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Abstract
Long-term effectiveness of NNRTI-based HAART in antiretroviral-naive HIV-infected children participating in Thailand´s National Access Program: 192-week result
Aurpibul L.1, Puthanakit T.1, Oberdorfer P.2, Akarathum N.3, Kanjanavanit S.4, Wannarit P.5, Sirisanthana T.1, Sirisanthana V.6
Objectives: Thailand´s national program for access to antiretroviral treatment in HIV-infected patients has been implemented since 2002. This study aimed to determine the long term effectiveness of nevirapine (NVP)- and efavirenz (EFV)-based HAART in advanced-stage, antiretroviral-naive children participating in the Thai national access program.
Methods: From August 2002 to July 2003, 107 HIV-infected antiretroviral-naive children, whose CD4 cells < 15% were enrolled. They received HAART consisting of either NVP or EFV, together with lamivudine and stavudine. Generic drugs and/or adult formulations were used. Primary endpoint was the percentage of patients with plasma HIV RNA level (pVL) <50 copies/ml at week 192. Secondary endpoints were the change in percentage of CD4, long-term outcomes; the incidence of resistance mutation virus and metabolic complications.
Results: At baseline, the mean age was 7.7 years (range 2.1 to 13.8), the median CD4 cell percentage was 3% (IQR 1-10), and the mean pVL was 5.4 (SD 0.5) log10 copies/mL. After 192 weeks of HAART, 79 children (74%) had pVL levels of < 50 copies/mL, 5 (5%) had pVL between 50-400 copies/ml, 18 (16%) had virological failure and developed resistance mutation (11 out of 18 had switched to PI-based regimen), 5 (5%) died from HIV-related illness. The median percentage of CD4 was 27% (IQR 23-31), 60% of patients reached CD4 > 25%. The mean(SD) weight-for-age and height-for-age z-scores increased from -2.0(1.1) to -1.1(0.9) and -2.4(1.3) to -1.4(1.2) (p<0.001), respectively. At 144 weeks of HAART, 57% of children developed clinical lipodystrophy, therefore d4t was substituted with AZT. At 192 weeks of HAART, hypercholesterolemia (cholesterol>200 mg/dl) was detected in 6% and hypertriglyceridemia (triglyceride >200 mg/dl) in 7% of children.
Conclusions: This study showed that NNRTI-based HAART is an effective regimen for HIV-infected children and is sustainable for long-term virological control.
Additional informations
Adverse events and complications:
# 18 (16%) had virological failure and developed resistance mutation (11 out of 18 had switched to PI-based regimen),
# 5 (5%) died from HIV-related illness.
# At 144 weeks of HAART, 57% of children developed clinical lipodystrophy, therefore d4T was substituted with AZT in all children who had no underlying hematologic diseases. We used fixed-dose combination (FDC) tablet (GPOvir Z250), consisting of zidovudine 250 mg, lamivudine 150 mg and nevirapine 200 mg to replace regimen 1 and another FDC tablet (Zilavir), consisting of zidovudine 300 mg and lamivudine 150 mgto replace stavudine and lamivudine in regimen 2.
# At 192 weeks of HAART, hypercholesterolemia (cholesterol>200 mg/dl) was detected in 6% and hypertriglyceridemia (triglyceride >200 mg/dl) in 7% of children.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
TUPEB127
Suggested Citation
"AurpibulL., et al.
Long-term effectiveness of NNRTI-based HAART in antiretroviral-naive HIV-infected children participating in Thailand´s National Access Program: 192-week result.
Poster exhibition:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
TUPEB127"
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