Generic Name and Formulations:
Sofosbuvir 400mg; tabs.

Company:
Gilead Sciences, Inc.
Indications for SOVALDI:
As a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection. Not for use as monotherapy.

Adult:
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). 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:
<18yrs: not established.

Pharmacological Class:
HCV NS5B polymerase inhibitor.

Contraindications:
Pregnant women and in men whose partners are pregnant (note: ribavirin is Cat. X). Peginterferon and ribavirin contraindications also apply to combination therapy with sofosbuvir.

Warnings/Precautions:
Female patients/partners of male patients must have (–) pregnancy test before initiating therapy; use 2 effective non-hormonal methods of contraception during and for 6 months after treatment completion; perform routine monthly pregnancy test. Severe renal impairment or ESRD. Decompensated cirrhosis. Post-liver transplant recipients. Pregnancy (Cat. B). Nursing mothers: not recommended.

Interactions:
Avoid concomitant strong P-gp inducers (eg, rifampin, St. John’s wort). Antagonized by carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, tipranavir/ritonavir; avoid concomitant use. May be co-administered with P-gp and/or BCRP inhibitors (see full labeling).

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