RESEARCH TRIANGLE PARK – ViiV Healthcare, which operates a major research and development operation in RTP, is seeking FDA approval for what it says would be the first long-term injectable HIV treatment that contains two drugs.

ViiV Healthcare

On Monday, ViiV, which is majority owned by drug giant GSK, said it filed a new drug application for a once-a-month combination of its own drug cabotegravir and a drug made by Janssen called rilpivirine which already is approved for use as a once-daily oral tablet marketed as Eduarnt.

Cabotegravir has not been approved for use and is being developed for the treatment and prevention of HIV, according to the company.

If approved, the injectable treatment would be a “novel option” for people afflicted with HIV.

“The long-acting, once-monthly, injectable regimen of cabotegravir and rilpivirine has the potential to give people living with HIV one month between doses with similar safety and efficacy as today’s standard of care – an oral three-drug regimen that has to be taken every day,” said Deborah Waterhouse, CEO of ViiV Healthcare, in a statement. “ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment and we look forward to working with the FDA to provide people living with HIV in the US  this novel option.”

Trial results found that “the combination of cabotegravir and rilpivirine, injected monthly, was as effective as a standard of care, daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period,” ViiV noted.

The treatment would be for adults who are not resistant to either drug.

The companies plan to seek approval for the treatment from the European Medicines Agency, Health Canada and others.

Read the full press release online.