Delstrigo ([doravirine + lamivudine + tenofovir disoproxil fumarate (TDF)]; Merck & Co) is a single-tablet regimen being developed for the treatment of HIV-1 infection. The drug is a co-formulation of the non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine and the two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), lamivudine and TDF. NRTIs and NNRTIs block the action of the viral reverse transcriptase enzyme, preventing synthesis of viral DNA and subsequently inhibiting viral replication.
Merck & Co’s low-cost Delstrigo single-tablet regimen is expected to achieve very limited uptake in the US market because of its inclusion of TDF, which is being rapidly replaced by Gilead’s successor product, tenofovir alafenamide (TAF), which has displayed reduced renal and bone toxicity. Additionally, TAF-based regimens have achieved strong market penetration in France, Germany, Italy, and Spain due to their potential to reduce the real-world incidence of renal dysfunction and bone fractures compared to TDF-based regimens, which is another barrier for Delstrigo’s uptake, as physicians are expected to be unwilling to swap or initiate new patients on a backbone with inferior safety.
4 Drug Overview
5 Product Profiles
5 Delstrigo : HIV
LIST OF FIGURES
10 Figure 63: Cabotegravir/rilpivirine sales for HIV across the US and five major EU markets, by country, 2018–27
11 Figure 64: Datamonitor Healthcare’s drug assessment summary of fostemsavir for HIV
14 Figure 65: Datamonitor Healthcare’s drug assessment summary of fostemsavir for HIV
LIST OF TABLES
6 Table 1: Delstrigo drug profile
6 Table 2: Approval history of Delstrigo for HIV in the US and five major EU markets
8 Table 3: Late-phase trials of Delstrigo for HIV
9 Table 4: Delstrigo for HIV – SWOT analysis
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