Ledipasvir Sofosbuvir

Ledipasvir Sofosbuvir Brand Name– Harvoni

What is Ledipasvir Sofosbuvir

Ledipasvir sofosbuvir is a combination oral product indicated for the treatment of adults and pediatric patients 3 years and older with chronic hepatitis C virus (HCV) infection (genotypes 1, 4, 5, and 6), including patients with decompensated cirrhosis, HIV coinfection, or who have undergone liver transplantation.

The product is available as a once-daily oral tablet, which contains an HCV NS5A protein inhibitor (ledipasvir) and a nucleotide analog HCV NS5B polymerase inhibitor (sofosbuvir).

The product labeling contains a Black Box Warning regarding reactivation of hepatitis B virus (HBV) infection in HCV/HBV coinfected patients who receive ledipasvir; sofosbuvir without concurrent HBV therapy.

All potential recipients of ledipasvir; sofosbuvir should be tested for evidence of current or prior HBV infection before initiating treatment.

Indications

  • hepatitis C infection
  • hepatitis C virus

NOTE: Consider baseline NS5A resistance-associated substitutions (RAS) testing for HCV genotype 1a-infected, treatment-experienced patients; if present, an alternative therapy should be used. RAS testing NOT recommended for genotype 1a-infected, treatment-naive patients or any patient infected with genotypes 1b, 4, 5, or 6.

Side Effects

  1. angioedema
  2. asthenia
  3. cough
  4. depression
  5. diarrhea
  6. dizziness
  7. dyspnea
  8. fatigue
  9. headache
  10. hepatic failure
  11. hepatitis B exacerbation
  12. hyperbilirubinemia
  13. insomnia
  14. irritability
  15. myalgia
  16. nausea
  17. rash
  18. suicidal ideation

Monitoring Parameters

  • hepatitis B serology
  • LFTs
  • plasma hepatitis C RNA
  • plasma HIV RNA
  • pregnancy testing
  • serum creatinine

Contraindications

  • anticoagulant therapy
  • breast-feeding
  • contraception requirements
  • diabetes mellitus
  • hepatitis B exacerbation
  • hepatitis C and HIV coinfection
  • hyperglycemia
  • hypoglycemia
  • male-mediated teratogenicity
  • pregnancy
  • pregnancy testing
  • reproductive risk
  • use with ribavirin

Interactions

  • Acalabrutinib
  • Acarbose
  • Acetohexamide
  • Afatinib
  • Albiglutide
  • Alogliptin
  • Alogliptin; Metformin
  • Alogliptin; Pioglitazone
  • Alpelisib
  • Aluminum Hydroxide
  • Aluminum Hydroxide; Magnesium Carbonate
  • Aluminum Hydroxide; Magnesium Hydroxide
  • Aluminum Hydroxide; Magnesium Hydroxide; Simethicone
  • Aluminum Hydroxide; Magnesium Trisilicate
  • Amiodarone
  • Amlodipine; Atorvastatin
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Antacids
  • Antidiabetic Agents
  • Apalutamide
  • Aspirin, ASA; Citric Acid; Sodium Bicarbonate
  • Aspirin, ASA; Omeprazole
  • Atazanavir; Cobicistat
  • Atorvastatin
  • Atorvastatin; Ezetimibe
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Belladonna Alkaloids; Ergotamine; Phenobarbital
  • Betrixaban
  • Boceprevir
  • Budesonide
  • Budesonide; Formoterol
  • Calcium Carbonate
  • Calcium Carbonate; Magnesium Hydroxide
  • Calcium Carbonate; Risedronate
  • Calcium Carbonate; Simethicone
  • Canagliflozin
  • Canagliflozin; Metformin
  • Carbamazepine
  • Carvedilol
  • Chlorpropamide
  • Cimetidine
  • Cobicistat
  • Cobimetinib
  • Colchicine
  • Colchicine; Probenecid
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  • Cyclosporine
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  • Dapagliflozin
  • Dapagliflozin; Metformin
  • Dapagliflozin; Saxagliptin
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Dexamethasone
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  • Digoxin
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  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
  • Empagliflozin
  • Empagliflozin; Linagliptin
  • Empagliflozin; Linagliptin; Metformin
  • Empagliflozin; Metformin
  • Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
  • Emtricitabine; Tenofovir disoproxil fumarate
  • Ertugliflozin
  • Ertugliflozin; Metformin
  • Ertugliflozin; Sitagliptin
  • Erythromycin
  • Erythromycin; Sulfisoxazole
  • Esomeprazole
  • Esomeprazole; Naproxen
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  • Fentanyl
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  • Fexofenadine; Pseudoephedrine
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  • Glimepiride; Pioglitazone
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  • Glipizide; Metformin
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  • Glyburide; Metformin
  • H2-blockers
  • Insulin Aspart
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