GENERIC NAME: ledipasvir and sofosbuvir
BRAND NAME: Harvoni
DRUG CLASS AND MECHANISM: Harvoni is an oral tablet containing two drugs used for the treatment of chronic infection with the hepatitis C virus (HCV), genotype 1 in adults. The components belong to a class of drugs called direct-acting antiviral agents. Similar drugs include
- boceprevir (Victrelis),
- sofosbuvir (Sovaldi),
- simeprevir (Olysio),
- telaprevir (Incivek), and
- Viekira Pak (ombitasvir, paritaprevir, ritonavir, dasabuvir).
Harvoni contains ledipasvir and sofosbuvir. Sofosbuvir is converted to an active form in the body before it is effective. The active form of sofosbuvir directly blocks replication of the HVC by interfering with a hepatitis C virus enzyme called NS5B. Ledipasvir is an inhibitor of another hepatitis C virus enzyme called NS5A, which also is needed for viral replication. Both drugs in Harvoni interfere with enzymes needed by hepatitis C virus to multiply and make new viruses, thus reducing the overall viral load. The efficacy of sofosbuvir has been established in subjects with hepatitis C virus genotype 1, 2, 3 and 4.
Harvoni does not require administration with interferons or ribavirin (Rebetol). In clinical studies, 96%-99% of patients who were not previously treated for their hepatitis C virus were cured after 12 weeks of Harvoni treatment. Cure was defined as undetectable levels of hepatitis C virus in the blood when measured three months after the completion of treatment. Harvoni was approved by the FDA in October, 2014.
PRESCRIBED FOR: Harvoni is used to treat chronic hepatitis C virus genotype 1 infection in adults.
The safety and effectiveness of Harvoni treatment in children under the age of 18 is not known.
Quick GuideHepatitis C (Hep C) Symptoms and Treatment
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