1. Indications and Usage
\nTreatment of Chronic Hepatitis C Virus (HCV) Infection:Indicated for the treatment of adults and pediatric patients aged 12 years and older (or weighing at least 35 kg) with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5, or 6 infection.
\nCombination Therapy:Can be used as a single tablet regimen or in combination with ribavirin, depending on the patient’s HCV genotype, presence of cirrhosis, and prior treatment history.
\n2. Dosage and Administration
\nRecommended Dosage:Adults and Adolescents (\u226512 years or \u226535 kg): One tablet orally, once daily. Each tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir.
\nAdministration Instructions:Can be taken with or without food.
\nSwallow the tablet whole; do not chew or crush due to the bitter taste.
\nTreatment Duration:Typically 8, 12, or 24 weeks, depending on the HCV genotype, presence of cirrhosis (compensated or decompensated), prior treatment experience, and whether ribavirin is co-administered.
\nMissed Dose:If a dose is missed and it is less than 18 hours since the usual time of dosing, take the dose as soon as possible and resume the normal schedule.
\nIf more than 18 hours have passed, skip the missed dose and resume the normal schedule. Do not take a double dose.
\n3. Mechanism of Action
\nDirect-Acting Antiviral (DAA) Combination:Ledipasvir and sofosbuvir are direct-acting antiviral agents that target different steps in the HCV life cycle.
\nLedipasvir:An NS5A (non-structural protein 5A) inhibitor, which is required for viral RNA replication and virion assembly.
\nSofosbuvir:A nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. It acts as a chain terminator.
\nPhysiological Effect:The combination of these two agents inhibits HCV replication, effectively reducing the viral load and clearing the infection.
\n4. Safety and Warnings
\nHepatitis B Virus (HBV) Reactivation:Test all patients for evidence of current or prior HBV infection before initiating treatment. HBV reactivation has been reported in patients coinfected with HCV and HBV who were treated with or completed HCV direct-acting antivirals.
\nBradycardia with Concomitant Amiodarone:Serious symptomatic bradycardia may occur in patients taking amiodarone concomitantly with sofosbuvir-containing regimens. Concomitant use is not recommended.
\nPregnancy and Lactation:If co-administered with ribavirin, the pregnancy precautions and contraindications for ribavirin apply. Ribavirin may cause birth defects and fetal death.
\nRenal Impairment:No dosage adjustment is required for patients with mild, moderate, or severe renal impairment, including those with end-stage renal disease (ESRD) requiring dialysis.
\n5. Adverse Reactions
\nMost Common:Fatigue, headache, nausea, diarrhea, and insomnia.
\nOther:Rash, pruritus, and elevations in ALT (alanine aminotransferase).
\n6. Drug Interactions
\nP-glycoprotein (P-gp) Inducers:Concomitant use with strong P-gp inducers (e.g., rifampin, St. John’s wort, carbamazepine, phenytoin, phenobarbital) significantly decreases ledipasvir and sofosbuvir plasma concentrations and is not recommended.
\nAcid-Reducing Agents:Ledipasvir solubility decreases as pH increases. Concomitant use with proton pump inhibitors (PPIs), H2-receptor antagonists, or antacids may decrease ledipasvir plasma concentrations. Follow specific dosing separation recommendations.
\nStatins:May increase plasma concentrations of certain statins (e.g., rosuvastatin), increasing the risk of myopathy. Monitor closely or avoid concomitant use.
\nAmiodarone:Serious symptomatic bradycardia may occur. Concomitant use is not recommended.
\n7. Pharmaceutical Information
\nChemical Name:
\nLedipasvir: Methyl N-[(1S)-1-[[(6S)-6-[5-[9,9-difluoro-7-[2-[(1R,3S,4S)-2-[(2S)-2-[(methoxycarbonyl)amino]-3-methyl-1-oxobutyl]-2-azabicyclo[2.2.1]heptan-3-yl]-1H-benzimidazol-6-yl]-9H-fluoren-2-yl]-1H-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]carbonyl]-2-methylpropyl]carbamate.
\nSofosbuvir: Isopropyl (2S)-2-[[[(2R,3S,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy-phenoxyphosphoryl]amino]propanoate.
\nMolecular Formula:
\nLedipasvir: C49H54F2N8O6.
\nSofosbuvir: C22H29FN3O9P.
\nStorage:Store at or below 30\u00b0C (86\u00b0F). Keep the bottle tightly closed to protect from moisture.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u590f\u5e06\u5b81\u00ae (Harvoni\u00ae)
\nGeneric Name: Ledipasvir and Sofosbuvir
\nStrength: Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir, 28 tablets per box
\nManufacturer: Gilead Sciences Ireland UC
\nMarketing Authorization Holder: Gilead Sciences, Inc.\uff08\u5883\u5185\uff1a\u5409\u5229\u5fb7\u79d1\u5b66\uff08\u4e0a\u6d77\uff09\u6709\u9650\u516c\u53f8\uff09
\nApproval Date in China: December 22, 2018
\nRegistration Number: \u56fd\u836f\u51c6\u5b57HJ20180036
\nStorage: Store below 30\u2103, keep sealed and away from moisture; keep out of sight and reach of children<\/p>\n
Price&Cost:Contact Us now for the best price of Ledipasvir and Sofosbuvir\uff08Harvoni\uff09<\/p>\n","protected":false},"featured_media":3104,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[27],"product_tag":[],"class_list":["post-3101","product","type-product","status-publish","has-post-thumbnail","product_cat-tablets","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n