations are consistent regardless of administration route and number of doses.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221110, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g008", "stats"=>{"downloads"=>3, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_TFV_A_and_TFVdp_B_concentrations_in_rectal_tissue_homogenate_are_predicted_by_Rectal_Sponge_TFV_/1221110", "title"=>"TFV (A) and TFVdp (B) concentrations in rectal tissue homogenate are predicted by Rectal Sponge TFV.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768563"], "description"=>"<p>(A) Vaginal fluid detection of both TFV and TFVdp concentration in vaginal fluid is higher following rectal dosing than following single oral dosing TFVdp. There is a linear correlation between vaginal fluid sponge TFV and plasma TFV concentrations (p<0.001, robust RSE  = 0.44). TFV penetration into vaginal fluid is 1-log<sub>10</sub> higher with rectal administration than oral, seen with higher y-intercept. (p<0.001). (B) There is a linear correlation between vaginal fluid TFV and both rectal tissue TFV and TFVdp (p<0.01, robust RSE<sub>TFV</sub>  = 0.47, RSE<sub>TFVdp</sub>  = 0.13). Shaded regions are the 10–90% confidence intervals of the mean predictions from robust linear regression model. Solid line is mean vaginal fluid TFV concentration, dashed TFVdp.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221112, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.g009", "stats"=>{"downloads"=>6, "page_views"=>56, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_There_is_vaginal_penetration_of_TFV_from_both_oral_and_topical_rectal_exposures_/1221112", "title"=>"There is vaginal penetration of TFV from both oral and topical rectal exposures.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768568"], "description"=>"<p>Demographics.</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221115, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.t001", "stats"=>{"downloads"=>4, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Demographics_/1221115", "title"=>"Demographics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-10-28 19:09:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1768570"], "description"=>"<p>*Insufficient data to perform NCA on CD4- and CD4+ PBMC; see companion publication Richardson-Harmon et.al for exposure-response analysis.</p><p>**Composite Profile.</p><p>Noncompartmental Pharmacokinetic Parameters (<sup><a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0106196#nt101\" target=\"_blank\">*</a></sup>Insufficient data to perform NCA on CD4- and CD4+ PBMC; see companion publication Richardson-Harmon et.al for exposure-response analysis; <sup><a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0106196#nt102\" target=\"_blank\">**</a></sup>Composite Profile).</p>", "links"=>[], "tags"=>["TFV gel dose", "rectal dosing", "Rectal tissue exposure", "rectal tissue TFV", "Multiple Dose Pharmacokinetic Comparison", "metabolite tenofovir diphosphate", "rectal dose", "Oral Tenofovir Disoproxil Fumarate", "pbmc", "TFV plasma concentrations", "hec", "rectal tissue homogenate", "tdf", "tissue MMC intracellular TFVdp concentration", "TFV concentrations", "rse", "TFV gel dosing", "tenofovir disoproxil fumarate", "nct"], "article_id"=>1221117, "categories"=>["Biological Sciences"], "users"=>["Kuo-Hsiung Yang", "Craig Hendrix", "Namandje Bumpus", "Julie Elliott", "Karen Tanner", "Christine Mauck", "Ross Cranston", "Ian McGowan", "Nicola Richardson-Harman", "Peter A. Anton", "Angela D. M. Kashuba"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106196.t002", "stats"=>{"downloads"=>10, "page_views"=>30, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Noncompartmental_Pharmacokinetic_Parameters_Insufficient_data_to_perform_NCA_on_CD4_and_CD4_PBMC_see_companion_publication_Richardson_Harmon_et_al_for_exposure_response_analysis_Composite_Profile_/1221117", "title"=>"Noncompartmental Pharmacokinetic Parameters (<sup>*</sup>Insufficient data to perform NCA on CD4- and CD4+ PBMC; see companion publication Richardson-Harmon et.al for exposure-response analysis; <sup>**</sup>Composite Profile).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-10-28 19:09:26"}

PMC Usage Stats | Further Information

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