Sofosbuvir/Ledipasvir
Pronunciation: pronunciation varies by local usage.
- Generic name
- ledipasvir and sofosbuvir
- Brand names
- HARVONI
- Drug class
- Fixed-dose combination of ledipasvir (HCV NS5A inhibitor) and sofosbuvir (HCV nucleotide analog NS5B polymerase inhibitor)
- Form
- Tablet, pellets (for pediatric use)
- Route
- Oral
- Legal status
- US legal/dispensing classification was not specifically extracted from the source reviewed for this page; availability and legal status outside the US were not verified in this research pass.
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What ledipasvir and sofosbuvir is and how it works
Sofosbuvir/ledipasvir (HARVONI) is a fixed-dose oral combination of ledipasvir, an HCV NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection. (1)
Approved in the US for adults and pediatric patients 3 years and older with specific HCV genotypes and cirrhosis status. Treatment duration, the need for ribavirin, and the formulation depend on genotype, liver disease stage, and weight. Baseline testing for hepatitis B virus is mandatory before starting.
Mechanism of action: how ledipasvir and sofosbuvir works
Ledipasvir is an HCV NS5A inhibitor; sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor. Further mechanistic detail was not established in the source reviewed for this page. (1)
What ledipasvir and sofosbuvir is used for
Genotype 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis
For adults and pediatric patients 3 years and older with chronic HCV genotype 1, 4, 5, or 6 infection who have no cirrhosis or compensated cirrhosis. Treatment duration is determined by genotype and cirrhosis status; whether prior treatment history is also a determining factor was not specifically established in the source reviewed for this page. (1)
Genotype 1 with decompensated cirrhosis
For adults with genotype 1 chronic HCV and decompensated cirrhosis, HARVONI is used in combination with ribavirin for 12 weeks. (1)
Genotype 1 or 4 in liver transplant recipients
For adults who have received a liver transplant and have genotype 1 or 4 chronic HCV without cirrhosis or with compensated cirrhosis, HARVONI is used in combination with ribavirin for 12 weeks. (1)
Before taking ledipasvir and sofosbuvir
Do not take / not appropriate for
- Baseline testing for hepatitis B virus (HBV) infection is required before the treating clinician starts HARVONI, because HBV reactivation can occur in people coinfected with HCV and HBV. (all patients) (1)
- If HARVONI is prescribed with ribavirin, pregnancy is contraindicated per ribavirin's own prescribing information. Specific contraception-duration requirements were not established in the source reviewed for this page — follow the ribavirin prescribing information and your specialist's guidance. (women of childbearing potential and their partners, when ribavirin is co-administered) (1)
Tell your clinician about
- Whether you have ever had hepatitis B infection, or if you have any liver problems other than hepatitis C.
- If you are taking amiodarone (a heart medicine), because serious slow heart rate can occur.
- All medicines you take, including St. John’s wort, rifampin, proton pump inhibitors, H2 blockers, antacids, digoxin, statins (rosuvastatin, atorvastatin), and any HIV medicines containing tenofovir.
- If you have diabetes, as blood glucose levels can change during HCV treatment.
- If you have kidney problems or are on dialysis.
- If you are pregnant, plan to become pregnant, or are breastfeeding, especially if ribavirin will be part of your treatment.
How to take ledipasvir and sofosbuvir
- Take HARVONI exactly as prescribed. For adults, the usual dose is one tablet (90 mg ledipasvir/400 mg sofosbuvir) once daily.
- Children 3 years and older receive weight-based doses: 35 kg or more take the adult tablet; 17 kg to under 35 kg take 45 mg/200 mg once daily; under 17 kg take 33.75 mg/150 mg once daily (pellet formulation).
- HARVONI may be taken with or without food.
- If ribavirin is co-prescribed, take it exactly as directed by your prescriber — it is weight-based, but its exact administration schedule was not established in the source reviewed for this page; follow ribavirin's own prescribing information.
- Treatment duration ranges from 8 to 24 weeks depending on your genotype and cirrhosis status.
- Do not change the dose or stop treatment yourself — contact your prescriber first if you are considering this.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
No specific missed-dose protocol was extracted from the reviewed US label. Contact your healthcare provider for guidance. Do not take an extra dose to make up for a missed one.
Overdose
No specific overdose protocol was extracted from the reviewed US label. If overdose is suspected, contact your healthcare provider or a poison control center immediately.
Side effects
The most common side effects are generally mild and may not affect everyone.
Fatigue
What to notice: Unusual tiredness or lack of energy.
What to do: Discuss any bothersome fatigue with your healthcare provider. Do not stop taking HARVONI without medical advice. (1)
Headache
What to notice: Aches or pain in the head.
