Joseph Eron, also from the University of North Carolina, presented long-term results from the EMERALD study,
which evaluated Symtuza – the first
protease inhibitor-based single-tablet regimen – which contains darunavir,
cobicistat as a booster, TAF and emtricitabine.
This phase 3
trial enrolled 1141 participants in Europe and the US. More than
80% were men and the median age was 46 years. They had been HIV positive for a
median of nine years and were highly treatment experienced. The median CD4
count was 628 cells/mm3 and they had normal kidney function.
At baseline, they were required to have viral load
below 50 copies/ml at for at least two months on their current regimen. Most
(70%) were already using boosted darunavir in a multi-pill regimen, while 22%
were on boosted atazanavir (Reyataz)
and 8% were on lopinavir/ritonavir (Kaletra).
They were randomly assigned to stay on this regimen or switch to Symtuza.
Eron presented the primary
48-week results at last year's IDWeek. At that point, those who had
stayed on their baseline regimen could also switch to Symtuza.
This year he reported that after 96 weeks, 91% of
those initially randomised to Symtuza still had HIV RNA below 50 copies/ml.
Just 3.1% experienced protocol-defined virological failure using this viral
load threshold, and 0.5% did so using a cut-off of 200 copies/ml. No new
resistance mutations were observed.
Here too, treatment was generally safe and well tolerated. At 96 weeks,
22% of Symtuza recipients had
experienced drug-related side-effects, but less than 1% were considered serious
and only 2% led to drug discontinuation.
There were no clinically relevant changes in eGFR through week 96 and no
one developed proximal
tubulopathy or Fanconi syndrome. Hip and spine bone density rose after
switching to Symtuza, with about a third of participants seeing at least a 3% gain.
Cholesterol and triglyceride levels also rose after the switch, but there were
no further increases between week 48 and week 96. Twenty people (3%) started
lipid-lowering drugs by week 48 and 59 (8%) did so by week 96.
"The 96-week results from the EMERALD
study demonstrate that Symtuza can
offer clinically appropriate people living with HIV a single-tablet option that
may help them maintain high rates of virologic suppression over time,"
data from the AMBER study, which is evaluating Symtuza for first-line treatment, will be presented at the HIV Glasgow Congress later this month.
together, the results of these studies provide reassurance that people taking
the most recently approved all-in-one antiretroviral regimens can expect
ongoing viral suppression and continued good tolerability.