Tivicay
Publisher: Datamonitor Healthcare
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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), Datamonitor Healthcare 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), Datamonitor Healthcare 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.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Tivicay : HIV
LIST OF FIGURES
11 Figure 55: Datamonitor Healthcare’s drug assessment summary of Truvada for HIV
12 Figure 56: Datamonitor Healthcare’s drug assessment summary of Truvada for HIV
14 Figure 57: Truvada sales for HIV across the US and five major EU markets, by country, 2018–27
LIST OF TABLES
6 Table 1: Tivicay drug profile
7 Table 2: Approval history of Tivicay for HIV in the US, Japan, and five major EU markets
8 Table 3: Late-phase trials of Tivicay for HIV
10 Table 4: Tivicay for HIV – SWOT analysis
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