Importance of Ethnicity, CYP2B6 and ABCB1 Genotype for Efavirenz Pharmacokinetics and Treatment Outcomes: A Parallel-Group Prospective Cohort Study in Two Sub-Saharan Africa Populations
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{"title"=>"Importance of Ethnicity, CYP2B6 and ABCB1 Genotype for Efavirenz Pharmacokinetics and Treatment Outcomes: A Parallel-Group Prospective Cohort Study in Two Sub-Saharan Africa Populations", "type"=>"journal", "authors"=>[{"first_name"=>"Eliford", "last_name"=>"Ngaimisi", "scopus_author_id"=>"36632585900"}, {"first_name"=>"Abiy", "last_name"=>"Habtewold", "scopus_author_id"=>"47861724900"}, {"first_name"=>"Omary", "last_name"=>"Minzi", "scopus_author_id"=>"6508326007"}, {"first_name"=>"Eyasu", "last_name"=>"Makonnen", "scopus_author_id"=>"6602090569"}, {"first_name"=>"Sabina", "last_name"=>"Mugusi", "scopus_author_id"=>"35111593500"}, {"first_name"=>"Wondwossen", "last_name"=>"Amogne", "scopus_author_id"=>"6507123166"}, {"first_name"=>"Getnet", "last_name"=>"Yimer", "scopus_author_id"=>"24449522300"}, {"first_name"=>"Klaus Dieter", "last_name"=>"Riedel", "scopus_author_id"=>"7101773082"}, {"first_name"=>"Mohammed", "last_name"=>"Janabi", "scopus_author_id"=>"6602663240"}, {"first_name"=>"Getachew", "last_name"=>"Aderaye", "scopus_author_id"=>"6602473171"}, {"first_name"=>"Ferdinand", "last_name"=>"Mugusi", "scopus_author_id"=>"6604082522"}, {"first_name"=>"Leif", "last_name"=>"Bertilsson", "scopus_author_id"=>"7103324839"}, {"first_name"=>"Eleni", "last_name"=>"Aklillu", "scopus_author_id"=>"6603381992"}, {"first_name"=>"Juergen", "last_name"=>"Burhenne", "scopus_author_id"=>"6701565530"}], "year"=>2013, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "scopus"=>"2-s2.0-84879813185", "pui"=>"369260916", "doi"=>"10.1371/journal.pone.0067946", "isbn"=>"1932-6203", "sgr"=>"84879813185", "pmid"=>"23861838"}, "id"=>"1457e797-4802-33b7-a2ab-99d4084c792a", "abstract"=>"OBJECTIVES: We evaluated the importance of ethnicity and pharmacogenetic variations in determining efavirenz pharmacokinetics, auto-induction and immunological outcomes in two African populations.\\n\\nMETHODS: ART naïve HIV patients from Ethiopia (n = 285) and Tanzania (n = 209) were prospectively enrolled in parallel to start efavirenz based HAART. CD4+ cell counts were determined at baseline, 12, 24 and 48 weeks. Plasma and intracellular efavirenz and 8-hydroxyefvairenz concentrations were determined at week 4 and 16. Genotyping for common functional CYP2B6, CYP3A5, ABCB1, UGT2B7 and SLCO1B1 variant alleles were done.\\n\\nRESULT: Patient country, CYP2B6*6 and ABCB1 c.4036A>G (rs3842A>G) genotype were significant predictors of plasma and intracellular efavirenz concentration. CYP2B6*6 and ABCB1 c.4036A>G (rs3842) genotype were significantly associated with higher plasma efavirenz concentration and their allele frequencies were significantly higher in Tanzanians than Ethiopians. Tanzanians displayed significantly higher efavirenz plasma concentration at week 4 (p<0.0002) and week 16 (p = 0.006) compared to Ethiopians. Efavirenz plasma concentrations remained significantly higher in Tanzanians even after controlling for the effect of CYP2B6*6 and ABCB1 c.4036A>G genotype. Within country analyses indicated a significant decrease in the mean plasma efavirenz concentration by week 16 compared to week 4 in Tanzanians (p = 0.006), whereas no significant differences in plasma concentration over time was observed in Ethiopians (p = 0.84). Intracellular efavirenz concentration and patient country were significant predictors of CD4 gain during HAART.