STRIBILD® is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen for =6 months with no history of treatment failure and no known resistance to any component of STRIBILD.

Use with acid-reducing agents
No dose adjustment is needed when STRIBILD is combined with either H2-receptor antagonists or proton pump inhibitors. It is recommended to separate STRIBILD and antacids, other than PPIs or H2-receptor antagonists, by at least 2 hours.

Renal impairment
Initiation of STRIBILD in patients with estimated creatinine clearance below 70 mL per minute is not recommended. Because STRIBILD is a fixed-dose combination tablet, STRIBILD should be discontinued if estimated creatinine clearance declines below 50 mL per minute during treatment with STRIBILD as the dose interval adjustments required for emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) cannot be achieved.

Hepatic impairment
No dose adjustment of STRIBILD is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of STRIBILD in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, STRIBILD is not recommended for use in patients with severe hepatic impairment.