Juluca ([dolutegravir + rilpivirine]; ViiV Healthcare/Johnson & Johnson) is a single-tablet regimen approved in the US for the treatment of patients infected with HIV-1 who have achieved viral suppression. The regimen is also in preregistration in the EU. It is a co-formulation of ViiV Healthcare’s Tivicay (dolutegravir; ViiV Healthcare), an integrase strand transfer inhibitor (INSTI) that blocks the insertion of the viral genome into the host genome, and Johnson & Johnson’s Edurant (rilpivirine), a non-nucleoside reverse transcriptase inhibitor that blocks the action of the viral reverse transcriptase enzyme, preventing synthesis of viral DNA and subsequently inhibiting viral replication.
The uptake of Juluca was muted at launch, generating only $172.9m in 2018, which Datamonitor Healthcare believes was due to physician concerns regarding the risk of resistance associated with Edurant as part of a two-drug regimen. However, three-year data from the SWORD studies released in April 2019 showed that no patients developed resistance to dolutegravir and <1% developed resistance to rilpivirine, which will reassure physicians of Juluca’s long-term efficacy.
4 Drug Overview
5 Product Profiles
5 Juluca : HIV
LIST OF FIGURES
10 Figure 58: Datamonitor Healthcare’s drug assessment summary of cabotegravir/rilpivirine for HIV
11 Figure 59: Cabotegravir/rilpivirine sales for HIV across the US and five major EU markets, by country, 2018–27
13 Figure 60: Datamonitor Healthcare’s drug assessment summary of fostemsavir for HIV
LIST OF TABLES
6 Table 1: Juluca drug profile
7 Table 2: Approval history of Juluca for HIV in the US, Japan, and five major EU markets
8 Table 3: Late-phase trials of Juluca for HIV
9 Table 4: Juluca for HIV – SWOT analysis
Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered office is Suite 1, 3rd Floor, 11 - 12 St. James's Square, London, England, SW1Y 4LB. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.