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Originally Published on May 12, 1999
Ait-Khaled M, Stone C, Mesogit D, Purdon S, Vernazza P, for the CNA3002 International Study Group.
6th Conference on Retroviruses and Opportunistic Infections. 31 Jan-4 Feb, 1999, Chicago, IL. Abstract 114.
ABSTRACT:
Objective: To relate baseline HIV-1 genotypes & phenotypes with Week 16 (Wk16) virologic response to ABC+SBG. Results: The proportion of subjects who achieved vRNA <400c/mL was similar in 3TC experience (3TCE) and 3TC naïve (3TCN) subjects (ITT 42% vs 32% respectively). Subjects with baseline vRNA <"5000" c/mL were more likely to reach vRNA<400c/mL than subjects with baseline vRNA>5000c/mL (ITT 62% vs 16%). Baseline isolates from the 3TCE subjects were 3TC resistant (31/32, 97%), but the majority were ABC sensitive [24/32 (<4x), 75%], showing low cross-resistance between ABC and 3TC in these subjects.
Subjects (%) with Wk16 plasma HIV-1 RNA reduction by baseline genotypes.
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RT Mutations |
>= 1 log10 c/mL or BLDa |
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WT |
1/3 (33%) |
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M184V alone |
19/26 (73%) |
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<= 2ZDV mutation without M184V* |
5/9 (56%) |
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< 2 ZDV mutation without M184V* |
5/9 (56%) |
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>= 3 ZDV mutation without M184V* |
1/9 (11%) |
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<= 2 ZDV mutation + M184V* |
7/16 (44%) |
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>= 3 ZDV mutation + M184V* |
1/6 (17%) |
a . Below level of detection of the assay (< 400 HIV-1 RNA copies/mL), * +/- any other mutation changes.
Because of low vRNA by Wk16, HIV-1 genotypes e obtained for only 35 subjects, no new (not present at baseline) ABC mutations (65R, 74V, 115F, 184V) were detected. New ZDV mutations were detected in 13/35 genotypes. Conclusions: Prior 3TC use or the presence of the M184V change alone at baseline did not prevent ABC+SBG antiviral efficacy through 16 weeks of treatment. ABC can be used as an active component of new combination regimen in ART experienced subjects.
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