In this pilot study, all 20 patients experienced virologic suppression (HIV-1 RNA < 50 copies/mL) by Week 8 of initial dolutegravir plus lamivudine therapy and maintained virologic suppression through Week 24 of treatment; there were no serious adverse effects.
High baseline HIV-1 RNA (≥ 100,000 copies/mL) or low CD4+ cell count (< 200 cells/mm3) were associated with a lower proportion of BMS-663068-treated patients with HIV-1 RNA < 50 copies/mL at Week 48
Although rare, virologic failure was associated with emergence of integrase gene mutations.
Secondary measures of cognitive function and patient-reported cognitive outcomes also did not differ according to treatment allocation.
In this randomized phase III trial, the switch to dolutegravir/abacavir/lamivudine was associated with a higher frequency of treatment discontinuation due to adverse events but higher treatment satisfaction score.
Rates of osteoporosis in the BMD substudy population and fracture in the overall START population did not differ statistically between groups.
Switching to the TAF-containing regimen improved renal and bone markers, but increased lipids.
Switch associated with reduced pill burden, greater treatment satisfaction, improvement in urinary markers of renal function, but more frequent AEs.
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