Adult Dosing

Chronic hepatitis C (CHC)

• 400 mg PO Daily in combination with ribavirin or in combination with pegylated interferon and ribavirin
• Patients with genotype 1 or 4 CHC, consider 12 weeks of treatment in combination with peginterferon alfa and ribavirin
• Patients with genotype 2 CHC, consider 12 weeks of treatment in combination with ribavirin
• Patients with genotype 3 CHC, consider 24 weeks of treatment in combination with ribavirin

• Sofosbuvir in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible
• Sofosbuvir should be used in combination with ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first.
• Refer package insert for dose modification

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen
• Efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.

• Hypersensitivity to any of the ingredients of the product
• When used in combination all contraindications to peg interferon alfa and/or ribavirin also apply to sofosbuvir
• Pregnant women and in men whose female partners are pregnant

• N/A

Renal Dose Adjustment

• Renal impairment: A dose recommendation cannot be made

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

• Therapy may cause birth defects or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Use contraceptive methods during treatment and for 6 months after completion of treatment, and undergo monthly pregnancy tests
• Drugs that are potent P-gp inducers in the intestine such as rifampin, St. John’s wort may decrease sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of Sofosbuvir

Pregnancy Category:X (with ribavirin or peginterferon alfa/ribavirin

Breastfeeding: It is unknown whether sofosbuvir and its metabolites are present in human breast milk. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with ribavirin-containing regimens, taking into account the importance of the therapy to the mother

• CNS: Headache
• NEURO: Asthenia
• PSYCHIATRY: Irritability
• GI: Nausea, diarrhea
• HEMA: Anemia, neutropenia
• METABOLIC: Decreased appetite
• DERM: Pruritus, rash
• MUSC: Myalgia
• MISC: Fatigue, insomnia, chills, influenza like illness, pyrexia

• Antiviral; nucleotide analogue inhibitor of HCV NS5B polymerase, which plays an essential role in HCV replication that interferes with the HCV life cycle by suppressing viral replication
• Metabolized by liver into GS-461203 (active metabolite) and further into GS-331007 (an inactive metabolite)
• Excreted in urine (80%), feces (14%), and expired air (2.5%)
• Half life: sofosbuvir (0.4 hours) and GS-331007 (27 hours)

US Trade Name(s)

• Sovaldi

US Availability

Sovaldi

• TABS: 400 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antiviral Agents

Nucleotide Analogue Inhibitor