Gilead Sciences’ fixed-dose combination pill of Sovaldi (sofosbuvir) and the investigational ledipasvir, likely to receive FDA approval on October 10, does not significantly interfere with five common HIV antiretrovirals. Gilead conducted three trials to look for drug-drug interactions between the combination hep C treatment and Isentress (raltegravir), Atripla (efavirenz/emtricita-bine/tenofovir) and Complera (rilpivirine/emtricitabine/tenofovir). The researchers found no dose adjustments were required for pairing those HIV meds or Truvada (tenofovir/emtricitabine) with Sovaldi-ledipasvir.
The investigators found that Atripla lowered levels of ledipasvir by about 30 percent and that Sovaldi-ledipasvir lowered Isentress levels by less than 20 percent. However, they determined that neither of these effects was clinically relevant. Sovaldi and ledipasvir raised tenofovir levels about 1.8 to 2.6-fold when the HIV drug was in Atripla and 1.3 to 1.9-fold when it was in Complera. Nevertheless, the researchers concluded that the tenofovir dose needed no adjusting.
Andrew H. Talal, MD, a hepatologist at State University of New York at Buffalo, called the study results “very good news for patients. And for the clinicians, it makes it substantially easier to think about treating coinfected patients, and it potentially opens the possibility for new physicians to treat patients they wouldn’t otherwise be willing to treat.”
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