ViiV Healthcare's dolutegravir shows promise in hard-to-treat HIV patients

ViiV Healthcare, and HIV/AIDS company jointly owned by GlaxoSmithKline (LSE: GSK), Pfizer (NYSE: PFE) and Shionogi & Co. (TYO: 4507) this week announced encouraging 24-week data from the VIKING-3 Phase III study evaluating the investigational integrase inhibitor (INI) dolutegravir in HIV-1 infected adults with multiple class antiretroviral (ARV) resistance including resistance to integrase inhibitors (raltegravir [Merck & Co.'s Isentress] and/or elvitegravir [from Gilead Sciences]).

ViiV Healthcare said last month that it plans to commence global regulatory submissions for dolutegravir before the end of 2012 (The Pharma Letter October 8).

In the study, mean HIV RNA levels declined by 1.4 log10 copies/mL after 7 days of dolutegravir 50mg twice-daily treatment was added to the current failing regimen [95% confidence interval for the difference (1.3, 1.5; p<0.001)]. The proportion of study participants who were subsequently virologically suppressed (HIV-1 RNA <50 copies/mL) with optimised background regimen (OBR) was 63% at week 24. Overall, 3% (6/183) of study participants discontinued due to adverse events. The most common drug-related adverse events were diarrhea, nausea, and headache, each reported in 5% of subjects. These data were presented at the 11th International Congress on Drug Therapy in HIV Infection in Glasgow.