JNJ Johnson and Johnson

By Denise Roland 

LONDON-- GlaxoSmithKline PLC's ViiV Healthcare announced positive phase-three trial results for its new HIV drug in a dual-drug regimen, supporting the company's audacious bet that it can shift the treatment orthodoxy away from three-drug combinations.

U.K.-based Glaxo said its HIV pill dolutegravir plus Johnson & Johnson's rilpivirine suppressed the virus as well as traditional three- or four-drug combinations in two identical, yearlong trials, each involving around 500 patients.

Dominique Limet, who leads ViiV Healthcare, said the company would submit the two-drug combination to regulators next year. Both medicines are already sold as components in combinations of three drugs or more.

The result adds momentum to Glaxo's strategy of establishing dolutegravir as the basis of simpler two-drug regimens for treating HIV, upending the long-held practice of combining at least three antiretroviral medicines to control the virus. Such three-drug combinations, when introduced in the mid-1990s, transformed HIV from a death sentence--uncontrolled, the virus causes AIDS--to an infection that could be managed long-term.

It also could help Glaxo defend its HIV business against its biggest rival, Gilead Sciences Inc., which is developing a drug that would make its already-dominant three-drug regimen more powerful still.

UBS analyst Michael Leuchten described the clinical-trial result as "a step in the right direction" but cautioned that it was still unclear whether Glaxo's strategy would win out over Gilead's in the long term. "The key debate remains whether Gilead will gain the upper hand again, or whether a disruptive two-drug regimen becomes standard of care," he wrote in a note to clients.

Reducing the number of drugs taken for HIV has the advantage of lowering the side effects of antiretroviral medicine, which include nausea, diarrhea, kidney problems and bone-thinning. That is especially beneficial to older HIV patients, who may be taking drugs for other health problems, too.

As dolutegravir and rilpivirine both are branded drugs, this particular two-drug combination wouldn't necessarily lighten the financial burden of HIV. Most three-drug regimens include no more than two branded drugs, while the remainder are older, generic drugs. A Glaxo spokesman said the company hadn't yet set a price for the two-drug combination.

Glaxo also is testing dolutegravir in combination with generic HIV drug 3TC, a combination that carries more cost-saving potential.

Write to Denise Roland at Denise.Roland@wsj.com

(END) Dow Jones Newswires

December 20, 2016 06:49 ET (11:49 GMT)

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