Abacavir safety and effectiveness in young infants with HIV in South African observational cohorts

Area of Science:

• Pediatric Infectious Diseases
• Antiretroviral Therapy Research
• Neonatal Pharmacology

Background:

• World Health Organization guidelines recommend abacavir for first-line antiretroviral treatment in children and neonates.
• Limited data and no approved dosage exist for infants under 3 months of age, particularly neonates.

Purpose of the Study:

• To evaluate the safety and efficacy of abacavir in infants younger than 3 months initiating antiretroviral therapy (ART).
• To compare discontinuation rates and viral suppression between abacavir and zidovudine in this vulnerable population.

Main Methods:

• Retrospective analysis of infants (<3 months) initiating ART between 2006-2019 across nine South African cohorts.
• Compared outcomes (antiretroviral discontinuation, viral suppression at 6 and 12 months) based on age (<28 vs. ≥28 days) and weight (<3 vs. ≥3 kg).
• Utilized survival analysis and logistic regression for comparisons, adjusting for relevant factors.

Main Results:

• 51% of infants received abacavir (n=837), 27% received zidovudine (n=443).
• Abacavir discontinuation rates were similar in infants <28 days and ≥28 days, and in those <3 kg and ≥3 kg.
• Abacavir discontinuations were significantly less frequent than zidovudine discontinuations (aHR 0.14).
• 12-month viral suppression rates were comparable between age and weight groups for abacavir, and similar between abacavir and zidovudine (aOR 1.8).

Conclusions:

• Abacavir can be safely used in infants younger than 28 days or weighing less than 3 kg.
• Findings support the use of abacavir in neonates and very young infants, addressing a critical gap in pediatric HIV treatment guidelines.