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Acceptability of lopinavir/r pellets (minitabs), tablets and syrups in HIV-infected children
Adeodata Kekitiinwa1, Victor Musiime2,3, Margaret J Thomason4
1Department of Pediatrics and Adolescent Health, Baylor College of Medicine Children's Foundation Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital Kampala, Kampala, Uganda.
Insights
Lopinavir/ritonavir pellets showed improved acceptability in young children initially but waned over time. Pellets offer storage advantages over syrup but taste is a concern for older children.
Area of Science:
- Pediatric infectious diseases
- Pharmaceutical formulation
- HIV/AIDS treatment
Background:
- Lopinavir/ritonavir pellets, a new formulation, have received tentative approval.
- Understanding the acceptability of this formulation in pediatric populations is crucial for treatment adherence.
Purpose of the Study:
- To evaluate the acceptability of lopinavir/ritonavir pellets compared to syrup and tablets in HIV-infected infants and children.
- To assess formulation preference and taste perception over a 48-week period.
Main Methods:
- A randomized, two-period crossover trial (CHAPAS-2) involving 77 HIV-infected children aged 3 months to 13 years.
- Participants were divided into three groups based on age: infants (3-<12 months), young children (1-<4 years), and older children (4-<13 years).
- Acceptability and preference data for syrup, pellets, and tablets were collected at multiple time points up to 48 weeks.
Main Results:
- For infants and young children (<4 years), pellet preference peaked at week 12 (72% and 64%, respectively) but decreased by week 48 (44% and 36%).
- Older children (4-<13 years) showed a progressive decrease in pellet preference compared to tablets over time (from 41% to 13%).
- Pellets had similar taste acceptability to syrup in younger children but were perceived as worse tasting than tablets in older children. Storage and transportation were easier for pellets than syrup.
Conclusions:
- Lopinavir/ritonavir pellets are more acceptable for children under 4 years at 12 weeks but not at 48 weeks.
- Pellets offer logistical benefits over syrup, particularly in terms of storage and transport.
- Taste improvements and healthcare worker support are recommended to enhance and sustain pellet acceptability in pediatric HIV treatment.
Background:
Lopinavir/ritonavir 'pellets' were recently tentatively approved for licensing. We describe their acceptability for infants and children up to 48 weeks.
Methods:
CHAPAS-2 was a randomized, two-period crossover trial comparing syrup and pellets in HIV-infected infants (n=19, group A, aged 3-<12 months) and children (n=26, group B, 1-<4 years) and tablets and pellets in older children (n=32, group C, 4-<13 years) from two clinics ('JCRC', 'PIDC') in Uganda. At week 8, all groups chose which formulation to continue. Acceptability data were collected at weeks 0, 4, 8, 12 and 48.
Results:
For groups A and B overall, the proportion preferring pellets increased between week 0 and week 12 and decreased at week 48 (group A 37%, 72%, 44%; group B 12%, 64% and 36%, respectively), although there were marked differences between clinics. For group C, pellets were progressively less preferred to tablets over time: 41%, 19% and 13% at weeks 0, 12 and 48, respectively. During follow-up unpleasant taste was similarly reported among young children taking pellets and syrups (37%/43% group A; 29%/26% group B), whereas among older children, pellets tasted worse than tablets (40%/2%). No participants reported problems with storage/transportation for pellets (0%/0%) unlike syrups (23%/13%).
Conclusions:
For children <4 years, pellets were more acceptable at week 12 but not week 48. Clinic differences could reflect bias among health-care workers for different formulations. Pellets taste similar to syrup, are easier to store and transport than syrup and represent an alternative formulation for young children unable to swallow tablets; improvements in taste and support for health-care workers may help sustain acceptability.
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