Janssen Sciences: Investigational two-drug HIV regimen showed positive results
Janssen Sciences Ireland UC announced that two Phase III studies to evaluate the safety and efficacy of switching virologically suppressed patients from a three or four drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimen to the two drug regimen of rilpivirine (Janssen) and dolutegravir (ViiV Healthcare) met the primary endpoint of non inferiority at week 48.
The primary endpoint in both studies was evaluated as the proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at week 48. Detailed study results will be presented at an upcoming scientific meeting. The safety profile for rilpivirine and dolutegravir in the two studies was consistent with the product labelling for each medicine.
"HIV has become a chronic, long-term condition in many parts of the world thanks to the availability of more than 20 approved medicines. As physicians, and those living with HIV, consider life-long treatment they must balance efficacy and the side effects of treatment," says Lawrence M. Blatt, global R&D head, infectious diseases and vaccines, Janssen. "We are committed to exploring new combination therapies to improve the lives of those facing life-long HIV treatment and these important results for a two-drug regimen support those efforts."
It is anticipated that regulatory submissions for the investigational two-drug regimen of rilpivirine and dolutegravir as a single tablet will be made in 2017.