|
|
Abstract
Once-daily abacavir/lamivudine (ABC/3TC) and boosted atazanavir (ATV/RTV) in antiretroviral-naive HIV-1 infected subjects: 48-week results from COL102060 (SHARE)
Elion R.1, DeJesus E.2, Sension M.3, Berger D.4, Towner W.5, Richmond G.6, Yau L.7, Ha B.7, COL102060 Study Team
Objectives: To evaluate the efficacy and safety of ABC/3TC combined with ATV/RTV in antiretroviral-naïve subjects.
Methods: This was an open-label, prospective study evaluating ATV/RTV 300 mg/100 mg +ABC/3TC (600 mg/300 mg) given once daily (QD) in subjects with entry HIV RNA >5,000 c/mL. Toxicity switches were permitted for ABC hypersensitivity and complications from hyperbilirubinemia. Lipoprotein subclasses were analyzed by nuclear magnetic resonance spectroscopy to determine particle concentration and size.
Results: 112 subjects were enrolled, of whom 111 were treated. Median baseline (BL) characteristics were: HIV RNA 5.06 log10 c/mL (56% ³ 100,000 c/mL), CD4+ 207 cells/mm3 (47% <200 cells/mm3), fasting cholesterol 165 mg/dL, fasting triglycerides 120 mg/dL. 16 subjects (14%) prematurely discontinued study: lost to follow-up (5), consent withdrawal (5), adverse event (3), protocol violation (1), non-compliance (1), and virologic failure (1). At week 48, by ITT M=F analysis, 77% (85/111) achieved HIV RNA <50 c/mL and 79% (88/111) achieved HIV RNA <400 c/mL; by ITT observed analysis, 90% (85/94) and 94% (88/94) had HIV RNA <50 and <400 c/mL, respectively. Median CD4+ increase from BL was 188 cells/mm3. No primary PI mutations were observed in 4 subjects who met confirmed protocol-defined virologic non-response, and in 6 subjects who had detectable viral load at the last study visit. Median fasting lipids at 48 weeks (% change from BL) were 174 mg/dL (+40%) for triglycerides, 198 mg/dL (+18%) for cholesterol, 46 mg/dL (+40%) for HDL, and 115 mg/dL (+9%) for LDL. Median LDL particle size did not vary from BL to week 48.
Conclusions: The ABC/3TC+ATV/RTV QD regimen demonstrated a high rate of virologic suppression through 48 weeks. Further study is underway to determine if stopping RTV after virologic suppression can reverse the mild hyperlipidemia observed.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
WEPEB033
Suggested Citation
"ElionR., et al.
Once-daily abacavir/lamivudine (ABC/3TC) and boosted atazanavir (ATV/RTV) in antiretroviral-naive HIV-1 infected subjects: 48-week results from COL102060 (SHARE).
Poster exhibition:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
WEPEB033"
|
|
|