Glaxo Two-Drug HIV Combo Meets Primary Endpoint in Phase III

GlaxoSmithKline plc’s (GSK Free Report) HIV company, ViiV Healthcare announced that the two late-stage studies testing its two-drug HIV regimen of dolutegravir (Tivicay) and lamivudine (Epivir) met the primary endpoint.

The two phase III studies, GEMINI-1 and GEMINI-2, evaluated the two-drug regimen in treatment naïve – those who have not received prior antiviral therapy –  HIV-1 infected adults compared to a three-drug regimen of dolutegravir plus tenofovir alafenamide fumarate and emtricitabine. The studies demonstrated that the dolutegravir and lamivudine regimen was non-inferior to the standard three-drug regimen in HIV control. This means a two-drug HIV regimen can control HIV in treatment-naïve patients as effectively as a three-drug regimen.

Shares of Glaxo were up almost 2% on Thursday in response to the positive news. This year so far, Glaxo’s shares have gained 18.2% against the industry’s decline of 4.2%. Shares of Glaxo also received a boost this week as Mylan’s (MYL Free Report) application to get approval for a generic version of Glaxo’s blockbuster respiratory drug, Advair was rejected for the second time by the FDA.


Full results from the studies will be presented at a future medical meeting. Regulatory application to get the two-drug regimen of dolutegravir and lamivudine approved are expected to be filed later this year.

Glaxo has several phase III studies ongoing evaluating two-drug regimens for HIV-1 treatment. These studies, conducted across global research centers, include approximately 1,400 HIV infected men and women.

The two-drug regimens reduce the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen, thereby reducing long-term toxicity concerns.

Juluca is Glaxo’s first and the only approved two-drug regimen. It gained approval in EU last month and in the United States in November last year. It generated sales of £10 million in the first quarter of 2018. Glaxo has developed Juluca in partnership with J&J (JNJ Free Report) . Juluca combines two approved HIV drugs — Glaxo’s Tivicay/dolutegravir(50 mg) and J&J’s Edurant/rilpivirine(25 mg) — into a single, once-daily pill for the treatment of virologically suppressed HIV-1 infection.

ViiV Healthcare is an HIV company majorly owned by Glaxo. Pfizer (PFE Free Report) and Japanese pharma company, Shinogi have minor stakes in ViiV Healthcare.

Glaxo currently 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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