Glaxo's HIV doublet pushes out to one month

Glaxosmithkline is already working hard to convince the HIV world that its once-daily, two-pill regimen is as good as established triplet or quad treatments at keeping the virus at bay. A once-monthly doublet will surely pose an even harder sell to people wary about drug resistance. The first look at pivotal data on a long-acting injectable formulation of cabotegravir and rilpivirine make for encouraging reading, however: Glaxo’s Viiv unit said that a switch study called Atlas found the two-drug regimen non-inferior to triple therapies. Specifically, stable patients who were switched from triples onto the injected doublet maintained similar rates of viral suppression as those who stayed on their existing regimens, when measured at 48 weeks. Confirmation of this doublet’s efficacy will come later this year with results from a second pivotal trial called Flair, conducted in treatment-naive patients. Concerns about drug resistance mean that many remain to be convinced about Glaxo’s doublet strategy, particularly in harder-to-treat patients, and longer-term data are crucial to support the company’s confidence. For now, the sellside seems comfortable to assign fairly ambitious sales forecasts to the projects – a surprising stance given that doublets represent something of a mindset change for this field.

The dawn of the doublets? HIV sales forecasts for combo therapies
      Annual sales ($bn)
Product Company Regimen 2019 2022 2024
Biktarvy Gilead  Triplet (oral once daily) 2.47 5.07 5.75
Triumeq Glaxo Triplet (oral once daily) 4.04 4.59 4.85
Genvoya Gilead  Quad (oral once daily) 4.14 3.62 3.49
Odefsey Gilead/J&J Triplet (oral once daily) 1.96 2.33 2.49
Dolutegravir & lamivudine Glaxo Doublet (oral once daily) 0.12 0.62 0.91
Cabotegravir & rilpivirine Glaxo/J&J Doublet (injected once monthly) 0.08 0.43 0.66
Total market incl others 25.56 26.88 27.28
Source: EvaluatePharma.

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