• Chronic hepatitis C virus (HCV) infection (genotypes 1 or 4) in patients without cirrhosis or with compensated cirrhosis (in combination with ribavirin and peginterferon alfa).
• Chronic HCV infection (genotypes 2 or 3) in patients without cirrhosis or with compensated cirrhosis (in combination with ribavirin).

Contraindicated in:

• Contraindications for ribavirin and/or peginterferon alfa
• Severe renal impairment/end-stage renal disease
• Concurrent use of P-gp inducers, including rifampin and St. John's wort
• OB: Pregnant women or men whose partners are pregnant (ribavirin may cause fetal harm).

Use Cautiously in:

• Receiving immunosuppressant or chemotherapy medications (↑ risk of hepatitis B virus reactivation)
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Rep: Women and men of reproductive potential
• Pedi: Children <3 yr (safety and effectiveness not established).

In combination with ribavirin

GI: diarrhea, nausea.

Derm: pruritus.

MS: myalgia.

Neuro: fatigue, headache, insomnia, irritability, weakness.

Misc: chills, fever, hepatitis B virus reactivation.

In combination with ribavirin and peginterferon alfa

CNS: fatigue, headache, insomnia, irritability, weakness.

Derm: rash, pruritus.

GI: diarrhea, nausea, hepatitis B virus reactivation.

Hemat: anemia.

MS: myalgia.

Misc: chills, fever.

Drug-Drug:

• Levels and effectiveness may be ↓ by concurrent use of carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine and tipranavir/ritonavir; avoid concurrent use.
• Amiodarone may ↑ risk of symptomatic bradycardia when used with sofosbuvir; concurrent use not recommended; if amiodarone necessary, monitor patients in inpatient setting for first 48 hr of concomitant use and then monitor heart rate on outpatient basis for at least the first 2 wk of treatment (follow same monitoring procedure if discontinuing amiodarone immediately before initiation of sofosbuvir therapy).
• May cause fluctuations in INR when used with warfarin; closely monitor INR.
• May ↑ risk of hypoglycemia when used with certain antidiabetic agents.

Drug-Natural Products:

• Levels and effectiveness may be ↓ by concurrent use of P-gp inducers including St. John's wort; avoid concurrent use.

• Oral pellets: 150 mg/pkt; 200 mg/pkt;
• Tablets: 200 mg; 400 mg;

• PO (Adults): Genotypes 1 or 4 (treatment-nave without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 400 mg once daily for 12 wk in combination with peginterferon alfa and ribavirin; Genotype 2 (treatment-nave and treatment-experienced without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 400 mg once daily for 12 wk in combination with ribavirin; Genotype 3 (treatment-nave and treatment experienced without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 400 mg once daily for 24 wk in combination with ribavirin; Patients with hepatocellular carcinoma awaiting liver transplantation — 400 mg once daily in combination with ribavirin for up to 48 wk or until transplantation, whichever occurs first.
• PO (Children 3 yr and 35 kg): Genotype 2 (treatment-nave and treatment-experienced without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 400 mg (as one 400–mg tablet, two 200–mg tablets or two 200–mg packets of oral pellets) once daily for 12 wk in combination with ribavirin; Genotype 3 (treatment-nave and treatment experienced without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 400 mg (as one 400–mg tablet, two 200–mg tablets or two 200–mg packets of oral pellets) once daily for 24 wk in combination with ribavirin.
• PO (Children 3 yr and 17–<35 kg): Genotype 2 (treatment-nave and treatment-experienced without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 200 mg (as one 200–mg tablet or one 200–mg packet of oral pellets) once daily for 12 wk in combination with ribavirin; Genotype 3 (treatment-nave and treatment experienced without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 200 mg (as one 200–mg tablet or one 200–mg packet of oral pellets) once daily for 24 wk in combination with ribavirin.
• PO (Children 3 yr and <17 kg): Genotype 2 (treatment-nave and treatment-experienced without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 150 mg (as one 150–mg packet of oral pellets) once daily for 12 wk in combination with ribavirin; Genotype 3 (treatment-nave and treatment experienced without cirrhosis or with compensated cirrhosis [Child-Pugh A]) — 150 mg (as one 150–mg packet of oral pellets) once daily for 24 wk in combination with ribavirin.

Sovaldi

• Inhibits RNA-dependent RNA polymerase, resulting in inhibition of viral replication.

• Decreased HCV RNA levels with decreased severity and sequelae of HCV.

Therapeutic Classification: antivirals

Pharmacologic Classification: polymerase inhibitors

Absorption: Rapidly metabolized following absorption.

Distribution: Unknown.

Metabolism/Excretion: Extensively metabolized with much conversion to GS-461203, an active antiviral moiety, then converted GS-331007, which does not have antiviral activity. 80% excreted in urine mostly as GS-331007 (3.5% as unchanged drug), 14% excreted in feces, 2.5% excreted in expired air.

Half-life: Sofosbuvir — 0.4 hr; GS-331007 — 27 hr.

(blood levels)

† Sofosbuvir (2–4 hr for GS-331007).

• Instruct patient to take sofosbuvir with ribavirin or ribavirin plus peg-interferon alfa as directed. Take missed doses on same day on one day as soon as remembered; do not double doses. Advise patient to read Patient Information before starting and with each refill in case of changes.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially St. Johns Wort.
• Rep: Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception due to risks for birth defects and fetal death and avoid breastfeeding. Women and male partners must use 2 forms of non-hormonal contraception during and for at least 6 mo after discontinuation of therapy. Encourage patients with HCV/HIV 1 co-infection taking antiretrovirals to enroll in the Antiviral Pregnancy Registry at 1-800-258-4263.

soe-FOS-bue-vir

NDC Code^*

• 61958- Gilead Sciences, Inc.
  • 61958-1501- Sovaldi
    • 61958-1501-1- 28 TABLET, FILM COATED in 1 BOTTLE (61958-1501-1)

• 61958- Gilead Sciences, Inc.
  • 61958-1503- Sovaldi
    • 61958-1503-1- 28 TABLET, FILM COATED in 1 BOTTLE (61958-1503-1)

• 61958- Gilead Sciences, Inc.
  • 61958-1504- Sovaldi
    • 61958-1504-1- 60 PELLET in 1 PACKET (61958-1504-1)

• 61958- Gilead Sciences, Inc.
  • 61958-1505- Sovaldi
    • 61958-1505-1- 80 PELLET in 1 PACKET (61958-1505-1)