Indications
Ledipasvir is an antiviral medicine used, in a fixed combination tablet with Sofosbuvir, to treat chronic (long-term) hepatitis C virus infection in adults and children, mainly genotypes 1, 4, 5 and 6, including people with compensated cirrhosis (scarring of the liver) and some people with HIV co-infection.
How It Works
Ledipasvir blocks a hepatitis C protein called NS5A, which the virus needs to copy itself and assemble new virus particles. Sofosbuvir blocks a different viral enzyme (NS5B polymerase). Together they stop the virus multiplying, and in most people the virus is cleared from the blood after a full course (sustained virological response).
Dosage and Administration
The usual adult dose is one tablet containing Ledipasvir 90 mg and Sofosbuvir 400 mg once a day, with or without food. Treatment usually lasts 8, 12 or 24 weeks depending on the virus genotype, previous treatment, and whether cirrhosis is present; your doctor decides the length. Take it at the same time each day and finish the full course. Children’s doses depend on weight and are prescribed by a specialist.
Interactions
Amiodarone must not be taken with this medicine, as it can cause a dangerously slow heartbeat. Rifampicin, Rifabutin, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine and St John’s Wort reduce its effect and should not be used. Antacids, H2 blockers such as Famotidine, and proton pump inhibitors such as Omeprazole reduce absorption; follow your doctor’s spacing advice. It raises levels of Rosuvastatin (avoid) and Digoxin, and can affect Tenofovir levels. Warfarin control and blood sugar may change as the liver improves.
Contraindications
Do not use if you are allergic to Ledipasvir or Sofosbuvir, or if you are taking Rosuvastatin, Amiodarone (unless in exceptional cases under close monitoring) or strong inducers such as Rifampicin or St John’s Wort.
Side Effects
Common side effects are tiredness, headache, nausea, trouble sleeping and diarrhoea, usually mild.
Get urgent medical help if you have a slow heartbeat, fainting, dizziness, chest pain or shortness of breath (especially if you have taken Amiodarone), yellowing of the skin or eyes, dark urine, confusion or swelling of the abdomen. People who have had hepatitis B should report any signs of liver problems, because hepatitis B can flare up during or after treatment.
Pregnancy and Lactation
Information in pregnancy is limited; use only if your doctor advises. If used with Ribavirin, pregnancy must be avoided by both partners during and after treatment. Ask your doctor about breastfeeding.
Precautions and Warnings
All patients are tested for hepatitis B before treatment. Liver tests and viral load are checked. Tell your doctor about kidney problems, liver transplant, heart conditions and all medicines you take. Treatment does not protect against reinfection; avoid sharing needles, razors or toothbrushes.
Overdose
There is no specific antidote. Contact a doctor or the nearest hospital for monitoring and supportive care.
Therapeutic Class
Direct-acting antiviral for hepatitis C, NS5A inhibitor.
Storage
Store below 30°C in a dry place, in the original pack, away from light and out of the reach of children.
Prepared by the Oshud Alo team from standard drug references. For information only; always follow your doctor's advice.