1 / 15

MOABO201. XIX International AIDS Conference 2012

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

nuala
Download Presentation

MOABO201. XIX International AIDS Conference 2012

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Lipid profile in children randomized to immediate versus deferrednevirapine-based antiretroviral therapy in the PREDICT study KanjanavanitS, PuthanakitT , KosalaraksaP, HansudewechakulR, NgampiyaskulC, PinyakornS, LuesomboonW, SaphonnV, AnanworanichJ, RuxrungthamK and on behalf of the PREDICT study group MOABO201. XIX International AIDS Conference 2012

  2. PREDICT Study Design(2006 to 2011) 299 HIV-infected Thai and Cambodian children Aged 1-12 years old, CD4 15-24%, no prior CDC C illnesses Randomized 1: 1 Immediate ART AZT/3TC/NVP Deferred ART until CD4 < 15% Outcomes at 144 weeks High AIDS-free survival rate (98%) in both arms No differences in CDC B event rates between arms Puthanakit T, 2011 IAS [TULBPE 023]

  3. Objective • To compare lipid profiles in children randomized to immediate versus deferred nevirapine-based antiretroviral therapy (ART)

  4. Methods • Data was collected in patients who first started and continued antiretroviral treatment with nevirapine – based regimen • Immediate ART group • Deferred starting ART group • Deferred not on ART group

  5. Lipid measurement • Patients > 4 hour fasting were included • Lipid measurement : standard techniques with automated chemistry analyzer • LDL by calculation

  6. Definition • The abnormal lipid level was defined as • Total cholesterol > 200 mg/dl • LDL-Cholesterol > 130 mg/dl • HDL-Cholesterol ≤ 40 mg/dl • Triglyceride > 130 mg/dl PACTG1045 study.AIDS 2009,23:661-672. National Cholesterol Education Program.Pediatrics1992;89:495-501. PACTG1045 study.AIDS2009,23:661-672. National Cholesterol Education Program.Pediatrics 1992;89:495-501.

  7. Results • Data were available for 263 participants • Group 1 immediate ART N= 129 • Group 2 deferred starting ART N=60 • Group 3 deferred not on ART N= 134 • Median(IQR0) age 6.5 (4.1-8.5) years • Male 42% • Median (IQR) of fasting time is 8 (8.5-9) hours

  8. Clinical characteristics at week 0 and 144 * p < 0.05

  9. Lipid profile of immediate and deferred treatment to nevirapine-based ART * p < 0.05 * p < 0.05 * p < 0.05 * p < 0.05

  10. At week144 lipid profiles of NVP-based ART

  11. Treatment effects on lipid profiles • Reference group • Results from multivariate models, adjusted for baseline of the given endpoints and study week

  12. 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 LethF.PLoS Medicine. 2004 • Jean-Jacques Parienti. CID2007 • Negredo E. CID2002 • Lainka E. Pediatrics2002 • Mankhatitham W. J Med Assoc Thai 2012

  13. 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.

  14. 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

  15. Acknowledgement • Children and their families who participated in this study • Funding • US National Institutes of Health (NIAID, NICHD, NIMH) • Antiretroviral supply • GSK/ViiV Healthcare (AZT, 3TC, ABC), Boehringer (NVP), Merck (EFV), Abbott (LPV/r), Roche (NFV) • Endpoint Review Committee members, Data Safety Monitoring Board members • Investigators and site staffs • Thailand • HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok • Bamrasnaradura Infectious Diseases Institute, Nonthaburi • Srinagarind Hospital, KhonKaen University, KhonKaen • Queen SavangVadhana Memorial Hospital, Chonburi • NakornpingHospital, Chiang Mai • ChiangraiPrachanukroh Hospital,Chiang Rai • Prapokklao Hospital, Chantaburi • Cambodia • National Pediatric Hospital, Phnom Penh • Social Health Clinic, Phnom Penh

More Related