Lipid profile in children randomized to immediate versus deferred nevirapine-based antiretroviral therapy in the PREDICT study Kanjanavanit S , Puthanakit T , Kosalaraksa P, Hansudewechakul R , Ngampiyaskul C , Pinyakorn S , Luesomboon W, Saphonn V , Ananworanich J, Ruxrungtham K and on behalf of the PREDICT study group MOABO201. XIX International AIDS Conference 2012
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Lipid profile in children randomized to immediate versus deferred nevirapine-based antiretroviral therapy in the PREDICT study Kanjanavanit S, Puthanakit.
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Lipid profile in children randomized to immediate versus deferred
nevirapine-based antiretroviral therapy in the PREDICT study
Kanjanavanit S , Puthanakit T , Kosalaraksa P, Hansudewechakul R , Ngampiyaskul C , Pinyakorn S ,
Luesomboon W, Saphonn V , Ananworanich J, Ruxrungtham K
and on behalf of the PREDICT study group
MOABO201.XIX International AIDS Conference 2012
PREDICT Study Design(2006 to 2011)
299 HIV-infected Thai and Cambodian childrenAged 1-12 years old, CD4 15-24%, no prior CDC C illnesses
Immediate ARTAZT/3TC/NVP
Deferred ART until CD4 < 15%
Randomized 1: 1
Outcomes at 144 weeksHigh AIDS-free survival rate (98%) in both arms
• Reference group• Results from multivariate models, adjusted for baseline of the given endpoints
and study week
Discussions
• ART Naïve HIV infected children randomized to NVP-
based treatment or deferred ART
– Long term FU data, mild immune suppression
– Low prevalence on dyslipidemia in treatment arm
– PI-based and EFV-based regimens have been associated
with higher rates of dyslipidemia than NVP-based
regimens • van Leth F.PLoS Medicine. 2004• Jean-Jacques Parienti. CID2007• Negredo E. CID2002• Lainka E. Pediatrics2002• Mankhatitham W. J Med Assoc Thai 2012
Discussions
• Overall dyslipidemia rate reduced from 64% to 37%
in immediate treatment arm where as the rate
increased to 78% in deferred not starting ART arm
• The randomized study design is a major strength;
however, low number and shorter duration of ART in
the deferred arm children limits longer-term
comparison.
Conclusions
• After 3 years of follow-up, nevirapine-based initiation
achieved favorable lipid profile in children with mild
to moderate HIV-associated immune deficiency
• Less dyslipidemia was found in treatment group
compared to deferred group
Acknowledgement
Children and their families who participated in this study Funding
– US National Institutes of Health (NIAID, NICHD, NIMH) Antiretroviral supply