Sofosbuvir

Dosing

국내허가사항Treatment-naïve, without cirrhosis or with compensated cirrhosis, in combination with Peginterferon + Ribavirin- HCV 단독감염: 본제+ 리바비린+ 페그인터페론 알파(12주) 또는 본제+ 리바비린(페그인터페론 알파 투여 부적격 또는 내약성이 없는 환자에 한해 사용, 24주)

  • HIV 동시감염: 본제+ 리바비린(24주)- BW <75 kg: 400 mg PO once daily + Peginterferon alfa + Ribavirin 500 mg PO twice daily x12w

  • BW ≥75 kg: 400 mg PO once daily + Peginterferon alfa + Ribavirin 600 mg PO twice daily x12w

Without cirrhosis or with compensated cirrhosis, in combination with Ribavirin- BW <75 kg: 400 mg PO once daily + Ribavirin 500 mg PO twice daily x12w

  • BW ≥75 kg: 400 mg PO once daily + Ribavirin 600 mg PO twice daily x12w

Without cirrhosis or with compensated cirrhosis, in combination with Ribavirin- BW <75 kg: 400 mg PO once daily + Ribavirin 500 mg PO twice daily x24w

  • BW ≥75 kg: 400 mg PO once daily + Ribavirin 600 mg PO twice daily x24w

국내허가사항Treatment-naïve, without cirrhosis or with compensated cirrhosis, in combination with Peginterferon + Ribavirin- HCV 단독감염: 본제+ 리바비린+ 페그인터페론 알파(12주) 또는 본제+ 리바비린(페그인터페론 알파 투여 부적격 또는 내약성이 없는 환자에 한해 사용, 24주)

  • HIV 동시감염: 본제+ 리바비린(24주)- BW <75 kg: 400 mg PO once daily + Peginterferon alfa + Ribavirin 500 mg PO twice daily x12w

  • BW ≥75 kg: 400 mg PO once daily + Peginterferon alfa + Ribavirin 600 mg PO twice daily x12w

Genotype 1-4, as component of combination antiviral treatmentNo renal dose adjustment- BW <75 kg: 400 mg PO once daily for up to 48w or until transplantation + Ribavirin 500 mg PO twice daily

  • BW ≥75 kg: 400 mg PO once daily for up to 48w or until transplantation + Ribavirin 600 mg PO twice daily

국내허가사항만12세 미만의 소아에 대한 이 약의 안전성 및 유효성은 입증되지 않았으며 이용 가능한 데이터가 없다- Safety and efficacy in pediatric patients with Genotypes 1 or 4 HCV have not been established

  • Safety and efficacy in post-liver transplant patients have not established

  • Take with food

Age ≥3yAge ≥3y: Without cirrhosis or with compensated cirrhosis in combination with RibavirinAge ≥3y: Liver carcinoma, Awaiting liver transplantationNo renal dose adjustment- BW >80 kg: 400 mg PO once daily + Ribavirin 600 mg twice daily

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

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

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

  • BW 35-46 kg: 400 mg PO once daily + Ribavirin 15 mg/kg/d PO (2 divided doses)

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

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

  • Genotype 3: x24wUp to 48w or until transplantation

No dose adjustment

General Information

Hepatitis C, chronic Genotype 1, 2, 3, and 4 in adults Genotype 2 and 3 in children

Black Box Warning: Test all patients for evidence of current or prior hepatitis B virus infection before initiating treatment with sofosbuvir. 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. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. 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 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.

Common

  • Diarrhea

  • Anemia

  • Headache

  • Insomnia

  • Fatigue

  • Pruritus

Severe

  • Bradyarrhythmia

  • Liver failure

  • Increased bilirubin level

  • Reactivation of HBV

  • Psychiatric effects

Contraindications:

  • Rifampin- may reduce plasma concentrations

Major drug-drug interactions:

  • Amiodarone

  • Warfarin

  • Capmatinib

  • Rifapentine

  • P-gp inducers

Antimicrobial class: Antiviral agent, NS5B RNA polymerase inhibitor

Average serum half life: 0.4 hour

Precautions:

  • Monotherapy or sofosbuvir dose reduction is not recommended.

  • 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.

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