Ledipasvir/Sofosbuvir

Dosing

1 tab = Ledipasvir 90 mg/Sofosbuvir 400 mg

  • Take with or without food

Decompensated cirrhosis (Child-Pugh B or C)Post-liver transplant, without cirrhosis or with compensated cirrhosis (Child-Pugh A)Treatment-experienced, with compensated cirrhosisTreatment-experienced, without cirrhosisTreatment-naïve, without cirrhosis or with compensated cirrhosis- BW <75 kg: 1 tab PO once daily x12w + Ribavirin 600 mg/d PO, titrated to 1,000 mg/d (2 divided doses)

  • BW ≥75 kg: 1 tab PO once daily x12w + Ribavirin 600 mg/d PO, titrated to 1,200 mg/d (2 divided doses)- BW <75 kg: 1 tab PO once daily x12w + Ribavirin 1,000 mg/d PO (2 divided doses)

  • BW ≥75 kg: 1 tab PO once daily x12w + Ribavirin 1,200 mg/d PO (2 divided doses)1 tab PO once daily x24w (국내허가사항: 12주)1 tab PO once daily x12w1 tab PO once daily x12w May consider x8w if HCV RNA level <6 million international units/mL

Post-liver transplant, without cirrhosis or with compensated cirrhosis- BW <75 kg: 1 tab PO once daily x12w + Ribavirin 1,000 mg/d PO (2 divided doses)

  • BW ≥75 kg: 1 tab PO once daily x12w + Ribavirin 1,200 mg/d PO (2 divided doses)

Without cirrhosis or with compensated cirrhosis1 tab PO once daily x12w

Dose in pediatric patients age ≥3y1 tab = Ledipsavir 90 mg/Sofosbuvir 400 mg

  • Take with food국내허가사항: 12세 이상~18세 미만 (체중별 구분 없음)

Decompensated cirrhosisTreatment-experienced, with compensated cirrhosisTreatment-experienced, without cirrhosisTreatment-naïve, without cirrhosis or with compensated cirrhosis- BW >80 kg: 1 tab PO once daily + Ribavirin 600 mg twice daily x12w

  • BW 66-80 kg: 1 tab PO once daily + Ribavirin 400 mg PO qAM and 600 mg PO qPM x12w

  • BW 50-65 kg: 1 tab PO once daily + Ribavirin 400 mg twice daily x12w

  • BW 47-49 kg: 1 tab PO once daily + Ribavirin 200 mg PO qAM and 400 mg PO qPM x12w

  • BW 35-46 kg: 1 tab PO once daily + Ribavirin 15 mg/kg/d PO (in 2 divided doses) x12w

  • BW 17-34 kg: Ledipasvir 45 mg/Sofosbuvir 200 mg PO once daily + Ribavirin 15 mg/kg/d PO (2 divided doses) x12w

  • BW <17 kg: Ledipasvir 33.75 mg/Sofosbuvir 150 mg PO once daily + Ribavirin 15 mg/kg/d PO (2 divided doses) x12w(국내허가사항: 12주)

  • BW ≥35 kg: 1 tab PO once daily x24w

  • BW 17-34 kg: Ledipasvir 45 mg/Sofosbuvir 200 mg PO once daily x24w

  • BW <17 kg: Ledipasvir 33.75 mg/Sofosbuvir 150 mg PO once daily x24w- BW ≥35 kg: 1 tab PO once daily x12w

  • BW 17-34 kg: Ledipasvir 45 mg/Sofosbuvir 200 mg PO once daily x12w

  • BW <17 kg: Ledipasvir 33.75 mg/Sofosbuvir 150 mg PO once daily x12w- BW ≥35 kg: 1 tab PO once daily x12w

  • BW 17-34 kg: Ledipasvir 45 mg/Sofosbuvir 200 mg PO once daily x12w

  • BW <17 kg: Ledipasvir 33.75 mg/Sofosbuvir 150 mg PO once daily x12w (May consider x8w if HCV RNA level <6 million international units/mL)

