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One-a-day HIV pill recommended for EU approval

Atripla, the first one-a-day combination HIV pill, is recommended for approval in the EU, according to Gilead Sciences

Atripla (efavirenz / emtricitabine / tenofovir), the first one-a-day combination HIV pill, has been recommended for approval in the EU, according to Gilead Sciences as they revealed positive data from a major study of Atripla's component active pharmaceutical ingredients.

Data presented at the 11th European AIDS Conference in Madrid last week, suggested that HIV patients taking GlaxoSmithKline's (GSK) twice-daily Combivir (lamivudine/zidovudine) with Bristol-Myers Squibb's (BMS) Sustiva (efavirenz) can be safely switched to a once-daily, simplified treatment regimen containing Gilead's Truvada (tenofovir/ emtricitabine) together with Sustiva.

The 48-week, phase III Simplification With Easier Emtricitabine and Tenofovir (SWEET) clinical trial examined virologically-suppressed patients with HIV who switched from treatment with twice-daily Combivir to treatment with Gilead's once-daily Truvada, as part of their combination drug therapy.

Patients who switched from Combivir to Truvada, both in combination with once-daily Sustiva experienced improvements in a number of treatment-related side effects. Patients in both study arms maintained virological suppression at 48 weeks.

Nearly one year after switching from Combivir to Truvada, patients experienced greater improvements in a number of treatment-related side effects while maintaining viral suppression.

Truvada and Sustiva have been available in the US since July 2006 as Atripla, which is currently the only once-daily single tablet regimen for the treatment of HIV-1 infection on the market.

On 18 October 2007, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recommended that the treatment be approved for use in the EU, and a final decision by EMEA is expected by the end of the year.

Dr Martin Fisher, of Brighton and Sussex University Hospitals and the principal investigator, said: "Data from this study indicate that patients on long-term Combivir therapy without clinical lipoatrophy may benefit from switching to Truvada, as virological control can be maintained and limb fat loss and recovery may be improved. These data support the new EACS 2007 guidelines regarding proactive switching."

New EU HIV treatment guidelines issued this week at EACS say that Truvada is among the recommended components of a first-line treatment regimen for treatment-naîve patients. Combivir, which was previously recommended as a first-line treatment option, is now considered to be an alternative treatment option.

A final decision on Atripla by the EU Commission is expected by the end of 2007.

According to Friedman, Billings & Ramsey analysts, Atripla's US patient pool will be enough to push it to near-blockbuster sales levels. In FY07, which will be Atripla's first full year on the market, the analysts expect US sales of approximately USD 822m. They also projected a surge in sales for Gilead's Truvada to USD 1.4bn for FY07.

30th September 2008

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