Ledipasvir and Sofosbuvir

Antiviral, Systemic · HCV NS5A inhibitors/Nucleotide analogue

Indications

Treatment of chronic hepatitis C.

Dosage

Adults: The recommended dose is one tablet taken orally once daily with or without food. Children: Not recommended.

Adverse Effects

Fatigue, headache and asthaenia.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: HCV genotype 2. Precautions: Severe renal impairment or end stage renal disease. HCV genotype 5 or 6 in patients with decompensated cirrhosis, awaiting liver transplant or post transplant. Prior exposure to HCV direct-acting antivirals. Risk of HBV reactivation; screen for co-infection before starting treatment.

Interactions

Famotidine, omeprazole, digoxin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, tipranavir / ritonavir, St. John's wort, pravastatin, dabigatran etexilate, rosuvastatin, other statins, antacids, amiodarone, simeprevir, atazanavir, tipranavir, vit K antagonists. Substrates of P-gp, BCRP.

Pharmacokinetics

Note: The pharmacokinetic profile in paediatric patients =12 yrs of age is similar to adult patients. LEDIPASVIR: Absorption: Well absorbed. Metabolism: Slow oxidative metabolism via unknown mechanism. Half-life elimination: 47 hrs. Time to peak: 4-4.5 hrs. Excretion: Faeces (approx. 86%). Urine (1%). SOFOSBUVIR: Absorption: well absorbed. Metabolism: Hepatic. Half-life elimination: Approx. 0.5 hrs. Time to peak: Approx. 0.8-1 hr. Excretion: Urine (80%). Faeces (14%).

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.