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Sofosbuvir: Drug information

Sofosbuvir: Drug information
(For additional information see "Sofosbuvir: Patient drug information" and see "Sofosbuvir: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
Sofosbuvir-Containing Products Safety Review January 2021

Health Canada has reviewed the potential risk of severe cutaneous adverse reactions (SCAR) with the use of sofosbuvir-containing products and concluded that there may be a link between the use of sofosbuvir-containing products and the risk of Stevens Johnson syndrome (SJS), but did not confirm a link with the risk of other types of SCAR (eg, erythema multiforme, toxic epidermal necrolysis). Health Canada will work with manufacturers to update the Canadian product safety information for sofosbuvir-containing products to include the risk of SJS.

Further information may be found at https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00256.

ALERT: US Boxed Warning
Hepatitis B virus reactivation:

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir. HBV reactivation has been reported in hepatitis C virus (HCV)/HBV co-infected 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 co-infected 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.

Brand Names: US
  • Sovaldi
Brand Names: Canada
  • Sovaldi
Pharmacologic Category
  • Antihepaciviral, Polymerase Inhibitor (Anti-HCV);
  • NS5B RNA Polymerase Inhibitor
Dosing: Adult
Chronic hepatitis C

Chronic hepatitis C (CHC):

Genotype 3, peginterferon + ribavirin treatment–experienced patients with compensated cirrhosis (Child-Pugh class A) (alternative agent): Oral: 400 mg once daily with concomitant elbasvir/grazoprevir for 12 weeks (Ref).

All genotypes, patients with prior glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir treatment failure, without cirrhosis or with compensated cirrhosis (Child-Pugh class A): Oral: 400 mg once daily in combination with ribavirin and glecaprevir/pibrentasvir for 16 weeks (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Estimated glomerular filtration rate (eGFR) ≥30 mL/minute: No dosage adjustment necessary.

eGFR <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Predominant metabolite accumulates in impaired renal function.

End stage renal disease (ESRD), including hemodialysis patients: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Predominant metabolite accumulates in impaired renal function.

Dosing: Hepatic Impairment: Adult

Mild, moderate, or severe impairment (Child-Pugh class A, B, or C): No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Sofosbuvir: Pediatric drug information")

Note: Prior to initiating therapy, test patient for evidence of hepatitis B infection (current or prior).

Chronic hepatitis C infection; treatment-naive or treatment-experienced without cirrhosis or with compensated cirrhosis

Chronic hepatitis C infection (monoinfection or coinfected with HIV-1); treatment-naive or treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh class A): Note: Use in combination with ribavirin. Treatment-experienced refers to patients who have failed prior treatment with an interferon-based regimen with or without ribavirin. Sofosbuvir dosage reduction is not recommended; however, other hepatitis C treatments (eg, ribavirin) may require dosage adjustments for toxicity. If other hepatitis C treatments require discontinuation due to toxicity, then discontinue sofosbuvir as well.

Children ≥3 years and Adolescents:

Patient weight:

<17 kg: Pellets: Oral: 150 mg once daily.

17 to <35 kg: Pellets, tablets: Oral: 200 mg once daily.

≥35 kg: Pellets, tablets: Oral: 400 mg once daily.

Treatment duration based on genotype:

Genotype 2: 12 weeks.

Genotype 3: 24 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children ≥3 years and Adolescents:

eGFR ≥30 mL/minute: No dosage adjustment necessary.

eGFR <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling. Predominant metabolite accumulates (up to 20-fold) in impaired renal function.

End stage renal disease, including hemodialysis patients: There are no dosage adjustments provided in the manufacturer's labeling. Predominant metabolite accumulates (up to 20-fold) in impaired renal function.

Dialysis: During a 4-hour dialysis session, 18% of sofosbuvir dose was removed.

Dosing: Hepatic Impairment: Pediatric

Children ≥3 years and Adolescents: Mild, moderate, or severe impairment: No dosage adjustment necessary.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported with combination therapy.

