WASHINGTON -- The FDA has approved Stribild, the four-drug combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate, for once-daily treatment of HIV in adults who have never received HIV treatment.
The "quad pill" combines the two widely-used HIV drugs, emtricitabine and tenofovir (the combination is marketed as Truvada -- which blocks the action of an enzyme the virus needs to replicate), with two new drugs.
Elvitegravir interferes with a different enzyme the virus uses to replicate, while cobicistat prolongs the effects of the drug.
The drug's approval makes it the third single-pill, once-daily complete HIV regimen, joining efavirenz, emtricitabine, and tenofovir (Atripla) and rilpivirine, emtricitabine, and tenofovir (Complera).
In May, an FDA Advisory Committee found Stribild had a similar, but not worse, adverse event profile to other available HIV treatments and recommended its approval 13 to 1.
Safety and efficacy was established in two trials of a combined 1,408 adult treatment-naive patients. Participants were randomized to the quad pill or Atripla once daily in the first trial or Truvada with atazanavir and ritonavir once daily in the second trial.
Patients were measured for undetectable viral load at 48 weeks. Of those in the Stribild groups, 87.6% and 89.5% achieved undetectable viral load, versus 84.1% of patients receiving Atripla and 86.8% of those receiving Truvada with atazanavir and ritonavir.
The drug will carry a boxed warning for risk of potentially fatal lactic acid buildup in the blood and renal events, as well as a warning that the drug is not approved to treat chronic hepatitis B virus infection.
Additional adverse events included nausea, diarrhea, new and worsening renal events, decreased bone mineral density, fat redistribution, and immune reconstitution syndrome.
The drug's manufacturer, Gilead Sciences, will conduct additional post-market testing to determine Stribild's safety in women and pediatric patients, as well as to establish how drug resistance develops, and possible drug interactions.
Cole Petrochko
Staff Writer
Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.
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