What to do: Mild headaches can be managed as recommended by your healthcare provider. Report persistent or severe headaches. (1)
Asthenia (weakness)
What to notice: General weakness or lack of strength.
What to do: Tell your treatment team if weakness interferes with daily activities. (1)
Possible hepatitis B reactivation
What to notice: A detailed symptom checklist was not established in the source reviewed for this page. This risk applies especially if you have ever had hepatitis B.
What to do: A detailed symptom checklist was not established in the source reviewed for this page. Contact your healthcare provider immediately for any new or unusual symptom, especially if you have ever had hepatitis B. (1)
Slow heart rate with amiodarone
What to notice: A detailed symptom checklist was not established in the source reviewed for this page. This risk is specifically linked to taking amiodarone with HARVONI.
What to do: Seek urgent medical attention; do not ignore these symptoms. (1)
Serious warnings
Hepatitis B virus (HBV) reactivation — emergency
Symptoms: HBV reactivation can cause life-threatening liver failure. A detailed early-symptom checklist was not established in the source reviewed for this page. All patients must be tested for HBV before starting HARVONI, and those with HBV coinfection require close monitoring during and after treatment.
Action: Seek immediate medical attention if you develop any new or unusual symptom. Baseline HBsAg and anti-HBc testing is required before the treating clinician starts HARVONI. (1)
Serious bradycardia with amiodarone — high
Symptoms: Severe slow heart rate (bradycardia) has occurred when HARVONI is taken with amiodarone. A detailed symptom checklist was not established in the source reviewed for this page.
Action: Tell your prescriber if you take or are prescribed amiodarone. Coadministration is not recommended; if the treating team judges it unavoidable, they will arrange appropriate cardiac monitoring. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Amiodarone | Coadministration may cause serious symptomatic bradycardia. | Not recommended. If unavoidable, cardiac monitoring in an inpatient setting for the first 48 hours after starting HARVONI, then ongoing monitoring. (1) |
| P‑glycoprotein (P‑gp) inducers: rifampin, St. John’s wort | Reduce HARVONI plasma concentrations, potentially lowering effectiveness. | Coadministration is not recommended. (1) |
| Other HCV protease inhibitors | Increase ledipasvir concentrations. | Your healthcare provider will decide if coadministration is appropriate based on your treatment regimen. (1) |
| Proton pump inhibitors (PPIs), e.g., omeprazole | Decrease ledipasvir solubility due to higher gastric pH, which may reduce HARVONI effectiveness. | Tell your prescriber or pharmacist if you take or need a PPI so they can give you an individual administration plan. (1) |
| H2‑receptor antagonists, e.g., famotidine | May affect ledipasvir absorption. | Tell your prescriber or pharmacist if you take or need an H2-receptor antagonist so they can give you an individual administration plan. (1) |
| Antacids | May decrease ledipasvir absorption. | Tell your prescriber or pharmacist if you take antacids so they can give you an individual administration plan. (1) |
| Digoxin | Digoxin is identified as requiring monitoring or dose consideration when co-administered with HARVONI. Specific mechanism and magnitude of effect were not established in the source reviewed for this page. | Tell your prescriber if you take digoxin so they can review your regimen. (1) |
| Rosuvastatin and atorvastatin | These statins are identified as requiring monitoring or dose consideration when co-administered with HARVONI. A specific muscle-injury risk mechanism was not established in the source reviewed for this page. | Tell your prescriber if you take rosuvastatin or atorvastatin so they can review your regimen. (1) |
| Tenofovir-containing HIV antiretroviral regimens | Tenofovir-containing HIV regimens are identified as requiring monitoring or dose consideration when co-administered with HARVONI. A specific kidney-risk mechanism was not established in the source reviewed for this page. | Tell your prescriber about any tenofovir-containing HIV regimen so they can review your combined treatment. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Children and adolescents (3 years and older)
Weight‑based dosing applies: 35 kg or more receive the adult tablet (90 mg/400 mg); 17 kg to under 35 kg receive 45 mg/200 mg once daily; under 17 kg receive 33.75 mg/150 mg once daily using the pellet formulation. Safety and efficacy in children under 3 years have not been established. (1)
Pregnancy and breastfeeding
No adequate human data are available for HARVONI. Animal studies did not show adverse developmental effects. However, if HARVONI is used with ribavirin, pregnancy is contraindicated because ribavirin can cause birth defects. It is unknown whether ledipasvir, sofosbuvir, or their metabolites pass into human breast milk; a risk‑benefit discussion with your healthcare provider is needed. (1)
Renal impairment
No dosage adjustment of HARVONI is required for any degree of renal impairment, including end‑stage renal disease requiring dialysis. (1)
Hepatic impairment
No specific hepatic‑impairment dose‑adjustment information was found in the reviewed US label for HARVONI. Dosing in decompensated cirrhosis is described under Uses. (1)
Patients coinfected with HBV
All patients must have baseline HBsAg and anti‑HBc testing. Those with HBV coinfection require careful monitoring for hepatitis flare or HBV reactivation during and after HARVONI treatment. (1)
Monitoring
Before starting
- Test all patients for HBsAg and anti‑HBc to rule out hepatitis B coinfection.
