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Once vs twice-daily abacavir and lamivudine in African children

Victor Musiime1, Philip Kasirye, Bethany Naidoo-James

  • 1aJoint Clinical Research Centre bDepartment of Paediatrics and Child Health, College of Health Sciences, Makerere University cBaylor-Uganda, Paediatric Infectious Diseases Clinic, Mulago Hospital, Kampala, Uganda dMedical Research Council (MRC) Clinical Trials Unit at University College London, London, UK eMedical Research Council/Uganda Research Unit on AIDS, Uganda Virus Research Institute, Entebbe, Uganda fUniversity of Zimbabwe, Harare, Zimbabwe gViiV HealthCare, Brentford, Middlesex, UK. *Diana M. Gibb and Ann Sarah Walker contributed equally to the writing of this manuscript.

AIDS (London, England)
|April 12, 2016
PubMed

Insights

Once-daily abacavir plus lamivudine is as effective as twice-daily dosing for HIV treatment in children. This simplified regimen improves adherence and maintains viral load suppression, offering a more convenient option for pediatric HIV care.

Area of Science:

  • Pediatric infectious diseases
  • HIV/AIDS treatment
  • Pharmacology

Background:

  • Antiretroviral therapy (ART) adherence is crucial for successful HIV treatment outcomes in children.
  • Once-daily dosing regimens are hypothesized to improve adherence compared to twice-daily regimens.
  • Previous studies demonstrated bioequivalence of once-daily versus twice-daily abacavir + lamivudine plasma concentrations in children, but lacked virological outcome data.

Purpose of the Study:

  • To compare the virological outcomes of once-daily versus twice-daily abacavir + lamivudine in children receiving first-line ART.
  • To assess the safety and adherence profiles of once-daily versus twice-daily abacavir + lamivudine regimens.

Main Methods:

  • A randomized, open-label trial (ARROW trial) involving 669 children (median age 5 years) on first-line ART.
  • Children on twice-daily abacavir + lamivudine for over 36 weeks were randomized to continue twice-daily or switch to once-daily dosing.
  • Co-primary outcomes included viral load suppression (<80 copies/mL) at week 48 and Grade 3/4 adverse events related to lamivudine or abacavir.

Main Results:

  • At week 48, viral load suppression (<80 copies/mL) was achieved in 73% of children on twice-daily dosing versus 72% on once-daily dosing (noninferiority met).
  • No significant differences were observed in viral load suppression (<400 copies/mL), drug resistance, adherence rates, or clinical/immunological outcomes between the groups.
  • Caregiver preference strongly favored the once-daily regimen, with similar safety profiles between the two dosing frequencies.

Conclusions:

  • Once-daily abacavir + lamivudine is noninferior to twice-daily dosing for viral load suppression in children with HIV.
  • The once-daily regimen simplifies ART, potentially improving adherence and treatment outcomes without compromising safety or efficacy.
  • This study establishes abacavir + lamivudine as a viable once-daily nucleoside backbone for simplifying pediatric ART regimens.
Abstract

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