Glasgow, UK - 13 November, 2012
ViiV Healthcare today announced 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 and/or elvitegravir). 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 diarrhoea, 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.
"At ViiV Healthcare we are committed to delivering treatment options for all populations of people living with HIV. VIKING-3 was designed to address a significant medical need in one of the most difficult populations to treat - those patients who have advanced disease and have developed resistance to integrase inhibitors as well as multiple other antiretroviral agents." said John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare. "We are encouraged by these results in integrase inhibitor-resistant patients and look forward to receiving further phase III data in treatment-experienced patients in the coming months."
At baseline the 183 patients enrolled in the VIKING-3 study had been on antiretroviral therapy (ART) for an average of 13 years and all had a broad range of genotypic and phenotypic resistance to integrase inhibitors (raltegravir and/or elvitegravir). In addition, 79% had resistance to