>10%:

Dermatologic: Pruritus (11% to 27%), skin rash (8% to 18%)

Gastrointestinal: Decreased appetite (18%), diarrhea (9% to 12%), nausea (22% to 34%)

Hematologic & oncologic: Anemia (6% to 21%), neutropenia (<1% [interferon-free regimen] to 17% [interferon-containing regimen])

Nervous system: Chills (2% to 17%), fatigue (30% to 59%), headache (24% to 36%), insomnia (15% to 25%), irritability (10% to 13%)

Neuromuscular & skeletal: Asthenia (5% to 21%), myalgia (6% to 14%)

Respiratory: Flu-like symptoms (6% to 16%)

Miscellaneous: Fever (4% to 18%)

1% to 10%:

Gastrointestinal: Increased serum lipase (>3 times ULN: ≤2%)

Hematologic & oncologic: Thrombocytopenia (≤1%)

Hepatic: Increased serum bilirubin (>2.5 times ULN: 3%)

Renal: Increased creatine phosphokinase in blood specimen (≥10 times ULN: 1% to 2%)

<1%:

Hematologic & oncologic: Pancytopenia

Nervous system: Severe depression, suicidal ideation

Postmarketing:

Cardiovascular: Bradycardia

Dermatologic: Stevens-Johnson syndrome (Verma 2017)

Endocrine & metabolic: Lactic acidosis (Smith 2019)

Hypersensitivity: Angioedema

Infection: Reactivation of HBV

Contraindications

There are no contraindications listed in the manufacturer's labeling. When administered with ribavirin and peginterferon alfa, the contraindications to ribavirin and peginterferon alfa also apply. See Ribavirin and Peginterferon Alfa monographs.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to sofosbuvir or any component of the formulation; males whose female partners may become pregnant

Warnings/Precautions

Disease-related concerns:

• Diabetes: Rapid reduction in hepatitis C viral load during direct-acting antiviral (DAA) therapy for hepatitis C may lead to improvement in glucose metabolism in patients with diabetes, potentially resulting in symptomatic hypoglycemia if antidiabetic agents are continued at the same dose. Monitor for changes in glucose tolerance and inform patients of the risk of hypoglycemia during DAA therapy, particularly within the first 3 months. Modification of antidiabetic therapy may be necessary (Ciancio 2018; Dawood 2017; Hum 2017).

• Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV) reactivation has been reported in hepatitis C virus (HCV)/HBV co-infected patients who were receiving 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. Test all patients for evidence of current or prior HBV infection prior to initiation of sofosbuvir; monitor HCV/HBV co-infected patients for hepatitis flare or HBV reactivation during treatment and post-treatment follow-up. Initiate treatment for HBV infection as clinically indicated. HBV reactivation has been reported in HBsAg positive patients and in patients with serologic evidence of resolved HBV infection (ie, HBsAg negative and anti-HBc positive) and is characterized by an abrupt increase in HBV replication manifested as a rapid increase in serum HBV DNA level; reappearance of HBsAg may occur in patients with resolved HBV infection. Risk of HBV reactivation may be increased in patients receiving certain immunosuppressants or chemotherapeutic agents.

Concurrent drug therapy issues:

• Amiodarone: Symptomatic bradycardia (some requiring pacemaker intervention) has occurred in patients receiving amiodarone and a sofosbuvir-containing regimen. Fatal cardiac arrest occurred in a patient taking amiodarone and the ledipasvir/sofosbuvir combination product. Bradycardia generally occurred within hours to days following coadministration, however some cases have occurred 2 weeks following the initiation of sofosbuvir. The risk of bradycardia may be increased in patients taking beta blockers or patients with underlying cardiac comorbidities and/or advanced liver disease. Bradycardia generally resolves following discontinuation of HCV treatment. Coadministration of amiodarone and sofosbuvir in combination with another DAA is not recommended. However, if patients have no treatment alternatives, patients should have inpatient cardiac monitoring for the first 48 hours, followed by daily outpatient or self-monitoring of heart rate for at least the first 2 weeks of treatment. Due to the long half-life of amiodarone, cardiac monitoring (as described) is also recommended if amiodarone was discontinued just prior to beginning treatment with sofosbuvir. Patients should seek medical attention immediately if they experience fainting or near-fainting, dizziness, lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pains, confusion or memory problems.

Special populations:

• Hepatic impairment: Safety and efficacy have not been established in patients with decompensated cirrhosis.

