Advice

following a full submission:

dolutegravir / rilpivirine film-coated tablet (Juluca®) is accepted for use within NHSScotland.

Indication under review: The treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor.

Dolutegravir plus rilpivirine was shown to be non-inferior to antiretroviral regimens containing a dual nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone plus a third agent (integrase inhibitor, protease inhibitor or NNRTI) in maintaining plasma HIV-1 RNA <50 copies/mL in two phase III randomised studies in virologically-suppressed adults.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dolutegravir / rilpivirine. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.

Medicine details

Medicine name:
dolutegravir rilpivirine (Juluca)
SMC ID:
SMC2091
Indication:
For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA copies <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).
Pharmaceutical company
ViiV Healthcare/GSK
BNF chapter
Infections
Submission type
Full submission
Status
Accepted
Date advice published:
10 September 2018