Paediatric ART Working Group. guideline review meetings

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1 Paediatric ART Working Group Report back from Sept 2009 and Dec 2009 ART guideline review meetings

2 Paediatric ARV working group priorities Continue to emphasise need for scored adult FDCs this avoids need for using numerous baby tabs in older children Market for baby forms will stay small, as they rapidly grow out of the need for baby forms Need to try to consolidate around a handful of products to simply programming & ensure countries likely to demand the volumes necessary to ensure production.

3 Simplifying dosing - Didanosine For many paediatric ARV products supply is constrained by low volumes, e.g ddi EC 125mg, EFV 100mg, paediatric AZT/3TC/ABC are all unavailable Also proliferation of different formulations For ddi there are 2 different forms, with overlapping dosing, different dosing schedules and conflicting guidance around administration PAWG valued keeping dosing practical and simple Revise Annex E dosing to limit the number of dosage forms to the minimum required i.e. 25mg buffered tabs, 125mg EC and 200mg EC Provide guidance on whether ddi EC caps can be open and taken with food Consider adding 100mg EC formulation to reduce required formulations to just 2

4 Simplifying dosing - Efavirenz Current dosing is based on historical data and breaks dosing into 50mg steps this makes it necessary to use multiple formulations EFV pk is highly variable in children and tends to be low especially in younger children Recommend simplifying dosing by removing the 50mg increments resulting in only 3 pediatric doses 200, 300 and 400mg. A single scored 200mg tablet is all that would be needed to deliver all those doses PAWG will review CHAPAS data and refine the dosing schedule to better understand whether we should round up or down As yet cannot recommend use below 3yrs/10kg

5 Paediatric Lopinavir sprinkles As the anticipated use of LPV expands a heat stable, infant friendly formulation is urgently needed Even for older children the paed tablet is actually NOT very popular A heat stable sprinkle is requested so PAWG discussed dosing and pack size Recommend minimum 'pack size' of 40mg LPV / 10mg RTV equivalent to 0.5 ml of syrup Dosing aligned with syrup dosing note that at higher end of dosing this will mean several capsules per dose

6 Dosing of infant prophylaxis for PMTCT Objective: Derive dosing simple, unified NVP dosing schedule for infant prophylaxis Prophylaxis Lower doses than for treatment effective e.g. ZDV 8mg/kg/day in divided doses NVP prophylaxis dosing Target keep NVP conc > 100 ng/ml (Note treatment Cmin >3,000 ng/ml) 2mg/kg dose x 1 over 100 ng/ml for 1 week Longer prophylaxis for BF infants needs to account for auto induction and maturation of metabolism NVP dose used in studies (HIVNET 023, PEPI, HPTN046, SIMBA, BAN) Initial induction/developmental dose ~2 4mg/kg/day or ~4 8mg/kg 2xs/wk 6

7 Dosing of infant prophylaxis for PMTCT Considerations Fixed dose easiest to implement Daily dosing easier logistically than twice weekly and robust to minor non adherence Harmonized with: standard Child health follow up visits Recommended Dosing Birth to 6 weeks: 10 mg/d (BW <2.5kg) Birth to 6 weeks: 15 mg/d (BW >= 2.5kg) 6 weeks to 6 months: 20 mg/d 6 months to 9 months: 30 mg/d 9 months to end of BF: 40 mg/d

8 Dosing of infant prophylaxis for PMTCT NVP Prophylactic Dosing NVP DAILY DOSE (MG/KG) PNA WEEKS 5TH PCT 50TH PCT 95TH PCT TX DOSE

9 Dosing of infant prophylaxis for PMTCT NVP Population PK Model from DACS 095 results (M Mirochnick PAS 2006) Induction and Maturation Elements in Model Monte Carlo Simulation 1000 male and 1000 female infants Infant Weight Distribution from WHO tables Goal always maintain NPV conc > 100ng/mL Assess steady state troughs Assess impact of missed doses

10 Dosing of infant prophylaxis for PMTCT NVP Prophylactic Dosing NVP Prophylactic Dosing NVP PRE-DOSE CONC (NG/ML) NVP PRE-DOSE CONC (NG/ML) PNA WEEKS 5TH PCT 50TH PCT 95TH PCT PNA WEEKS 5TH PCT 50TH PCT 95TH PCT

11 Protease inhibitor use in children Recommendations? Remove SQV and NFV dosing guidance from Annex E Develop heat stable pediatric RTV formulation Next steps Keep drugs in but do not provide dosing Incorporate pediatric RTV tablet or RTV sprinkle into the priority list of preferred ARVs for infants and children Add ATV/r (alternative PI) and DRV/r (second line PI, > 3yr) to the dosing guidance in Annex E Review PK Develop dosing schedule and in particular provide a ratio for PI:RTV. For ATV/r 3:1. For DRV/r 6:1 Incorporate into Annex E List pediatric formulations of ATV and DRV in the priority list of preferred ARVs for children Change dosing guidance for pediatric LPVr tablets in the kg weight band Change Annex E dosing in the kg weight band to 2 tabs am and 2 tabs pm 11

12 Lead-in dosing of NVP Initiation of therapy results in auto induction of metabolism and a high rash frequency when initiated at full dose (q12). Rash occurs in first 8 32 days most by 2 weeks NVP related rash may be less common in younger children and more common in children with higher CD4. Recommendations Lead in dosing if formulations are available but if they are not available, to start full dose triple FDCs and monitor closely for the development of rash. Next steps Incorporate into Annex E guidance

13 Revised priority list of needed ARVs Drugs for infant prophylaxis NEVIRAPINE 20mg scored tablet Use from 6 weeks For < 6 weeks, need smaller bottle size for dosing in young infants and need to examine the syringe ZIDOVUDINE 12mg sachet (no progress) May be less used Need better packaging and spec for existing liquid Drugs for treatment of children with HIV LOPINAVIR/ritonavir 40/10 mg sprinkle High priority ABC/3TC 120/60 mg tab This is designed for once daily use equivalent to a junior ABC/3TC ABC/3TC/NVP 60/30/50 mg Dual exists, but need the triple FDC in order to provide an option to countries that are now changing their guidelines to recommend first line treatment with ABC EFV 200mg scored tablet Scored adult 600mg This exists but is not prequalified RTV 50mg heat stable sprinkle or tablet Useful for co administration with unboosted PIs and for super boosting. Needs to have a longer shelf life TDF TDF/3TC ATV/r DARUNAVIR/r RALTEGRAVIR ETRAVIRINE Scored adult 300 mg tab 75 mg tab 75/75 mg tab Scored 300/300 mg tab Need ped co formulation Ratio of 3:1?dose Need ped co formulation Ratio of 6:1?dose No formulation as yet No formulation as yet Although no safety data if above 13 could use TDF for adoss with Hep B Allternate second line option *** urgently needed. Need to model this formally within the harmonized dosing schedule from age 6 and above Third line use

14 Ped ARV working group missing meds ABC/3TC once daily 120/60mg score adult form Lop/r 40/10 mg sprinkle Abacavir/3TC/NVP 60/30/50 NVP 20 mg scored EFV 600 mg scored Ritonavir 50 mg sprinkle ABC/3TC 300/150 score this

15 Ped ARV WG missing meds Would like to include TDF/3TC 75/75 TDF 300 mg scored Darunavir/r? which dose studied in 3 6 yr old ATAZANAVIR/rit difficult dosing Suggested that the following are considered for patent pool Raltegravir Etravarine

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