- Confirm HCV genotype and cirrhosis status to determine HARVONI regimen and need for ribavirin.
- Assess current medications for interactions (amiodarone, acid‑reducing agents, P‑gp inducers, statins, tenofovir‑containing HIV therapy, digoxin).
- In women of childbearing potential, verify pregnancy status before adding ribavirin.
- In diabetic patients, note baseline blood glucose control because HCV clearance may alter glucose levels.
During treatment
- Monitor HBV‑coinfected patients for signs of hepatitis flare; follow post‑treatment monitoring as well.
- If amiodarone coadministration is unavoidable, conduct cardiac monitoring for the first 48 hours and continue as appropriate.
- Monitor blood glucose in diabetic patients; adjustments to diabetes therapy may be needed.
- Assess adherence and any adverse effects, particularly fatigue, headache, or signs of liver injury.
Storage
No storage conditions were extracted from the reviewed US label. Store as directed by the current product packaging and your pharmacist.
Professional information
Clinician‑facing context only. Always use the current local prescribing information and hepatitis C treatment guidelines for dosing, monitoring, and management decisions.
United States
Indication: Adult and pediatric dosing for chronic HCV genotypes 1, 4, 5, 6
Dose summary: Adults: one tablet (90 mg ledipasvir/400 mg sofosbuvir) once daily. Pediatric (3 years+, weight‑based): 35 kg+ adult tablet; 17‑<35 kg 45/200 mg daily; <17 kg 33.75/150 mg daily (pellets). Duration 8‑24 weeks depending on genotype and cirrhosis status (whether prior treatment history is also a determining factor was not established in the source reviewed for this page). Ribavirin added for decompensated cirrhosis (genotype 1) and liver transplant (genotype 1 or 4).
Renal context: No dosage adjustment required for any degree of renal impairment, including end‑stage renal disease on dialysis. (1)
Hepatic guidance
No hepatic‑impairment‑specific dose adjustment was found in the reviewed label. Dosing for decompensated cirrhosis is described above under Uses.
Overdose note
No specific overdose-management protocol was established in the source reviewed for this page; this is an evidence gap. (1)
Frequently asked questions
What is HARVONI used for?
HARVONI is used to treat chronic hepatitis C. Specific outcome/cure-rate claims were not established in the source reviewed for this page. Your healthcare provider will explain the expected outcome for your situation. (1)
Why do I need a hepatitis B test before starting HARVONI?
People who have ever had hepatitis B can experience reactivation of the virus during HCV treatment, which can be serious. Testing is required to identify those at risk so they can be monitored closely. (1)
Do I need to take ribavirin with HARVONI?
Ribavirin is only needed for certain patients, such as those with decompensated cirrhosis (genotype 1) or liver transplant recipients (genotypes 1 or 4). Many patients take HARVONI alone. (1)
Can I take HARVONI if I have kidney problems?
Yes. HARVONI does not require dose adjustment for any severity of kidney disease, including if you are on dialysis. (1)
What should I know about acid‑reducing medicines (PPIs, H2‑blockers, antacids) while on HARVONI?
These can affect how much ledipasvir is absorbed. Tell your prescriber or pharmacist about any PPI, H2-blocker, or antacid you take or need, so they can give you an individual administration plan. (1)
What is the mechanism of action of ledipasvir and sofosbuvir?
Ledipasvir is an HCV NS5A inhibitor; sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor. Further mechanistic detail was not established in the source reviewed for this page. (1)
What is the generic name of Sofosbuvir/Ledipasvir?
The generic name is ledipasvir and sofosbuvir. It is sold under brand names including HARVONI. (1)
What class of drug is ledipasvir and sofosbuvir?
Sofosbuvir/Ledipasvir is classed as: Fixed-dose combination of ledipasvir (HCV NS5A inhibitor) and sofosbuvir (HCV nucleotide analog NS5B polymerase inhibitor). (1)
References
- HARVONI (ledipasvir and sofosbuvir) full prescribing informationU.S. Food and Drug Administration / DailyMed · United States · dated Not specified in research notes · accessed 2026-08-05 · source 1
- HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Ledipasvir and Sofosbuvir — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Ledipasvir and Sofosbuvir — FDA approval record (Drugs@FDA NDA205834)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- ledipasvir and sofosbuvir — RxNorm normalized drug concept (RXCUI 1591942)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient ledipasvir and sofosbuvir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Harvoni