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Abstract
A RANDOMISED, OPEN LABEL STUDY TO INVESTIGATE ABACAVIR ( ABC) AND LAMIVUDINE ( 3TC) AS ONCE DAILY (QD) COMPONENTS OF A TRIPLE COMBINATION REGIMEN (EPV40001).
BOWONWATANUWONG C, MOOTSIKAPUN P, SUPPARATPINYO K, TANSUPHASWADIKUL S, ATHISEGRAN R, PASOOK P, JONES A
Objective
EPV40001 was initiated to assess the virological efficacy and safety of ABC QD or 3TC QD as a component of a triple regimen over 48 weeks in therapy-naïve HIV-1 positive adults
Methods
151 subjects were centrally randomised (1:1:1) to one of the following treatment groups: Control: ZDV(300mg BID)/3TC(150mg BID)/ABC(300mg BID) or ZDV(300mg BID)/3TC(300mg QD)/ABC(300mg BID) or ZDV(300mg BID)/3TC(150mg BID)/ABC(600mg QD). Hodges-Lehman estimators were used to produce confidence intervals around the AAUCMB treatment difference ( log10 reductions in HIV-1 RNA from baseline).
Results
The baseline median HIV-1 RNA was 4.8 log10c/ml and the CD4 positive cell count was 380 cells/ul. In a planned week 24 analsysis, in the Intent to Treat (ITT) exposed population (ITTE), median AAUCMB was –2.0, -2.0 and –1.8log10 c/ml in the control, 3TC(QD) and ABC(QD) arms respectively. This result demonstrated similar results between control and QD treatment groups (both 95% CIs were below the chosen level of similarity of 0.4 log10 ). The proportions of subjects with HIV-1 RNA <400c/ml in the ITTE switch equals failure analysis was 40/50(80%), 35/50(70%) and 36/51(71%) in the control, 3TC QD and ABC QD arms respectively with a corresponding success rate of 91%,87% and 90% in the as treated analysis. The median CD4 positive cell count increase was +130, +136 and +100 cells/ul in the three treatment arms respectively. Tolerance to treatment was comparable between the treatment arms with no new or unexpected adverse events reported during the study. The incidence of ABC related hypersensitivity reactions was 6% overall with no difference between treatment arms.
Conclusion
In this pilot study, both 3TC QD and ABC QD were effective as components of HAART. Both 3TC and ABC warrant further investigation as components of complete once daily regimens.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
4
Suggested Citation
"BOWONWATANUWONGC, et al.
A RANDOMISED, OPEN LABEL STUDY TO INVESTIGATE ABACAVIR ( ABC) AND LAMIVUDINE ( 3TC) AS ONCE DAILY (QD) COMPONENTS OF A TRIPLE COMBINATION REGIMEN (EPV40001)..
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
4"
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