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Description : Pediatric Drug Pipeline: New Drugs, New Strategies.

Tags : Pediatrics, Child Health, pediatric practice, pediatrician, health providers, Pediatric Drug

Published on : Jul 16, 2020 | Views : 1305 | Downloads : 0

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Pediatric Drug Pipeline: New Drugs, New Strategies Dr. Martina Penazzato Paediatric HIV Advisor HIV Department, WHO-Geneva July 15th 2016
Slide 2-

OUTLINE What do we have now? What to expect “tomorrow”? Formulations pipeline New drugs pipeline What to do differently? Where next?
Slide 3-

OUTLINE What do we have now? What to expect “tomorrow”? Formulations pipeline New drugs pipeline What to do differently? Where next?
Slide 4-

2016 WHO ARV Consolidated Guidelines Test earlier and closer Treat earlier and better Tailor service delivery Treat more newborns Simplify strategies Introduce new drugs
Slide 5-

Offer optimal regimens in age-appropriate formulations Age at first line First-line ART regimen failure Second-line ART regimen LPV/r-based first line AZT or ABC + 3TC + RAL Younger than 3 ABC + 3TC + LPV/r years AZT + 3TC + LPV/r 3 years and older ABC + 3TC + LPV/r AZT + 3TC + EFV or RAL AZT + 3TC + LPV/r ABC or TDF + 3TC + EFV or RAL NNRTI-based first-line regimen All ages ABC + 3TC + EFV (or NVP) AZT + 3TC + ATV/r or LPV/r TDF + 3TC + EFV (or NVP) AZT + 3TC + EFV (or NVP) ABC or TDF + 3TC + ATV/r or LPV/r Simplification strategy: substitute LPVr with EFV at 3 years RAL first line in special circumstances DRV/r and DTG most appropriate for 3rd line use.
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Introduction of better options doesn’t happen overnight LPVr pellets LPV/r pellet was USFDA tentatively approved in May 2015. Approved for use from 2 weeks but no dosing for <5kg Palatability still not optimal Acceptability data from CHAPAS2 Administration in exclusive BF and young infants below 3 months is problematic Feasibility data being gathered In country registration undergoing but happening slowly RAL Full paediatric programme now almost down to neonates Granules formulation is not practical in resource limited settings Chewable tablets could be used as dispersible but bioequivalence to be demonstrated Limited experience in first line use for infants and young children No generic production and price remains relatively high
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OUTLINE What do we have now? What to expect “tomorrow”? Formulations pipeline New drugs pipeline What to do differently? Where next?
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LPVr 4-in-1: first line for under 3 years to address the lack of optimal formulations EFV triple: first line 3-10 years to provide an FDC to maximise adherence and simplify procurement ATVr and DRVr: use in 2nd and 3rd line formulations and overcome issue with separate administration of RTV NVP/AZT : FDC to facilitate dosing for enhanced PnP RAL better formulation: use in infants and young children to enable rapid introduction of INI for use in 1st line regimen DTG single or FDCs: identified as key drug to introduce INI in first line with potential for harmonisation across the full age spectrum TAF: key drug for future use in 1st line to minimise toxicity with potential for harmonization across the full age spectrum PADO PRIORITIES
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Progress…despite several hiccups Fully taste masked granules developed Clinical studies to be undertaken for establishing dosing LPVr 4-in-1 Development by 3 manufacturers based on PK modelling Regulatory guidance provided completion by Q4 2017 ABC/3TC/EFV Dosing and ratio agreed upon based on PK modelling Work undergoing to address regulatory requirements DRVr Scored dispersible tablet based on PK modelling Two generic manufacturers have started development RAL Dosing recommendations available (1/3 of adult tablet) Modest interest by generics ATVr Dosing and ratio being discussed by the PAWG Interest by generics to be generated NVP/AZT
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LPVr 4-in-1: first line for under 3 years to address the lack of optimal formulations EFV triple: first line 3-10 years to provide an FDC to maximise adherence and simplify procurement ATVr and DRVr: use in 2nd and 3rd line formulations and overcome issue with separate administration of RTV NVP 20 mg: better dosage form to facilitate dosing for PnP RAL better formulation: use in infants and young children to enable rapid introduction of INI for use in 1st line regimen DTG single or FDCs: identified as key drug to introduce INI in first line with potential for harmonisation across the full age spectrum TAF: key drug for future use in 1st line to minimise toxicity with potential for harmonization across the full age spectrum PADO PRIORITIES Some good news …and some “not so good”
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The good news is… DOLUTEGRAVIR (E/C/F) TAF Wiznia et al. CROI 2016 Gaur et al. CROI 2016 DTG and TAF are approved > 12 y DTG for 6-12y submitted to FDA which approved it for >30 kg P1093 and ODYSSEY will generate data on weight-band dosing E/C/F/TAF and F/TAF studies in children <12 ongoing
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But studies are taking longer than we would like… DOLUTEGRAVIR TAF Most recent approval >30 kg only The paediatric plan designed on age rather than weight: potential adjustments needed. This is resulting in delays with ODYSSEY Enrolment not completed for ECFTAF and to be started for FTAF
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And the newborn pipeline is still lagging behind Source: Polly Clayden and Ted Ruel
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OUTLINE What do we have now? What to expect “tomorrow”? Formulations pipeline New drugs pipeline What to do differently? Where next?
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Innovative strategies are needed Simplification strategies Long-acting and injectable Immunotherapy Remission Dual therapy NRTI sparing Cabotegravir Rilpivirine LA Neutralizing antibodies Therapeutic vaccine Early treatment Combination strategies Life-long triple antiretrovirals should not be our long-term goal
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Only one ongoing study: SMILE trial (virologically suppressed children >6 years switching to DRVr +EVG). “NEVEREST 4” start with RAL and substitute with DTG ? INSTI+PIs for 2nd line (NRTI sparing strategies, 7 randomized trials in adults as a switch) INSTI+3TC in switching strategies INSTI+3TC in naive (2 studies investigating DTG+3TC following positive results form the PADDLE trial) Weekends off: is there still a role for this with new regimens? Breather 2.0?
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Where next? Drugs and formulations for infants (enhanced prophylaxis and treatment) Importance of formulations suitable to LMIC New drugs will be largely used for an experienced population: Shift focus from 1st line to 2nd and 3rd line and to optimise sequencing and adherence Adolescents wave: Innovations to adolescents first and not “second” Strategic study design: address multiple questions and respond to the needs of children where they live Speeding up the pipeline is not trivial but … YES WE CAN! Registration Strategies Implement
Slide 18-

WHO GDG members PADO and PAWG members PHTI partners WHO colleagues Thank you

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