UK pharma giant GlaxoSmithKline (LSE: GSK) and Japanese drugmaker Shionogi (TYO: 4507) have reported initial results from the Phase III SINGLE study (n=414) showing that dolutegravir was superior to single tablet regimen of Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) in treatment-naive adults with HIV-1.
At week 48, about 88% of study participants receiving dolutegravir regimen were virologically suppressed versus 81% on the single tablet regimen Atripla (treatment difference and 95%CI: 7.4%, p=0.003). The study showed that about 2% of subjects on dolutegravir- regimen discontinued due to adverse events vs. 10% on Atripla regimen.
Additionally, GSK and partner Theravance (Nasdaq: THRX) have reported positive top line results from their Phase IIb 0084 study (n=217) showing that TD-1211 achieved its primary efficacy endpoint for all doses and produced significant improvements in spontaneous bowel movements in chronic, non-cancer pain patients with opioid-induced constipation.
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