Pediatric ARV Working Group Dosing Recommendations
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1 Pediatric ARV Working Group Dosing Recommendations
2 Overall Goals To develop pediatric weight band dosing for ARVs that would simplify dosing and produce therapeutic drug exposure Recommend dosing strengths for manufacturers for individual agents and FDCs
3 Guiding Principles Attempted to avoid dosing any single ARV component below 90% of intended delivered dose and not more than 25 % above intended dose. Better to give a bit too much than too little. For nevirapine, the group sought to avoid dosing below (150mg/m 2 ). Each individual drug considered was assessed for a range of tablet strengths using the same tool and principles.
4 General Criteria Maximum number of tablets at any one dose should be no more than three. Minimum dose is one half tablet of products that are scored Limit the number of dosing forms for each single ARV or FDC required for prevention and treatment of HIV in adults and children. Harmonize dosing schedules and weightbased dose switching points for all products wherever possible Facilitate FDC switches
5 Challenge Various drug clearance and distribution pathways have different age dependency ideal dosing changes vary by age and drug Consequences Expected to result in non approved doses. FDCs not limited to same ratio as adult formulation While aimed a achieving a target dose done with consideration that are actually shooting for a target exposure (labeled doses are not always optimal) Some compromising needed
6 Sizing Issues and Harmonization Although FDA approved dosing is often weight based, CL and exposure (AUC) correlates more closely with BSA True for drugs that are dosed based on weight Focused on most critical agent (narrow therapeutic range) and linked dosing for other agents
7 NRTIs with Weight Based Dosing ABC Age Effects 3TC Age Effects 60 ABC CL/F (ml/min/kg) Age (y) Accepted higher dosing for children < 3 years based on PK: Nevirapine, Lamivudine, Stavudine, Abacavir, Lopinavir.
8 Approach to Challenge In FDC priority placed on achieving target NVP doses due to correlation with Cmin (>3) and treatment success. FDCs dosing established first to harmonize mg doses between FDCs and non-fdc. The doses for individual components should be the same. Established BSA based targets for all drugs Quadratic BSA estimator from Weight
9 Weight Bands 3-3.9kg* 4-4.9kg* kg kg kg kg kg *some differences based on age
10 Dose Assessments Developed Excel Template to provide visual guidance of proposed tablet strength and dose weight bands (Tony Nunn) Additional assessment performed applying recommended to existing PK data for NVP from CHAPAS, PACTG-US, IMPAACT- Thailand. (Observed * WTBND/Actual) Monte Carlo simulations on population model
11 Dose Tables - NRTIs & NVP Number of Tablets by Weight Band (Twice Daily) Drug Strength of Child Tab (mg) kg kg kg kg kg Adult kg AZT AZT/3TC 60/ /150 1 AZT/3TC/NVP 60/30/ /150/200 1 ABC ABC/3TC 60/ /150 1 ABC/AZT/3TC 60/60/ /300/ TC d4t d4t/3tc 6/ /150 1 d4t/3tc/nvp 6/30/ /150/200 1 NVP
12 WHO Weight Band Dosing NVP dose (mg/m 2 ) Weight (kg)
13 Predicted Exposure if WHO dosing vs FDA Figure 4. Varying NVP Tablet Strength vs FDA Dosing (Liquid) 100 Percentage of Subjects Exceeding Threshold C FDA AUC > 48 Cmin > 3.0 AUC > 120
14 NVP MC Exposure by Age Group WHO 2007 Dosing NVP AUC (mcg*h/ml) Percentiles 75th 50th 25th 5th Adult Ave 20 0 <2 yr 2-6 yr 6-12 yr >12yr Age Groups
15 Dose Tables (<6kg) Number of Tablets by Weight Band (Twice Daily) Drug Strength of Child Tab (mg) kg kg kg AZT 60 1* 1* 1 AZT/3TC 60/30 1* 1* 1 AZT/3TC/NVP 60/30/50 1* 1* 1 ABC ABC/3TC 60/ ABC/AZT/3TC 60/60/ TC d4t d4t/3tc 6/ d4t/3tc/nvp 6/30/ NVP * Except in the infant < 6m of age where kg 0.5/0.5 and kg 1/0.5 is recommended.
16 WHO Weight Band Dosing 240 NVP dose (mg/m 2 ) Weight (kg) NVP NVP with ZDV in FDC
17 Future Plans Approval of simple tables New drugs Population modeling for NVP, 3TC and d4t Evaluate each ARV and incorporate new data
18 Dosing Tables LPV/RTV Number of Tablets by Weight Band (Twice Daily) Drug Strength of Child Tab (mg) kg kg kg kg kg kg kg kg Adult Strength kg kg Lop/Rit 100/ / Rit (boost)
19 WHO Weight Band Dosing for LPV 450 LPV dose (mg/m 2 ) Weight (kg) Modified W Original WT FDA Liq Do
20 d4t CHAPAS d4t CL/F by Age CHAPAS d4t AUC by Age d4t CL/F (L/h/m2) d4t AUC Age (yr) Age (yr)
21 d4t d4t Exposure from CHAPAS th AUC (mcg*hr/ml) Adult Mean Target th 50th 75th th mg 7mg Dose Formulation
22 3TC CHAPAS 3TC AUC by Age TC AUC Age (yr)
23 3TC 3TC Exposure from CHAPAS th AUC (mcg*hr/ml) Adult Mean Target th 50th 75th 4 90th mg Dose Formulation
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REVIEW No Assessment of safety a. Have all relevant studies on safety been included Yes X No (if no, please provide reference and information)
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Republic of Namibia. Ministry of Health and Social Services. Directorate of Special Programmes. National Guidelines for Antiretroviral Therapy
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Efavirenz, stavudine and lamivudine
efavirenz, stavudine, lamivudine: 1 efavirenz, stavudine and lamivudine First line ART treatment for HIV infection Efavirenz, stavudine and lamivudine efavirenz, stavudine, lamivudine: 2 Slide 1 Information