What does Harvoni do to your body?

• Harvoni is a combination tablet containing ledipasvir and sofosbuvir
• Ledipasvir works by interfering with a protein, called HCV NS5A that is needed by the virus to replicate itself
• Sofosbuvir interferes with the reproduction of genetic material of the hepatitis C virus, by inhibiting an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself
• The ingredients in Harvoni initially greatly reduce and then completely stop the production of new copies of the hepatitis C virus
• After a period of time, Harvoni will eliminate the hepatitis C virus in 95% of people who take it, technically curing them.

What is Harvoni?

Harvoni is a combination tablet containing ledipasvir and sofosbuvir. It may be used to treat certain genotypes of hepatitis C virus in adults and children over 12.

How does Harvoni work?

Harvoni contains ledipasvir and sofosbuvir.

Ledipasvir is an NS5A (hepatitis C virus nonstructural protein 5A) inhibitor and sofosbuvir is an NS5B (hepatitis C virus nonstructural protein 5B) nucleotide polymerase inhibitor. Ledipasvir works by interfering with a protein, called HCV NS5A that is needed by the virus to replicate itself. This protein is the main target for ledipasvir, which is one of the reasons Harvoni has few side effects, as ledipasvir works directly on the virus, not on human cells.

Sofosbuvir interferes with the reproduction of genetic material of the hepatitis C virus, by inhibiting an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself. Sofosbuvir is actually a prodrug, which means it is metabolized in the body to its active component and incorporated into the DNA of the HCV virus. Sofosbuvir also works directly on viral RNA and does not inhibit human DNA or RNA.

The ingredients in Harvoni initially greatly reduce and then completely stop the production of new copies of the hepatitis C virus.

After a period of time, Harvoni will eliminate the hepatitis C virus in 95% of people who take it, technically curing them. A cure is defined as a lack of detection of the hepatitis C virus in the blood for 12 weeks. However, a person can become reinfected with the hepatitis C virus if they are exposed to it again.

Harvoni prevents the hepatitis C virus (HCV) from multiplying in the body. It is a single combination pill that is given by mouth once a day for 8, 12, or 24 weeks, depending upon your HCV status.

What are the side effects of Harvoni?

Usually, the side effects that occur with Harvoni are mild. In fact, in clinical studies, only 1% (1 out of 100) or less of patients stopped treatment due to side effects. The most common side effects occurring in greater than 5% to 10% of patients included:

• Asthenia (lack of energy)
• Headache
• Fatigue
• Cough
• Myalgia (muscle pains)
• Dyspnea (shortness of breath)
• Irritability
• Dizziness
• Nausea
• Insomnia
• Diarrhea.

In addition, reactivation of hepatitis B has been reported, in some cases resulting in severe and rapid liver disease, hepatic failure, and death, in people who have a current or prior hepatitis B virus (HBV) infection before initiating treatment with Harvoni.