Gilead HIV drug aces phase 2, teeing up tussle with GSK quoting : FierceBiotech

Gilead has posted upbeat phase 2 data on its next-generation integrase inhibitor bictegravir in HIV patients. But overall the bictegravir patients performed marginally better on a check of how well their kidneys were working. Dolutegravir is already approved and data from two phase 3 trials released this week suggest it will pose stiff competition to Gilead. At the very least, the phase 2 data suggest Gilead has a drug that can hold its own against dolutegravir in terms of efficacy. After 24 weeks, 94% of patients in that cohort had undetectable viral loads.




The overall rate of serious adverse events was comparable between treatment groups, GSK claimed, with 27 adverse events for dolutegravir + rilpivirine and 21 for CAR. The patients were randomised to either stay on their three- or four-drug regimen or switch to a dolutegravir and rilpivirine regimen. Headline results were announced in December 2016 and detailed study results were being presented at the annual Conference on Retroviruses and Opportunistic Infections in Seattle. Virologic failure rates were less than 1% in the dolutegravir and rilpivirine arm and 1% in the three- or four- antiretroviral-drug arm, and no INSTI resistance-associated mutations were reported. GSK reiterated that the use of dolutegravir and rilpivirine as a two-drug regimen for HIV-1 maintenance therapy remained investigational and was not approved anywhere in the world.

Gilead challenges GSK with strong HIV drug data

Potential drug resistance is a key consideration for the new drug because dolutegravir is valued by doctors for its excellent resistance profile. REUTERS/Toby Melville/File PhotoLONDON Gilead Sciences has thrown down a challenge to GlaxoSmithKline with good clinical trial results for an experimental HIV drug that works in the same way as the British group's successful dolutegravir. GSK, meanwhile, is working on a dolutegravir-based two-drug treatment regimen for controlling the virus behind AIDS, a development that marks a departure from conventional triple drug cocktails. GSK sells its HIV drugs through its majority-owned ViiV Healthcare unit, in which Pfizer and Japan's Shionogi hold minority stakes. Gilead is pinning its hopes on bictegravir to stay competitive with GSK and the U.S. company has been testing the new medicine alongside two older drugs.



collected by :Lucy William
To follow all the new news about

VIRUSES and INFECTIONS