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Abstract
ABACAVIR/COMBIVIR (ABC/COM) IS COMPARABLE TO INDINAVIR/COMBIVIR IN HIV-1 INFECTED ANTIRETROVIRAL THERAPY NAIVE ADULTS: PRELIMINARY RESULTS OF A 48-WEEK OPEN LABEL STUDY (CNA3014)
VIBHAGOOL A, CAHN P, SCHECHTER M, SOTO-RAMIREZ L, MONTRONI M, SMAILL F, THOMAS N
Objectives: To compare efficacy, safety and adherence of ABC (300mg bid) plus COM (150mg lamivudine and 300mg zidovudine bid) vs. IDV (800mg tid) plus COM.
Methods: Subjects were randomized (n=342) to receive open-label treatment with ABC/COM (n=169) or IDV/COM (n=173) for 48 weeks and stratified based on screening HIV-1 RNA (stratum1: = 5,000 to 100,000 c/mL; stratum 2: >100,000 c/mL). Plasma HIV-1 RNA was assessed (< 400 c/mL and < 50 c/mL).
Results: Median baseline HIV-1 RNA and CD4+ cell counts were similar between the two groups (ABC/COM 4.78 log10 c/mL and 331 cells/mm3; IDV/COM 4.82 log10 c/mL and 299 cells/mm3). Sixteen percent (27/169) of ABC/COM subjects vs. 23% (40/173) IDV/COM subjects discontinued the study. At Week 48, ITT Exposed (switch/missing = failure), 105/164 (64%) ABC/COM subjects had HIV-1 RNA < 400 c/mL vs. 82/165 (50%) IDV/COM subjects. For stratum 1 and 2, the values were 73/106 (69%) and 32/58 (55%) respectively for ABC/COM subjects vs. 49/100 (49%) and 33/65 (51%) for IDV/COM subjects. At Week 48, 96/164 (59%) ABC/COM vs. 79/165 (48%) IDV/COM had HIV-1 RNA < 50 c/mL. For the As-Treated population, 105/123 (85%) ABC/COM subjects vs. 82/99 (83%) IDV/COM subjects had HIV-1 RNA < 400 c/mL. By Week 48, 40/164 (24%) ABC/COM vs. 62/165 (38%) IDV/COM had confirmed loss of virological response (= 400 c/mL on two consecutive occasions). Both treatment regimens were generally well tolerated. Eleven percent (19/164) ABC/COM subjects vs. 13% (22/165) IDV/COM subjects primarily discontinued randomized study therapy due to an adverse event. Ten ABC/COM subjects (10/165; 6%) reported possible hypersensitivity to ABC. Nine percent (13/151) of ABC/COM subjects vs. 37% (56/150) of IDV/COM subjects reported difficulty taking the regimen, as scheduled.
Conclusion: At 48 weeks, ABC/COM is a highly active antiretroviral regimen that is generally well tolerated and comparable to IDV/COM, in subjects with low and high viral load at screening
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
63
Suggested Citation
"VIBHAGOOLA, et al.
ABACAVIR/COMBIVIR (ABC/COM) IS COMPARABLE TO INDINAVIR/COMBIVIR IN HIV-1 INFECTED ANTIRETROVIRAL THERAPY NAIVE ADULTS: PRELIMINARY RESULTS OF A 48-WEEK OPEN LABEL STUDY (CNA3014).
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
63"
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