Renal monitoring should be performed prior to initiation of, and during therapy with STRIBILD.
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 rates due to renal adverse events
- 10 (1.4%) subjects in the STRIBILD group (N=701) and 2 (0.3%) subjects in the combined comparator groups (N=707) discontinued study drug through 96 weeks due to a renal adverse event. Of these discontinuations, 8 in the STRIBILD group and 1 in the combined comparator groups occurred during the first 48 weeks1
4/701 (0.6%) subjects taking STRIBILD developed laboratory findings consistent with proximal renal tubular dysfunction leading to discontinuation compared to none in the comparator groups1
- 2 of these 4 subjects had renal impairment at baseline (ie, eGFR <70 mL/min)
- Laboratory findings improved but did not completely resolve in all subjects upon discontinuation of STRIBILD; renal replacement therapy was not required.
Through week 144
- In Study 103, 2 subjects in the STRIBILD arm and 6 subjects in the ATV + RTV + FTC/TDF arm discontinued study drug due to renal events between weeks 96 and 144. Of these, there were no cases of proximal renal tubulopathy among STRIBILD subjects and 3 cases among ATV + RTV + FTC/TDF subjects2
- In Study 102, 1 subject in the STRIBILD group and no subjects in the EFV/FTC/TDF group discontinued study drug due to a renal adverse event between weeks 96 and 144. No new cases of proximal renal tubulopathy were reported3
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 are antiretroviral treatment-naive.
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