\\n\\nCONCLUSION: We report substantial differences in efavirenz pharmacokinetics, extent of auto-induction and immunologic recovery between Ethiopian and Tanzanian HIV patients, partly but not solely, due to pharmacogenetic variations. The observed inter-ethnic variations in efavirenz plasma exposure may possibly result in varying clinical treatment outcome or adverse event profiles between populations.", "link"=>"http://www.mendeley.com/research/importance-ethnicity-cyp2b6-abcb1-genotype-efavirenz-pharmacokinetics-treatment-outcomes-parallelgro", "reader_count"=>60, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>1, "Researcher"=>7, "Student > Doctoral Student"=>5, "Student > Ph. D. Student"=>14, "Student > Postgraduate"=>4, "Other"=>1, "Student > Master"=>13, "Student > Bachelor"=>6, "Lecturer"=>6, "Lecturer > Senior Lecturer"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>1, "Researcher"=>7, "Student > Doctoral Student"=>5, "Student > Ph. D. Student"=>14, "Student > Postgraduate"=>4, "Other"=>1, "Student > Master"=>13, "Student > Bachelor"=>6, "Lecturer"=>6, "Lecturer > Senior Lecturer"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Biochemistry, Genetics and Molecular Biology"=>4, "Nursing and Health Professions"=>2, "Medicine and Dentistry"=>31, "Agricultural and Biological Sciences"=>13, "Pharmacology, Toxicology and Pharmaceutical Science"=>5, "Social Sciences"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>31}, "Social Sciences"=>{"Social Sciences"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>13}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>4}, "Unspecified"=>{"Unspecified"=>4}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>5}}, "reader_count_by_country"=>{"Tanzania"=>1, "South Africa"=>1, "Ethiopia"=>1, "Germany"=>1}, "group_count"=>0}

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  • {"files"=>["https://ndownloader.figshare.com/files/1112875"], "description"=>"<p>Log transformed efavirenz plasma concentration was used in ANOVA test.</p>", "links"=>[], "tags"=>["Drugs and devices", "Clinical pharmacology", "Ethnopharmacology", "pharmacogenetics", "epidemiology", "Biomarker epidemiology", "Infectious diseases", "Viral diseases", "hiv", "HIV diagnosis and management", "HIV epidemiology", "Non-clinical medicine", "Health care policy", "Ethnic differences", "median", "plasma", "efavirenz", "concentrations", "ethiopian", "tanzanian", "patients", "stratified", "week-4", "week-16", "initiation"], "article_id"=>740802, "categories"=>["Medicine"], "users"=>["Eliford Ngaimisi", "Abiy Habtewold", "Omary Minzi", "Eyasu Makonnen", "Sabina Mugusi", "Wondwossen Amogne", "Getnet Yimer", "Klaus-Dieter Riedel", "Mohammed Janabi", "Getachew Aderaye", "Ferdinand Mugusi", "Leif Bertilsson", "Eleni Aklillu", "Juergen Burhenne"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0067946.t003", "stats"=>{"downloads"=>1, "page_views"=>21, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Comparison_of_median_plasma_efavirenz_concentrations_between_Ethiopian_and_Tanzanian_HIV_patients_in_all_and_stratified_by_genotypes_at_week_4_and_week_16_after_initiation_of_efavirenz_based_HAART_/740802", "title"=>"Comparison of median plasma efavirenz concentrations between Ethiopian and Tanzanian HIV patients (in all and stratified by genotypes) at week-4 and week-16 after initiation of efavirenz based HAART.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-05 02:01:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1112871"], "description"=>"<p>IC EFV = intracellular efavirenz, EFV = efavirenz.</p>", "links"=>[], "tags"=>["Drugs and devices", "Clinical pharmacology", "Ethnopharmacology", "pharmacogenetics", "epidemiology", "Biomarker epidemiology", "Infectious diseases", "Viral diseases", "hiv", "HIV diagnosis and management", "HIV epidemiology", "Non-clinical medicine", "Health care policy", "Ethnic differences", "linear", "regression"], "article_id"=>740797, "categories"=>["Medicine"], "users"=>["Eliford Ngaimisi", "Abiy Habtewold", "Omary Minzi", "Eyasu Makonnen", "Sabina Mugusi", "Wondwossen Amogne", "Getnet Yimer", "Klaus-Dieter Riedel", "Mohammed Janabi", "Getachew Aderaye", "Ferdinand Mugusi", "Leif Bertilsson", "Eleni Aklillu", "Juergen Burhenne"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0067946.t004", "stats"=>{"downloads"=>0, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Multiple_linear_regression_models_for_various_study_dependent_variables_/740797", "title"=>"Multiple linear regression models for various study dependent variables.