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IDWeek 2014: Complera Matches Atripla for Women Starting HIV Treatment

The Complera (rilpivirine/tenofovir/emtricitabine) single-tablet regimen worked as well as Atripla (efavirenz/tenofovir/emtricitabine) for treatment-naive women and was somewhat better tolerated in the open-label STaR trial, according to a report at the IDWeek 2014 meeting last week in Philadelphia.

Cathy Creticos from the Howard Brown Health Center in Chicago reported findings from STaR, the first head-to-head comparison of Complera vs Atripla in people starting antiretroviral therapy (ART) for the first time. Unlike the earlier ECHO and THRIVE trials, which compared the same drug combinations taken as separate pills plus placebos -- requiring multiple daily pills -- all participants in STaR took a single tablet once-daily.

The full study included 786 participants, of whom more than 90% were men. The present analysis focused on the 56 women in the study, half assigned to take Complera and half to Atripla. Among the women, about 30% were white and 65% were black (compared with 70% and 21%, respectively, among the men). The mean baseline CD4 T-cell count was approximately 330 cells/mm³ (compared with 395 cells/mm³ for the men); 14% in the Complera arm and 36% in the Atripla arm had baseline viral load >100,00 copies/mL.

Results

• Overall, both single-tablet regimens produced good viral suppression: 86% of participants in the Complera arm and 82% in the Atripla arm had undetectable viral load (<50 copies/mL) at 48 weeks in a snapshot analysis.
• At 96 weeks, response rates were 78% and 72%, respectively.
• Virological failure occurred in 8% and 6% of participants, respectively, at 48 weeks, and 9% and 6% at 96 weeks.
• 96-week CD4 cell gains were 278 and 259 cells/mm³, respectively.
• Outcomes did not differ significantly for women compared with men in the study.
• Among the women, viral suppression rates were 79% in the Complera arm and 61% in the Atripla arm at 48 weeks, and 68% and 57% at 96 weeks.
• Virological failure rates were 7% in the Complera arm and 14% in the Atripla arm at both time points.
• 96-week CD4 cell gains were 263 and 282 cells/mm³, respectively.
• Serious adverse events occurred somewhat more often among women in the Complera arm (21% for women vs 8% for men), while they were similar in the Atripla arm (14% vs 12%, respectively).
• 7% of women and 3% of men taking Complera discontinued due to adverse events compared with 11% for both sexes in the Atripla arm.
• Nervous system and psychiatric side effects such as dizziness, abnormal dreams, anxiety, and depression occurred significantly less often in the Complera arm than in the Atripla arm overall, but the difference was less pronounced for women due to lower rates in the Atripla arm.
• Women, however, were more likely than men to experience rash on Atripla, leading to a greater advantage for Complera.

"Overall, [Complera] was non-inferior to [Atripla] in terms of virologic suppression at both Week 48 and Week 96 with low rates of virologic failure in both arms," the researchers concluded. "There was no difference in rates of virological suppression between genders."

10/15/14

Reference

C Creticos, C Brinson, C McDonald, et al. STaR: Single-Tablet Regimen Rilpivirine/Emtricitabine/Tenofovir DF has Similar Efficacy and is Well-Tolerated Compared to Efavirenz/Emtricitabine/Tenofovir DF in ART-Naive Females at Week 96. IDWeek 2014. Philadelphia, October 8-12, 2014. Abstract 537.