GlaxoSmithKline plc’s GSK HIV subsidiary, ViiV Healthcare, announced that the late-stage study, evaluating its newly approved single-tablet two-drug HIV regimen of Dovato met the primary endpoint. The phase III TANGO study assessed the antiviral efficacy and safety of switching to Dovato in HIV-1 infected patients, who are virally suppressed and stable on a three-drug tenofovir alafenamide fumarate TAF-based regimen.
The 48-week data from the study showed that Dovato was non-inferior in maintaining viral suppression in such patients compared with the TAF-containing, three-drug regimen, thereby achieving the study’s primary goal. This suggests that such patients can maintain viral suppression if they change to the two-drug regimen from the three-drug, TAF-containing regimen, thereby reducing their pill burden. The study also confirmed that no patients met virologic withdrawal criteria or developed any treatment resistance in the Tivicay plus Epivir arm.
Glaxo plans to present these results at the International AIDS Society Conference on HIV Science to be held later in July. ViiV Healthcare is majorly owned by Glaxo and Pfizer PFE.
Shares of Glaxo have increased 6.6% so far this year, outperforming the industry’s rise of 1.9%.
Dovato, a single tablet regimen ofGlaxo’s HIV drugs — Tivicay (dolutegravir- 50 mg) + Epivir (lamivudine) — for treatment-naïve HIV patients, was approved in the United States during April this year and in the EU this month.
HIV is a key therapeutic area for Glaxo with successful dolutegravir-based regimens, namely Tivicay, Triumeq and Juluca in its portfolio. HIV sales totaled £1.1 billion in the first quarter of 2019. The metric increased 4% at CER on the back of 7% growth in dolutegravir franchise (Triumeq and Tivicay and Juluca), which partly offset lower sales of the established HIV products.
Zacks Rank & Stocks to Consider
Glaxo currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large-cap pharma sector include Merck & Co., Inc. MRK and Novartis AG NVS, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings estimates have been revised 0.4% upward for 2019 and 1% for 2020 in the past 60 days. The stock has rallied 11% so far this year
Novartis’ earnings estimates have moved 0.6% north for 2019 and 1.5% for 2020 in the past 60 days. The stock has gained 6.1% so far this year.
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