Ledifos combines Ledipasvir and Sofosbuvir, two direct‑acting antiviral drugs formulated in a single oral tablet. It is FDA‑approved (under the brand name Harvoni) for treating chronic hepatitis C virus (HCV) infection, particularly genotypes 1, 4, 5, and 6, in adults and children aged 3 and above—with or without compensated cirrhosis. It’s also used in certain cases with decompensated liver disease, often combined with ribavirin.

Mechanism of Action

• Ledipasvir inhibits the HCV NS5A protein, disrupting essential processes involved in viral replication, assembly, and secretion.

• Sofosbuvir is a nucleotide analog that targets NS5B RNA polymerase, acting as an RNA chain terminator once incorporated into viral RNA. Together, they produce a synergistic antiviral effect.

  Uses
  Ledifos is prescribed for:

  • Treating adults and children (≥ 3 years) with chronic HCV genotype 1, 4, 5, or 6 infection, regardless of cirrhosis status.

  • Treating genotype 1 infection in patients with liver transplant or decompensated cirrhosis, often combined with ribavirin.

  • An effective option for HCV/HIV co-infected patients under compatible antiretroviral regimens, showing cure (SVR12) rates around 96–98 %.

    Adverse Effects
    Common side effects (in > 10 % of patients):

    • Fatigue, headache, weakness; also insomnia.

    • Nausea, diarrhea, rash, and cough occur in 1–10 % of people.

    Serious warnings:

    • Risk of reactivation of hepatitis B virus (HBV) in co-infected patients, which can cause liver failure or death. Consultants should be screened before starting therapy.

    • Risk of bradycardia or slow heart rate when used with amiodarone, sometimes with fatal outcomes. Requires monitoring.