HTB

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”.

Reference:

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).

http://aidsinfo.nih.gov/contentfiles/AdultARVStatementOnEVG_COBI_TDF_FTC.pdf

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