January 12, 2016
A small case study using dolutegravir monotherapy in treatment naive patients1 has reported similar results to several other small studies presented at the EACS conference last year.2,3
Given the significance of this data in showing a lack of viral rebound, this highlights the the urgency of data from randomised controlled studies.
The current study was reported in a letter to JAIDS from Massimiliano Lanzafame from University Hospital Verona, and colleagues.1
After four weeks, viral load was <50 copies/mL for all participants. This was reported as undetectable in three patients, <20 copies/mL in another three and at 31, 35 and 45 copies/mL in the remaining three.
Viral load at the last result, after a mean follow-up of 7.3 months (range 6 to 10 months) was <20 copies/mL for all participants. This was reported as undetectable in seven patients, and <20 copies/mL in the remaining two.
CD4 counts increased in all participants by a mean 152 cells/mm3 (range +94 to +284 cells/mm3).
The limited details in the JAIDS study mean that the results are laregly case reports.
Of note however, it shows than another research group independently initiated a study of dolutegravir monotherapy almost a year ago in early 2015.
At least half a dozen groups are now running small uncontrolled studies of monotherapy2 and dual therapy with 3TC.3
Given the potential savings in drug exposure and financial cost of treatment (if proved successful) it is a considerable missed opportunity for future research not to include a standard of care arm in a randomised design. Should this strategy not prove successful, there is an urgency to establish these concerns quickly, as off-label switching to reduced therapy in the absence of data is otherwise very likely.
The NIH-sponsored ACTG dual therapy study, is already enrolling but unfortunately also has no control group.5
This means that it might take several years until a sufficiently powered study establishes whether or not a significant risk exists for this strategy.
|Why Dolutegravir Might Get Us Closer to Ending AIDS: Next Step, Further Research|
|Is Dolutegravir Alone Enough to Control HIV?|
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