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Patient Eligibility

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Task

Determine what populations of children will be targeted in the initial rollout.

Overview

At this stage the Ministry of Health (MOH) can engage its stakeholders, such as policy-makers, clinicians, project and funding agencies, implementing partners, civil society organizations and nongovernmental organizations, to decide on the clinical aspects of the use of LPV/r pellets within their system.

Patient Eligibility Recommendations

Specifically, the MOH needs to decide whether the LPV/r pellets should only be considered for newly initiated patients, or whether to switch children under 3 years old who are currently doing well on NVP-containing regimens or other LPV/r formulations.

Country programs are encouraged to consider the following suggestions from the Antiretroviral (ARV) Procurement Working Group when articulating eligibility groups for LPV/r pellets, so as to target the pellets to those patients who need it most:

Patient Description Patient Eligibility
Patients to be optimized for LPV/r pellets
  • Patients currently on or needing LPV/r-containing regimens (1st or 2nd line) who cannot tolerate LPV/r solution and are not able to swallow LPV/r 100mg/25mg tablets whole.
  • Patients < 3 years old who are newly initiating antiretroviral treatment.
Patients for whom transition to pellets may be delayed
  • Patients currently stable on an NVP- or efavirenz (EFV)-containing 1st-line regimen (i.e. viral suppression, or if viral load is not available, those who are clinically or immunologically stable).
  • Patients tolerating LPV/r solution, if the program is able to maintain a sufficient supply of solution.
Patients for whom LPV/r pellets should NOT be used
  • Patients weighing 10 kilograms or more AND are able to swallow LPV/r 100mg/25mg tablets whole.
  • Patients < 3 months old (until further information is available about safety and tolerability in this group).
  • Newly initiating patients aged 3 years or older who may be initiated on an EFV-containing regimen.
Additional recommendations for older children
  • Consider procurement of the LPV/r 100mg/25mg tablet for children weighing 10 kilograms or more who are able to swallow tablets whole.
  • Consider adopting the recommendation to transition children aged 3 years or older who are on an LPV/r-containing 1st-line regimen and have maintained sustained viral suppression, to an EFV-based regimen.

Additional Resource