Population Pharmacokinetics of Atazanavir in Naïve HIV Infected Patients using Medication Events Monitoring System (MEMS) for drug intake timing

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1 Population Pharmacokinetics of Atazanavir in Naïve HIV Infected Patients using Medication Events Monitoring System (MEMS) for drug intake timing ANRS -COPHAR clinical trial Céline Verstuyft Pharmacologie, Université Paris Sud, CHU Bicêtre, On behalf of investigators (RM Savic, A Barrail-Tran, X Duval, G Nembot, X Panhard, D Descamps, B Vrijens, A-M Taburet, C Goujard, F Mentré and the ANRS COPHAR Study Group)

2 Rationale of the study ARVs exposure depends on: Pharmacokinetic parameters of a given drug Treatment adherence Adherence measure Pill count Self questionnaire MEMS -> exact timing of drug intake MEMS+PK-> optimization of drug concentrations and exposure Pharmacokinetics /pharmacogenetics of ATV analysis administered with ritonavir, using adherence rates as measured by MEMS

3 Oral Drug and interpatient variability PHENOTYPE D Dose Absorption Target Metabolism/ Elimination Polymorphism of transporter Polymorphism of target Polymorphism of enzyme (CYP) GENOTYPE

4 Patients and Method (I) Treatment naive HIV-infected patients (N=) for months ARV drugs : Reyataz (Atazanavir) ( mg) /ritonavir ( mg) Truvada (Emtricitabine/Tenofovir) In MEMS-capped bottles Sampling For drug assay Extensive PK at week post treatment initiation Through samples up to the end of study at weeks 8, and DNA for genetics of enzymes and transporters

5 Medication Event Monitoring System MEMS «Medication Event Monitoring System» Dosing Date Dosing Time 8 : : : 8: : N= N= Concentration of ATV and exact timing of drug intake

6 Material and method () ATV and RTV assayed by HPLC Pharmacogenetics study : Allelic discrimination / Taqman - Efflux transporters : MRP (rs77), MRP (rs7), MDR (rs) - Metabolism : CYPA (rs777), UGTA*8 (rs 877) - α Glycoprotein : ORM (A7G)

7 ATAZANAVIR CYPA CYPA*/* CYPA*/* Génotypes Frequencies (%) CYPA*/* Africans Caucasians Americans 8.. UGTA*8 CYPA CYPA UGTA CYPA*/* CYPA*/* Low Bioavaibility (Blanco et al., Pharmacogenetics, ) hepatic uptake: OAT, OATP, NTCP biliary excretion: MDR, BSEP, MRP, BCRP Ho R, Kim RB, Clin Pharm Ther, 7

8 Patients characteristics at baseline and clinical outcome Sex Masculin (N=9) Féminin (N=) Age Minimum = ans Médiane = ans Maximum = ans Mode de contamination Voie sexuelle (N=) Indéterminé (N=) HIV-RNA (cp/ml) Minimum= Médiane= Maximum= 7 Nbre de patients avec CV> = TCD+ (/mm ) Minimum= Médiane= 8 Maximum= patients with CD< = virological failures severe side events 8

9 Results (I) : Pharmacogenetics data Gene (rs number) CYPA (A98G) (rs 777) Genotype Number Phenotype * /* Higher expression * /* 7 Higher expression * /* No expression UGTA * /* Gain of function * /*8 *8 /*8 8 Lost of function MDR (CT) (rs ) CC Lower intracellular concentration CT TT 7 Higher intracellular concentration MRP (AG) (rs7) AA 9 Lower intracellular concentration AG GG Higher intracellular concentration MRP (rs77) (C-T) CC CT Higher Concentration TT ORM (A 7G ) AA AG GG 9

10 Results (II) : Atazanavir concentrations «lag-time»

11 Results (III) : Model selection : Several models investigated Transit compartments selected absorption Ke

12 FINAL MODEL FOR ALL OCCASIONS GOLD STANDARD ANALYSIS*: Parameter Estimate RSE (%) IIV (CV %) RSE (%) IOV (CV %) RSE (%) CL (L/h) <% NA V (L) ka (h-) MTT (h) NN.. *GOLD - standard data (MEMS data corrected for what has been reported RV S (%) 9.. in the patient diary) after that all samples which are unreliable has been excluded. RV, >S (%)..7 7 samples from patients samples excluded

13 Effect of CYPA polymorphism on ATV At least copy CYPA* allele CL/F +% And in ATV concentrations

14 Conclusion Le couplage des MEMS et des caractéristiques PK des ARV apporte une mesure de l exposition thérapeutique «globale», permettant d expliquer la réponse virologique L enregistrement des horaires de prise par les MEMS permet de corriger la variabilité individuelle des mesures de concentration des médicaments, et pourrait faciliter l adaptation des posologies Le MEMS est un nouvel outil, dont la place est à définir pour interpréter les données pharmacologiques dans le suivi des patients, en particulier dans les initiations de traitement (molécules nouvelles) ou les modifications chez les patients en échec

15 Acknowledgements Hopital Bicêtre : Pr C. Goujard Inserm U78 : F.Mentré, G.Nembot, X.Panhard, R. Savic Hopital Bichat : X.Duval (co-ip), D.Descamps Bicêtre : AM.Taburet, A.Barrail-Tran, A. Brunet AARDEX: B.Vrijjens Patients Investigators of clinical centers Pharmacists and pharmacologists BMS and Gilead for providing Reyataz and Truvada ANRS

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