Please login to the form below

Not currently logged in
Email:
Password:

Gilead's HIV drug meets phase III endpoint

A phase III clinical trial has shown Gilead's investigational antiretroviral agent elvitegravir is as effective as Merck's Isentress after 48 weeks

A phase III clinical trial has shown Gilead's investigational antiretroviral agent elvitegravir is as effective as Merck's Isentress after 48 weeks.

During the trial, elvitegravir was dosed once daily, compared to raltegravir, dosed twice daily. Both drugs were administered with a background regimen that includes a ritonavir-boosted protease inhibitor (PI) and a second antiretroviral agent. 

Gilead is studying the use of elvitegravir as part of a separate investigational fixed-dose, single-tablet "Quad" regimen. The Quad contains four Gilead compounds in a fixed-dose, single-tablet and is currently in phase III testing.

"We are very pleased to have achieved the primary endpoint in this clinical trial, as data from this study will support regulatory filings for elvitegravir as well as Gilead's investigational Quad pill," said Dr Norbert Bischofberger, executive vice president, R&D and chief scientific officer, Gilead Sciences. 

"By analysing these data now we will be in a better position to advance filings as quickly as possible once data from subsequent phase III clinical trials in our Quad development programme become available later this year."

The elvitegravir phase III, randomised, double-blind trial continues and will measure secondary endpoints including various additional measures of the efficacy, safety and tolerability of the two treatment regimens.

23rd March 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Blue Latitude Health

Blue Latitude Health is a creative marketing consultancy. Founded in 2003, our combination of heritage, approach and capability gives us...

Latest intelligence

ema1
The European Medicines Agency: PRIME’d for access?
Leela Barham examines the impact of the EMA's PRIME fast track system after two years...
How can pharma engage with key stakeholders on NHS service transformation?
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare consulting team, explain how pharma should make its case for change...
michael elliot
The race for an HIV ‘cure’
Supercharging therapies as pharma and patients work together...

Infographics