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Rilpivirine combo not inferior to efavirenz combo in HIV
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GLASGOW — A new combination tablet including rilpivirine, emtricitabine and tenofovir was non-inferior to the existing combination tablet including efavirenz, emtricitabine and tenofovir, according to results from the STaR study presented here at the HIV11 Congress.
“This study was done in response to the fact that the drug rilpivirine (Edurant, Janssen) was recently approved by the FDA based on studies that showed the drug was not inferior to efavirenz,” Calvin Cohen, MD, of the Community Research Initiative of New England, told Infectious Disease News. “However, these studies weren’t designed to resemble how we would use the drugs in clinical practice. The STaR study evaluates how these drugs do if we used them as we do in clinic.”
Cohen and colleagues randomly assigned 786 ART-naïve patients to a single-tablet regimen including rilpivirine, emtricitabine and tenofovir (Complera, Gilead) or a single-tablet regimen including efavirenz, emtricitabine and tenofovir (Atripla, Gilead). They measured safety and efficacy of the drugs.
At week 48, 85.8% of patients receiving the rilpivirine tablet and 81.6% of patients receiving the efavirenz tablet had HIV-1 RNA levels of less than 50 copies/mL. Patients who had baseline HIV-1 RNA levels of more than 500,000 copies/mL had a higher resistance rate and higher rate of virologic failure with the rilpivirine tablet.
The rilpivirine tablet is also better tolerated, leading to fewer adverse events and fewer treatment discontinuations.
“For patients with a baseline viral load up to 100,000 copies/mL, these data demonstrate that the rilpivirine single tablet is now a viable treatment option, especially because of the fact that fewer toxicities are associated with the drug,” Cohen said. “In this study, only 2.5% of patients had to stop taking the rilpivirine tablet, compared with 9% of patients who had to discontinue the efavirenz tablet.”
For more information:
Cohen C. O425. Presented at: HIV11 Congress; Nov. 11-15, 2012; Glasgow.
Disclosure: Cohen receives research funding and is on the advisory boards of BMS, Gilead, Janssen, Merck, Tobira and Viiv.