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Juluca ([dolutegravir + rilpivirine]; ViiV Healthcare/Johnson & Johnson) Drug Overview 2019

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    Report

  • 14 Pages
  • June 2019
  • Region: Global
  • Citeline
  • ID: 4846115
Drug Overview
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 the author 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.

Table of Contents

OVERVIEW
  • Drug Overview
  • Product Profiles
  • Juluca: HIV

LIST OF FIGURES
Figure 1: The author's drug assessment summary of cabotegravir/rilpivirine for HIV
Figure 2: Cabotegravir/rilpivirine sales for HIV across the US and five major EU markets, by country, 2018–27
Figure 3: The author's drug assessment summary of fostemsavir for HIV
LIST OF TABLES
Table 1: Juluca drug profile
Table 2: Approval history of Juluca for HIV in the US, Japan, and five major EU markets
Table 3: Late-phase trials of Juluca for HIV
Table 4: Juluca for HIV – SWOT analysis