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.
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.


OBJECTIVE
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.
Unité de recherche Santé de la Reproduction VIH et Maladies Associées, Centre MURAZ, Bobo-Dioulasso, Burkina Faso ; Institut de recherche en sciences de la santé, Bobo-Dioulasso, Burkina Faso.
H
H
Hien
N
N
Meda
S
S
Diagbouga
E
E
Zoure
S
S
Yaméogo
H
H
Tamboura
J
J
Somé
A
A
Ouiminga
F
F
Rouet
A
A
Drabo
A
A
Hien
J
J
Nicolas
H
H
Chappuy
P
P
Van de Perre
P
P
Msellati
B
B
Nacro
D000293:Adolescent; D000349:Africa; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D048588:Benzoxazines / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D003521:Cyclopropanes; D016049:Didanosine / Q000008:administration & dosage* / Q000493:pharmacokinetics; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000493:pharmacokinetics; D008297:Male; D055118:Medication Adherence; D012367:RNA, Viral / Q000187:drug effects; D011795:Surveys and Questionnaires; D019562:Viral Load / Q000187:drug effects
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D012367:RNA, Viral; D019259:Lamivudine; C098320:efavirenz; D016049:Didanosine
Didanosine; Efavirenz; Lamivudine; child; once-a-day therapy