A Mechanism-Based Population Pharmacokinetic Analysis Assessing the Feasibility of Efavirenz Dose Reduction to 400 mg in Pregnant Women

[1]  R. Greupink,et al.  Free dug concentrations in pregnancy: Bound to measure unbound? , 2017, British journal of clinical pharmacology.

[2]  M. Karlsson,et al.  Improving the estimation of parameter uncertainty distributions in nonlinear mixed effects models using sampling importance resampling , 2016, Journal of Pharmacokinetics and Pharmacodynamics.

[3]  G. Maartens,et al.  Effect of mid-dose efavirenz concentrations and CYP2B6 genotype on viral suppression in patients on first-line antiretroviral therapy. , 2016, International journal of antimicrobial agents.

[4]  Kristin M. Darin,et al.  Antiretroviral Pharmacokinetics in Pregnant Women , 2015, Pharmacotherapy.

[5]  D. Cooper,et al.  Pharmacokinetic and Pharmacodynamic Comparison of Once‐Daily Efavirenz (400 mg vs. 600 mg) in Treatment‐Naïve HIV‐Infected Patients: Results of the ENCORE1 Study , 2015, Clinical pharmacology and therapeutics.

[6]  G. Maartens,et al.  Lower-dose efavirenz: what is needed before implementation? , 2015, The Lancet. Infectious diseases.

[7]  S. Khoo,et al.  Pharmacogenetics of pregnancy‐induced changes in efavirenz pharmacokinetics , 2015, Clinical pharmacology and therapeutics.

[8]  K. Dooley,et al.  Pharmacokinetics of efavirenz and treatment of HIV-1 among pregnant women with and without tuberculosis coinfection. , 2015, The Journal of infectious diseases.

[9]  Leon Aarons,et al.  Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data , 2015, British journal of clinical pharmacology.

[10]  B. Gazzard,et al.  Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naive adults (ENCORE1): a randomised, double-blind, placebo-controlled, non-inferiority trial , 2014, The Lancet.

[11]  J. McArthur,et al.  Protein-Free Efavirenz Concentrations in Cerebrospinal Fluid and Blood Plasma Are Equivalent: Applying the Law of Mass Action To Predict Protein-Free Drug Concentration , 2013, Antimicrobial Agents and Chemotherapy.

[12]  R J Keizer,et al.  Modeling and Simulation Workbench for NONMEM: Tutorial on Pirana, PsN, and Xpose , 2013, CPT: pharmacometrics & systems pharmacology.

[13]  N. Isoherranen,et al.  Quantitative Prediction of CYP2B6 Induction by Estradiol During Pregnancy: Potential Explanation for Increased Methadone Clearance During Pregnancy , 2013, Drug Metabolism and Disposition.

[14]  J. McArthur,et al.  Protein-Free Efavirenz Concentrations in Cerebrospinal Fluid and Blood Plasma Are Equivalent: Applying the Law of Mass Action To Predict Protein-Free Drug Concentration , 2013, Antimicrobial Agents and Chemotherapy.

[15]  G. Kibiki,et al.  Efavirenz, Tenofovir and Emtricitabine Combined with First-Line Tuberculosis Treatment in Tuberculosis–Hiv-Coinfected Tanzanian Patients: A Pharmacokinetic and Safety Study , 2013, Antiviral therapy.

[16]  Marylyn D Ritchie,et al.  Genome-wide association study of plasma efavirenz pharmacokinetics in AIDS Clinical Trials Group protocols implicates several CYP2B6 variants , 2012, Pharmacogenetics and genomics.

[17]  M. Hebert,et al.  Pharmacokinetics of Tacrolimus During Pregnancy , 2012, Therapeutic drug monitoring.

[18]  W. Chantratita,et al.  Pharmacogenetic markers of CYP2B6 associated with efavirenz plasma concentrations in HIV-1 infected Thai adults. , 2012, British journal of clinical pharmacology.

[19]  C. Petropoulos,et al.  Novel Method To Assess Antiretroviral Target Trough Concentrations Using In Vitro Susceptibility Data , 2012, Antimicrobial Agents and Chemotherapy.

[20]  J. Nachega,et al.  Integration of data from multiple sources for simultaneous modelling analysis: experience from nevirapine population pharmacokinetics. , 2012, British journal of clinical pharmacology.

[21]  Amin Rostami-Hodjegan,et al.  Anatomical, Physiological and Metabolic Changes with Gestational Age during Normal Pregnancy , 2012, Clinical Pharmacokinetics.

[22]  J. Schellens,et al.  Performance of Methods for Handling Missing Categorical Covariate Data in Population Pharmacokinetic Analyses , 2012, The AAPS Journal.

