Glaxo, Pfizer's ViiV Healthcare Begins HIV Drug Combo Study

GlaxoSmithKline GSK along with partner Pfizer, Inc. PFE announced that its HIV-focused company, ViiV Healthcare, has initiated a phase III program to evaluate combination of long-acting, injectable cabotegravir and Johnson & Johnson’s JNJ rilpivirine for treating adults with virally suppressed HIV-1 infection.

Shares of GlaxoSmithKline have underperformed the industry so far this year. The stock has lost 7.7%, comparing unfavorably with the industry’s 15.3% rally during the period.

The ATLAS-2M trials comprise the third phase III study undertaken by ViiV Healthcare to 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 when administered every 8 weeks versus every 4 weeks. The study will also evaluate pharmacokinetics, safety and tolerability of the combination therapy. Preliminary data from the study is anticipated in 2019.

Notably, ViiV Healthcare was formed in November 2009 by GlaxoSmithKline and Pfizer. The partners were later joined by Shionogi in October 2012.

We remind investors that another phase III ATLAS study is already evaluating the monthly dosing of the combination regimen in virally suppressed patients, while the FLAIR study is evaluating the combination in the first-line setting. Outcomes from the study are expected in 2018.

Notably, last week, GlaxoSmithKline and partner J&J JNJ announced the FDA approval for Juluca, a two-drug complete regimen of Tivicay/rilpivirine and Edurant/dolutegravir as a single tablet for treating HIV-1 infection. Most medicines for HIV treatment are made up of three or more antiretroviral drugs. Juluca is the first two-drug regimen that reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen.

Meanwhile, several companies are working on developing drugscombination regimens to treat HIV. Gilead's GILD bictegravir single table regimen (STR) is under priority review in the United States. The FDA is expected to announce its decision in February next year.

To the uninitiated, Mylan has received a tentative approval to treat HIV from the FDA for its combination tablet comprising efavirenz, lamivudine and tenofovir disoproxil fumarate.

With companies increasingly developing drugs to treat this life-threatening disease, competition has intensified manifold in the space.

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