Gilead Study Confirms Atripla Efficacy
Posted on: Tuesday, 24 July 2007, 12:16 CDT
Gilead Sciences has reported that 144-week data from an ongoing trial evaluating the HIV treatment Atripla in comparison to a Combivir with Sustiva regimen demonstrated the drug's safety and efficacy.
The study is an ongoing phase III, open-label clinical trial in the US and Europe. Truvada is a fixed-dose once-daily tablet containing Gilead's Viread and Emtriva. At study initiation, patients received Viread and Emtriva with Sustiva.
At week 96, which coincided with commercial availability of Truvada in the US, all patients receiving Viread, Emtriva and Sustiva were switched to receive a simplified regimen of Truvada and Sustiva. Truvada is currently the most commonly prescribed nucleoside backbone for combination HIV therapy in the US.
Truvada and Sustiva are also available in the US as the fixed-dose product Atripla, through a US joint venture between Bristol-Myers Squibb Company and Gilead Sciences. Atripla was approved in the US on July 12, 2006.
After 144 weeks of treatment, 71% of Truvada/Sustiva patients compared to 58% of Combivir/Sustiva patients achieved and maintained viral load less than 400 copies/mL. In total, 64% of patients in the Truvada/Sustiva arm compared to 56% of patients in the Combivir/Sustiva arm achieved and maintained viral load less than 50 copies/mL. The mean increase from baseline in CD4 cell counts at week 144 was 312 and 271 cells/mm in the Truvada/Sustiva and Combivir/Sustiva arms, respectively.
"These data demonstrate the safety and efficacy profile of the components of Atripla over three years," said Dr Jose Arribas, who presented the data at the fourth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention. "As the treatment landscape for HIV improves and patients live longer, the importance of a proven and durable first-line regimen with simple dosing is critical."
Source: Datamonitor
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