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P1060 commentary

P1060 commentary. Philippa Musoke MBChB Makerere University –Johns Hopkins University Research Collaboration, Kampala Uganda. Cohort 1. NVP exposed infants with higher treatment failure rates on a NVP based regimen Emergence of NVP resistance after sd NVP

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P1060 commentary

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  1. P1060 commentary Philippa Musoke MBChB Makerere University –Johns Hopkins University Research Collaboration, Kampala Uganda

  2. Cohort 1 • NVP exposed infants with higher treatment failure rates on a NVP based regimen • Emergence of NVP resistance after sd NVP • There are higher rates of NNRTI resistance after prolonged NVP prophylaxis • Recommendation • Children below 2 years of age • PI as 1st line therapy should be the standard of care BUT • Option for use of NVP where PIs unavailable • Children > 2 years • NVP based regimen as 1st line regimen

  3. Challenge of 1st line PI regimenin NVP exposed children • Large numbers of NVP exposed children expected • Can all countries afford scale up of PI based 1st line ART ? • If PMTCT coverage is high then • Fewer HIV infected children but .. • Implementation of PI based regimens – more complex • Syrup requires refrigeration • Tablet 100mg ( Alluvia) can not be cut in half • Lack of a fixed dose combination • More expensive than NNRTIs • Not widely available in many resource limited settings Protease Inhibitors need to be made available for these children

  4. Cohort II • NVP unexposed - baseline NNRTI resistance should not be an issue • Previous studies have shown treatment success with NVP > 70 % virological success at 24 – 48 wks • P1060 NVP arm, had higher treatment failure • Adherence to syrups vs FDC ? • Lead in phase of NVP - emergence of resist. ? • Subtype C – higher rates of NNRTI resistance ?

  5. Challenge of implementation of PI in non exposed children • Implementation of PI based regimen for all HIV infected children under 2 years • This may be feasible for some RLS – S Africa • May not as feasible other countries • Zimbabwe ?, Malawi ?, Tanzania ? , Uganda ? • There should be an option for children NOT exposed to NVP to initiate a NVP based regimen • Need to ensure good adherence and close monitoring • Not easy to detect early treatment failure without access to viral loads

  6. Immune response and Growth • Wide scale implementation of PI in infants may affect future growth of these infected children • Critical issue in view of the high rates of malnutrition and food insecurity • Do the children gain weight more slowly but catch up over time ? • Needs further follow up ( Version 5.0)

  7. Summary • NVP exposed HIV infected children • Every effort should be made to make PIs available for these children • Development of FDC of AZT/3TC/LPV/r a priority, if we are to scale up early initiation of ART • Where there are no PIs children should not be denied ART • Non-exposed HIV infected children • Where PIs are available they may be used BUT • NVP based 1st line regimen should still remain an option for this group of children ( 60% had treatment success) • However, some may feel it is easier to have one 1st line regimen for all infants BUT $$$$$$

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