Early signs good for Glaxo/Pfizer HIV drug
Shionogi-ViiV Healthcare, a company in which pharmaceuticals leviathans GlaxoSmithKline and Pfizer have stakes, has published test results which suggest its HIV treatment might be more effective than the Atripla drug jointly developed by Gilead Sciences and Bristol-Myers Squibb.
Initial results from the phase III SINGLE (ING114467) study of dolutegravir in previously untreated adults with HIV-1 demonstrated the superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla, a fixed dose combination drug for the treatment of HIV.
At 48 weeks, 88% of study participants on the dolutegravir regimen were virologically suppressed versus 81% of participants on the single tablet regimen Atripla. Differences in efficacy were primarily driven by a higher rate of discontinuation due to adverse events on the Atripla side of the study.
The SINGLE double-blind double-dummy study was designed to demonstrate that the dolutegravir-based regimen was at least as good as Atripla, and the primary analysis met this criterion. Statistical superiority was concluded as part of a subsequent, pre-specified testing procedure.
Shionogi-ViiV Healthcare is a joint venture between ViiV Healthcare (a global specialist HIV company established by GlaxoSmithKline and Pfizer) and Shionogi & Co.
"Taken together with the results of the SPRING-2 trial, the SINGLE findings suggest that, if approved by regulators, a treatment regimen containing dolutegravir may offer people living with HIV an important additional first line option in the future" said Dr Tsutae "Den" Nagata, Chief Medical Officer, Shionogi & Co.
"This study represents an important milestone in the development of dolutegravir-based regimens, including a single-tablet regimen, and also for the Shionogi-ViiV Healthcare joint venture," said Dr John Pottage, Chief Medical Officer, ViiV Healthcare.