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
- Status
- Accepted
- Date advice published
- 10 September 2018