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SOVALDI
Viral infections
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Drug Name:

SOVALDI Rx

Generic Name and Formulations:
Sofosbuvir 400mg; tabs.

Company:
Gilead Sciences, Inc.

Therapeutic Use:

Indications for SOVALDI:

Chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis in adults with genotype 1 or 4, in combination with pegylated interferon and ribavirin, or in adults and children with genotype 2 or 3, in combination with ribavirin.

Adult:

Test for HBV infection prior to initiation. ≥18yrs: 400mg once daily. Genotype 1: treat for 12 wks (with PegIFN alfa + RBV) or 24 wks (with RBV) if interferon-based regimen ineligible. Genotype 2: treat for 12 wks (with RBV). Genotype 3: treat for 24 wks (with RBV). Genotype 4: treat for 12 wks (with PegIFN alfa + RBV). Patients with HCV/HIV-1 co-infection: follow same dosage recommendations. Hepatocellular carcinoma: treat up to 48 wks (with RBV) or until time of liver transplant, whichever occurs first. Dose reduction of sofosbuvir is not recommended. Other dose modifications: see full labeling. If peginterferon alfa or ribavirin are discontinued, sofosbuvir should also be discontinued.

Children:

<12yrs and <35kg: not established. Test for HBV infection prior to initiation. ≥12yrs or ≥35kg: 400mg once daily. Genotype 2: treat for 12 wks (with RBV). Genotype 3: treat for 24 wks (with RBV). Patients with HCV/HIV-1 co-infection: follow same dosage recommendations. Dose reduction of sofosbuvir is not recommended. Other dose modifications: see full labeling. If peginterferon alfa or ribavirin are discontinued, sofosbuvir should also be discontinued.

Contraindications:

Ribavirin or peginterferon alfa/ribavirin contraindications are also applicable to combination therapy with sofosbuvir (eg, Pregnancy).

Warnings/Precautions:

Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Increased risk of symptomatic bradycardia when concomitant amiodarone with sofosbuvir-containing regimen, esp. in patients also taking beta-blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Severe renal impairment or ESRD. Decompensated cirrhosis. Post-liver transplant recipients. Pregnancy. Nursing mothers: not recommended.

Interactions:

See full labeling. Concomitant amiodarone with sofosbuvir-containing regimen: not recommended; if no alternatives, monitor cardiac function for at least the first 2 weeks of treatment. Antagonized by P-gp inducers (eg, rifampin, St. John’s wort), carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, tipranavir/ritonavir; concomitant use not recommended. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May be co-administered with P-gp and/or BCRP inhibitors.

Pharmacological Class:

HCV NS5B polymerase inhibitor.

Adverse Reactions:

Fatigue, headache, nausea, insomnia, anemia, pruritus, rash.

Note:

For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective PI.

How Supplied:

Tabs—28

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