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-05 02:01:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1112869"], "description"=>"<p>PRED = Population prediction, IPRED = Individual prediction, DV = Observed CD4 cell counts, WRES = Weighted residuals, IWRES = Individual weighted residuals.</p>", "links"=>[], "tags"=>["Drugs and devices", "Clinical pharmacology", "Ethnopharmacology", "pharmacogenetics", "epidemiology", "Biomarker epidemiology", "Infectious diseases", "Viral diseases", "hiv", "HIV diagnosis and management", "HIV epidemiology", "Non-clinical medicine", "Health care policy", "Ethnic differences", "goodness", "pred", "ipred", "dv", "plotted", "graph"], "article_id"=>740796, "categories"=>["Medicine"], "users"=>["Eliford Ngaimisi", "Abiy Habtewold", "Omary Minzi", "Eyasu Makonnen", "Sabina Mugusi", "Wondwossen Amogne", "Getnet Yimer", "Klaus-Dieter Riedel", "Mohammed Janabi", "Getachew Aderaye", "Ferdinand Mugusi", "Leif Bertilsson", "Eleni Aklillu", "Juergen Burhenne"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0067946.g005", "stats"=>{"downloads"=>3, "page_views"=>55, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Basic_goodness_of_fit_plots_for_the_final_model_PRED_and_IPRED_versus_DV_are_plotted_on_same_graph_with_IPRED_VS_DV_shown_by_black_square_points_/740796", "title"=>"Basic goodness of fit plots for the final model, PRED and IPRED versus DV are plotted on same graph with IPRED VS DV shown by black, square points.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-07-05 02:01:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1112866"], "description"=>"<p>Comparison of efavirenz concentration between week 4 and week 16 with in Ethiopians and Tanzanian patients was done using paired t test. Boxes indicate mean ± SE of the mean; bars indicate mean ±1.96 × SE of the mean.</p>", "links"=>[], "tags"=>["Drugs and devices", "Clinical pharmacology", "Ethnopharmacology", "pharmacogenetics", "epidemiology", "Biomarker epidemiology", "Infectious diseases", "Viral diseases", "hiv", "HIV diagnosis and management", "HIV epidemiology", "Non-clinical medicine", "Health care policy", "Ethnic differences", "se", "efavirenz", "plasma", "weeks", "initiation", "haart", "separately", "ethiopian", "tanzanian", "patients"], "article_id"=>740793, "categories"=>["Medicine"], "users"=>["Eliford Ngaimisi", "Abiy Habtewold", "Omary Minzi", "Eyasu Makonnen", "Sabina Mugusi", "Wondwossen Amogne", "Getnet Yimer", "Klaus-Dieter Riedel", "Mohammed Janabi", "Getachew Aderaye", "Ferdinand Mugusi", "Leif Bertilsson", "Eleni Aklillu", "Juergen Burhenne"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0067946.g002", "stats"=>{"downloads"=>4, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Comparison_of_mean_SE_of_mean_efavirenz_plasma_concentration_on_the_4_th_and_16_th_weeks_after_initiation_of_efavirenz_based_HAART_separately_between_Ethiopian_and_Tanzanian_patients_using_independent_t_test_/740793", "title"=>"Comparison of mean ± SE of mean efavirenz plasma concentration on the 4<sup>th</sup> and 16<sup>th</sup> weeks after initiation of efavirenz based HAART separately between Ethiopian and Tanzanian patients using independent t test.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-07-05 02:01:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1112865"], "description"=>"<p>Acronyms: Withdraw = defaulter or Lost to follow up; EFVT = exited from the study due to efavirenz toxicity; ETB = exited from the study due to tuberculosis (TB) diagnosis; DILI = drug induced liver injury; LTFU = lost to follow-up; Anemia = exited due to anemia and regimen change to nevirapine based HAART; TF = exited after regimen change to second line ARVs due to treatment failure.