AEGiS-13IAC: Preliminary efficacy, adherence and satisfaction with COM/ABC versus COM/IDV, an open-label randomised comparative study (CNAB3014).

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Preliminary efficacy, adherence and satisfaction with COM/ABC versus COM/IDV, an open-label randomised comparative study (CNAB3014).

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB606)

Cahn P;;; P. Cahn, Glaxo Wellcome, Fundacion, Pasaje Angel Peluffo 3932, CP1202, Buenos Aires, Argentina, Tel.: +54 1 981 7777, Fax: +54 1 981 1855, E-mail: pcahn@huesped.org.ar

Background/methods.342 antiretroviral naive adults were randomised to COM/ABC(n = 171) or COM/IDV(n = 171)open-label therapy for 48 weeks. Subjects were stratified at baseline as >5000 to >100000 (63%) or >100000 (37%)c/mL. Median HIV-1 RNA was 62000 and 73000c/mL and CD4 count 312 and 298cells/m l for COM/ABC and COM/IDV respectively. HIV-1 RNA was assayed locally (>400c/mL) and by central laboratory (>50c/mL). Adherence was assessed by self-report using the Treatment Assessment and Satisfaction Questionnaire (TRaSQ). Local laboratory data for 98 subjects and central laboratory data for 108 subjects is available at 24 weeks. All will be through 24 weeks by June 2000.

RESULTS: At Week 24, based on an Intention-To-Treat (ITT) missing = failure analysis 30/45(67%) subjects on COM/ABC were >400c/mL compared to 31/53(58%) on COM/IDV. In the As Treated (AT) population these figures were 29/33(88%) and 30/37(81%) respectively. Using the >50c/mL assay, 38/52(73%) subjects on COM/ABC compared to 34/56(61%) on COM/IDV were below the threshold. When stratified, 28/34(82%) COM/ABC and 25/35(71%) COM/IDV subjects >100000 at baseline were >50copies /mL. In the >100000c/mL stratum, values were 10/18(56%) and 9/21(43%) respectively. 49 COM/ABC subjects had an AE compared to 58 on COM/IDV; 40 and 54 respectively were considered drug related. Preliminary TRaSQ data available on the above subjects indicated that 32/41(78%) subjects on COM/ABC and 15/33(48%) on COM/IDV reported taking all doses over the last 4 weeks or missed less than one dose per week. 10/32(31%) on COM/IDV said their triple regimen was difficult to take as scheduled, versus 3/41(7%) on COM/ABC.

CONCLUSION: These encouraging preliminary data suggest the open-label nature of this study will provide further insight into use of COM/ABC treatment in antiretroviral naive subjects.

Keywords: AEGIS, CD4 Lymphocyte Count, Adult
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