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Sovaldi Oral Pellets Generic Name & Formulations
Legal Class
Rx
General Description
Sofosbuvir 150mg, 200mg.
Pharmacological Class
HCV NS5B polymerase inhibitor.
See Also
How Supplied
Tabs, pellets—28
Manufacturer
Generic Availability
NO
Sovaldi Oral Pellets Indications
Indications
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.
Sovaldi Oral Pellets Dosage and Administration
Adult
Test for HBV infection prior to initiation. ≥18yrs: 400mg (tabs) 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). 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
<3yrs: not established. Test for HBV infection prior to initiation. ≥3yrs (<17kg): 150mg (pellets) once daily; (17–<35kg): 200mg (tabs or pellets) once daily; (≥35kg): 400mg (tabs or pellets) once daily. Genotype 2: treat for 12 wks (with RBV). Genotype 3: treat for 24 wks (with RBV). 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.
Sovaldi Oral Pellets Contraindications
Contraindications
Ribavirin or peginterferon alfa/ribavirin contraindications are also applicable to combination therapy with sofosbuvir (eg, Pregnancy).
Sovaldi Oral Pellets Boxed Warnings
Boxed Warning
Risk of HBV reactivation in patients coinfected with HCV and HBV.
Sovaldi Oral Pellets Warnings/Precautions
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.
Sovaldi Oral Pellets Pharmacokinetics
See Literature
Sovaldi Oral Pellets Interactions
Interactions
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. Monitor INR with warfarin.
Sovaldi Oral Pellets Adverse Reactions
Adverse Reactions
Fatigue, headache, nausea, insomnia, anemia; children: also decreased appetite.
Sovaldi Oral Pellets Clinical Trials
See Literature
Sovaldi Oral Pellets Note
Notes
For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective PI.
Sovaldi Oral Pellets Patient Counseling
See Literature
