Dovato ([dolutegravir + lamivudine]; ViiV Healthcare) is a single-tablet regimen approved in the US for the treatment of HIV-1 infection in patients who are treatment-naïve. It is also being developed in the EU for the treatment of HIV-1 infection in patients who are treatment-naïve (with an approval decision expected by Q3 2019), as well as for patients who are virologically suppressed (US/Japan/EU). The drug is a co-formulation of ViiV Healthcare’s Tivicay (dolutegravir), an integrase strand transfer inhibitor (INSTI) that blocks the insertion of the viral genome into the host genome, and Epivir (lamivudine), a nucleoside reverse transcriptase inhibitor (NRTI) that prevents viral RNA replication.
Dovato is the cornerstone of ViiV Healthcare’s ambitious strategy to capture market share from Gilead by simplifying treatment and reducing treatment costs. Dovato’s key advantages include its removal of abacavir, which is associated with hypersensitivity and cardiovascular safety concerns, its potential for reduced side effects compared to standard three-drug regimens, and its inclusion of dolutegravir, which is considered the best-in-class INSTI owing to its high barrier to resistance. Dovato has also been launched at a discount to Gilead’s rival single-tablet regimens in a bid to gain preferential formulary placement, as well as to provide physicians with an incentive to utilize two-drug regimens, which have a theoretical higher risk of virologic failure and resistance generation.
4 Drug Overview
5 Product Profiles
5 Dovato : HIV
LIST OF FIGURES
10 Figure 66: Datamonitor Healthcare’s drug assessment summary of fostemsavir for HIV
11 Figure 67: Datamonitor Healthcare’s drug assessment summary of fostemsavir for HIV
13 Figure 68: Fostemsavir sales for HIV across the US and five major EU markets, by country, 2018–27
LIST OF TABLES
6 Table 1: Dovato drug profile
7 Table 2: Approval history of Dovato for HIV in the US
8 Table 3: Late-phase trials of Dovato for HIV
9 Table 4: Dovato for HIV – SWOT analysis
Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered office is Suite 1, 3rd Floor, 11 - 12 St. James's Square, London, England, SW1Y 4LB. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.