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Gilead’s Once-Daily Single Tablet Regimen Complera® Maintains HIV Suppression Among Patients Switching From Protease Inhibitor-Based Regimens

Gilead Sciences, Inc. (Nasdaq: GILD) today announced 24-week data from a Phase 3 clinical trial, SPIRIT ( Switching boosted PI to Rilpivirine In Combination with Truvada as a Single Tablet Regimen), which evaluated virologically suppressed treatment-experienced HIV patients switching from a multi-pill regimen containing a ritonavir-boosted protease inhibitor to the once-daily single tablet regimen Complera ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate). The study met its 24-week primary endpoint, which found that switching to Complera was non-inferior to remaining on a ritonavir-boosted protease inhibitor regimen. These findings will be presented today in an oral session (Abstract #TUAB0104) at the 19th International AIDS Conference (AIDS 2012) in Washington, D.C.

“Since its approval last year for patients new to HIV therapy, the daily single tablet regimen of Complera has become an important addition to the list of treatment options available for these patients,” said Frank J. Palella Jr., MD, Professor of Medicine at the Northwestern University Feinberg School of Medicine and Principal Investigator of the SPIRIT study. “In this current study, data demonstrate Complera has the potential to help a broader range of HIV-infected patients.”

Complera was approved by the U.S. Food and Drug Administration (FDA) in August 2011 for treatment-naïve patients, and is the latest complete HIV regimen available in a once-daily single tablet. The product combines Gilead’s Truvada ® (emtricitabine and tenofovir disoproxil fumarate), which itself is a fixed-dose combination of two HIV medicines, with Janssen R&D Ireland’s rilpivirine (marketed as Edurant ®).

At 24 weeks of treatment, 94 percent of patients (n=297/317) who switched to Complera maintained HIV RNA (viral load) levels less than 50 copies/mL compared to 90 percent of patients (n=143/159) who remained on a regimen containing a ritonavir-boosted protease inhibitor-based regimen (FDA snapshot algorithm; 95 percent CI for the difference: -1.6 percent to +9.1 percent; predefined criterion for non-inferiority was the lower bound of a two sided 95 percent CI of -12 percent). Fewer patients taking Complera experienced virologic failure compared to those taking a protease-based regimen (0.9 percent versus 5 percent, respectively). Additionally, patients in the Complera arm demonstrated statistically significant improvements in total cholesterol levels. The ratio of total cholesterol to HDL (high-density lipoprotein or “good” cholesterol) declined by an average of 0.27 in the Complera arm, compared to an increase of 0.08 in the protease inhibitor arm (p<0.001).

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