Other warnings/precautions:

• Appropriate use: Do not use as monotherapy; use only as part of a multiple drug regimen for treatment of HCV; consult current HCV treatment guidelines for guidance (AASLD/IDSA 2021).

Product Availability

Sovaldi oral pellets: FDA approved August 2019; anticipated availability is currently unknown. Consult the prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Sovaldi: 150 mg (28 ea); 200 mg (28 ea)

Tablet, Oral:

Sovaldi: 200 mg, 400 mg

Generic Equivalent Available: US

No

Pricing: US

Pack (Sovaldi Oral)

150 mg (per each): $1,200.00

200 mg (per each): $1,200.00

Tablets (Sovaldi Oral)

200 mg (per each): $1,200.00

400 mg (per each): $1,200.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Sovaldi: 400 mg

Administration: Adult

Oral:

Tablets: Administer with or without food.

Pellets: Administer with or without food. If administered without food, pour packet contents directly in the mouth and swallow without chewing to avoid bitter aftertaste; follow with water if needed. If administered with food, sprinkle packet contents on ≥1 spoonfuls of non-acidic soft foods (eg, pudding, chocolate syrup, mashed potatoes, ice cream) at or below room temperature; gently mix. Swallow entire contents within 30 minutes of mixing; do not chew to avoid bitter aftertaste.

Administration: Pediatric

Oral:

Pellets: Administer with or without food. May be sprinkled on 1 or more spoonfuls of non-acidic soft foods (eg, pudding, chocolate syrup, mashed potatoes, ice cream) at or below room temperature; gently mix. Swallow entire contents within 30 minutes of mixing; to avoid bitter aftertaste, do not chew.

Tablets: Administer with or without food.

Use: Labeled Indications

Chronic hepatitis C: Treatment of genotype 1, 2, 3, or 4 chronic hepatitis C virus (HCV) infection in adults and genotype 2 or 3 chronic HCV infection in pediatric patients ≥3 years of age, without cirrhosis or with compensated cirrhosis, as a component of a combination antiviral treatment regimen. Note: The American Association for the Study of Liver Diseases/Infectious Diseases Society of America guidelines for testing, managing, and treating hepatitis C only recommend single-agent sofosbuvir, in combination with other appropriate agents, for HCV infection (all genotypes) in limited situations (see "Dosing: Adult") (AASLD/IDSA 2021).

Metabolism/Transport Effects

Substrate of BCRP/ABCG2, P-glycoprotein/ABCB1 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Amiodarone: Sofosbuvir may enhance the bradycardic effect of Amiodarone. Management: Use alternative to a sofosbuvir-containing combo or to amiodarone when possible. If alternatives not possible, monitor in inpatient setting for first 48 hours of coadministration with daily outpatient monitoring for at least 2 weeks. Risk D: Consider therapy modification

Antidiabetic Agents: Direct Acting Antiviral Agents (HCV) may enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Atorvastatin: Sofosbuvir may increase the serum concentration of Atorvastatin. Risk C: Monitor therapy

Lumacaftor and Ivacaftor: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may decrease the serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Risk C: Monitor therapy

Modafinil: May decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

OXcarbazepine: May decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

PHENobarbital: May decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

Primidone: May decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

Rifabutin: May decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

Rifapentine: May decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

Tacrolimus (Systemic): Direct Acting Antiviral Agents (HCV) may decrease the serum concentration of Tacrolimus (Systemic). Direct Acting Antiviral Agents (HCV) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Tipranavir: May decrease the serum concentration of Sofosbuvir. Risk X: Avoid combination

Vitamin K Antagonists (eg, warfarin): Direct Acting Antiviral Agents (HCV) may diminish the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Reproductive Considerations

Patients with hepatitis C virus (HCV) infection should be treated before considering pregnancy to optimize maternal health and reduce the risk of HCV transmission (AASLD/IDSA 2021).

Sofosbuvir is not used as monotherapy; if used in combination with ribavirin or peginterferon, all warnings related to the use of ribavirin or peginterferon and contraception should be followed. Refer to the ribavirin and peginterferon monographs for additional information.

