+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Atripla ([efavirenz + emtricitabine + tenofovir disoproxil fumarate (TDF)]; Gilead/Bristol-Myers Squibb) Drug Overview 2019

  • PDF Icon

    Report

  • 14 Pages
  • June 2019
  • Region: Global
  • Citeline
  • ID: 4846130
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.

Table of Contents

OVERVIEW
  • Drug Overview
  • Product Profiles
  • Atripla: HIV

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