Gilead Phase 3 trial of Complera meets 24-week primary endpoint

25th July 2012 (Last Updated July 25th, 2012 18:30)

Gilead Sciences has reported positive 24-week data from its Switching boosted PI to Rilpivirine In Combination with Truvada as a Single Tablet Regimen (SPIRIT) trial of Complera.

Gilead Sciences has reported positive 24-week data from its Switching boosted PI to Rilpivirine In Combination with Truvada as a Single Tablet Regimen (SPIRIT) trial of Complera.

The Phase 3 clinical trial identified that once-daily single tablet regimen Complera maintains HIV suppression among patients switching from a multi-pill regimen containing ritonavir-boosted protease inhibitor regimens.

The SPIRIT study principal investigator and the Northwestern University Feinberg School of Medicine professor of medicine Frank Palella said that since its approval 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.

"In this current study, data demonstrate Complera has the potential to help a broader range of HIV-infected patients," Palella added.

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.

At 24 weeks of treatment, 94% of patients (n=297/317) who switched to Complera maintained HIV RNA (viral load) levels less than 50 copies/mL compared to 90% of patients (n=143/159) who remained on a regimen containing a ritonavir-boosted protease inhibitor-based regimen.

Fewer patients taking Complera experienced virologic failure compared to those taking a protease-based regimen and the patients in the Complera arm demonstrated statistically significant improvements in total cholesterol levels.

Gilead is even evaluating Complera in two post-marketing studies, Phase 3b head-to-head trial comparing Complera to Atripla among patients who are new to therapy and a Phase 2b open-label pilot study evaluating the efficacy and safety of switching virologically suppressed Atripla patients to Complera.