oral pellets and oral granules for infants and young children living with HIV
have proven advantages in terms of efficacy and tolerability over other
formulations of LPV/r, but uptake has been slow in low- and middle-income
countries with the highest HIV burden, according to Dr Christine Y Malati and
colleagues in a commentary published in the Journal
of the International AIDS Society.
They identified three
challenges: limited manufacturing capacity; the current unit cost of pellets
and granules; and the slow uptake of these new drug formulations by policy
makers and health care workers.
Only 52% of children under 15
years living with HIV are on lifesaving antiretroviral therapies and in many
cohorts rates of viral suppression are low.
Without effective treatment
half of children will die before their second birthday and only one in five will
survive to five years of age. However, there is a paucity of paediatric
Nevirapine is available as a
syrup or tablets, but children on nevirapine-based regimens are twice as likely
to have drug resistance and thus treatment failure as children on protease
inhibitors, such as LPV/r.
While the integrase
inhibitors, raltegravir and dolutegravir are recommended as preferred or
alternative first-line antiretrovirals for paediatric use, notably raltegravir
for neonates, they are currently not readily accessible due to cost,
manufacturing capacity and other factors.
This means LPV/r-based
regimens are the only available optimal first-line antiretrovirals for young
infants and children in high-burden countries. LPV/r is available as oral
solution, heat-stable tablets, oral pellets and oral granules.
solution is required for infants under three months of age, but needs refrigeration and has an unpleasant
taste. The tablets cannot be crushed, affecting correct dosage.
Oral pellets and granules are
similar products, introduced in 2015 and 2018 by two different generic
manufacturers. Although they are clinically-equivalent and dosed at the same
frequency, switching between the two products is not recommended.
Oral pellets and granules have
several advantages over oral solution and heat-stable tablets, including being
easier to provide at a range of doses, easier storage and improved taste. They
are usually given to the child along with semi-solid food such as porridge or
yoghurt, or a liquid such as water or breastmilk.
Nonetheless uptake of the
newer LPV/r formulations is significantly lower than expected. The authors focus
on oral pellets due to more experience with pellets compared to granules.