Once-daily highly active antiretroviral therapy for HIV-infected children: safety and efficacy of an efavirenz-containing regimen.
OBJECTIVE
To improve adherence and virologic suppression, we assessed the feasibility and effectiveness of a once-daily regimen of efavirenz with 3 nucleoside reverse transcriptase inhibitors as first-line or second-line highly active antiretroviral therapy in a cohort of HIV-1-infected children.


METHODS
HIV-1-infected children naive to efavirenz were treated with a combination of efavirenz, abacavir, didanosine, and lamivudine in an observational, prospective, single-center study. Virologic failure-free survival was assessed with Kaplan-Meier analysis. The CD4+ T-cell increase was estimated by using a generalized linear model incorporating repeated measurements.


RESULTS
Thirty-six children received the study medication for a median of 69 weeks. Virologic failure-free survival rates were 76% and 67% after 48 weeks and 96 weeks, respectively. No significant difference was found in efficacy between first-line and second-line highly active antiretroviral therapy. All children receiving highly active antiretroviral therapy showed a sustained CD4+ T-cell increase, irrespective of virologic suppression. Growth rates improved with highly active antiretroviral therapy. Study medication administration was stopped for 14 children, mostly because of nonadherence (4 cases) or virologic rebound (5 cases) and because of adverse events (unrelated death and grade 2 liver toxicity) in 2 cases. Lipid abnormalities and abacavir-related hypersensitivity were not observed.


CONCLUSIONS
For the first time, once-daily highly active antiretroviral therapy is demonstrated to be a safe, convenient, and potent antiretroviral regimen for HIV-1-infected children.
Scherpbier
Henriëtte J
HJ
Emma Children's Hospital, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
Bekker
Vincent
V
Pajkrt
Dasja
D
Jurriaans
Suzanne
S
Lange
Joep M A
JM
Kuijpers
Taco W
TW
D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D048588:Benzoxazines; D018791:CD4 Lymphocyte Count; D002648:Child; D002657:Child Development / Q000187:drug effects; D002675:Child, Preschool; D002784:Cholesterol / Q000097:blood; D015331:Cohort Studies; D003521:Cyclopropanes; D016049:Didanosine / Q000008:administration & dosage; D015224:Dideoxynucleosides / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D007223:Infant; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D010078:Oxazines / Q000008:administration & dosage*; D010349:Patient Compliance; D011446:Prospective Studies; D016896:Treatment Outcome; D000099227:Abacavir
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D002784:Cholesterol; D003521:Cyclopropanes; D016049:Didanosine; D015224:Dideoxynucleosides; D019259:Lamivudine; D010078:Oxazines; D000099227:Abacavir; C098320:efavirenz