Gilead’s HIV drug meets goal in four late-stage studies
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 AIDS.
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 week.
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 Sriraj Kalluvila)