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Efficacy similar between two single-tablet ART regimens in females

Issue: November 2014

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PHILADELPHIA — There was no difference in efficacy or adverse events between two single-tablet regimens in treatment-naive women with HIV at week 96, according to data presented at IDWeek 2014.

The two combinations — rilpivirine/emtricitabine/tenofovir (Complera, Gilead Sciences) and efavirenz/emtricitabine/tenofovir (Atripla, Bristol-Myers Squibb/Gilead Sciences) — were compared in the STaR trial, the first to directly compare two single-tablet regimens, according to the researchers.

“Overall, the rilpivirine combination was noninferior to the efavirenz combination in terms of virologic suppression at both week 48 and week 96 with low rates of virologic failure in both arms,” Catherine Creticos, MD, of the Howard Brown Health Center in Chicago, said during her presentation. “There was also no difference in rates of virologic suppression between genders. In females, there was a numerically lower rate of virologic suppression and a higher rate of subjects with no data in the window for both arms, compared to males.”

The study included 394 patients in the rilpivirine combination arm and 392 patients in the efavirenz combination arm. Most patients were male; each arm had 28 women. Overall, 78% of patients in the rilpivirine combination arm and 72% in the efavirenz combination arm achieved viral suppression at week 96, for a difference of 5.5% (95% CI, –0.6 to 11.5).

For males, the rates of viral suppression were 79% for the rilpivirine combination and 74% for the efavirenz combination, a difference of 5.1% (95% CI, –1.1 to 11.3). For females, the rates of viral suppression were 68% for the rilpivirine combination and 57% for the efavirenz combination, a difference of 12% (95% CI, –15.5 to 39.5).

The rates of treatment discontinuation due to adverse events were lower in the rilpivirine combination arm for both females and males. The rates of adverse events were similar between males and females, and dizziness and headache were the most frequent nervous system adverse events for males and females.

For more information:

Creticos C. Abstract 537. Presented at: IDWeek 2014; Oct. 8-12; Philadelphia.

Disclosure: Creticos is an investigator and receives research fees from Gilead Sciences.