Efficacy and Safety of Darunavir and Lopinavir in Treating HIV in Pediatric and Adolescent Populations: A Systematic Review
By
John O’Rourke
Claire L. Townsend
Edith Milanzi
Hannah Castro
Intira Jeannie Collins
Ali Judd
Julie Jesson
Valériane Leroy
Martina Penazzato
Marissa Vicari
Françoise Renaud
April 3, 2026
Clinical Scorecard: Efficacy and Safety of Darunavir and Lopinavir in Treating HIV in Pediatric and Adolescent Populations: A Systematic Review
At a Glance
Category Detail
Condition HIV in pediatric and adolescent populations Key Mechanisms Protease inhibitors (Darunavir and Lopinavir) used in treatment regimens Target Population Children and adolescents aged 0–19 years living with HIV Care Setting Clinical management in pediatric healthcare settings
Key Highlights
WHO recommends therapy initiation for all children living with HIV regardless of disease stage or CD4 count. Darunavir (DRV) is an alternative second-line therapy if dolutegravir fails. Lopinavir (LPV) is recommended as an alternative first-line regimen when dolutegravir is unsuitable. LPV oral solution is no longer preferred for neonates due to palatability and toxicity concerns. Investigations into fixed-dose combinations of DRV/r are ongoing. Guideline-Based Recommendations
Diagnosis
Initiate therapy for all children living with HIV regardless of disease stage or CD4 count. Management
Use DRV/r as an alternative second-line therapy if dolutegravir-based regimens have failed. Use LPV/r as an alternative first-line regimen if dolutegravir is unsuitable. Monitoring & Follow-up
Assess effectiveness and safety outcomes in populations receiving DRV or LPV solid formulations. Risks
Consider potential toxicity of LPV/r oral solution in neonates and young children. Patient & Prescribing Data
Children and adolescents aged 0–19 years living with HIV
DRV and LPV formulations are available in various forms, with specific recommendations based on age and ability to swallow tablets.
Clinical Best Practices
Utilize heat-stable taste-masked oral pellets and dispersible granules for younger children unable to swallow tablets. Monitor lipid values and other safety outcomes during treatment. References
