3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

48 WEEK VIROLOGICAL RESPONSE TO A TRIPLE NUCLEOSIDE/NUCLEOTIDE ANALOGUE REGIMEN IN ADULTS WITH HIV INFECTION IN AFRICA WITHIN THE DART TRIAL

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WeOaLB0203

Kaleebu P.¹, DART Trial Team T.^2
1MRC/UVRI Programme on AIDS, Entebbe, Uganda, ²DART Trial, Entebbe, Kampala, Harare, London, Uganda

INTRODUCTION: As there are few viral load (VL) data on ZDV+3TC+TDF (tenofovir DF), we evaluated VL response through 48 weeks, and emergence of genotypic mutations in those with VL >1000 c/ml at 24 weeks, in naive adults initiating ART in the DART trial.

METHODS: Plasma HIV-1 RNA was retrospectively assayed in 300 adults with baseline CD4 <200 cells/mm³ from 3 sites in Uganda and Zimbabwe using the Roche Amplicor assay v1.5. All assays were performed in Africa under cross-site QA. Samples with VL >1000 c/ml at 24 weeks were sequenced.

RESULTS: Median baseline CD4 was 100 cells/mm³ (IQR 37150) and VL was 262,100 c/ml (IQR 93,400-625,300). At 48 weeks, 62% had VL <50 c/ml and 71% <400 c/ml (ITT M=F 55% and 63% respectively), compared to 59% and 79% at 24 weeks (ITT M=F 56% and 74%). At 24 and 48 weeks, 15% and 24% had VL >1000 c/ml (6% and 18% >10,000 c/ml), and mean CD4 increases were 103 and 127 cells/mm³ respectively. No patient switched to second-line therapy before 48 weeks (based on clinical/immunological criteria for failure). Genotypes were obtained for 20/38 samples with VL >1000 c/ml at 24 weeks, 12 of the remaining 18 having VL <5000 c/ml. 18/20 showed key mutations; 14 had M184V, 11 with additional NAMs (mean 2.4, range 1 – 4); 1 had NAMs alone; and the remaining 3 had K65R, one with T215Y, one with Y115F, and one alone (substituted d4T for ZDV at week 14). Two of the 14 with M184V (1/11 with additional NAMs) had major NNRTI mutations, despite no documented treatment with this class.

CONCLUSIONS: ZDV+3TC+TDF maintains good virological efficacy from 24 to 48 weeks in advanced disease. In this population infected with HIV-1 subtypes A, C or D, M184V with or without NAMs was the most common route to resistance, whereas K65R was identified infrequently.

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