[23]  E. Capparelli,et al.  Efavirenz Pharmacokinetics During the Third Trimester of Pregnancy and Postpartum , 2012, Journal of acquired immune deficiency syndromes.

[24]  M. Karlsson,et al.  Rapid Sample Size Calculations for a Defined Likelihood Ratio Test-Based Power in Mixed-Effects Models , 2012, The AAPS Journal.

[25]  F. Nosten,et al.  Population Pharmacokinetics of Dihydroartemisinin and Piperaquine in Pregnant and Nonpregnant Women with Uncomplicated Malaria , 2012, Antimicrobial Agents and Chemotherapy.

[26]  Lin Shen,et al.  A Quantitative Basis for Antiretroviral Therapy for HIV-1 Infection , 2012, Nature Medicine.

[27]  C. Hendrix,et al.  The Male Genital Tract Is Not a Pharmacological Sanctuary From Efavirenz , 2011, Clinical pharmacology and therapeutics.

[28]  T. Snyman,et al.  Presence of the CYP2B6 516G> T polymorphism, increased plasma Efavirenz concentrations and early neuropsychiatric side effects in South African HIV-infected patients , 2010, AIDS research and therapy.

[29]  D. Chiappetta,et al.  A highly concentrated and taste-improved aqueous formulation of efavirenz for a more appropriate pediatric management of the anti-HIV therapy. , 2010, Current HIV research.

[30]  Andrew C. Hooker,et al.  Modeling Subpopulations with the $MIXTURE Subroutine in NONMEM: Finding the Individual Probability of Belonging to a Subpopulation for the Use in Model Analysis and Improved Decision Making , 2009, The AAPS Journal.

[31]  France Mentré,et al.  Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: The npde add-on package for R , 2008, Comput. Methods Programs Biomed..

[32]  M Schwab,et al.  Predictive Value of Known and Novel Alleles of CYP2B6 for Efavirenz Plasma Concentrations in HIV‐infected Individuals , 2007, Clinical pharmacology and therapeutics.

[33]  France Mentré,et al.  Metrics for External Model Evaluation with an Application to the Population Pharmacokinetics of Gliclazide , 2006, Pharmaceutical Research.

[34]  Mats O Karlsson,et al.  A semiphysiological pharmacokinetic model for artemisinin in healthy subjects incorporating autoinduction of metabolism and saturable first-pass hepatic extraction. , 2005, British journal of clinical pharmacology.

[35]  F. van Leth,et al.  Nevirapine and Efavirenz Pharmacokinetics and Covariate Analysis in the 2Nn Study , 2005, Antiviral therapy.

[36]  J. Bartlett,et al.  Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to reduce Perinatal HIV-1Transmission in the United States , 2003 .

[37]  B. Gazzard,et al.  Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study , 2004, The Lancet.

[38]  P. Toutain,et al.  Free drug fraction vs free drug concentration: a matter of frequent confusion. , 2002, Journal of veterinary pharmacology and therapeutics.

[39]  A. Telenti,et al.  Efavirenz Plasma Levels Can Predict Treatment Failure and Central Nervous System Side Effects in Hiv-1-infected Patients , 2022 .

[40]  James H. Brown,et al.  The fourth dimension of life: fractal geometry and allometric scaling of organisms. , 1999, Science.

[41]  J. J. Henning,et al.  Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, January 28, 2000 , 1998, HIV clinical trials.

[42]  P. Chowienczyk,et al.  PHARMACOKINETICS IN PREGNANCY , 1981 .

[43]  Jos H. Beijnen,et al.  Piraña and PCluster: A modeling environment and cluster infrastructure for NONMEM , 2011, Comput. Methods Programs Biomed..

[44]  Yang Xi-qiang Introduction of WHO's"Use of Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants" , 2010 .

[45]  W. Hayton,et al.  Allometric scaling of xenobiotic clearance: Uncertainty versus universality , 2008, AAPS PharmSci.

[46]  S. Khoo,et al.  Population Pharmacokinetics of Efavirenz in an Unselected Cohort of HIV-1-Infected Individuals , 2006, Clinical pharmacokinetics.

[47]  June Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to reduce Perinatal HIV-1Transmission in the United States , 2003 .

[48]  A. Nakai,et al.  Assessment of the hepatic arterial and portal venous blood flows during pregnancy with Doppler ultrasonography , 2002, Archives of Gynecology and Obstetrics.

[49]  P. Chowienczyk,et al.  Drugs in pregnancy. Pharmacokinetics in pregnancy. , 2001, Best practice & research. Clinical obstetrics & gynaecology.

[50]  L B Sheiner,et al.  The population approach to pharmacokinetic data analysis: rationale and standard data analysis methods. , 1984, Drug metabolism reviews.