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Tivicay (dolutegravir; ViiV Healthcare) Drug Overview 2019

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    Report

  • 26 Pages
  • June 2019
  • Region: Global
  • Citeline
  • ID: 4846132
Drug Overview
Tivicay (dolutegravir; ViiV Healthcare) is a once-daily, unboosted integrase strand transfer inhibitor (INSTI) for the treatment of HIV-1 infection. It is indicated for use in combination with other antiretrovirals, and is also approved as a component of the single-tablet regimen Triumeq (dolutegravir/abacavir/lamivudine; ViiV Healthcare). INSTIs block the activity of the HIV integrase enzyme, preventing reverse-transcribed viral DNA from integrating into the human genome, and subsequent viral replication.

Since launching in 2013, Tivicay has rapidly achieved blockbuster status as a best-in-class INSTI. Its higher barrier to resistance and superior efficacy in INSTI-experienced patients have allowed it to capture significant patient share from Merck & Co’s Isentress (raltegravir), while its high barrier to resistance, clean tolerability profile, and favorable efficacy comparisons have facilitated successful competition with the established protease inhibitors Prezista (darunavir; Johnson & Johnson) and Reyataz (atazanavir; Bristol-Myers Squibb). Outside of the single-tablet regimen Triumeq ([dolutegravir + abacavir + lamivudine]; ViiV Healthcare), the author expects dolutegravir’s patient share to continue to grow, aided by the launch of the ambitious two-drug regimens Dovato ([dolutegravir + lamivudine]; ViiV Healthcare) and Juluca ([dolutegravir + rilpivirine]; ViiV Healthcare/Johnson & Johnson), which are anticipated to capture share from Gilead’s portfolio of regimens because of their lower cost.

Analyst Outlook
Since launching in 2013, Tivicay (dolutegravir; ViiV Healthcare) has rapidly achieved blockbuster status as a best-in-class integrase strand transfer inhibitor (INSTI). Its higher barrier to resistance and superior efficacy in INSTI-experienced patients have allowed it to capture significant patient share from Merck & Co’s Isentress (raltegravir), while its high barrier to resistance, clean tolerability profile, and favorable efficacy comparisons have facilitated successful competition with the established protease inhibitors (PIs) Prezista (darunavir; Johnson & Johnson) and Reyataz (atazanavir; Bristol-Myers Squibb). Outside of the single-tablet regimen (STR) Triumeq ([dolutegravir + abacavir + lamivudine]; ViiV Healthcare), the author expects dolutegravir’s patient share to continue to grow, aided by the launch of the ambitious two-drug regimens Dovato ([dolutegravir + lamivudine]; ViiV Healthcare) and Juluca ([dolutegravir + rilpivirine]; ViiV Healthcare/Johnson & Johnson), which are anticipated to capture share from Gilead’s portfolio of regimens because of their lower cost.

Table of Contents

OVERVIEW
  • Drug Overview
  • Product Profiles
  • Tivicay: HIV

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