24-Month adherence, tolerance and efficacy of once-a-day antiretroviral therapy with didanosine, lamivudine, and efavirenz in African HIV-1 infected children: ANRS 12103/12167

Afr Health Sci. 2013 Jun;13(2):287-94. doi: 10.4314/ahs.v13i2.13.

Abstract

Background: There is no data on long-term benefit of once-a-day antiretroviral therapy (ART) with combination of DDI, 3TC and EFV to allow its use in future therapeutic strategies.

Objectives: To assess 24-month immuno-virological, adherence, tolerance, and effectiveness of a once-a-day ART with DDI, 3TC and EFV.

Methods: A phase 2 open trial including 51 children aged from 30 months to 15 years, monitored a once-a-day regimen for 24 months from 2006 to 2008 in the Departement de Pediatrie du CHUSS, at Bobo-Dioulasso in Burkina Faso. We tested immunological and virological response, adherence, tolerance and resistance of the treatment.

Results: Children with CD4 >25% at 24 months were 67.4% (33/49) CI 95% [54%, 80%]. The proportion of children with viral plasma RNA <300 cp / ml at 24 months of treatment was 81.6 % (40/49) CI [68.0% 91.2%]. Good adherence was obtained with more than 88% adherence > 95% over the 24 months. Drugs were well tolerated.

Conclusions: Given the limited number of antiretroviral drugs available in Africa and the inadequacy of laboratory monitoring in support program, once-a-day treatment and especially the DDI-based combination strategies could be an attractive operational option.

Keywords: Didanosine; Efavirenz; Lamivudine; child; once-a-day therapy.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Africa
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / pharmacokinetics
  • Benzoxazines / administration & dosage*
  • Benzoxazines / pharmacokinetics
  • CD4 Lymphocyte Count
  • Child
  • Child, Preschool
  • Confidence Intervals
  • Didanosine / administration & dosage*
  • Didanosine / pharmacokinetics
  • Female
  • HIV Infections / drug therapy*
  • Humans
  • Lamivudine / administration & dosage*
  • Lamivudine / pharmacokinetics
  • Male
  • Medication Adherence*
  • RNA, Viral / drug effects
  • Surveys and Questionnaires
  • Viral Load / drug effects

Substances

  • Anti-HIV Agents
  • Benzoxazines
  • RNA, Viral
  • Lamivudine
  • efavirenz
  • Didanosine