For children and adolescents with HIV, a simpler, effective treatment is emerging from clinical trials, offering new hope for lifelong viral suppression.
Imagine being a child facing the daunting task of taking multiple HIV medications every day. Some might be bitter liquids, others large pills that are difficult to swallow, each with different dosing schedules.
This complex reality for young people living with HIV has made treatment adherence challenging and sometimes overwhelming for both children and their caregivers. However, a recent breakthrough in pediatric HIV research is transforming this reality, offering a simpler path forward.
Children and adolescents with HIV require lifelong antiretroviral therapy (ART) to suppress the virus and maintain healthy immune function. Historically, treatment for younger patients has involved multiple tablets and liquids that can be challenging to administer and often come with unpleasant tastes 5 .
These adherence challenges are particularly problematic during adolescence, when young people begin to take more responsibility for their own medication management. The consequences of poor adherence are serious—virological failure, drug resistance, and compromised long-term health.
The medical community has long recognized that fixed-dose combinations—single tablets containing multiple medications—could significantly improve adherence by simplifying treatment regimens. Until recently, however, many such combinations were unavailable for children, especially those weighing less than 25 kg 6 .
Complex regimens with different dosing schedules
Particularly challenging during adolescence
Few child-friendly formulations available
A recent clinical trial has investigated a promising solution: a fixed-dose combination containing three medications—bictegravir, emtricitabine, and tenofovir alafenamide—in a single small tablet taken just once daily 1 6 .
Class: Integrase strand transfer inhibitors (INSTIs)
Function: Blocks HIV from integrating genetic material into human DNA 3
Class: Nucleos(t)ide reverse transcriptase inhibitors (NRTIs)
Function: Targets early stage of viral replication 3
Class: Nucleos(t)ide reverse transcriptase inhibitors (NRTIs)
Function: Works with emtricitabine to block viral replication 3
To evaluate this single-tablet regimen specifically for younger patients, researchers designed an open-label, single-arm trial conducted across 22 hospital clinics in South Africa, Thailand, Uganda, and the United States 1 6 .
The trial enrolled 100 participants aged 6 to under 18 years who met specific criteria 1 6 :
All participants switched to the single-tablet combination of:
Taken once daily 1
| Characteristic | Cohort 1 (Adolescents) | Cohort 2 (Children) |
|---|---|---|
| Age range | 12 to <18 years | 6 to <12 years |
| Number of participants | 50 | 50 |
| Median weight | 54.6 kg | 31.8 kg |
| Median CD4 count | 796 cells/μL | 927 cells/μL |
| Region of enrollment | South Africa, Thailand, Uganda, USA | |
Open-label, single-arm trial begins across 22 clinics in multiple countries.
100 participants aged 6 to under 18 years enrolled with specific criteria.
All participants switch to single-tablet regimen taken once daily.
Comprehensive evaluation of pharmacokinetics, efficacy, and safety.
After 48 weeks of treatment with the single-tablet regimen, the results were highly encouraging across multiple dimensions.
Pharmacokinetic analyses confirmed that both children and adolescents achieved drug exposures within the range deemed safe and effective for adults 1 .
| Population | AUCtau (Exposure over time) | Ctau (Trough concentration) |
|---|---|---|
| Adolescents (12 to <18 years) | Similar to adults | 35% lower than adults, but well above effective threshold |
| Children (6 to <12 years) | Modestly higher than adults | Similar to adults |
| Both groups | Within predefined equivalence boundary | Within safe and effective range |
The single-tablet regimen demonstrated exceptional efficacy in maintaining viral suppression 1 :
100% of participants (100/100) maintained viral suppression (HIV-1 RNA <50 copies/mL)
98% of participants (98/100) maintained viral suppression
Critically, no participants developed treatment-emergent resistance to any of the three drugs in the regimen, underscoring the high genetic barrier to resistance especially of bictegravir 1 .
The medication was well-tolerated among participants 1 :
| Research Component | Function in the Study |
|---|---|
| Fixed-dose combination tablet | Single-tablet regimen containing bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg |
| Population pharmacokinetic modeling | Method to determine appropriate drug dosing for different age groups and weights |
| HIV-1 RNA PCR | Highly sensitive test to measure viral load and confirm suppression (<50 copies/mL) |
| CD4 count monitoring | Assesses immune function and treatment effectiveness |
| Schwartz formula | Calculates estimated glomerular filtration rate (eGFR) to monitor kidney function in children |
| Adherence assessment | Evaluates how consistently participants take medication |
The 48-week results from this pioneering trial have significant implications for the treatment of HIV in children and adolescents. The single-tablet regimen of bictegravir, emtricitabine, and tenofovir alafenamide represents a major advancement for several reasons 1 6 :
One small tablet daily instead of multiple medications makes adherence easier for both children and their caregivers.
98% viral suppression at week 48 provides confidence in the regimen's reliability.
Minimal serious side effects addresses concerns about long-term treatment in growing bodies.
Ensures the treatment remains effective over time, which is crucial for lifelong therapy.
This research has already influenced treatment guidelines, with this single-tablet regimen now recommended as first-line treatment in the United States for adolescents and as an alternative regimen in children 1 . The potential impact on global pediatric HIV treatment outcomes is substantial, particularly as formulations for younger children and lower weights continue to be developed.
As we look to the future, the success of this trial underscores the importance of continuing to develop child-friendly formulations that can help overcome the persistent global disparity in treatment outcomes between children and adults with HIV 5 . With simpler, more effective treatments becoming available, the goal of ensuring all children with HIV can lead long, healthy lives becomes increasingly attainable.