</p>", "links"=>[], "tags"=>["Drugs and devices", "Clinical pharmacology", "Ethnopharmacology", "pharmacogenetics", "epidemiology", "Biomarker epidemiology", "Infectious diseases", "Viral diseases", "hiv", "HIV diagnosis and management", "HIV epidemiology", "Non-clinical medicine", "Health care policy", "Ethnic differences", "enrollment", "ethiopia", "tanzania"], "article_id"=>740792, "categories"=>["Medicine"], "users"=>["Eliford Ngaimisi", "Abiy Habtewold", "Omary Minzi", "Eyasu Makonnen", "Sabina Mugusi", "Wondwossen Amogne", "Getnet Yimer", "Klaus-Dieter Riedel", "Mohammed Janabi", "Getachew Aderaye", "Ferdinand Mugusi", "Leif Bertilsson", "Eleni Aklillu", "Juergen Burhenne"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0067946.g001", "stats"=>{"downloads"=>2, "page_views"=>158, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Parallel_flow_chart_of_patient_enrollment_and_follow_up_in_Ethiopia_and_Tanzania_during_the_study_period_/740792", "title"=>"Parallel flow chart of patient enrollment and follow up in Ethiopia and Tanzania during the study period.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-07-05 02:01:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1112874"], "description"=>"<p>Comparison of genotype and variant allele frequency distribution between Ethiopian and Tanzanian HIV patients.</p>", "links"=>[], "tags"=>["Drugs and devices", "Clinical pharmacology", "Ethnopharmacology", "pharmacogenetics", "epidemiology", "Biomarker epidemiology", "Infectious diseases", "Viral diseases", "hiv", "HIV diagnosis and management", "HIV epidemiology", "Non-clinical medicine", "Health care policy", "Ethnic differences", "genotype", "variant", "allele", "ethiopian", "tanzanian"], "article_id"=>740801, "categories"=>["Medicine"], "users"=>["Eliford Ngaimisi", "Abiy Habtewold", "Omary Minzi", "Eyasu Makonnen", "Sabina Mugusi", "Wondwossen Amogne", "Getnet Yimer", "Klaus-Dieter Riedel", "Mohammed Janabi", "Getachew Aderaye", "Ferdinand Mugusi", "Leif Bertilsson", "Eleni Aklillu", "Juergen Burhenne"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0067946.t002", "stats"=>{"downloads"=>5, "page_views"=>42, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Comparison_of_genotype_and_variant_allele_frequency_distribution_between_Ethiopian_and_Tanzanian_HIV_patients_/740801", "title"=>"Comparison of genotype and variant allele frequency distribution between Ethiopian and Tanzanian HIV patients.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-05 02:01:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/1112872"], "description"=>"<p>OFV = objective function value, BSV = between subject variability, N.E† = Not estimated, ‡ = Fixed to this value.</p>", "links"=>[], "tags"=>["Drugs and devices", "Clinical pharmacology", "Ethnopharmacology", "pharmacogenetics", "epidemiology", "Biomarker epidemiology", "Infectious diseases", "Viral diseases", "hiv", "HIV diagnosis and management", "HIV epidemiology", "Non-clinical medicine", "Health care policy", "Ethnic differences", "nonlinear", "cd4", "initiation", "haart", "patients"], "article_id"=>740799, "categories"=>["Medicine"], "users"=>["Eliford Ngaimisi", "Abiy Habtewold", "Omary Minzi", "Eyasu Makonnen", "Sabina Mugusi", "Wondwossen Amogne", "Getnet Yimer", "Klaus-Dieter Riedel", "Mohammed Janabi", "Getachew Aderaye", "Ferdinand Mugusi", "Leif Bertilsson", "Eleni Aklillu", "Juergen Burhenne"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0067946.t005", "stats"=>{"downloads"=>1, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Parameter_values_for_final_nonlinear_mixed_effect_model_for_absolute_CD4_count_gain_after_initiation_of_HAART_among_HIV_patients_n_8202_8202_492_/740799", "title"=>"Parameter values for final nonlinear mixed effect model for absolute CD4 count gain after initiation of HAART among HIV patients (n = 492).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-05 02:01:26"}

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Relative Metric

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