ViiV Healthcare’s Juluca has been green lighted in the US as the first two-drug regimen for some patients with HIV.
Juluca is comprised of ViiV’s dolutegravir, an integrase strand transfer inhibitor, and Janssen’s rilpivirine 25mg, a non-nucleoside reverse transcriptase inhibitor.
Physicians can now prescribe the once-daily pill for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to Juluca’s individual components.
“This is the start of a new era in HIV treatment,” said Deborah Waterhouse, ViiV’s chief executive. “We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”
Clinical trials showed that the two-drug regimen achieved non-inferior viral suppression at 48 weeks compared with a three- or four-drug regimen.
On the safety side, the most common side effects in patients taking Juluca were diarrhea and headache. Serious side effects include skin rash and allergic reactions, liver problems and depression or mood changes.
“Juluca, our new two-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen,” noted John Pottage, ViiV’s chief scientific and medical officer.
“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.