On December 6, 2013, FDA approved SOVALDI (sofosbuvir) tablets for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon, andis the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir).
Below is a summary of the basis of approval and highlights from the prescribing information for Sovaldi. Please refer to the full prescribing information for all the information needed to use Sovaldi safely and effectively.
The recommended dose of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food
SOVALDI should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC in adults. The recommended regimen and treatment duration for SOVALDI combination therapy is provided in Table 1.
a. See peginterferon alfa prescribing information for dosing recommendation for patients with genotype 1 or 4 CHC.
b. Dose of ribavirin is weight-based (75 kg = 1000 mg and 75 kg = 1200 mg). The daily dose of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤ 50 mL/min) require ribavirin dose reduction; refer to ribavirin prescribing information.
SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient.
Use with Potent P-gp Inducers
Drugs that are potent P-gp inducers in the intestine (e.g., rifampin, St. John’s wort) may significantly decrease sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of SOVALDI. Rifampin and St. John’s wort should not be used with SOVALDI.
Get emergency medical help if you have any of these signs of an allergic reaction to Sovaldi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
fever, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough.
Common Sovaldi side effects may include:
headache, tired feeling;
sleep problems (insomnia);