| Table 1. Comparison of six prospective clinical trials of the clinical utility of HIV drug resistance testing. |
| Genotype Testing |
| Study (N) |
ARV Hx |
Expert advice |
CD4 (cells/ uL) |
HIV RNA (log10 copies/mL) |
Primary EP |
Outcomes |
P-value |
| ARGENTA (174) |
Median, 24 months (41% NNRTI) |
Yes |
265 |
4.25 |
VL < 500 copies/mL at 3 months |
At 3 months:
G: 27%
SOC: 12%
At 6 months:
G: 21%
SOC: 17% |
3 mos: 0.01;
6 mos: NS |
| GART (153) |
>16 weeks, 2 NA + 1 PI
QUERY: Any exposure data |
Yes |
230 |
4.44 |
Change in HIV-1 RNA levels (baseline vs. average
of 4 and 8 week levels) |
G: -1.19 log10 copies/mL
No-G: 0.61 log10 copies/mL |
0.00001 |
| HAVANA (326) |
Median, 4.3 years
(22.6% NNRTI) |
Subjects randomized to advice/no advice |
387 |
4.0 |
VL < 500 copies/mL at 24 weeks |
G: 48.5%
No-G: 36.2%
Advice: 47.2%
No Advice: 37.4%
|
G: <0.05
Advice: NS
[Multivariate analysis OR:
G: 1.92
Advice: 2.13]
|
| VIRADAPT (108) |
Mean, 39.5 mo NA, 11.6 mo PI
(2.5% NNRTI) |
No |
G: 221
SOC: 202 |
G: 4.7
SOC: 4.8 |
VL < 200 copies/mL at 3 months |
At 3 months:
G: 29%
SOC: 14%
At 6 months:
G: 32%
SOC: 14%
|
3 months: 0.017
6 months:
0.067
|
| Genotype and Phenotype |
| NARVAL (541) |
Median, 56 months (26% NNRTI) |
No |
280 |
4.3 log |
VL < 200 copies/mL at 12 weeks |
G: 44%
P: 35%
SOC: 36% |
NS |
| Phenotype Testing |
| VIRA3001 (272) |
2 NA + 1 PI; no exposure data provided
(4% NNRTI) |
No |
P: 348
SOC: 347 |
P: 4.18
SOC: 3.92 |
VL < 400 copies/mL at 16 weeks |
P: 46% (ITT, M=F), 59% (ITT, O)
SOC: 34% (ITT, M=F), 43% (ITT, O) |
0.079 (ITT, M =F); 0.036 (ITT, O) |
The TruGene HIV-1 genotype assay (Visible Genetics) was used in the ARGENTA, GART, Havana, Narval and VIRADAPT studies.
The Antivirogram phenotypic assay (Tibotec-Virco) was used in the VIRA3001 trial; an in-house phenotypic assay was used in the Narval study.
|
