US guidelines include Stribild (Quad) as alternative rather than preferred option for treatment naive adults (2012)
Shortly after FDA approval of the new once-daily single-pill formulation of elvitegravir/cobicistat/tenofovir/emtricitabine (Stribild) the US HHS guideline panel issued a statement on how this combination has been assessed in its recommendations for treatment naive adult patients.
The included the recommendation for elvitegravir 150 mg / cobicistat 150 mg / tenofovir 300 mg / emtricitabine 200 mg once daily (with food) as an “alternative” regimen for ART-naive HIV-infected patients with CrCl >70 mL/min. The recommendation was rated BI (moderate strength recomendation, based on results from randomised clinical trials).
Factors behind the decision not to make this a “preferred” option included “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”.
HHS Panel Statement. HHS panel on antiretroviral guidelines for adults and adolescents recommends a fixed-dose combination product of elvitegravir/cobicistat/tenofovir/emtricitabine as an alternative regimen in antiretroviral treatment-naive Individuals with HIV-1 infection. (18 September, 2012).