Harvoni (ledipasvir and sofosbuvir)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

What is Harvoni , and how does it work (mechanism of action)?

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

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.

What brand names are available for Harvoni ?


Is Harvoni available as a generic drug?


Do I need a prescription for Harvoni ?


What are the side effects of Harvoni ?


  • There is an increased risk of low heart rate (bradycardia) when Harvoni is combined with amiodarone (Cordarone).
  • Harvoni should not be combined with Sovaldi (sofosbuvir) or other drugs containing sofosbuvir.

Medically Reviewed by a Doctor on 8/10/2015

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