Pregnancy Considerations

Based on a placental perfusion study, GS-331007 (the main metabolite of sofosbuvir) is expected to cross the placenta (Freriksen 2020).

Sofosbuvir is not used as monotherapy; combination therapy with ribavirin is contraindicated in pregnant patients and males whose partners are pregnant. If used in combination with ribavirin or peginterferon, all warnings related to the use of ribavirin or peginterferon and pregnancy should be followed. Refer to the ribavirin and peginterferon monographs for additional information.

Outcome data following maternal use of sofosbuvir and other direct-acting antiviral (DAA) medications during pregnancy are limited. Use of a DAA is not currently recommended for the purpose of reducing mother to child transmission of hepatitis C virus due to a lack of safety and efficacy data. The decision to continue treatment in a patient who becomes pregnant while taking a DAA should be individualized after considering the potential benefits and risks of therapy. DAA medications should not be initiated during pregnancy outside of clinical trials until safety and efficacy data are available (AASLD/IDSA 2021; AbdAllah 2021; Mandimika 2019; SMFM [Dotters-Katz 2021]).

Breastfeeding Considerations

It is not known if sofosbuvir is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Breastfeeding is not linked to the spread of hepatitis C virus; however, if nipples are cracked or bleeding, breastfeeding is not recommended (milk should be expressed and discarded) (AASLD/IDSA 2021; SMFM [Dotters-Katz 2021]).

Monitoring Parameters

Baseline (obtain any time prior to treatment initiation) quantitative hepatitis C virus (HCV) RNA; HCV genotype and subtype (if a non–pan-genotypic direct-acting antiviral [DAA] will be prescribed); staging of fibrosis. Baseline (within 6 months prior to treatment initiation) CBC, INR, hepatic function (albumin, total and direct bilirubin, ALT, AST, alkaline phosphatase), calculated GFR. Before initiating DAA therapy, serum pregnancy test (women of childbearing age) and assessment for HIV coinfection. During treatment, monitor CBC, serum creatinine, calculated GFR, hepatic function panel (as clinically indicated). Quantitative HCV viral load testing (at ≥12 weeks after completion of therapy). Hepatitis B virus (HBV) surface antigen, HBV core antibody, and HBV surface antibody prior to initiation (AASLD/IDSA 2021). If used in combination with amiodarone and another DAA (or in patients who discontinued amiodarone just prior to initiating sofosbuvir in combination with a DAA), inpatient cardiac monitoring for the first 48 hours of coadministration, then daily outpatient or self-monitoring of heart rate through at least the first 2 weeks of treatment.

In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during treatment and during post-treatment follow-up.

In patients with diabetes, monitor blood glucose and for signs/symptoms of hypoglycemia (AASLD/IDSA 2021; Ciancio 2018; Dawood 2017; Hum 2017); in patients taking warfarin, monitor INR during and post-therapy (AASLD/IDSA 2021).

Mechanism of Action

Sofosbuvir, a direct-acting antiviral agent against the hepatitis C virus, is a prodrug converted to its pharmacologically active form (GS-461203) via intracellular metabolism. It inhibits HCV NS5B RNA-dependent RNA polymerase, essential for viral replication, and acts as a chain terminator.

Pharmacokinetics (Adult Data Unless Noted)

Note: The pharmacokinetic profile in pediatric patients ≥3 years of age is similar to adult patients.

Protein binding: ~61% to 65%

Metabolism: Hepatic; forms pharmacologically active nucleoside (uridine) analog triphosphate GS-461203; dephosphorylation results in the formation of nucleoside inactive metabolite GS-331007

Half-life elimination: 0.4 hours

Time to peak: ~0.5 to 2 hours

Excretion: Urine (80%; primarily as metabolite); feces (14%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: AUC0-∞ was higher in mild (eGFR ≥50 and <80 mL/minute/1.73 m2), moderate (eGFR ≥30 and <50 mL/minute/1.73 m2), and severe (eGFR <30 mL/minute/1.73 m2) renal impairment.

