Dolutegravir as maintenance monotherapy


In an open label phase 2 study, virologically suppressed HIV-positive patients without history of virological failure, were randomized to switch to monotherapy with dolutegravir or stay on their current therapy for 24 weeks and then switch to dolutegravir monotherapy. 51 patients were randomized to immediate switch and 53 to delayed switch. The primary endpoint was viral
load < 200 copies after 24 weeks. After 24 weeks, monotherapy was non-inferior to combination therapy. 47 patients in the delayed arm switched to monotherapy. One patient in the immediate
arm and 3 in the delayed arm discontinued monotherapy due to sleep disturbances and headache. A total of 95 patients continued monotherapy. During the continued monotherapy 8 individuals
(8%) failed virologically. Three of the eight failed with development of resistance mutations to integrase inhibitors. The authors conclude that dolutegravir monotherapy maintenance cannot be recommended.

Wijting et al. Lancet HIV 2017;Published online October 26, 2017 http://dx.doi. org/10.1016/S2352-3018(17)30152-2

Comment: Monotherapy with protease inhibitors turned out to be inferior to combination therapy. This is obviously also true for dolutegravir. It remains to be seen if two-drug combinations will be sufficient or if “classic” triple combinations still are superior.