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What is the difference between Sovaldi and Harvoni?

Medically reviewed by Carmen Fookes, BPharm. Last updated on Apr 23, 2020.

Official Answer

by Drugs.com
  • Sovaldi contains only sofosbuvir and Harvoni contains ledipasvir and sofosbuvir as a fixed combination tablet.
  • Sovaldi is ALWAYS given in combination with other hepatitis C treatments, Harvoni is a stand-alone treatment.
  • The wholesale cost of Sovaldi is $1000 per 400mg tablet and Harvoni costs around $1,175 per tablet.
  • A 12-week treatment course of Sovaldi would cost around $84,000 and a 24-week course, $168,000. However, this does not take into account the cost of the other treatment needed to be given with Sovaldi.
  • A 12-week treatment course of Harvoni costs approximately $98,500 and a 24-week course approximately $197,000.
  • Both Sovaldi and Harvoni are usually covered by insurance companies or Medicare if certain criteria are met.
  • Gilead, the manufacturer of both Sovaldi and Harvoni has a special patient assistance program called Support Path™ that may assist with co-pays or make Sovaldi or Harvoni available at no charge for eligible and qualified uninsured patients.
  • Both Sovaldi and Harvoni cause few side effects but those that may occur include a headache, fatigue, itching, asthenia (lack of energy), and nausea. Harvoni is also likely to cause cough, myalgia (muscle pains), dyspnea (shortness of breath), insomnia, and diarrhea.

All hepatitis C drugs are expensive and Sovaldi and Harvoni are no exception.

The price reflects reflects the cost of bringing the drugs to market; a need for hepatitis C treatments, especially cures; a lack of competition; and few generics.

The wholesale cost of Sovaldi is $1000 per 400mg tablet. This means a 12-week treatment course of Sovaldi would cost around $84,000 and a 24-week course, $168,000. This does not take into account the cost of the other treatment used with Sovaldi, and Sovaldi is always given in combination with other treatments, never alone.

The cost of Harvoni is approximately $1,175 per pill, $65,000 for an 8-week treatment course, $98,500 for a 12-week treatment course, and $197,000 for a 24-week course.

Harvoni is available as a generic, under the name ledipasvir/sofosbuvir. The cost for oral ledipasvir/sofosbuvir tablets (90 mg/400 mg) is around $10,090 for a supply of 28, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.

Most insurance companies and Medicare cover the cost of Sovaldi and Harvoni; however, you may have to meet certain criteria and you should always check with your insurance company first before you and your doctor make it your preferred treatment. There may also be a co-pay.

Gilead, the manufacturer of both Sovaldi and Harvoni has a special patient assistance program called Support Path™ that may assist with co-pay insurance coupons or make Sovaldi or Harvoni available at no charge for eligible and qualified uninsured patients insurance who need assistance paying for their out-of-pocket medication costs. To learn more about Support Path, call +1 855 769 72846, Monday through Friday between 9:00 a.m. and 8:00 p.m. (Eastern Time).

If you have no success getting Sovaldi or Harvoni at a reduced cost through Gilead’s Support Path, you could try organizations that offer help to people with hepatitis C, such as the American Liver Foundation, Hepatitis Foundation International, or Needy Meds.

What is Sovaldi?

Sovaldi (sofosbuvir) is an antiviral medicine that is used to treat certain genotypes of chronic hepatitis C in adults and children who are at least 3 years old.

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.

Sovaldi (sofosbuvir) was a breakthrough medicine when it was FDA approved in 2013 for the treatment of patients with chronic hepatitis C, in combination with other medications (usually ribavirin).

It was the first of its kind that offered people with chronic hepatitis C the chance of a cure and represented a treatment option for those who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting transplantation, addressing unmet medical needs.

Sofosbuvir is primarily used now in fixed-dose combinations, such as Harvoni (which contains sofosbuvir in combination with Ledipasvir) or Epclusa ((which contains sofosbuvir in combination with velpatasvir).

The recommended dose of Sovaldi is 400mg taken orally once a day, with or without food.

What is Harvoni?

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 Sovaldi?

The most common Sovaldi side effects occurring in 10% or more of patients are:

  • Headache
  • Fatigue
  • Itching
  • Asthenia (lack of energy)
  • Nausea.

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

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 reported with Harvoni are:

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

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

For more information see Oral Hepatitis C Treatments: The Evolving Landscape

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