CD4 Cell Count

Mean increase from baseline in CD4 cell count at week 1441

Mean CD4 cell count increase at week 96

Click here to view the virologic outcomes at week 48 (primary endpoint) and weeks 96 and 144 (secondary endpoints) using FDA snapshot analysis

Click here to review the study designs.

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.

Reference:

  • STRIBILD [package insert]. Foster City, CA: Gilead Sciences, Inc; 2014.

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

Important Safety Information

Drug interactions

  • CYP3A substrates: STRIBILD can alter the concentration of drugs metabolized by CYP3A or CYP2D6. Do not use with drugs highly dependent on these factors for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening adverse events.
  • CYP3A inducers: Drugs that induce CYP3A can decrease the concentrations of components of STRIBILD. Do not use with drugs that strongly induce CYP3A as this may lead to loss of efficacy and possible resistance to STRIBILD.
  • Drugs affecting renal function: Coadministration of STRIBILD with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir and the risk of adverse reactions.
  • Antacids: Separate STRIBILD and antacid administration by at least 2 hours.
  • Prescribing information: Consult the full Prescribing Information for STRIBILD for more information on potentially significant drug interactions, including clinical comments.

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