An HIV drug candidate developed under a joint venture between GlaxoSmithKline (NYSE:GSK) and Japanese pharmaceutical company Shionogi is showing promise as a contender to take on a blockbuster drug from rival Merck (NYSE:MRK).
Initial phase 3 clinical trial results for dolutegravir show the GSK-Shionogi compound matches Merck’s HIV treatment raltegravir. But dolutegravir’s advantage will be once-a-day dosing compared to twice-a-day dosing for the Merck drug. Marketed under the brand name Isentress, the Merck antiretroviral treatment generated $1.3 billion in 2011 sales.
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The compound S/GSK1349572, now called dolutegravir, is one of the compounds to emerge from a joint venture formed by GSK and Shionogi in 2001. GSK’s HIV drug development is now handled under ViiV Healthcare, a 2009 joint venture with Pfizer (NYSE:PFE). London-based ViiV’s U.S. headquarters is on GSK’s campus in Research Triangle Park, North Carolina.
Shionogi-ViiV Healthcare’s dolutegravir is an integrase inhibitor. The company says it blocks HIV replication by preventing the viral DNA from integrating into the genetic material of human T-cells.
The SPRING-2 phase 3 study of 822 patients compared the efficacy and safety of dolutegravir to raltegravir with the primary goal of demonstrating the ViiV compound’s antiviral activity over 48 weeks. The secondary goal was to measure ViiV’s dolutegravir against raltegravir over 96 weeks. Through 48 weeks, dolutegravir suppressed HIV in 88 percent of study participants. Raltegravir suppressed the virus in 85 percent of participants.
“The SPRING-2 findings indicate that once-daily unboosted dolutegravir may offer people living with HIV an additional treatment option in the future,” ViiV chief medical officer Dr. John Pottage said in a statement. “These are the first large-scale safety and efficacy data in naïve patients, and we look forward to seeing further data in 2012 to build a more comprehensive picture of the role of dolutegravir.”
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Shionogi-ViiV said that full results of the study, including the full results of the secondary endpoints, will be presented at an upcoming scientific meeting. SPRING-2 is the first of four dolutegravir phase 3 studies that are due to be reported in 2012.
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