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DAA HCV (NS5A + NS5B inhibitor)

Ledipasvir with sofosbuvir

Brand names: Harvoni

Ledipasvir with sofosbuvir is a fixed-dose direct-acting antiviral combination taken once daily for the treatment of chronic hepatitis C infection.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

Ledipasvir inhibits the HCV NS5A protein required for viral replication and assembly, while sofosbuvir is a nucleotide NS5B polymerase inhibitor that terminates viral RNA synthesis.

Prescribing in practice

  • Co-administration with amiodarone has caused serious symptomatic bradycardia and is not recommended; check for hepatitis B status before starting because of the risk of HBV reactivation.
  • Ledipasvir absorption depends on gastric acidity, so acid-suppressing drugs such as proton pump inhibitors require careful timing and dose consideration.
  • It interacts with potent P-glycoprotein inducers (for example rifampicin and St John's wort), which reduce antiviral levels and should be avoided.

Monitoring

Assess hepatitis B serology before treatment, monitor for HBV reactivation, and confirm sustained virological response after completing the course.

Counselling the patient

  • Take the tablet once daily and complete the full course for the best chance of cure.
  • Tell your clinician about all medicines, including antacids and herbal products like St John's wort.
  • Report dizziness, fainting or a very slow heartbeat, especially if you take heart-rhythm medicines.

Evidence & guidelines

High sustained virological response rates were demonstrated in the ION programme of phase 3 trials; NICE recommends direct-acting antivirals for chronic hepatitis C.

Reference: NICE TA363; EASL HCV guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.