Renal Monitoring

Renal monitoring should be performed prior to initiation of, and during therapy with STRIBILD.

Renal monitoring and dosing guidance1

Stage Action
At initiation
  • In all patients, document estimated creatinine clearance (CrCl), urine glucose, and urine protein
  • Do not initiate STRIBILD if estimated CrCl is <70 mL/min
During treatment
  • 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

  • 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.

Indication

STRIBILD is indicated as a complete single-tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive.

References:

  • STRIBILD [package insert]. Foster City, CA: Gilead Sciences, Inc; 2014.
  • Clumeck N, Molina JM, Henry K, et al; for the GS-236-0103 Study Team. A randomized, double-blind comparison of co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir versus ritonavir-boosted atazanavir plus co-formulated emtridtabine and tenofovir DF for initial treatment of HIV-1 infection:analysis of week 144 results. J Acquir Immune Defic Syndr. 2014;65(3):e121-e124.
  • Wohl DA, Cohen C, Gallant JE, et al; for the GS-US-236-0102 Study Team. A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014;65(3):e118-e120.

Please click here to view full Prescribing Information for STRIBILD, including BOXED WARNING

Important Safety Information

Warnings and precautions

  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir DF and STRIBILD.
  • In all patients, monitor estimated creatinine clearance (CrCl), urine glucose, and urine protein prior to initiating and during therapy. In patients with or at risk for renal impairment, additionally monitor serum phosphorus.
  • Do not initiate STRIBILD in patients with CrCl <70 mL/min. Discontinue STRIBILD if CrCl declines to <50 mL/min.
  • Cobicistat may cause modest increases in serum creatinine and modest declines in CrCl without affecting renal glomerular function; patients with an increase in serum creatinine >0.4 mg/dL from baseline should be closely monitored for renal safety.
  • Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure, some requiring hospitalization and renal replacement therapy, have been reported after initiation of high dose or multiple NSAIDs in patients with risk factors for renal dysfunction; consider alternatives to NSAIDs in these patients.
  • Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function.

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