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Response Rates With Complera Versus Atripla in Women at 96 Weeks in STaR
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4th International Workshop on HIV & Women, January 13-14, 2014, Washington DC
Mark Mascolini
A higher proportion of women in the STaR trial reached an undetectable viral load with single-tablet rilpivirine/tenofovir/emtricitabine (Complera) than with efavirenz/tenofovir/emtricitabine (Atripla), but the difference was not statistically significant [1]. Few women in either arm dropped out because of adverse events in this 56-woman substudy.
STaR is the first direct comparison of two single-tablet antiretroviral regimens, Complera and Atripla [2]. The trial enrolled 786 antiretroviral-naive adults with a viral load at or above 2500 copies and randomized them to one of the single-tablet once-daily combinations. After 48 weeks, 86% randomized to Complera and 82% randomized to Atripla had a viral load below 50 copies in a snapshot analysis, a result establishing the noninferiority of Complera at a noninferiority margin of 12% (difference 4.1%, 95% confidence interval [CI] -1.1% to 9.2%). After 96 weeks, 78% randomized to Complera and 72% randomized to Atripla had a sub-50 viral load (difference 5.5%, 95% CI -0.6% to 11.5%).
The new analysis involved 28 women randomized to Complera and 28 randomized to Atripla. The Complera and Atripla groups had median ages of 41 and 42, 68% and 57% were black, and pretreatment CD4 counts averaged 338 and 322. Four women assigned to Complera and 10 assigned to Atripla had a pretreatment viral load above 100,000 copies (14% versus 36%). (In the United States rilpivirine is licensed for people with a viral load at or below 100,000 copies.)
At the 48-week point, 79% in the Complera arm and 61% in the Atripla arm had a viral load below 50 copies in the snapshot analysis (difference 17.4%, 95% CI -8.8% to 43.6%). At 96 weeks, 68% randomized to Complera and 57% randomized to Atripla had a sub-50 viral load (difference 12%, 95% CI -15.5% to 39.5%). Neither difference was statistically significant.
The researchers counted 2 virologic failures in the Complera group and 4 in the Atripla group (7% versus 14%). Resistant virus evolved in 1 woman in each group. The researchers did not report how many virologic failures occurred in women with a pretreatment viral load above 100,000 copies. CD4 changes at week 96 were similar in the two study arms.
Two women (7%) in the Complera arm and 3 (11%) in the Atripla arm discontinued treatment because of adverse events, all of them in the first 48 weeks. Discontinuations in the Complera arm were caused by stroke and gout, and in the Atripla arm by depression, pyrexia, and toxic skin eruption.
Grade 3 or 4 adverse events affected 5 women (18%) randomized to Complera and 6 (21%) randomized to Atripla. Grade 3 or 4 lab abnormalities occurred in 8 women (29%) in the Complera arm and 7 (25%) in the Atripla arm.
The most frequent adverse events were upper abdominal pain (11% Complera, 4% Atripla), nausea (7%, 14%), vomiting (4%, 11%), folliculitis (11%, 0%), bronchitis (4%, 14%), upper respiratory tract infection (18%, 18%), urinary tract infection (11%, 7%), muscle spasms (0%, 11%), extremity pain (4%, 11%), somnolence (4%, 14%), headache (11%, 11%), dizziness (11%, 29%), insomnia (7%, 18%), and rash (4%, 29%).
References
1. Creticos C, McDonald C, Segal-Maurer S, et al. Single-tablet regimen rilpivirine / emtricitabine / tenofovir DF is safe and well-tolerated to efavirenz / emtricitabine / tenofovir DF in art-naive females. 4th International Workshop on HIV & Women, January 13-14, 2014, Washington DC. Abstract 16.
2. Cohen C, Wohl D, Arribas J, et al. STaR study: single-tablet regimen rilpivirine / emtricitabine / tenofovir DF has non-inferior efficacy compared to efavirenz / emtricitabine / tenofovir DF and improves patient reported outcomes. 7th IAS Conference on HIV Pathogenesis Treatment and Prevention. June 30-July 3, 2013. Kuala Lumpur, Malaysia. Abstract TUPE284. http://www.natap.org/2013/IAS/IAS_56.htm
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