HARVONI VS. ZEPATIER
Here we look at how Harvoni and Zepatier are alike and different.
Harvoni contains the drugs ledipasvir and sofosbuvir in one pill. Zepatier also contains two drugs in one pill: elbasvir and grazoprevir.
Harvoni and Zepatier are both FDA-approved to treat hepatitis C virus in adults with genotypes 1 or 4. Harvoni is also approved for treating genotypes 5 and 6 in adults, and genotypes 1, 4, 5, or 6 in children ages 12 or older or who weigh at least 77 pounds. Zepatier isn’t approved for use in children.
Harvoni is approved to treat hepatitis C virus in adults with decompensated cirrhosis or who’ve had a liver transplant. With these conditions, your doctor will likely prescribe ribavirin with Harvoni.
Zepatier isn’t approved for use in people with moderate or severe liver disease, decompensated cirrhosis, or after a liver transplant.
Zepatier is FDA-approved for use in people with genotypes 1 and 4 who have a condition called polymorphism. With this condition, a person has certain genetic variations (mutations) that make the virus resistant to certain medications. When a virus is resistant, it’s difficult to treat with certain drugs.
Your doctor will perform a blood test see if you have one of these variations. If you do, you may need to take ribavirin with Zepatier.
Drug forms and administration
Harvoni and Zepatier both come as a single tablet that’s taken once daily. Each can be taken with or without food.
Harvoni treatment lasts for 8, 12, or 24 weeks. Zepatier treatment lasts for 12 or 16 weeks. The duration of treatment your doctor prescribes will be based on your genotype, liver function, and history of past hepatitis C treatments.
Side effects and risks
Harvoni and Zepatier are similar medications and their effects on the body are alike. Therefore, they cause many of the same side effects.
Below are some examples of their side effects.
More common side effects
These lists contain examples of more common side effects that can occur with Harvoni, with Zepatier, or with both drugs (when taken individually).
- Can occur with Harvoni:
- feeling weak
- insomnia (trouble sleeping)
- feeling irritable
- Can occur with Zepatier:
- stomach pain
- elevated liver enzyme (alanine aminotransferase)
- Can occur with both Harvoni and Zepatier:
Serious side effects
Serious side effects that can occur with both Harvoni and Zepatier include:
- hepatitis B reactivation (when a previous infection becomes active again), which can lead to severe liver damage, liver failure, or death (see “Boxed warnings” below)
- serious allergic reaction, with symptoms that can include trouble breathing and angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
Harvoni and Zepatier both have boxed warnings from the FDA. A boxed warning is the strongest warning the FDA requires.
The warning describes a risk of hepatitis B reactivation after starting treatment with either drug. Hepatitis B reactivation can lead to serious liver damage, liver failure, or death.
Your doctor will test you for hepatitis B before you start taking Harvoni or Zepatier. If you test positive for hepatitis B, you may need to take medication to treat it.
Harvoni and Zepatier haven’t been compared in clinical studies, but both are effective for treating hepatitis C.
According to treatment guidelines, both Harvoni and Zepatier are recommended as first-choice options to treat hepatitis C in adults with genotypes 1 and 4. Harvoni is also a first-choice option for treating genotypes 5 and 6, but Zepatier isn’t.
Guideline recommendations for Harvoni and Zepatier also differ in the following conditions:
- Children ages 12 and older or who weigh 77 pounds or more: Harvoni is a first-choice option for treating these children who have genotypes 1, 4, 5, and 6. Zepatier isn’t recommended for use in children.
- Severe kidney disease: Zepatier is recommended as a first-choice option for people with this condition, while Harvoni isn’t.
- Decompensated cirrhosis: In people with decompensated cirrhosis, Harvoni is recommended as a first-choice option. Zepatier isn’t recommended for people with this condition.
- Liver or kidney transplant: Harvoni is a first-choice option for treating hepatitis C in people who’ve had a liver or kidney transplant. Zepatier isn’t recommended for people with these conditions.
Harvoni and Zepatier are both brand-name medications. Brand-name medications usually cost more than generics.
Note: A generic version of Harvoni was released in early 2019. The manufacturer estimates the cost for a course of the drug is approximately $24,000. This price is considerably less than the price of the brand-name version.