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JULUCA (dolutegravir/rilpivirine), combination of anti-viral agents

INFECTIOUS DISEASES - New medicinal product
Opinions on drugs - Posted on Nov 14 2018

Reason for request

Inclusion

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.

 


Actual benefit

Important

-


Improvement in actual benefit

V (absence)

-


Therapeutic use

-