What are the Indications for Harvoni?
Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) infection. It is used to treat HCV genotypes 1, 4, 5, and 6. Harvoni is not recommended for the treatment of HCV genotype 2 or 3.
The medication is also indicated for those with HCV and human immunodeficiency virus (HIV) co-infection. In these conditions, Harvoni is used as part of a combination antiretroviral therapy regimen.
Harvoni should be stored at room temperature between 68° – 77°F(20° – 25°) in a tightly closed container, away from light and moisture.
Keep out of reach of children and pets.
Harvoni should be taken by mouth once a day with or without food at the same time every day.
Harvoni is available in tablet form in the following strengths (ledipasvir/sofosbuvir):
Harvoni is also available in oral pellets form in the following strengths (ledipasvir/sofosbuvir):
The recommended starting dose is dependent on your age and weight:
- If you are 18 years of age or older, the recommended dose is 90mg/400mg once per day.
- If you are 3 years of age or older, the recommended dose is dependent on weight.
It’s important to understand that although Harvoni is FDA-approved, it comes with side effects that may or may not affect you.
Before starting Harvoni, you should discuss possible side effects with your doctor or pharmacist.
Common Side Effects
Not all side effects require medical attention. As your body adjusts to Harvoni, side effects may go away.
Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:
- Feeling tired or fatigued
Serious Side Effects
Severe adverse reactions while using Harvoni can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:
- Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
- Reactivation of hepatitis B virus (HBV): liver failure
- Slow heartbeat or bradycardia
The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.
Warnings & Precautions
Before using Harvoni, tell your doctor or pharmacist:
- If you are allergic to any medications such as ledipasvir
- If you have or have had hepatitis B
- If you have HIV
- If you have kidney problems or are on dialysis
- If you have liver problems or have had a liver transplant
- If you are pregnant or expect to become pregnant
- If you are breastfeeding or plan to breastfeed
Reactivation of Hepatitis B
If you’ve had a Hepatitis B infection previously, taking Harvoni can cause the hepatitis B virus to become active. This means that the virus could start causing liver problems again. Your doctor will test you for hepatitis B before starting treatment, and should continue to monitor you for signs of hepatitis B reactivation during treatment.
Taking Harvoni can cause a temporary increase in liver enzymes which can cause serious liver problems in rare cases. Your doctor should monitor your liver functions regularly during your treatment.
Pregnant or Planning to Become Pregnant
It is not known if using Harvoni during pregnancy can harm your unborn child. It is recommended to use effective contraceptive while taking. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately.
It is not known if Harvoni passes through breast milk. If you are breastfeeding or considering breastfeeding, speak to a doctor for the best course of action before taking.
Interactions & Contraindications
Before using Harvoni, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.
Taking Harvoni with amiodarone can lead to bradycardia where your heart rate is slower than normal. It is not recommended to be taken with amiodarone. Consult with your doctor to determine if change of therapy is needed.
Taking Harvoni with a P-gp inducer such as rifampin and St. John’s wort can reduce the effect. It is not recommended to be taken with P-gp medications. Consult with your doctor to determine if a change of therapy is needed.