The U.S. Department of Health and Human Services (HHS) has removed Atripla (efavirenz/tenofovir/emtricitabine) from the priority list of first-line antiretrovirals in its most recent treatment guidelines. Both Atripla and Norvir (ritonavir)–boosted Reyataz (atazanavir) plus Truvada (tenofovir/emtricitabine) have been downgraded from “recommended” regimens for treatment-naive people with HIV to an “alternative” category.
Atripla, the first single-pill HIV regimen approved by the U.S. Food and Drug Administration (FDA), was knocked off the list because of concerns about its Sustiva (efavirenz) component, in particular the high rate of central nervous system- related side effects and a possible link to suicide.
The top-recommended regimens are Triumeq (dolutegravir/abacavir/lamivudine); Stribild (elvitegravir/cobicistat/tenofovir/emtricitabine); and Truvada plus either Tivicay (dolutegravir), Isentress (raltegravir) or Norvir–boosted Prezista (darunavir).
Tim Horn, HIV project director at Treatment Action Group, disagrees with HHS’s decision to demote Atripla, pointing to the tablet’s “extremely well-documented efficacy” and “forgiveness” (meaning that it’s typically OK to miss a certain percentage of doses), and to conflicting research findings about whether efavirenz raises the risk of suicide.
Efavirenz is set to lose its patent in December 2017, “which could potentially translate into significant cost savings in the U.S.,” Horn says.
Atripla Dethroned
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