JULUCA (dolutegravir/rilpivirine), combination of anti-viral agents
Reason for request
High clinical benefit in the treatment of HIV infection in adults who are virologically-suppressed, but no demonstrated clinical benefit over conventional tritherapies or over the free-dose combination of its two components.
JULUCA has been granted marketing authorisation for the treatment of virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL), receiving stable anti-retroviral treatment for at least the past 6 months, with no history of virological treatment failure and with no known or suspected resistance to non-nucleoside reverse transcriptase inhibitors or to integrase inhibitors.
This dual therapy should preferably be reserved for patients whose viral load has been undetectable for at least one year and with no history of virological failure or resistance, with a CD4 count greater than 400 cells/mm3 and whose CD4 count has never dropped below 200 cells/mm3.
Considering the potential risk of congenital malformation with dolutegravir, JULUCA is not recommended in women of child-bearing age.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |