Sofosbuvir

DRUG INFORMATION

  ADULT
    - ( 2.1 ) Recommended dosage in adults: One 400 mg tablet taken once daily with or
      without food.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.4 ) 2.1 Testing Prior to the Initiation of Therapy Test all patients for
      evidence of current or prior HBV infection by measuring hepatitis B surface
      antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV
      treatment with SOVALDI [see Warnings and Precautions (5.1)] .
      Source: US FDA label for sofosbuvir (Sovaldi), section 'dosage and
      administration', retrieved 2026-08-29
    - Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by
      measuring HBsAg and anti-HBc. ( 2.1 ) Recommended dosage in adults: One 400 mg
      tablet taken once daily with or without food. ( 2.2 ) Recommended dosage in
      pediatric patients 3 years of age and older: Recommended dosage of SOVALDI in
      pediatric patients 3 years of age and older with genotype 2 or 3 HCV using SOVALDI
      tablets or oral pellets is based on weight.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety, pharmacokinetics, and efficacy of SOVALDI in pediatric patients 3
      years of age and older with genotype 2 and 3 infection have been established.
      SOVALDI was evaluated in an open-label clinical trial (Study 1112), which included
      106 subjects (31 genotype 2; 75 genotype 3) 3 years of age and older.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'pediatric use', retrieved
      2026-08-29
    - Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by
      measuring HBsAg and anti-HBc. ( 2.1 ) Recommended dosage in adults: One 400 mg
      tablet taken once daily with or without food. ( 2.2 ) Recommended dosage in
      pediatric patients 3 years of age and older: Recommended dosage of SOVALDI in
      pediatric patients 3 years of age and older with genotype 2 or 3 HCV using SOVALDI
      tablets or oral pellets is based on weight.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Patients with renal impairment (CrCl ≤50 mL/min) require ribavirin dosage
      reduction; refer to ribavirin tablet prescribing information. 12 weeks Genotype 2
      Treatment-naïve and treatment-experienced Treatment-experienced patients have
      failed an interferon-based regimen with or without ribavirin.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'dosage and
      administration', retrieved 2026-08-29
    - Refer to the peginterferon alfa and ribavirin prescribing information for
      additional information about how to reduce and/or discontinue the peginterferon
      alfa and/or ribavirin dosage. 2.6 Discontinuation of Dosing If the other agents
      used in combination with SOVALDI are permanently discontinued, SOVALDI should also
      be discontinued.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'dosage and
      administration', retrieved 2026-08-29
    - No dosage adjustment of SOVALDI is warranted in geriatric patients [see Clinical
      Pharmacology (12.3) ] . 8.6 Renal Impairment No dosage adjustment of SOVALDI is
      required for patients with mild or moderate renal impairment.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Table 1 Recommended Treatment Regimen and Duration in Adult Patients with Genotype
      1, 2, 3, or 4 HCV Patient Population Treatment Regimen and Duration Genotype 1 or
      4 Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)
      SOVALDI + peginterferon alfa See peginterferon alfa prescribing information for
      dosage recommendation for patients with genotype 1 or 4 HCV.
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for sofosbuvir (Sovaldi),
      section 'dosage and administration', retrieved 2026-08-29
    - Patients with renal impairment (CrCl ≤50 mL/min) require ribavirin dosage
      reduction; refer to ribavirin tablet prescribing information. 12 weeks Genotype 2
      Treatment-naïve and treatment-experienced Treatment-experienced patients have
      failed an interferon-based regimen with or without ribavirin.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'dosage and
      administration', retrieved 2026-08-29
    - Table 2 Recommended Treatment Regimen and Duration in Pediatric Patients 3 Years
      and Older with Genotype 2 or 3 HCV Patient Population Treatment Regimen and
      Duration Genotype 2 Treatment-naïve and treatment-experienced Treatment-
      experienced patients have failed an interferon based regimen with or without
      ribavirin.
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for sofosbuvir (Sovaldi),
      section 'dosage and administration', retrieved 2026-08-29

  PREGNANCY   [ AVOID ]
    The label says not to use it. Read the quote below before deciding.
    - Risk Summary If SOVALDI is administered with ribavirin or peginterferon alfa and
      ribavirin, the combination regimen is contraindicated in pregnant women and in men
      whose female partners are pregnant.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'pregnancy', retrieved
      2026-08-29
    - Refer to the ribavirin and/or peginterferon alfa prescribing information for more
      information on ribavirin- and peginterferon alfa-associated risks of use during
      pregnancy.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'pregnancy', retrieved
      2026-08-29
    - No adequate human data are available to establish whether or not SOVALDI poses a
      risk to pregnancy outcomes.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Data Animal Data Sofosbuvir was administered orally to pregnant rats (up to 500
      mg/kg/day) and rabbits (up to 300 mg/kg/day) on gestation days 6 to 18 and 6 to
      19, respectively, and also to rats (oral doses up to 500 mg/kg/day) on gestation
      day 6 to lactation/post-partum day 20.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'use in specific
      populations', retrieved 2026-08-29
    - Systemic exposures (AUC) to the predominant circulating metabolite of sofosbuvir
      (GS-331007) were ≥5 (rats) and 12 (rabbits) times the exposure in humans at the
      RHD, with exposures increasing during gestation from approximately 5 to 10 (rats)
      and 12 to 28 (rabbits) times the exposure in humans at the RHD.
      Source: US FDA label for sofosbuvir (Sovaldi), section 'use in specific
      populations', retrieved 2026-08-29
    - The predominant circulating metabolite of sofosbuvir (GS-331007) was the primary
      component observed in the milk of lactating rats, without effect on nursing pups
      [see Data ] .
      Source: US FDA label for sofosbuvir (Sovaldi), section 'use in specific
      populations', retrieved 2026-08-29