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Atripla three times weekly maintains HIV viral suppression for 24 weeks
Liz Highleyman, 2016-07-05 06:10:00
People with undetectable viral load who switched from taking the Atripla single-tablet regimen
(efavirenz/tenofovir/emtricitabine) every day to just every other weekday were
able to maintain viral suppression for six months, and longer follow-up is
planned, according to research presented last month at the ASM Microbe
conference in Boston.
Fixed-dose combination pills have made HIV treatment more convenient,
with several once-daily all-in-one regimens now available. Reducing the
frequency of dosing even further would cost less, could reduce side-effects and
could potentially promote better adherence; on the other hand, a non-daily
regimen might make it harder to remember to take pills consistently.
Esteban Martínez and Jose Gatell of
the University of Barcelona and
colleagues conducted a proof-of-concept study to test whether simplifying treatment with Atripla to three days a week would be less toxic and able to
maintain viral suppression. The component drugs in Atripla appear to allow for less frequent than once-daily dosing,
analysis included 61 people with HIV who were currently taking once-daily Atripla with suppressed viral load
(< 37 copies/ml) for at least two years, a CD4 count above 350 cells/mm3,
no history of virological failure, and no known resistance to efavirenz, tenofovir
disoproxil fumarate or emtricitabine.
participants were white men, the median age was about 48 years, the median CD4
count was approximately 560 cells/mm3 and most had undetectable HIV
RNA using an ultrasensitive single-copy assay.
participants were randomly assigned to either stay on their once-daily Atripla regimen or reduce it to three
days a week – on Mondays, Wednesdays and Fridays – for 24 weeks. Plasma viral
load was measured at baseline, 12 and 24 weeks in both arms, and also at 1, 2,
4, 6 and 8 weeks in the thrice-weekly arm.
researchers also looked at measures of tolerability including sleep quality, as
efavirenz can cause insomnia and unusual dreams, and bone mineral density and
kidney biomarkers, as tenofovir can cause bone loss and kidney function
was well tolerated and all participants completed the study. Adherence was
good, as assessed by patient questionnaires and pill counts. As expected, efavirenz blood levels fell to lower levels
between doses in the three-times-weekly arm compared to the once-daily arm.
No participants in either arm experienced
virological failure over the 24 weeks of the study. Of the more than 300
plasma samples collected for HIV RNA measurement, none showed a viral load > 37
copies/ml. Participants in both the thrice-weekly and once-daily arms also
maintained undetectable viral load using a single-copy assay.
24 weeks, Pittsburgh Sleep Quality Index scores improved among people taking Atripla less often, according to the study
(thigh bone) bone density scores increased slightly in the three-times-weekly
arm, while lumbar spine density did not change. Kidney biomarkers also showed
improvement in the thrice-weekly arm. However, total cholesterol levels rose in
the three-times-weekly arm; tenofovir is known to raise cholesterol, and this
effect was smaller with less frequent dosing.
per week Atripla in patients with
sustained viral suppression is a feasible option that should be further
confirmed in larger clinical trials," the researchers concluded.
Martínez said participants in the thrice-weekly arm reported
that they were highly satisfied with the new regimen and did not want to return
to daily dosing. The team now plans to extend the study through three years to
see if less frequent Atripla can be
used as a long-term maintenance regimen.