pharmacopeia
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Boxed warning

RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with SOVALDI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1) ] . WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )

Mechanism of action

Sourced from openFDA

Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus [see Microbiology (12.4) ].

RNA Replicase

Indications

Sourced from openFDA
  • SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of: Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. ( 1 ) Pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.ICD-10: B18.2

Contraindications

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  • When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.contraindicated

Dosage & administration

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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. Refer to Table 3 of the full prescribing information for specific dosing guidelines based on body weight. ( 2.3 ) HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables below, respectively. ( 2.2 , 2.3 ) Recommended adult treatment regimen and duration: ( 2.2 ) Adult Patient Population Regimen and Duration Genotype 1 or 4 Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + peginterferon alfa + ribavirin 12 weeks Genotype 2 Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirin 12 weeks Genotype 3 Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirin 24 weeks SOVALDI in combination with ribavirin for 24 weeks can be considered for adult patients with genotype 1 infection who are interferon ineligible.

Warnings & precautions

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Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. ( 5.1 ) Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone with a sofosbuvir-containing regimen, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with SOVALDI is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended. ( 5.2 , 6.2 , 7.1 ) 5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive).

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described below and elsewhere in the labeling: Serious Symptomatic Bradycardia When Coadministered with Amiodarone [see Warnings and Precautions (5.2) ] . The most common adverse events (incidence greater than or equal to 20%, all grades) observed with SOVALDI in combination with ribavirin were fatigue and headache. The most common adverse events observed with SOVALDI in combination with peginterferon alfa and ribavirin were fatigue, headache, nausea, insomnia and anemia. ( 6.1 ). The most common adverse events observed with SOVALDI in combination with ribavirin oral solution in pediatric patients was decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. When SOVALDI is administered with ribavirin or peginterferon alfa/ribavirin, refer to the respective prescribing information for a description of adverse reactions associated with their use.

Use in specific populations

Sourced from openFDA

Patients with HCV/HIV-1 coinfection: Safety and efficacy have been studied. ( 14.4 ) Patients with hepatocellular carcinoma awaiting liver transplantation: Safety and efficacy have been studied. ( 8.8 ) 8.1 Pregnancy 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. Refer to the ribavirin and/or peginterferon alfa prescribing information for more information on ribavirin- and peginterferon alfa-associated risks of use during pregnancy. No adequate human data are available to establish whether or not SOVALDI poses a risk to pregnancy outcomes. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with sofosbuvir at exposures greater than those in humans at the recommended human dose (RHD) [see Data ] . During organogenesis in the rat and rabbit, 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. In the rat pre/postnatal development study, maternal systemic exposure (AUC) to GS-331007 was ≥6 times the exposure in humans at the RHD. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration of SOVALDI, sofosbuvir was absorbed with a peak plasma concentration observed at ~0.5–2 hour post-dose, regardless of dose level.

Overdosage

Sourced from openFDA

The highest documented dosage of sofosbuvir was a single dose of sofosbuvir 1200 mg (three times the recommended dosage) administered to 59 healthy subjects. In that trial, there were no untoward effects observed at this dosage level, and adverse events were similar in frequency and severity to those reported in the placebo and sofosbuvir 400 mg treatment groups. The effects of higher dosages are not known. No specific antidote is available for overdose with SOVALDI. If overdose occurs, the patient must be monitored for evidence of toxicity. Treatment of overdose with SOVALDI consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. A 4-hour hemodialysis session removed 18% of the administered dose.

Approval history

Sourced from openFDA
  • Dec 6, 2013NDANDA204671Gilead Sciences Inc
  • Oct 10, 2014NDANDA205834Gilead Sciences Inc
  • Jun 28, 2016NDANDA208341Gilead Sciences Inc
  • Jul 18, 2017NDANDA209195Gilead Sciences Inc
  • Aug 28, 2019NDANDA212477Gilead Sciences Inc
  • Aug 28, 2019NDANDA212480Gilead Sciences Inc
  • Jun 10, 2021NDANDA214187Gilead Sciences Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
52,253 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue9,25318%
  2. 2Headache7,69215%
  3. 3Nausea3,9087.5%
  4. 4Drug Ineffective3,6216.9%
  5. 5Hepatitis C3,0395.8%
  6. 6Insomnia2,4364.7%
  7. 7Diarrhoea2,3974.6%
  8. 8Treatment Failure1,6063.1%
  9. 9Anaemia1,5783.0%
  10. 10Off Label Use1,5753.0%
  11. 11Vomiting1,4772.8%
  12. 12Dizziness1,4452.8%
  13. 13Hepatocellular Carcinoma1,4352.7%
  14. 14Asthenia1,3282.5%
  15. 15Dyspnoea1,2362.4%

Literature

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Recent PubMed references pinned to Sofosbuvir as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 421 ClinicalTrials.gov registrations naming Sofosbuvir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sofosbuvir work?
Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus [see Microbiology (12.4) ].
What is Sofosbuvir used for?
According to FDA labeling, Sofosbuvir carries indications including: SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of: Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. ( 1 ) Pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sofosbuvir?
Sofosbuvir is classified as Antivirals for treatment of HCV infections, Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor, RNA Replicase Inhibitors.
What are the brand names for Sofosbuvir?
Sofosbuvir is marketed under brand names including Epclusa, Harvoni, Sovaldi, Vosevi.
What are the contraindications for Sofosbuvir?
Sofosbuvir labeling lists contraindications including: When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.. Always consult the full prescribing information and a clinician.
Note. Data for sofosbuvir is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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