Viral infections:
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 Dosage:
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 Dosage:
<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 Contraindications:
Ribavirin or peginterferon alfa/ribavirin contraindications are also applicable to combination therapy with sofosbuvir (eg, Pregnancy).
Boxed Warning:
Risk of HBV reactivation in patients coinfected with HCV and HBV.
SOVALDI 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.
See Also:
SOVALDI Classification:
HCV NS5B polymerase inhibitor.
SOVALDI 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.
Adverse Reactions:
Fatigue, headache, nausea, insomnia, anemia; children: also decreased appetite.
Note:
For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective PI.
Generic Drug Availability:
NO
How Supplied:
Tabs, pellets—28
