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news.Gilead Sciences Phase 3 trial met its 24-week primary endpoint, which found that switching to Complera was non-inferior to remaining on a ritonavir-boosted protease inhibitor regimen.
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The Switching boosted PI to Rilpivirine In Combination with Truvada as a Single Tablet Regimen (SPIRIT) 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.
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.