Harvoni (Ledipasvir/Sofosbuvir)

What it is and what it treats

Ledipasvir/sofosbuvir is a fixed-dose combination direct-acting antiviral (DAA) tablet developed by Gilead Sciences for the treatment of chronic hepatitis C virus (HCV) infection in adults and, in some jurisdictions, adolescents. Ledipasvir inhibits the viral NS5A protein, which is required for HCV replication and assembly, while sofosbuvir is a nucleotide prodrug that inhibits the NS5B RNA-dependent RNA polymerase, terminating viral RNA synthesis. Combined, the two agents interrupt the HCV lifecycle at two distinct points.

Regulatory approvals, including from the FDA and EMA, cover ledipasvir/sofosbuvir primarily for HCV genotypes 1, 4, 5 and 6, with or without compensated cirrhosis, and in certain settings for patients with HIV co-infection or prior treatment failure. It is not the preferred option where the infecting genotype is unknown or where genotype 2 or 3 infection is confirmed, since its labelled efficacy data are strongest for the genotypes above.

Treatment decisions, including genotype testing, assessment of liver fibrosis, and selection of regimen and duration, are made by a hepatologist or physician experienced in managing chronic hepatitis C, in line with the applicable national label and clinical practice guidelines. This monograph is descriptive of the approved product information and does not constitute a treatment recommendation.

Presentations and dosage forms

• 90 mg ledipasvir / 400 mg sofosbuvir film-coated tablets
• Supplied in bottles or blister packs for oral administration
• Paediatric-strength formulations are registered in some jurisdictions for younger age groups
• One tablet contains the complete fixed-dose combination; no separate components are co-administered

How it is administered

The EU SmPC and FDA prescribing information describe ledipasvir/sofosbuvir as one tablet taken orally once daily, with or without food, for a duration determined by treatment history, genotype and the presence or absence of cirrhosis. Labelled treatment durations range from 8 weeks in selected treatment-naïve patients without cirrhosis to 24 weeks in treatment-experienced patients with compensated cirrhosis, in some cases combined with ribavirin per the label.

The product information notes that co-administration with amiodarone is not recommended owing to a risk of symptomatic bradycardia, and that certain acid-reducing agents, P-glycoprotein inducers and other interacting medicines can alter drug exposure and should be reviewed before starting treatment. The prescribing hepatologist determines the specific regimen following the current label; this description is not a dosing instruction.

Before starting therapy, all patients are tested for hepatitis B virus (HBV) markers, in line with the boxed warning regarding HBV reactivation in patients co-infected with HBV and HCV who are treated with direct-acting antivirals. Patients are monitored during and after treatment as directed by the treating clinician, including virological response testing to confirm sustained virological response.

Storage and handling

• Store below 30°C in the original packaging
• No refrigeration or cold-chain handling is required
• Keep the container tightly closed and protect from moisture
• Keep out of reach of children
• Do not use beyond the expiry date printed on the pack

Side effects

The following reflects the adverse reaction profile described in the approved EU SmPC and FDA prescribing information for ledipasvir/sofosbuvir. As an interferon-free, all-oral regimen, it is generally well tolerated compared with older hepatitis C therapies.

Commonly reported

Serious effects requiring medical attention

Any new or unusual symptom, particularly signs of liver dysfunction such as jaundice or dark urine, or symptoms of slow heart rate such as dizziness or fainting, should be reported to the prescribing clinician promptly. Suspected adverse reactions should also be reported through the applicable national pharmacovigilance scheme.

Harvoni vs Epclusa and Maviret

Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir) and Maviret (glecaprevir/pibrentasvir) are all interferon-free, oral direct-acting antiviral regimens for chronic hepatitis C, but they differ in genotype coverage and typical treatment duration. Harvoni's approved label centres on genotypes 1, 4, 5 and 6, whereas Epclusa and Maviret are pan-genotypic, meaning they are approved across genotypes 1 through 6, which is relevant when genotype testing is unavailable or inconclusive.

Maviret combines a protease inhibitor (glecaprevir) with an NS5A inhibitor (pibrentasvir) rather than the NS5B polymerase inhibitor approach shared by Harvoni and Epclusa, giving it a shorter labelled duration in some treatment-naïve populations without cirrhosis. Epclusa shares sofosbuvir with Harvoni but pairs it with velpatasvir, extending genotype coverage relative to ledipasvir.

The choice between these regimens is guided by confirmed genotype, cirrhosis status, prior treatment history, renal function and potential drug interactions, and is made by the treating hepatologist with reference to the current product information for each medicine. None of the three is interchangeable without clinical assessment.

Availability and supply route

Registration of ledipasvir/sofosbuvir, and the specific indications and durations covered under each national label, vary by country and are subject to local regulatory approval and reimbursement policy. Hepatologists and procurement teams should confirm current registration status with the relevant national medicines authority before initiating or sourcing treatment.

Where the product is not registered for a given population or is temporarily unavailable through standard channels, some healthcare systems permit named-patient supply, allowing a physician to request an unlicensed or foreign-registered medicine for an individual, identified patient under documented clinical justification and import controls. This is distinct from routine retail sale and requires a valid prescription throughout.

Pharmacy Remedy is a licensed Turkish pharmaceutical wholesaler operating in the B2B channel, supplying hospitals, clinics and other licensed healthcare entities against valid prescriptions and appropriate import documentation. It does not sell medicines to members of the public, and all supply is subject to verification of licensure and compliance with destination-country import and pharmacovigilance requirements.

Frequently asked questions

Primary sources

• EMA — Harvoni (ledipasvir/sofosbuvir) product information
• FDA — Harvoni prescribing information

Further reading and regulatory routes

• How to verify a medicine is genuine
• Why medicines cost less in Türkiye
• WHO falsified medicine alerts
• Named patient supply
• UAE import guide
• For healthcare professionals
• All medicine monographs

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