Two phase III studies of two-drug HIV treatment regimen conducted by GSK’s HIV specialist ViiV Healthcare, Pfizer and Shinogi Limited, showed that it could be submitted for approval as a single tablet next year.
ViiV Healthcare on Tuesday said that both of its Phase III studies to evaluate the safety and efficacy of switching virologically suppressed patients from a three or four-drug antiretroviral regimen to a two-drug regimen of dolutegravir and rilpivirine met the primary endpoint of non inferiority at Week 48.
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson announced a partnership to investigate the potential of combining dolutegravir (ViiV Healthcare) and rilpivirine (Janssen) in a single tablet.
ViiV said that the safety profiles for dolutegravir and rilpivirine in these studies were consistent with the product labelling for each medicine. ViiV didn’t specify when will the detailed results from the studies be presented, as it only said it would happen at an upcoming scientific meeting.
Dominique Limet, CEO ViiV Healthcare, said: “These are important results for the HIV scientific community and represent an important milestone in our understanding of how HIV can be treated. The results support our strategy of investigating two-drug regimens as innovative treatment options for people living with HIV and we are planning regulatory submissions for this two-drug regimen as a single tablet in 2017.”
The use of dolutegravir and rilpivirine as HIV maintenance treatment is investigational and not approved anywhere in the world.