LONDON (Alliance News) - GlaxoSmithKline PLC said on Tuesday that its majority-owned HIV specialist company ViiV Healthcare secured positive headline results from its phase III antiretroviral therapy as long-acting suppression study for the treatment of human immunodeficiency virus.
ViiV Healthcare is a joint venture among GlaxoSmithKline, Pfizer Inc and Shionogi Ltd.
The FTSE 100-listed pharmaceutical company said the study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to a standard of care, daily, oral three-drug regimen at Week 48.
The rilpivirine is a once-daily non-nucleoside reverse transcriptase inhibitor used for the treatment of HIV, while cabotegravir is an investigational integrase inhibitor, developed by ViiV Healthcare for the treatment and prevention of HIV.
The injectable treatment regimen met the primary endpoint for non-inferiority, GlaxoSmithKkline said. Overall safety, virologic response and drug resistance results for the injectable regimen were consistent with results from the phase II LATTE and LATTE-2 studies.
LATTE-2 is a phase IIb, open-label study investigating the long-acting, injectable formulations of cabotegravir and rilpivirine as a two-drug treatment for patients with HIV. Following 96 weeks of maintenance treatment in the LATTE-2 study, viral suppression rates for the two-drug regimen dosed every eight weeks or every four weeks were comparable to the rate observed in patients continuing with a three-drug oral regimen.
"This novel approach is another step towards potentially reducing the treatment burden for people living with HIV," said John Pottage, chief scientific & medical officer of ViiV Healthcare.
"If approved, this regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12," added Pottage.
Shares in Glaxo were trading 1.6% higher on Wednesday at 1,584.40 pence each.
Glaxosmithkline (GSK)