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U.K.-based GlaxoSmithKline PLC’s ViiV Healthcare on Tuesday announced positive results for its phase-three trial of its experimental HIV drug in a dual-drug regimen.
The company announced that the combination of its HIV pill dolutegravir and Johnson & Johnson’s (J&J’s) rilpivirine drug successfully suppressed the HIV virus as capably as the existing three- or four-drug regimen can.
The positive results of the year-long trial, involving nearly 500 patients, supported Glaxo’s bold bet that it can shift the HIV treatment orthodoxy away from three-drug combinations to two-drug regimen.
The results of the trial also raised the possibility of a challenge to incumbent companies like Gilead.
UBS analyst Michael Leuchten said, “The key debate remains whether Gilead will gain the upper hand again or whether a disruptive two-drug regimen becomes standard of care, favoring GSK.”
Reducing the number of drugs will lower antiretroviral medicine’s side effects, such as nausea, diarrhea, bone-thinning and kidney problems. In addition, it will lighten the patient’s financial burden.
Dominique Limet, the chief of ViiV Healthcare, said the two-drug regimen would be submitted to regulators sometime next year. However, both medicines used in the two-drug regimen are already sold as components in combinations of three or more drugs.