May 30 Gilead Sciences Inc said on
Tuesday a combination of its experimental HIV drug with existing
therapies met the main goal in four late-stage studies.
Gilead, which already has approved treatments for HIV, is
pinning its hope on the combination to better compete with
Britain's GlaxoSmithKline Plc, which is working on
two-drug treatment regimen for controlling the virus behind
The U.S. drugmaker evaluated the addition of its
experimental drug, bictegravir, to emtricitabine/tenofovir
alafenamide (FTC/TAF), which are already in use to treat HIV.
The company said it planned to submit marketing applications
for the combination in the United States in the second quarter
and the EU in the third quarter.
Three of the studies tested Gilead's combination against a
regimen containing GSK's dolutegravir in previously untreated
patients. The fourth trial included patients who were already on
HIV therapies, but were switched to the Gilead combination.
Data showed the Gilead combination was as effective as what
it was being evaluated against.
The regimen was also well tolerated and no patients
discontinued the study due to renal events, a frequent side
effect seen with HIV treatments.
"If the results point to superiority (rather than
non-inferiority) for Gilead's drug it will likely be taken
negatively (for GSK)," Berenburg analysts said in a note last
U.S.-listed shares of GSK were up 1.4 percent at
$43.27 in early trading.
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.
(Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by