What is Harvoni?
Harvoni is a prescription medicine that is used to treat chronic Hepatitis C in adults. It contains two active ingredients, ledipasvir and sofosbuvir, which work by preventing the virus from replicating in the body. Harvoni was approved by the U.S. Food and Drug Administration (FDA) in October 2014 and has since become a popular treatment for Hepatitis C.
Harvoni is manufactured by Gilead Sciences , a California-based biopharmaceutical company. The drug was developed as a successor to Gilead's other Hepatitis C treatment, Sovaldi, and contains a combination of both Sovaldi and ledipasvir. Clinical trials have shown that Harvoni is highly effective in treating several genotypes of the Hepatitis C virus, with cure rates ranging from 94 to 99 percent.
Although Harvoni is a highly effective treatment for Hepatitis C, it can be quite expensive. The cost of a 12-week course of Harvoni can be upwards of $90,000 in the United States. However, patient assistance programs are available to help reduce the cost for uninsured or underinsured patients.
Overall, Harvoni has been a significant breakthrough in the treatment of Hepatitis C, offering high cure rates and shorter treatment durations compared to older treatments.
Frequently Asked Questions about harvoni
This medication is a combination of ledipasvir and sofosbuvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It may sometimes be used with another antiviral medication (ribavirin).
Harvoni is a fixed-dose combination tablet containing ledipasvir 90 mg and sofosbuvir 400 mg that is administered once daily. The medication can be taken with or without food and patients can follow the usual missed-dose instructions.
18 Ledipasvir (Harvoni®)
This combination was discovered and developed at Gilead Sciences and is marketed as the fixed combination with brand name of Harvoni®.
Harvoni (ledipasvir / sofosbuvir) is available as a generic medication and may be significantly cheaper compared to the brand version.
Harvoni is a brand-name prescription medication that's used to treat hepatitis C. Harvoni is a type of drug called a direct-acting antiviral (DAA).
The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.
Development timeline for Harvoni
| Date | Article |
|---|
| Oct 10, 2014 | Approval FDA Approves Harvoni (ledipasvir and sofosbuvir) for Hepatitis C |
| Apr 7, 2014 | Gilead Announces FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination |
In most clinical trials for Harvoni, the success rate for curing hepatitis C was greater than 90%. This means that most people who took Harvoni achieved a sustained virologic response (SVR). SVR means that no virus was detected in their body 12 weeks or longer after treatment ended.
The cure rate for Harvoni is 94% to 99% when you don't have other serious illnesses.
How is Harvoni used? Harvoni is taken once daily, with or without food, for 8 to 24 weeks. Treatment length depends on HCV treatment history, whether a person has cirrhosis, and the amount of hepatitis C virus in a person's bloodstream (called HCV RNA or viral load).
Liver damage may also occur if a person being treated with Harvoni for hepatitis C, also has an underlying hepatitis B infection, and it reactivates, causing liver damage.
FDA warning: Risk of reactivated hepatitis B
This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA).
