Select 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.
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.
<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.
Ribavirin or peginterferon alfa/ribavirin contraindications are also applicable to combination therapy with sofosbuvir (eg, Pregnancy).
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.
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. Monitor INR with warfarin.
HCV NS5B polymerase inhibitor.
Fatigue, headache, nausea, insomnia, anemia, pruritus, rash.
For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective PI.