Hepatic function impairment: AUC0-24 was higher in moderate and severe hepatic impairment.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Sovaldi;
  • (AR) Argentina: Anisovir | Evaldix | Ferasin | Fozvir | Hepagris | Pemutol | Probirase | Sovaldi | Ultrabuvir;
  • (AT) Austria: Sovaldi;
  • (AU) Australia: Sovaldi;
  • (BD) Bangladesh: Hopetavir | Sofovir c | Soventa | Suvirux;
  • (BE) Belgium: Sovaldi;
  • (BG) Bulgaria: Sovaldi;
  • (BR) Brazil: Sophir | Sovaldi;
  • (CH) Switzerland: Sovaldi;
  • (CL) Chile: Sovaldi;
  • (CO) Colombia: Sovaldi;
  • (CZ) Czech Republic: Sovaldi;
  • (DE) Germany: Sovaldi;
  • (EG) Egypt: Andohepasuvir | Augispov | Episovir | Grateziano | Gratisovir | Heterosofir | Hopforhep | Magicbuvir | Mpiviropack | Myhep | Nucleobuvir | Serinospirevir | Sofocivir | Sofodelevier | Sofohep | Sofolanork | Sofomerase | Soforoyal | Sofosbuvir biomed | Sofozav | Sovaldi;
  • (ES) Spain: Sovaldi;
  • (ET) Ethiopia: Hepcinat | Hepcivir | Nucleobuvir | Sovihep | Virso;
  • (FI) Finland: Sovaldi;
  • (FR) France: Sovaldi;
  • (GB) United Kingdom: Sovaldi;
  • (GR) Greece: Sovaldi;
  • (HK) Hong Kong: Sovaldi;
  • (HR) Croatia: Sovaldi;
  • (HU) Hungary: Sovaldi;
  • (ID) Indonesia: Hepcinat | Myhep;
  • (IE) Ireland: Sovaldi;
  • (IN) India: Cimivir | Hepcinat | Hepcvir | Myhep | Novisof | Resof | Sofab | Sofocure | Sofokem | Sofovir | Sovihep | Viroclear | Zosovir;
  • (IT) Italy: Sovaldi;
  • (JP) Japan: Sovaldi;
  • (KE) Kenya: Myhep | Sovaldi;
  • (KR) Korea, Republic of: Sovaldi;
  • (KW) Kuwait: Sovaldi;
  • (LT) Lithuania: Hepcinat | Myhep | Sovaldi;
  • (LV) Latvia: Sovaldi;
  • (MA) Morocco: Isof | Sophos | Ssb 400;
  • (MX) Mexico: Sovaldi;
  • (MY) Malaysia: Sovaldi | Virso;
  • (NG) Nigeria: Grateziano | Hepcinat | Hepcvir | Myhep | Sofgen;
  • (NL) Netherlands: Sovaldi;
  • (NO) Norway: Sovaldi;
  • (NZ) New Zealand: Sovaldi;
  • (PE) Peru: Sovaldi;
  • (PH) Philippines: Myhep;
  • (PK) Pakistan: Abriva | Basovir | C off | Chc | Cure c | Hep c vir | Hepaldi | Hepcinat | Hepcvir | Hepgard | Lesof | Myhep | Novus | Ocvir | Ozbir | Qvir | Safaldi | Saferon | Savera | Scihop | Sobvi | Sofhep | Sofiget | Sofohil | Sofomac | Sofonil | Sofos | Sofotel | Sovaldi | Sovihep | Sovir | Vebuvir | Vibrenta | Virohep | Virso | Ziqar | Zoval;
  • (PL) Poland: Sovaldi;
  • (PR) Puerto Rico: Sovaldi;
  • (PT) Portugal: Sovaldi;
  • (PY) Paraguay: Probirase;
  • (RO) Romania: Sovaldi;
  • (RU) Russian Federation: Sovaldi;
  • (SA) Saudi Arabia: Sovaldi | Sovira;
  • (SE) Sweden: Sovaldi;
  • (SG) Singapore: Sovaldi;
  • (SI) Slovenia: Sovaldi;
  • (SK) Slovakia: Sovaldi;
  • (TH) Thailand: Myhep | Sovaldi;
  • (TN) Tunisia: Ebuvir | Myhep;
  • (TR) Turkey: Sovaldi;
  • (TW) Taiwan: Sovaldi;
  • (UA) Ukraine: Grateziano | Hepcinat | Myhep | Sofgen | Sovaldi | Virso;
  • (UG) Uganda: Myhep | Sofgen | Sovaldi | Sovihep;
  • (UY) Uruguay: Biancal | Sovaldi;
  • (VN) Viet Nam: Soravir;
  • (ZW) Zimbabwe: Myhep | Sofgen
  1. AbdAllah M, Alboraie M, Abdel-Razek W, et al. Pregnancy outcome of anti-HCV direct-acting antivirals: real-life data from an Egyptian cohort. Liver Int. 2021;41(7):1494-1497. doi:10.1111/liv.14913 [PubMed 33905164]
