The approach is a departure from conventional triple drug cocktails
that can cause troublesome side effects, especially among older
patients who make up a growing proportion of those treated for the
disease.
Antiretroviral therapy has turned HIV from a death sentence into a
manageable condition but patients need to stay on treatment for
life, so there is a growing focus on making medication as
well-tolerated as possible.
GSK has developed the new two-drug cocktail through its
majority-owned ViiV Healthcare, in which Pfizer and Shionogi also
hold stakes. The aim is to offer the two-drug regimen as a single
tablet.
Easing back from triple therapy is the opposite approach to that
being pursued by HIV market leader Gilead Sciences, which is banking
on improving triple regimens.
"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," said UBS analyst Michael Leuchten.
In addition to developing its new two-in-one HIV tablet, GSK is also
working on long-acting drug injections for both treating and
preventing HIV.
Results of the two Phase III tablet studies, announced late on
Monday, showed that the combination of GSK's dolutegravir and
Johnson & Johnson's rilpivirine worked as well as three- or
four-drug regimens.
Dominique Limet, chief executive of ViiV, said the results were "an
important milestone in our understanding of how HIV can be treated",
since they represent the first late-stage trial evidence for the
two-drug approach.
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ViiV will release detailed findings from the studies at a medical
meeting next year and plans to seek regulatory approval for the new
treatment approach in 2017.
Deutsche Bank analyst Richard Parkes said doctors may require
reassurance from longer-term studies over the risk of resistance
developing before dual therapy is widely accepted.
HIV dual therapy is one of a number of pipeline projects that GSK is
banking on to revive its core prescription drug business as new
chief executive Emma Walmsley prepares to take over from the end of
March.
In all, the company expects important clinical results for between
20 and 30 experimental medicines by the end of 2018.
GSK also announced on Monday it was bolstering scientific expertise
on its board by establishing a new science committee, charged with
overseeing research.
(Editing by Louise Heavens and Susan Fenton)
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