Post-liver transplant, without cirrhosis or with compensated cirrhosis- BW >80 kg: 1 tab PO once daily + Ribavirin 600 mg twice daily x12w

  • BW 66-80 kg: 1 tab PO once daily + Ribavirin 400 mg PO qAM and 600 mg PO qPM x12w

  • BW 50-65 kg: 1 tab PO once daily + Ribavirin 400 mg twice daily x12w

  • BW 47-49 kg: 1 tab PO once daily + Ribavirin 200 mg PO qAM and 400 mg PO qPM x12w

  • BW 35-46 kg: 1 tab PO once daily + Ribavirin 15 mg/kg/d PO (2 divided doses) x12w

  • BW 17-34 kg: Ledipasvir 45 mg/Sofosbuvir 200 mg PO once daily + Ribavirin 15 mg/kg/d PO (2 divided doses) x12w

  • BW <17 kg: Ledipasvir 33.75 mg/Sofosbuvir 150 mg PO once daily + Ribavirin 15 mg/kg/d PO (2 divided doses) x12w

Without cirrhosis or with compensated cirrhosis- BW ≥35 kg: 1 tab PO once daily x12w

  • BW 17-34 kg: Ledipasvir 45 mg/Sofosbuvir 200 mg PO once daily x12w

  • BW <17 kg: Ledipasvir 33.75 mg/Sofosbuvir 150 mg PO once daily x12w

No dose adjustment

국내허가사항Mild, moderate, or severe renal impairmentSevere with comorbid decompensated cirrhosisSevere (estimated GFR < 30 mL/min/1.73 m(2)) with HCV Genotype 1, not on dialysis)End-Stage Renal Disease (ESRD) on hemodialysisESRD on hemodialysis with comorbid decompensated cirrhosis투석을 받는 말기 신장 질환(ESRD)을 포함하여 신장애 정도에 관계없이 이 약의 용량조절은 요구되지 않는다. No dose adjustment recommendedNo safety data are availableNo adjustment necessary although increased exposure was observed No adjustment recommended No safety data are available

General Information

Hepatitis C, chronic, Genotype 1, 2, 4, 5, and 6.

Black Box Warning: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Test for HCV genotype prior to initiation of therapy.

Test for hepatitis B surface antigen and hepatitis B core antibody prior to initiation.

Monitor signs and symptoms of hepatitis flare or HBV reactivation during treatment and post-treatment follow-up in patients with evidence of current or prior HBV infection.

Monitor hepatic function in patients with decompensated cirrhosis who are co-administered ribavirin.

Common

  • Headache

  • Fatigue

  • Asthenia

Severe

  • Liver failure

  • Reactivation of HBV

  • Suicidal behavior

Contraindicated

  • Rifampin- reduced plasma cooncentrations

Concomitant use not recommended:

  • Amiodarone

  • Simeprevir

  • Capmatinib

  • Rosuvastatin

  • Rifapentine

  • Digoxin

  • Tenofovir disoproxil fumarate

  • Warfarin

  • P-gp inducers

  • P-glycoprotein inducers

  • Anticonvulsant drugs

  • Proton pump inhibitors

  • Antacids

  • H2-receptor antagonists

Antimicrobial class: Antiviral agent, HCV NS5A Inhibitor

Average serum half life: 47 hours (Ledipasvir), 0.5 (Sofosbuvir) 27 hours (Primary sofosbuvir metabolite)

Precautions: Bradycardia and fatal cardiac arrest have been reported during concurrent use of amiodarone, with some cases requiring pacemaker intervention; monitoring recommended and discontinuation may be necessary. Increased risk of bradycardia during concurrent amiodarone among patients with concomitant beta blocker use, underlying cardiac comorbidities, and advanced liver disease; monitoring recommended.

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