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Complera Not Inferior to Atripla Among Men and Women in 786-Person Trial
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53rd ICAAC, September 10-13, 2013, Denver
Mark Mascolini
Rilpivirine-containing Complera proved noninferior to efavirenz-containing Atripla at 48 weeks in a randomized trial involving antiretroviral-naive adults [1]. Analysis of 56 women enrolled found a better virologic response rate, fewer virologic failures, and fewer discontinuations for adverse events or death in the Complera group. But the small proportion of women in this trial (7% in both arms) weighs against reading too much into these differences.
The STaR trial randomized 786 antiretroviral-naive people with a viral load at or above 2500 copies and viral sensitivity to rilpivirine, efavirenz, tenofovir (TDF), and emtricitabine (FTC) to once-daily Complera (rilpivirine plus TDF/FTC) or Atripla (efavirenz plus TDF/FTC). The primary endpoint was the proportion of participants with a viral load below 50 copies at week 48 by snapshot analysis. Among 394 people randomized to Complera, 28 (7.1%) were women, and among 392 people randomized to Atripla, 28 (7.1%) were women.
The Complera and Atripla groups were similar in age (median 37 and 35), race (68% and 67% white, 25% and 24% black, 15% and 19% Hispanic), average pretreatment CD4 count (396 and 385), and average viral load (4.8 log10 copies/mL in both groups, or about 63,000 copies).
At 48 weeks snapshot analysis determined sub-50-copy response rates of 85.8% with Complera and 81.6% with Atripla, a result establishing the noninferiority of Complera (difference 4.1%, 95% confidence interval -1.1% to 9.2%). Virologic failure rates at week 48 were 8.1% with Complera and 5.6% with Atripla. A substantially lower proportion of people stopped Complera than Atripla because of an adverse event or death (7 people, 1.8% versus 32 people, 8.2%).
Twenty-two women randomized to Complera and 17 randomized to Atripla (78.6% versus 60.7%) had a week-48 viral load below 50 copies by snapshot analysis. Two women taking Complera and 4 taking Atripla (7.1% and 14.3%) met virologic failure criteria at week 48. One woman on Complera and 4 on Atripla (3.6% versus 14.3%) discontinued treatment because of an adverse event or death. Among women, average CD4 counts rose by 188 with Complera and 196 with Atripla (P = 0.74).
In the whole population, resistance data were available for 20 people (5%) in whom Complera failed and 7 (2%) in whom Atripla failed. Seventeen and 16 people in the Complera group had any resistance mutation and a primary nonnucleoside mutation detectable (4% and 4%), compared with 3 and 3 people in the Atripla group (1% and 1%).
Rates of discontinuation for treatment-emergent adverse events were 2.5% and 8.7% with Complera and Atripla in the overall population and 7.1% and 10.7% among women. Central nervous system problems affected 29.7% and 50.5% randomized to Complera and Atripla in the overall population and 28.6% and 35.7% of women. Rates of rash were lower with Complera than Atripla in the overall population (6.1% versus 12.0%) and among women (3.6% and 25.0%).
Among women average triglycerides fell less with Complera than Atripla though 48 weeks (14 versus 37 mg/dL). Women randomized to Atripla had larger gains in total cholesterol (21 versus 2 mg/dL), LDL cholesterol (14 versus 1 mg/dL), and HDL cholesterol (16 versus 3 mg/dL). The researchers did not report changes in total-to-HDL cholesterol ratio. Estimated glomerular filtration rate fell by an average 0.9 mL/min through 48 weeks in the Complera group and rose by an average 16.3 mL/min in the Atripla group.
Reference
1. Brinson C, Segal-Maurer S, Brar I, et al. STaR: virologic outcomes and safety in ART-naive adult females for single-tablet regimen rilpivirine/emtricitabine/tenofovir DF compared to efavirenz/emtricitabine/tenofovir DF at week 48. 53rd ICAAC. September 10-13, 2013. Denver. Abstract H-655.
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