{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "sofosbuvir",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sofosbuvir.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated in pregnan'."
    }
  }
}