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Gilead study confirms Atripla efficacy

US-headquartered Gilead Sciences has reported positive from an ongoing trial evaluating the HIV treatment Atripla (efavirenz, emtricitabine, tenofovir) in comparison to a Combivir (AZT + 3TC), with Sustiva (efavirenz) regimen.

US-headquartered Gilead Sciences has reported positive from an ongoing trial evaluating the HIV treatment Atripla (efavirenz, emtricitabine, tenofovir) in comparison to a Combivir (AZT + 3TC), with Sustiva (efavirenz) regimen.

The open-label clinical trial held in the US and EU phase III trails demonstrated the drug's safety and efficacy at week 96. Truvada (tenofovir/ emtricitabine) is a fixed-dose once-daily tablet containing Gilead's Viread (tenofovir) and Emtriva (emtricitabine). At study initiation, patients received Viread and Emtriva with Sustiva.

The trial, which coincided with commercial availability of Truvada in the US, took patients receiving Viread, Emtriva and Sustiva and switched them to receive a simplified regimen of Truvada and Sustiva. Truvada is 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 jv between Bristol-Myers Squibb (BMS) and Gilead. Atripla was approved in the US in July 2006.

After 144 weeks of treatment, 71 per cent of Truvada/Sustiva patients compared with 58 per cent of Combivir/Sustiva patients achieved and maintained viral load less than 400 copies/mL.

In total, 64 per cent of patients in the Truvada/Sustiva arm compared with 56 per cent 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.

Dr Jose Arribas, who presented the data at the fourth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, said: "These data demonstrate the safety and efficacy profile of the components of Atripla over three years. 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."

Miraviroc approved in EU
The positive news follows the EMEA approval of maraviroc, the first of a new class of anti-HIV drugs called chemokine antagonists, or CCR5 inhibitors.

The drug could be available for prescription by November 2007 and will be the first new HIV treatment on the EU market for over 10 years.

Maraviroc will be marketed as Celsentri and will be prescribed for treatment-experienced patients who have only CCR5-tropic virus (HIV which uses the CCR5 receptor to gain entry to CD4 cells.

CCR5 inhibitors block the CCR5 receptor, making it impossible for HIV to lock onto this target. Blocking the receptor means that HIV can infect fewer of its target cells.

Pfizer's US-based partner Monogram Biosciences, which is conducting study, said that Pfizer reported the data at the International AIDS Society conference in Sydney.

Shares of Monogram closed Tuesday down USD 0.4, or 2.4 per cent, at USD 1.71.


25th July 2007


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