Two-drug regimen JULUCA offers a new treatment option for adults living with HIV-1.

Janssen Therapeutics announced the FDA’s approval of JULUCA®, the first, complete, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. The new treatment, which combines Dolutegravir and Rilpivirine is now indicated for adults who have the disease and are virologically suppressed.

JULUCA is a once-daily dose of Janssen’s antiretroviral combination, featuring an in integrase strand transfer inhibitor (INSTI) marketed by ViiV Healthcare as TIVICAY®, and a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Janssen as EDURANT®. With JULUCA, virologically suppressed patients, on a stable antiretroviral regimen for at least six months with no prior history of treatment failure and no known resistance to individual components of the medicine now have a new option for care.

The approval of JULUCA, noted Janssen’s Global Head of Late Development, Brian Woodfall, “Marks a significant milestone in the treatment of HIV.  As the first single-pill, complete two-drug regimen, JULUCA® maintains the safety and efficacy of a traditional three-drug regimen without an N(t)RTI,” explained Woodfall. “This is exciting because it offers those living with HIV who are compliant and stably suppressed a new, simplified treatment option to consider."

The FDA approved the combination based on data from the two pivotal and identical Phase III SWORD studies designed to assess the safety and efficacy of switching to the two-drug regimen of dolutegravir and rilpivirine. According to Janssen, the studies included more than 1,000 patients previously able to achieve stable viral suppression for at least six months on other antiretroviral regimens (integrase inhibitor, NNRTI, or boosted protease inhibitor-based).

Rick Nettles, Vice President, US Medical Affairs, Janssen Infectious Diseases, said: "At Janssen, we strive to advance science and develop new treatments to help those living with HIV better manage their condition and adhere to therapy by simplifying dosing regimens and reducing pill burden.” The FDA approval of JULUCA®, which he explained was the result of a partnership with ViiV Healthcare, “exemplifies our continued commitment to meeting the diverse needs of the HIV community."