6th IAS Conference On HIV Pathogenesis, Treatment and Prevention

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MOPE240 - Poster Exhibition


Incidence and risk factors for nevirapine related toxicities among HIV-infected Asian children randomized to starting ART at different CD4%

C. Kea1, T. Puthanakit2, T. Apornpong2, P. Lumbiganon3, V. Ung4, R. Hansudewechakul5, S. Kanjanavanit6, J. Wongsawat7, C. Ngampiyaskul8, W. Luesomboon9, T. Suwanlerk2, J. Intasan2, S. Vonthanak1, K. Ruxrungtham2

1National Center for HIV/AIDS, Dermatology and STDs, Phnom Penh, Cambodia, 2The HIV Netherlands, Australia, Thailand Research Collaboration, Bangkok, Thailand, 3Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand, 4National Pediatric Hospital, Phnom Penh, Cambodia, 5Chiangrai Regional Hospital, Chiangrai, Thailand, 6Nakornping Hospital, Chiang Mai, Thailand, 7Bamrasnaradura Infectious Disease Institute, Nonthaburi, Thailand, 8Prapokklao Hospital, Chantaburi, Thailand, 9Queen Savang Vadhana Memorial Hospital, Sriracha, Thailand

Background: High baseline CD4 is a risk factor for nevirapine(NVP) toxicity in adults. This study compared the incidence of NVP toxicity between children who initiated ART when CD4 >15% versus CD4 < 15% and identified predictive factors related to NVP-toxicity in children.
Methods: This is a substudy of the PREDICT study in which children were randomized to start ART at CD4 < 15% versus 15-24%. Adverse events after ART initiation were collected. A multivariate logistic regression analysis was performed to assess potential risk factors.
Results: From March 2006 to October 2010, 201 HIV infected children initiated NVP-containing ART(137 started with CD4 15-24%). The median age,CD4% and HIV RNA at time of ART initiation were 7 years, 19% and 4.9 log10copies/ml, respectively. Incidence of overall NVP-related toxicities, rash, hepatotoxicity and hypersensitivity were 32%, 14%, 22% and 7%, respectively. Median onset of NVP toxicity was 2.0 weeks (IQR:1.64 - 8.4). 8.5% needed to substitute NVP with lopinavir/ritonavir, nelfinavir or efavirenz. Multivariate analysis showed that the overall NVP toxicity was 2.65 times higher among children with baseline CD4 >15% (95% CI;1.29 to 5.45) and 1.87 times higher in Cambodians (95% CI; 1.02-3.45). The risk of NVP rash was 2.2 times greater in girls (95% CI;0.93 to 5.18) and 2.58 times greater for children with CD4 ≥15% (95%CI;0.92 to 7.20). Risk of NVP hepatotoxicity was 2.2 times greater for boys (95% CI;1.06 to 4.55), 2.15 times greater for children with CD4 ≥15% (95% CI;0.90 to 5.12) and 3.98 times greater among Cambodians (95% CI; 1.92 to 8.28).
Conclusion: One-third of HIV had NVP toxicity of which 8.5% needed ART substitution. Children who started ART when CD4 was >15% were at almost 3 times a higher risk for NVP toxicity. This risk should be carefully observed when implementing earlier ART treatment using NVP-based regimens.

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