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
- angioedema
- asthenia
- cough
- depression
- diarrhea
- dizziness
- dyspnea
- fatigue
- headache
- hepatic failure
- hepatitis B exacerbation
- hyperbilirubinemia
- insomnia
- irritability
- myalgia
- nausea
- rash
- 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
- Conivaptan
- Cyclosporine
- Dabigatran
- Dapagliflozin
- Dapagliflozin; Metformin
- Dapagliflozin; Saxagliptin
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Dexamethasone
- Dexlansoprazole
- Dextromethorphan; Quinidine
- Digoxin
- Docetaxel
- Doravirine; Lamivudine; Tenofovir disoproxil fumarate
- Doxorubicin
- Dulaglutide
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Elbasvir; Grazoprevir
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- 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
- Exenatide
- Famotidine
- Famotidine; Ibuprofen
- Fentanyl
- Fexofenadine
- Fexofenadine; Pseudoephedrine
- Fosamprenavir
- Fosphenytoin
- Fostamatinib
- Glecaprevir; Pibrentasvir
- Glimepiride
- Glimepiride; Pioglitazone
- Glimepiride; Rosiglitazone
- Glipizide
- Glipizide; Metformin
- Glyburide
- Glyburide; Metformin
- H2-blockers
- Insulin Aspart
- Insulin Aspart; Insulin Aspart Protamine
- Insulin Degludec; Liraglutide
- Insulin Detemir
- Insulin Glargine
- Insulin Glargine; Lixisenatide
- Insulin Glulisine
- Insulin Lispro
- Insulin Lispro; Insulin Lispro Protamine
- Insulin, Inhaled
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Isophane Insulin (NPH)
- Itraconazole
- Lamivudine; Tenofovir Disoproxil Fumarate
- Lansoprazole
- Lansoprazole; Naproxen
- Lapatinib
- Lefamulin
- Lente Insulin
- Linagliptin
- Linagliptin; Metformin
- Liraglutide
- Lixisenatide
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Lorlatinib
- Lumacaftor; Ivacaftor
- Magnesium Hydroxide
- Maraviroc
- Mefloquine
- Metformin
- Metformin; Pioglitazone
- Metformin; Repaglinide
- Metformin; Rosiglitazone
- Metformin; Saxagliptin
- Metformin; Sitagliptin
- Methadone
- Miglitol
- Mitomycin
- Morphine
- Morphine; Naltrexone
- Nateglinide
- Nizatidine
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole
- Omeprazole; Amoxicillin; Rifabutin
- Omeprazole; Sodium Bicarbonate
- Ondansetron
- Osimertinib
- Ozanimod
- Paclitaxel
- Pantoprazole
- Pazopanib
- Phenobarbital
- Phenytoin
- Pioglitazone
- Posaconazole
- Pramlintide
- Prednisone
- Primidone
- Proton pump inhibitors
- Quinidine
- Quinine
- Rabeprazole
- Ranitidine
- Ranolazine
- Regular Insulin
- Regular Insulin; Isophane Insulin (NPH)
- Repaglinide
- Rifabutin
- Rifampin
- Rifapentine
- Rifaximin
- Rimegepant
- Risperidone
- Ritonavir
- Rivaroxaban
- Rolapitant
- Rosiglitazone
- Rosuvastatin
- Sapropterin
- Saxagliptin
- Semaglutide
- Silodosin
- Simeprevir
- Simvastatin; Sitagliptin
- Sirolimus
- Sitagliptin
- Sodium Bicarbonate
- Sofosbuvir; Velpatasvir
- Sofosbuvir; Velpatasvir; Voxilaprevir
- St. John’s Wort, Hypericum perforatum
- Tafamidis
- Talazoparib
- Tedizolid
- Telotristat Ethyl
- Temsirolimus
- Teniposide
- Tenofovir Alafenamide
- Tenofovir, PMPA
- Ticagrelor
- Tipranavir
- Tolazamide
- Tolbutamide
- Tolvaptan
- Topotecan
- Ubrogepant
- Ultralente Insulin
- Vemurafenib
- Venetoclax
- Vincristine
- Vincristine Liposomal
- Warfarin
- Zonisamide