ledipasvir/sofosbuvir
Brand names: Harvoni
Harvoni is a medicine that contains ledipasvir and sofosbuvir. It is used to treat chronic hepatitis C virus (HCV) infection in adults and children 3 years and older.
What it does
Harvoni treats chronic Hepatitis C virus (HCV) genotypes 1, 4, 5, or 6.
Common side effects
Feeling tired, Headache, Feeling weak
Key warnings
Harvoni can cause Hepatitis B to become active again if you have had it in the past.
How It Works
Harvoni contains two medicines that stop the hepatitis C virus from multiplying in your body. Ledipasvir blocks a protein called NS5A. Sofosbuvir blocks another protein called NS5B.
How to Take It
Take one Harvoni tablet once a day. You can take it with or without food. For children, the dose is based on their weight. Follow your doctor's instructions carefully.
Pregnancy & Breastfeeding
If you are pregnant or plan to become pregnant, talk to your doctor before taking Harvoni. If Harvoni is taken with ribavirin, it is unsafe during pregnancy. Talk to your doctor if you are breastfeeding or plan to breastfeed.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store Harvoni tablets or pellets below 86°F (30°C) in the original container.
Side Effects (from patient reports)
Based on 14,161 FDA adverse event reports.
Serious Warnings
Harvoni can cause Hepatitis B to become active again if you have had it in the past. This can cause serious liver problems, including liver failure and death. Your doctor will test you for Hepatitis B before you start Harvoni and monitor you during and after treatment.
Known Drug Interactions
atorvastatin ↑ atorvastatin Coadministration of HARVONI with atorvastatin may be associated with increased risk of myopathy, including rhabdomyolysis.
Mechanism: Harvoni can increase the amount of atorvastatin in your system, which may lead to severe muscle problems.
What to do: Your doctor should monitor you for muscle pain or consider changing your medication.
( 5.2 , 6.2 , 7.2 ) P-gp inducers (e.g., rifampin, St. P-gp inducers (e.g., rifampin, St. Antimycobacterials: rifabutin rifampin rifapentine ↓ ledipasvir ↓ sofosbuvir Coadministration of HARVONI with rifampin, rifabutin, or rifapentine is not recommended [see Warnings and Precautions (5.3) ].
Mechanism: Rifampin reduces the levels of Harvoni in your body, which can prevent the medicine from treating your infection properly.
What to do: This combination is not recommended and should be avoided.
7 DRUG INTERACTIONS Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of HARVONI with amiodarone is not recommended. Antiarrhythmics: amiodarone Effect on amiodarone, ledipasvir, and sofosbuvir concentrations unknown Coadministration of amiodarone with HARVONI may result in serious symptomatic bradycardia.
Mechanism: Taking these drugs together can cause your heart rate to drop to a dangerously slow level. While the exact reason is unknown, the combination interferes with your heart's normal rhythm.
What to do: This combination is not recommended and should be avoided. If you must take both, your doctor will need to monitor your heart rate very closely.
Intervention: Sofosbuvir/velpatasvir/voxilaprevir Ledipasvir/sofosbuvir Avoid concomitant use with rosuvastatin.
Mechanism: These medications can raise the levels of rosuvastatin in your blood to unsafe levels. This increases your risk of developing serious muscle problems.
What to do: You should avoid using these two medications at the same time.
Intervention: Sofosbuvir/velpatasvir/voxilaprevir Ledipasvir/sofosbuvir Avoid concomitant use with rosuvastatin.
Mechanism: These medications can cause rosuvastatin to build up in your system, which increases the risk of harmful side effects.
What to do: You should avoid taking these two medications at the same time.
Common Questions
How long will I need to take Harvoni?
Can I take Harvoni if I have kidney problems?
What should I do if I experience side effects?
Can I drink alcohol while taking Harvoni?
Will Harvoni interact with other medications I am taking?
How will I know if Harvoni is working?
What if I have HIV?
Can children take Harvoni?
What tests will I need before starting Harvoni?
What do the tablets look like?
What are the common side effects of ledipasvir/sofosbuvir?
Does ledipasvir/sofosbuvir interact with other medications?
What drug class is ledipasvir/sofosbuvir?
Is ledipasvir/sofosbuvir safe during pregnancy?
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What the FDA Data Shows for ledipasvir/sofosbuvir
The FDA label for ledipasvir/sofosbuvir (sold under brand names such as Harvoni) classifies it as a prescription-only medication in the NS5A/NS5B Inhibitor (HCV) class. Harvoni treats chronic Hepatitis C virus (HCV) genotypes 1, 4, 5, or 6. Official labeling lists 4 commonly reported side effects, including Feeling tired, Headache, Feeling weak.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 14,161 voluntary reports. The database also lists 22 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 26, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages