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General Medication Fact Sheet for Harvoni
| Field | Information |
|---|---|
| Medication Name | Harvoni |
| Generic Name | Ledipasvir/Sofosbuvir |
| Boxed/Label Warning | Reactivation of Hepatitis B Virus (HBV) has been reported in patients co-infected with Hepatitis C Virus (HCV) and HBV, some of which have resulted in serious liver problems or death. HCV/HBV co-infected patients should be tested for HBV infection before starting Harvoni. |
| Purpose | Treatment of chronic Hepatitis C virus (HCV) infection in adults and children. |
| Mechanism of Action | Ledipasvir inhibits the HCV NS5A protein, and sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B polymerase. |
| Dosage Forms | Oral tablets |
| Available Strengths | 90 mg ledipasvir / 400 mg sofosbuvir |
| Dosage Frequency | Once daily |
| Common Side Effects | Fatigue, headache, weakness |
| Serious Side Effects | Reactivation of Hepatitis B virus (HBV), slowed heart rate (bradycardia when used with amiodarone). |
| Drug Interactions | Amiodarone, rifampin, St. John’s Wort, carbamazepine, phenytoin, oxcarbazepine, tipranavir/ritonavir, elbasvir/grazoprevir, tenofovir disoproxil fumarate. |
| Important Notes | Harvoni is a complete treatment regimen for HCV. Do not take with other products containing sofosbuvir. Before starting Harvoni, tell your doctor about all of your medical conditions, including liver problems other than hepatitis C, kidney problems, and any other medical conditions. |
| Storage | Store at room temperature away from moisture and light. |
| Missed Dose | Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at one time. |
| Alternatives | Epclusa (sofosbuvir/velpatasvir), Mavyret (glecaprevir/pibrentasvir), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) |
Harvoni Alternatives
| Medication | Mechanism of Action | Notes |
|---|---|---|
| Epclusa (sofosbuvir/velpatasvir) | Inhibits HCV NS5A and NS5B proteins. | A single-tablet regimen for all 6 genotypes of HCV. |
| Mavyret (glecaprevir/pibrentasvir) | Inhibits HCV NS3/4A protease and NS5A. | A pan-genotypic treatment with a shorter treatment duration in some cases. |
| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) | Inhibits HCV NS5A and NS5B proteins, and NS3/4A protease. | Used for patients who have failed previous treatment with other HCV medications. |
Harvoni Side Effects
| Common Side Effects | Serious Side Effects |
|---|---|
| Fatigue | Reactivation of Hepatitis B virus (HBV) |
| Headache | Slowed heart rate (bradycardia, especially when taken with amiodarone) |
| Weakness | Serious allergic reactions (rare) |
Harvoni Dosage Guide
| Condition | Starting Dose | Maintenance Dose | Administration Notes |
|---|---|---|---|
| Chronic Hepatitis C (HCV) Genotype 1, 4, 5, or 6 | 90 mg ledipasvir/400 mg sofosbuvir | 90 mg ledipasvir/400 mg sofosbuvir once daily | Treatment duration varies based on prior treatment history and presence of cirrhosis. |
| HCV/HIV-1 Coinfection | 90 mg ledipasvir/400 mg sofosbuvir | 90 mg ledipasvir/400 mg sofosbuvir once daily | Follow the same duration as for HCV monoinfection. |
Harvoni Price With And Without Insurance
| Purchase Context | Estimated Price |
|---|---|
| With Insurance | $1,000 – $3,000 |
| Without Insurance (U.S.) | $25,000 – $35,000 |
| From Canada | $22,000 |
