Sovaldi

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.

Table 1 Recommended Regimens and Treatment Duration for SOVALDI Combination Therapy in HCV Mono-infected and HCV/HIV-1 Co-infected Patients

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;
mild itching;
nausea;
sleep problems (insomnia);