Renal monitoring should be performed prior to initiation of, and during therapy with STRIBILD1.
Renal monitoring and dosing guidance1
- In all patients, document estimated creatinine clearance (CrCl), urine glucose, and urine protein
- Do not initiate STRIBILD if estimated CrCl is <70 mL/min
- In all patients, monitor estimated CrCl, urine glucose, and urine protein; additionally, measure serum phosphorus in patients at risk for renal impairment
- If serum creatinine increases >0.4 mg/dL from baseline, closely monitor for renal safety
- Discontinue STRIBILD if estimated CrCl is <50 mL/min
Learn about changes in serum creatinine observed in clinical studies.
Discontinuation rate due to renal adverse events in adults who had no antiretroviral treatment history
- 4/701 (0.6%) subjects taking STRIBILD vs 1 (0.3%) subject in the ATV + RTV + FTC/TDF arm and no subjects in the EFV/FTC/TDF arm developed laboratory findings consistent with proximal renal tubular dysfunction leading to discontinuation through week 144
- 2 of these 4 subjects had renal impairment at baseline (ie, CrCl <70 mL/min)
- These findings improved but did not completely resolve in all subjects upon discontinuation of STRIBILD; renal replacement therapy was not required
Important Safety Information
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH
STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (tenofovir DF), a component of STRIBILD, in combination with other antiretrovirals.
- STRIBILD is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of STRIBILD have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF, components of STRIBILD. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
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.
Please click here for additional Important Safety Information for STRIBILD