Atripla
Publisher: Datamonitor Healthcare
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Drug Overview
Atripla ([efavirenz + emtricitabine + tenofovir disoproxil fumarate (TDF)]; Gilead/Bristol-Myers Squibb) is a single-tablet regimen approved for the treatment of HIV-1 infection. It is a co-formulation of the marketed HIV non-nucleoside reverse transcriptase inhibitor (NNRTI) Sustiva (efavirenz; Bristol-Myers Squibb) and two nucleos(t)ide reverse transcriptase inhibitors (NRTIs): Emtriva (emtricitabine; Gilead) and Viread (TDF; Gilead). NRTIs and NNRTIs block the action of the viral reverse transcriptase enzyme, preventing synthesis of viral DNA and subsequently inhibiting viral replication.
Since 2013, Atripla’s sales have entered a protracted decline as its patient share is gradually cannibalized by Gilead’s more recently launched single-tablet regimens, which have demonstrated superior central nervous system tolerability. Indeed, efavirenz’s poor tolerability profile has resulted in US and EU treatment guidelines downgrading Atripla from a “preferred” regimen to an “alternative” regimen, which has further hastened Atripla’s decline.
Analyst Outlook
Since 2013, Atripla’s ([efavirenz + emtricitabine + tenofovir disoproxil fumarate (TDF)]; Gilead) sales have entered a protracted decline as its patient share is gradually cannibalized by Gilead’s more recently launched single-tablet regimens (STRs), which have demonstrated superior central nervous system tolerability. Indeed, efavirenz’s poor tolerability profile has resulted in US and EU treatment guidelines downgrading Atripla from a “preferred” regimen to an “alternative” regimen, which has further hastened Atripla’s decline. Additionally, since September 2017, Atripla’s sales have been severely threatened by the availability of generics, which have been heavily promoted by payers in order to reduce the growing cost burden of lifelong HIV treatment. Within the US, Atripla is not expected to lose exclusivity until September 2021, but by this time its use is expected to be minimal, as integrase strand transfer inhibitor-based and tenofovir alafenamide (TAF)-based STRs have largely replaced it in the first-line setting.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Atripla : HIV
LIST OF FIGURES
9 Figure 1: Datamonitor Healthcare’s drug assessment summary of Atripla for HIV
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Atripla for HIV
12 Figure 3: Atripla sales for HIV across the US and five major EU markets, by country, 2018–27
LIST OF TABLES
5 Table 1: Atripla drug profile
6 Table 2: Approval history of Atripla for HIV in the US and five major EU markets
7 Table 3: Late-phase trials of Atripla for HIV
8 Table 4: Atripla for HIV – SWOT analysis
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