sofosbuvir, Sovaldi

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GENERIC NAME: sofosbuvir

BRAND NAME: Sovaldi

DRUG CLASS AND MECHANISM: Sofosbuvir is an oral, direct-acting antiviral agent used for treating infections with the hepatitis C virus (HCV). Boceprevir (Victrelis), Telaprevir (Incivek), and simeprevir (Olysio) are other direct-acting HCV treatments. After administration sofosbuvir is first converted to an active form. The active form of sofosbuvir interferes with multiplication of the ribonucleic acid (RNA) of HCV leading to reduced numbers of HCV in the body. Sofosbuvir is effective for treating infection with HCV genotype 1,2,3, or 4, and in clinical trials, 50% to 90% of individuals treated with sofosbuvir cleared HCV from their blood. The FDA approved Sovaldi in December 2013.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Tablets: 400 mg

STORAGE: Tablets should be stored at room temperature below 30 C (86 F).

PRESCRIBED FOR: Sofosbuvir is used in combination with ribavirin (Rebetol, Copegus) or ribavirin plus interferon to treat HCV.

DOSING: The recommended dose of sofosbuvir is one 400 mg tablet once daily with or without food for 12 to 24 weeks.

DRUG INTERACTIONS: Rifampin and St. John's wort may reduce blood levels of sofosbuvir by increasing its metabolism (break-down) in the intestine. Therefore, sofosbuvir should not be combined with rifampin or St. John's wort. Other drugs that also may reduce blood levels of sofosbuvir include carbamazepine (Tegretol, Tegretol XR , Equetro, Carbatrol), phenytoin (Dilantin, Dilantin-125), phenobarbital, oxcarbazepine (Tripetal), rifabutin, rifampin, rifapentine, and tipranavir (Aptivus)/ritonavir (Norvir).

PREGNANCY: Sofosbuvir has not been adequately evaluated in pregnant women. However, ribavirin which is combined with sofosbuvir should not be used by pregnant women or their male partners.

NURSING MOTHERS: It is not known sofosbuvir is secreted into breast milk.

SIDE EFFECTS: The most common side effects associated with sofosbuvir treatment are fatigue, headache, nausea, insomnia, anemia, and itching. Decreased appetite, diarrhea, irritability, rash, muscle pain, and flu like symptoms also occur. Reduced blood cells, severe depression, and increases in bilirubin levels also were reported in clinical studies.

Reference: FDA Prescribing Information


Last Editorial Review: 1/23/2014 6:34:26 PM




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