Glaxo's (GSK) Begins Phase III HIV Two-Drug Regimen Study

GlaxoSmithKline (NYSE:GSK) along with partner Pfizer, Inc. (NYSE:PFE) announced that their HIV-focused joint venture company, ViiV Healthcare, has initiated a phase III program to evaluate its two-drug HIV regimen of dolutegravir (Tivicay) and lamivudine (Epivir) The study will evaluate the two-drug regimen for maintenance of viral suppression achieved in HIV-1 infected patients on a three-drug regimen – tenofovir alafenamide fumarate ("TAF")-based regimen.

We remind investors that Glaxo is also evaluating another two-drug based regimen – cabotegravir and Johnson & Johnson’s (NYSE:JNJ) rilpivirine – in another phase III study for treating adults with virally suppressed HIV-1 infection. Moreover, the company is also evaluating cabotegravir monotherapy for the prevention of HIV infection in sexually active women.

HIV treatments generally are three-drug based regimens. The latest entrant in the market is Gilead Sciences, Inc.’s (NASDAQ:GILD) once-daily single tablet regimen, Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide), approved earlier this month. However, Glaxo is trying to reduce the number of medicines in a HIC treatment regimen without compromising on the efficacy of a conventional three-drug regimen

Shares of GlaxoSmithKline have underperformed the industry so far this year. The stock has lost 9.6% against the industry’s 10.1% rally during the period.

The phase III TANGO study will investigate a two-drug regimen for the treatment of HIV. The phase III program is designed to evaluate non-inferior antiviral activity of the combination regimen at 48 weeks compared to continuation of a TAF-based regimen. The study will also evaluate long-term antiviral activity, tolerability and safety of the combination therapy for up to 96 weeks.

Glaxo is also evaluating the combination regimen in GEMINI studies in patients with HIV-1 who have received no prior treatment. Data from the GEMINI and TANGO studies are anticipated in 2018.

We note that Glaxo’s newest HIV medicine – Juluca is a single tablet containing dolutegravir and J&J’s rilpivirine. Juluca is the first two-drug regimen approved by the FDA.

Meanwhile, with several companies interested in developing drugs to treat this life-threatening disease, competition has intensified manifold in the space.

Zacks Rank

GlaxoSmithKline carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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