Stribild was recently approved by the U.S. Food and Drug Administration for treating people with HIV who have not been on treatment before. Stribild is made up of three HIV drugs (elvitegravir [a new integrase inhibitor], tenofovir and emtricitabine) and one boosting drug (cobicistat) for elvitegravir.
As the now-third one-pill regimen on the market, Stribild offers people easier daily dosing and equal effectiveness compared to the full regimens Atripla or Reyataz + Truvada. However, on September 18 the HHS Panel announced giving the pill only an “alternative regimen” status due to several outstanding concerns.
From the HHS Panel statement: “Limitations include a significant potential for drug-drug interactions, the availability of only 48 weeks of safety data, usage limited to individuals with pre-treatment CrCl >70 mL/min, a possible increased risk of proximal renal tubulopathy, limited data in patients with advanced HIV disease and in women, and the need for the drug to be taken with food. Based on these factors, the Panel recommends EVG/COBI/FTC/TDF as an alternative regimen for ART-naive patients.”