Genvoya
Publisher: Datamonitor Healthcare
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Drug Overview
Genvoya ([elvitegravir + cobicistat + emtricitabine + tenofovir alafenamide (TAF)]; Gilead/Japan Tobacco) is a single-tablet regimen (STR) approved in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) for the treatment of HIV-1 infection. It is a co-formulation of elvitegravir, cobicistat, emtricitabine, and TAF. Elvitegravir is an integrase inhibitor that is marketed as a component of the STR Stribild ([elvitegravir + cobicistat + emtricitabine + tenofovir disoproxil fumarate (TDF)]; Gilead/Japan Tobacco) and as a standalone agent under the brand name Vitekta (Gilead/Japan Tobacco). Cobicistat is a boosting agent that enhances the activity of elvitegravir, and is currently marketed as a component of Stribild as well as being marketed as a standalone boosting agent under the brand name Tybost (Gilead). Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and is marketed as a standalone agent for HIV-1 therapy under the brand name Emtriva (Gilead). TAF is a prodrug of TDF, which is currently a staple component of NRTI backbones in HIV-1 treatment regimens.
Genvoya remains the top prescribed HIV regimen in the US in all patients; however, it has lost its market-leading position to Biktarvy ([bictegravir + emtricitabine + TAF]; Gilead) in treatment-naïve patients. Biktarvy offers the same advantages as Genvoya, including TAF’s renal and bone safety improvements compared to TDF, while bictegravir’s higher barrier to resistance than elvitegravir and no requirement for a boosting agent, which is a clear advantage given the gradual aging of the HIV-infected population, will allow Biktarvy to continue cannibalizing Genvoya’s sales.
Analyst Outlook
Genvoya ([elvitegravir + cobicistat + emtricitabine + tenofovir alafenamide (TAF)]; Gilead/Japan Tobacco) remains the top prescribed HIV regimen in the US in all patients (Gilead, 2019); however, it has lost its market-leading position to Biktarvy ([bictegravir + emtricitabine + TAF]; Gilead) in treatment-naïve patients. Biktarvy offers the same advantages as Genvoya, including TAF’s renal and bone safety improvements compared to tenofovir disoproxil fumarate (TDF), while bictegravir’s higher barrier to resistance than elvitegravir and no requirement for a boosting agent, which is a clear advantage given the gradual aging of the HIV-infected population, will allow Biktarvy to continue cannibalizing Genvoya’s sales.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Genvoya : HIV
LIST OF FIGURES
11 Figure 45: Datamonitor Healthcare’s drug assessment summary of Symtuza for HIV
12 Figure 46: Symtuza sales for HIV across the US and five major EU markets, by country, 2018–27
14 Figure 47: Datamonitor Healthcare’s drug assessment summary of Tivicay for HIV
LIST OF TABLES
6 Table 1: Genvoya drug profile
6 Table 2: Approval history of Genvoya for HIV in the US, Japan, and five major EU markets
8 Table 3: Late-phase trials of Genvoya for HIV
10 Table 4: Genvoya for HIV – SWOT analysis
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