- The U.S. Food and Drug Administration approved Harvoni in 2014.
- In studies, Harvoni has been shown to be up to 99 percent effective.
- A typical course of treatment lasts 12 weeks.
Hepatitis C is a potentially life-threatening disease of the liver. Over time, it can lead to cirrhosis, liver cancer, and liver failure. Hepatitis C is caused by the hepatitis C virus (HCV), which is spread through contact with infected blood.
More than 71 million people are infected with HCV worldwide. Most people with HCV don’t experience any symptoms for years. Some people don’t have symptoms at all.
If early symptoms are present, they can include:
- mild fatigue
- joint pain
- muscle pain
- low energy
- a lack of appetite
As the disease advances, symptoms can include:
- severe fatigue
- persistent nausea
- a loss of appetite
- yellowing of the skin and whites of the eyes, which is called jaundice
- low-grade fever
For many years, there were only a few medications available to treat HCV, such as interferons and ribavirin. These medications often came with serious side effects, and they weren’t always effective.
New treatment approach
In the early 2000s, researchers began to develop more effective ways to cure HCV.
Researchers began to develop drugs that could effectively target the particular genotype of HCV. A genotype is the particular strain of a virus. HCV strains include genotypes 1, 2, 3, 4, 5, and 6. Genotype 1 is the most common in the United States.
These new drugs, called direct-acting antivirals (DAAs), can directly attack HCV and prevent the virus from replicating. DAAs are a major step forward in the ongoing effort to treat HCV.
Approval of Harvoni
The FDA approved Harvoni in 2014. Harvoni was the first combination pill that allowed people with genotype 1 to follow an all-oral medication regimen.
Harvoni is a combination pill made up of the drugs ledipasvir and sofosbuvir. As DAAs, these drugs work by interfering with the action of a protein needed for the growth of HCV. This prevents HCV from multiplying. Harvoni is used to treat people with HCV genotypes 1, 4, 5, and 6.
Harvoni has been shown to cure up to 99 percent of people (without cirrhosis) who take it for 12 weeks.
Harvoni is an oral tablet that’s taken once per day, with or without food.
A typical course of Harvoni treatment takes 12 weeks. For people with cirrhosis of the liver, treatment may last 24 weeks. You may have the best results if you take the drug at the same time every day.
Be sure to follow your doctor’s prescription about dosage. Taking a smaller or larger dose than the one prescribed may make the drug less effective.
It's important to note that you can still pass the virus to another person while you’re taking Harvoni. Be sure to follow your doctor’s orders about safety and preventing the spread of HCV. Your doctor may order frequent blood tests throughout your treatment to determine whether the virus has been eliminated.
Harvoni is generally well-tolerated. The most common side effects are headache and fatigue. Other side effects include nausea and vomiting, weakness, diarrhea, and trouble sleeping.
There are some drug interactions that can occur in people taking Harvoni. For example, you shouldn’t take an antacid within four hours of taking a Harvoni pill. You should also avoid the herbal supplement St. John’s wort and the antibiotic rifampin, which is usually prescribed to treat tuberculosis.
There are many other interactions that can occur between Harvoni and different medications. If you take other medications, tell your doctor before starting treatment with Harvoni.
Harvoni, like all HCV treatments, is expensive. The wholesale cost of a 12-week treatment is more than $90,000. That price doubles for a 24-week treatment.
Medicare, Medicaid, and some private insurers cover Harvoni, at least in part. You should discuss your coverage of Harvoni with your insurer before starting therapy.
The medication’s manufacturer, Gilead Sciences, has an assistance program to help those who can’t afford the drug. Your doctor or pharmacist may also know of other programs to help cover the cost of treatment.
Harvoni is proving to be an expensive but effective drug. If it’s taken correctly, this medication can clear the virus from your system in as little as 12 weeks.
If you’ve been diagnosed with HCV, you should discuss your treatment options with your doctor as soon as possible. In addition to Harvoni, there are several other DAAs available that could help treat your hepatitis C infection. Together you and your doctor can decide which course of treatment is best for you.