Sofosbuvir (brand name Sovaldi) is a drug developed by Gilead Sciences used to treat hepatitis C infection. In combination with other therapies, Sofosbuvir can effectively cure hepatitis in 90 percent of patients. It inhibits the RNA polymerase that the hepatitis C virus (HCV) uses to replicate its RNA. It was discovered at Pharmasset and developed by Gilead Sciences.
Sofosbuvir is a component of the first all-oral, interferon-free regimen approved for treating chronic hepatitis C. Interferon-free therapy for treatment of hepatitis C reduces the side effects associated with use of interferon.
In 2013, the Food and Drug Administration (FDA) approved sofosbuvir in combination with ribavirin (RBV) for oral dual therapy of HCV genotypes 2 and 3, and for triple therapy with injected pegylated interferon (pegIFN) and RBV for treatment-naive patients with HCV genotypes 1 and 4. Sofosbuvir treatment regimens last 12 weeks for genotypes 1, 2 and 4, and 24 weeks for treatment of genotype 3. This is typically half the time as with prior treatments. The label further states that sofosbuvir in combination with ribavirin may be considered for patients infected with genotype 1 who are interferon-ineligible.
The price of sofosbuvir, quoted in various media sources as $84,000 to $168,000 for a course of treatment in the U.S., £35,000 for 12 weeks in the UK, and €60,000 in Germany has engendered considerable controversy, particularly with respect to accessibility in developing countries.
In a study of 327 patients who had no prior Hep C treatments and who all received SOVALDI once daily for 12 weeks along with another oral medicine (ribavirin) and a weekly injection (peginterferon alfa), 89% of those with the most common type of Hep C (genotype 1) were cured. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.
SOVALDI is a once-a-day prescription medicine that is used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C (Hep C) infection in adults. SOVALDI should not be taken alone. It is not known if SOVALDI is safe and effective in children under 18 years of age.