Etravirine in combination with darunavir/ritonavir and optimized background regimen results in suppression of HIV replication in treatment-experienced patients

Figures & data

Figure 1. Response to etravirine and background regimen (BR) stratified by number of active background antiretrovirals by phenotypic sensitivity score (PSS).

Table 1. Comparison of 48-week analysis of recent randomized trials for treatment-experienced HIV-infected patients.

	TORO [16] (n = 1013)	POWER-1,2 [9] (n = 674)	DUET-1,2 [1] (n = 1203)	BENCHMRK-1,2 [6] (n = 703)	MOTIVATE-1,2 [7] (n = 1049)
Inclusion criteria	6 months of previous treatment with agents in 3 classes or Resistance to ≥ 1 NRTI, 1 NNRTI, 2 PIs Viral load > 5000 copies/ml	3 months of previous treatment with agents in 3 classes ≥ 1 primary PI mutation Viral load > 1000 copies/ml	2 months of stable regimen ≥ 1 NNRTI RAM ≥ 3 primary PI mutations Viral load > 5000 copies/ml	Evidence of resistance to ≥ 1 agent in each of 3 classes Viral load > 1000 copies/ml	6 months of previous treatment with agents in 3 classes or Resistance to ≥ 1 agent in each of 3 classes Viral load > 5000 copies/ml
Study agent	Enfuvirtide vs optimized background regimen	Darunavir/ritonavir vs currently available PIs	Etravirine vs placebo (both plus darunavir/ritonavir)	Raltegravir vs placebo	Maraviroc vs placebo
ARVs excluded	None	Enfuvirtide	Tipranavir	Etravirine, maraviroc not used	Darunavir, etravirine, raltegravir
Male (%)*	89.7	89	90	87.7	46
Age* (median)	41	43.9 (mean)	46	45	88% (once-daily dose) 90% (twice-daily dose)
Median no. previous ARVs*	12	97% ≥ 4 NRTI 95% ≥ 2 PIs	N/A	12	N/A
Baseline PSS score (%)* 0 1 > 2	28.9 24.5 44	N/A	17 37 47	14.9 31.4 49.1	All subjects receiving at least dose of study drug: 62% had PSS < 2
Viral load < 50 copies/ml at 48 weeks	18.3 vs 7.8%	45 vs 10%	61 vs 40%	62.1 vs 32.9%	43% (once-daily dose), 46% (twice daily dose) vs 17%
Mean CD4 cell count change at 48 weeks (cells/mm^3)	91 vs 45	102 vs 19	98 vs 73	109 vs 45 (median)	116 (once-daily dose), 124 (twice-daily dose) vs 61

*Demographics of study intervention arm.

ARV: antiretroviral; N/A: not applicable/available data; PI: protease inhibitor; PSS: phenotypic sensitivity score.

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