INDICATIONS AND USAGE（适应症）

GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA.

DOSAGE（服用剂量）

GENVOYA is a four-drug fixed dose combination product containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (TAF). The recommended dosage of GENVOYA is one tablet taken orally once daily with food in:

adults and pediatric patients with body weight at least 25 kg and creatinine clearance greater than or equal to 30 mL per minute; or

adults with creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis. On days of hemodialysis, administer GENVOYA after completion of hemodialysis treatment.

ADVERSE REACTIONS（不良反应）

Severe Acute Exacerbations of Hepatitis B

Immune Reconstitution Syndrome

New Onset or Worsening Renal Impairment

Lactic Acidosis/Severe Hepatomegaly with Steatosis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/34784acf-15ed-4715-b504-eb30430518e9/spl-doc?hl=elvitegravir

elvitegravirinformation