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Raltegravir/Etravirine Effective Maintenance
Through 48 Weeks in 45 or Older Group
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16th European AIDS Conference, October 25-27, 2017. Milan
Mark Mascolini
Only 1 of 165 people switching to raltegravir/etravirine in the French ANRS-163 trial had virologic failure through 48 weeks [1]. Nine participants in this trial involving adults 45 years old or older had viral blips and regained a viral load below 20 copies without changing antiretrovirals.
ANRS-163 is a noncomparative phase 2 trial that enrolled people 45 years old or older who had a viral load below 50 copies with a regimen containing a boosted protease inhibitor. Participants in France and Spain stopped their current regimen and switched to the integrase inhibitor/nonnucleoside duo raltegravir/etravirine (400/200 mg twice daily). This analysis involved 165 people, 156 of whom continued treatment through week 48. The researchers defined virologic failure as consecutive viral loads above 50 copies after the switch.
Study participants had to be fully sensitive to raltegravir and etravirine on a historical RNA/DNA genotypic resistance test and on a screening DNA genotypic test. Nonnucleoside resistance mutations could be detected on 14 of 106 historical genotypes (13.2%) and 21 of 143 screening genotypes (14.7%).
The 165 enrollees had a median age of 52 (interquartile range [IQR] 48 to 58). Most acquired HIV heterosexually (44%) or during sex between men (40%). The group had taken antiretrovirals for a median 16.8 years (IQR 11.1 to 19.3) and had an undetectable viral load for a median of 6.9 years (IQR 3.4 to 9.3). At the switch median CD4 count stood at 700 (IQR 525 to 904).
Only 1 of 165 participants had virologic failure through 48 weeks to yield a virologic success rate of 99.4%. Seven additional people had therapeutic failure (without virologic failure) to yield a therapeutic success rate of 94.5%. Researchers detected the virologic failure at week 24. Three transient viral load blips occurred at week 4, two at week 12, one at week 24, and three at week 48. All 9 people with blips regained virologic control (below 20 copies/mL) without switching regimens.
In a retrospective analysis, the person with virologic failure had etravirine resistance mutations detectable at baseline by ultradeep sequencing. At failure, etravirine mutations were detectable by Sanger sequencing and ultradeep sequencing and raltegravir mutations only by ultradeep sequencing. This individual regained virologic control after switching to darunavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate. In participants with blips, neither Sanger sequencing nor ultradeep sequencing spotted etravirine or raltegravir mutations at baseline or at the blip.
Cellular HIV DNA levels were lower at baseline in participants without rebound (including blips) than in those with rebound, but the difference did not reach statistical significance (average 237 versus 275 copies/million cells, P = 0.060). Overall cellular DNA levels did not change between baseline and week 48.
The ANRS investigators concluded that raltegravir/etravirine is an effective maintenance regimen through 48 weeks in people 45 or older who attain viral control with a standard triple regimen including a boosted protease inhibitor.
Reference
1. Soulie C, Assoumou L, Sayon S, et al. Virological factors associated with outcome of dual ETR/RAL Therapy (ANRS-163 Trial). 16th European AIDS Conference. October 25-27, 2017. Milan. Abstract PS6/4.
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