Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced that the U.S. Food and Drug Administration (FDA) has approved JULUCA®, the first, complete, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in certain adults living with the disease who are virologically suppressed.
JULUCA® is a once-daily, antiretroviral combination of dolutegravir, an integrase strand transfer inhibitor (INSTI) marketed by ViiV Healthcare as TIVICAY®, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Janssen as EDURANT®. With JULUCA®, people living with HIV who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months and have no prior history of treatment failure – and no known resistance to the individual components of JULUCA® – now have a new treatment option to consider.
“Today’s approval of JULUCA® marks a significant milestone in the treatment of HIV,” said Brian Woodfall, Global Head of Late Development, Janssen Research & Development. “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. This is exciting because it offers those living with HIV who are compliant and stably suppressed a new, simplified treatment option to consider.”
JULUCA® received FDA approval based on data from the two pivotal Phase 3 SWORD studies, which are identical, randomized, multicenter, open-label, non-inferiority studies designed to assess the safety and efficacy of switching to the two-drug regimen of dolutegravir and rilpivirine compared with remaining on current antiretroviral regimen (CAR). The studies included more than one thousand patients who previously achieved stable viral suppression for at least six months on other antiretroviral regimens (integrase inhibitor, NNRTI, or boosted protease inhibitor-based) and had no history of virologic failure or known resistance to dolutegravir or rilpivirine.
Reaching and maintaining suppression of viral load is a key treatment goal for people living with HIV. Results demonstrated that JULUCA® achieved non-inferior viral suppression (HIV-1 RNA <50 c/mL) at 48 Weeks compared with a three-drug CAR in both studies (dolutegravir + rilpivirine [DTG+RPV] 486/513 (95%), CAR 485/511 (95%), adjusted difference -0.2%, (95% CI: [2.5%,-3.0%])). Virologic failure rates were <1% in the DTG+RPV arm and 1% in the CAR arm. No INSTI resistance-associated mutations or clinically significant resistance to rilpivirine were reported. The proportion of patients who discontinued treatment due to an adverse event (AE) was 4% in those receiving DTG+RPV once daily and less than 1% in those who remained on their CAR. The most common AEs leading to discontinuation were psychiatric disorders in 2% receiving DTG+RPV and less than 1% on the CAR. The most common AEs (all grades) reported in at least 2% of patients were diarrhea and headache.
Switching to the two-drug regimen of JULUCA® showed a neutral effect on lipids – at 48 Weeks, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and total cholesterol to HDL ratio were similar between the treatment arms. In addition, while the long-term clinical significance of bone mineral density (BMD) changes is not known, a substudy demonstrated mean BMD increased from baseline to Week 48 in people who switched from an antiretroviral treatment (ART) regimen containing tenofovir disoproxil fumarate (TDF) to JULUCA® (1.34% total hip and 1.46% lumbar spine) compared with those who continued on treatment with a TDF-containing ART regimen (0.05% total hip and 0.15% lumbar spine). The SWORD trials are ongoing and planned to continue through 148 Weeks. Future long-term data and analyses will be presented at upcoming medical congresses.
“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,” said Rick Nettles, MD, Vice President, US Medical Affairs, Janssen Infectious Diseases. “The FDA approval of JULUCA®, which is the result of a partnership with ViiV Healthcare, exemplifies our continued commitment to meeting the diverse needs of the HIV community.”