  2. American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA). HCV guidance: recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org. Updated October 5, 2021. Accessed March 24, 2022.
  3. Ciancio A, Bosio R, Bo S, et al. Significant improvement of glycemic control in diabetic patients with HCV infection responding to direct-acting antiviral agents. J Med Virol. 2018;90(2):320-327. doi:10.1002/jmv.24954. [PubMed 28960353]
  4. Dawood AA, Nooh MZ, Elgamal AA. Factors associated with improved glycemic control by direct-acting antiviral agent treatment in Egyptian type 2 diabetes mellitus patients with chronic hepatitis C genotype 4. Diabetes Metab J. 2017;41(4):316-321. doi: 10.4093/dmj.2017.41.4.316. [PubMed 28868829]
  5. Dienstag JL, McHutchison JG. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology. 2006;130(1):225-230. [PubMed 16401485]
  6. Dotters-Katz SK, Kuller JA, Hughes BL. Society for Maternal-Fetal Medicine Consult Series #56: hepatitis C in pregnancy-updated guidelines: replaces Consult Number 43, November 2017. Am J Obstet Gynecol. 2021;225(3):B8-B18. doi:10.1016/j.ajog.2021.06.008 [PubMed 34116035]
  7. FDA Safety Alert. MedWatch. Direct-acting antiviral for hepatitis C: drug safety communication – risk of hepatitis B reactivating. Food and Drug Administration website. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm. Accessed December 8, 2016.
  8. Fontaine H, Lazarus A, Pol S, et al. Bradyarrhythmias associated with sofosbuvir treatment. N Engl J Med. 2015;373(19):1886-1888. [PubMed 26535533]
  9. Freriksen JJM, Meijerhof M, van Drongelen J, et al. Transfer of daclatasvir and sofosbuvir's main metabolite, GS-331007, across the human placenta ex vivo. Am J Obstet Gynecol. 2020;223(6):941-943. doi:10.1016/j.ajog.2020.08.107 [PubMed 32877661]
  10. Hum J, Jou JH, Green PK, et al. Improvement in Glycemic Control of Type 2 Diabetes After Successful Treatment of Hepatitis C Virus. Diabetes Care. 2017;40(9):1173-1180. doi: 10.2337/dc17-0485. [PubMed 28659309]
  11. Mandimika C, Ogbuagu O. Successful sofosbuvir lead-in monotherapy for the treatment of hepatitis C virus (HCV) infection in a pregnant woman living with HIV. BMJ Case Rep. 2019;12(10):e230529. doi:10.1136/bcr-2019-230529 [PubMed 31645394]
  12. Smith ZR, Horng M, Rech MA. Medication-induced hyperlactatemia and lactic acidosis: a systematic review of the literature. Pharmacotherapy. 2019;39(9):946-963. [PubMed 31361914]
  13. Sovaldi (sofosbuvir) [prescribing information]. Foster City, CA; Gilead Sciences Inc; March 2020.
  14. Sovaldi (sofosbuvir) [product monograph]. Mississauga, Ontario, Canada: Gilead Sciences Canada Inc; June 2021.
  15. Verma N, Singh S, Sawatkar G, Singh V. Sofosbuvir induced Steven Johnson Syndrome in a patient with hepatitis C virus-related cirrhosis. Hepatol Commun. 2017;2(1):16-20. doi:10.1002/hep4.1126 [PubMed 29404508]
  16. Workowski KA, Bolan GA; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64(RR-03):1-137. [PubMed 26042815]
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