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Harvoni
Ledipasvir/sofosbuvir
$76305.00
3 × 28 tablets · 3 months supply
BrandBranded medicine· By Gilead Sciences
$25435.00 per month
How long a supply?
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Annual cost
$330655a year at this pack size
Prescription required
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FDA boxed warningRisk of hepatitis b virus reactivation in patients coinfected with hcv and hbv
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
About Harvoni
Overview
Harvoni is a prescription tablet containing ledipasvir and sofosbuvir, two antiviral medicines. It treats chronic hepatitis C of genotypes 1, 4, 5 or 6 in adults and children aged 3 years and older who have no cirrhosis or compensated cirrhosis. It is also used with ribavirin for genotype 1 infection with decompensated cirrhosis, or for genotype 1 or 4 infection in liver transplant recipients with no cirrhosis or compensated cirrhosis. The two ingredients act directly against the hepatitis C virus to block processes it needs to multiply.
What it treats
For adults and children aged 3 years and older with chronic hepatitis C: • Genotypes 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis. • Genotype 1 with decompensated cirrhosis, in combination with ribavirin. • Genotypes 1 or 4 in liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
Safety information
Side effects
Common side effects include tiredness, headache and weakness. Serious risks include a slow heartbeat that causes symptoms when Harvoni is taken with amiodarone. Taking these medicines together is not recommended. The risk is particularly important if you also take a beta blocker, have a heart condition or have advanced liver disease. Contact a doctor if you develop a slow heartbeat or symptoms associated with it. Hepatitis B can become active again during or after hepatitis C treatment, causing a flare of liver inflammation. Patients should be tested for current or past hepatitis B before treatment. Those with both hepatitis B and hepatitis C need monitoring during treatment and follow-up. Contact a doctor if hepatitis B reactivation or a flare is suspected.
FDA boxed warning
Risk of hepatitis b virus reactivation in patients coinfected with hcv and hbv
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
If Harvoni is taken with ribavirin, anyone who cannot take ribavirin must not take this combination. Refer to ribavirin’s prescribing information for its contraindications. Before starting Harvoni, all patients should be tested for current or previous hepatitis B infection. Hepatitis B can reactivate during hepatitis C treatment. Patients with both infections need monitoring during treatment and follow-up afterward. Taking Harvoni with amiodarone is not recommended because it can cause a serious, symptomatic slowing of the heartbeat. This risk is especially important in people also taking beta blockers or who have underlying heart conditions or advanced liver disease. If no suitable alternative treatment is available, heart monitoring is recommended. No safety data are available for Harvoni in children with impaired kidney function.
Interactions
Tell your doctor about all medicines and supplements you take before starting Harvoni. Important interactions include: - Amiodarone: taking it with Harvoni can cause a serious slow heartbeat with symptoms. Use together is not recommended. - P-gp inducers, such as rifampin and St. John’s wort: these may change levels of ledipasvir and sofosbuvir. Use together is not recommended. Clearing hepatitis C can change liver function and affect how other medicines work. Your doctor may need to check your INR (a blood-clotting measure) or blood glucose more often and adjust certain other medicines.
Using Harvoni
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC] (DailyMed, retrieved 19 September 2026).
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