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Isentress (raltegravir; Merck & Co) Drug Overview 2019

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    Report

  • 14 Pages
  • June 2019
  • Region: Global
  • Citeline
  • ID: 4846125
Drug Overview
Isentress (raltegravir; Merck & Co) is a once-daily, unboosted integrase strand transfer inhibitor (INSTI) that is approved in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) for the treatment of HIV-1 infection in combination with other antiretroviral drugs. INSTIs block the activity of the HIV integrase enzyme, preventing reverse-transcribed viral DNA from integrating into the human genome, and subsequent viral replication.
Isentress’s position in the HIV market is severely threatened by ViiV Healthcare’s INSTI Tivicay (dolutegravir), as well as ViiV Healthcare’s two-drug regimens containing dolutegravir, which offer overall cost savings. While the Q2 2017 approval of a once-daily formulation has negated one of Isentress’s drawbacks, its inferior efficacy in treatment-experienced patients and lack of incorporation into a convenient single-tablet regimen (STR) will drive a continued decline in sales. Indeed, the launch of Biktarvy ([bictegravir + emtricitabine (F) + tenofovir alafenamide (TAF)]; Gilead) has triggered a further downturn in Isentress’s sales, as most physicians who wish to prescribe an INSTI in combination with the F/TAF backbone are likely to prescribe the Biktarvy STR rather than Descovy ([emtricitabine + TAF]; Gilead/Japan Tobacco) + Isentress in separate pills.

Analyst Outlook
Isentress’s (raltegravir; Merck & Co) position in the HIV market is severely threatened by ViiV Healthcare’s integrase strand transfer inhibitor (INSTI) Tivicay (dolutegravir), as well as ViiV Healthcare’s two-drug regimens containing dolutegravir, which offer overall cost savings. While the Q2 2017 approval of a once-daily formulation has negated one of Isentress’s drawbacks, its inferior efficacy in treatment-experienced patients and lack of incorporation into a convenient single-tablet regimen (STR) will drive a continued decline in sales. Indeed, the launch of Biktarvy ([bictegravir + emtricitabine (F) + tenofovir alafenamide (TAF)]; Gilead) has triggered a further downturn in Isentress’s sales, as most physicians who wish to prescribe an INSTI in combination with the F/TAF backbone are likely to prescribe the Biktarvy STR rather than Descovy ([emtricitabine + TAF]; Gilead/Japan Tobacco) + Isentress in separate pills.

Table of Contents

OVERVIEW
  • Drug Overview
  • Product Profiles
  • Isentress: HIV

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