Sofosbuvir
SOVALDI
Pronunciation: soe-FOS-byoo-veer (soe-VAHL-dee)
What it isA nucleotide-analog HCV NS5B polymerase inhibitor that acts as a chain terminator of viral RNA synthesis.
Why this oneThe backbone of pan-genotypic direct-acting antiviral regimens that cure the large majority of chronic hepatitis C infections.
What limits itA boxed warning for HBV reactivation and serious symptomatic bradycardia when co-administered with amiodarone are key cautions.
Sofosbuvir prescription history
Animated chart of estimated U.S. prescriptions per year, Hepatitis C meds (1987–2026). Sofosbuvir enters in 2013 (estimated).
FDA-approved for
- chronic hepatitis C, genotypes 1–4, in combination (adults); genotypes 2–3 with ribavirin (≥3 y) (2013)
Principal riskBoxed warning: risk of hepatitis B virus reactivation, which can be fatal, in patients coinfected with HCV and HBV.
Generic entry2022
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic HCV genotype 1 or 4, without cirrhosis or with compensated cirrhosis | Adults | 400 mg QD + peginterferon alfa + ribavirin | 12 weeks | 400 mg QD |
| Chronic HCV genotype 2, without cirrhosis or with compensated cirrhosis | Adults | 400 mg QD + ribavirin | 12 weeks | 400 mg QD |
| Chronic HCV genotype 3, without cirrhosis or with compensated cirrhosis | Adults | 400 mg QD + ribavirin | 24 weeks | 400 mg QD |
| Chronic HCV genotype 2 or 3, without cirrhosis or with compensated cirrhosis | Pediatric ≥3 y | ≥35 kg: 400 mg QD; 17 to <35 kg: 200 mg QD; <17 kg: 150 mg QD (oral pellets); + ribavirin | Genotype 2: 12 weeks; genotype 3: 24 weeks | 400 mg QD |
Renal No adjustment for mild or moderate renal impairment; no dosage recommendation for severe impairment (eGFR <30 mL/min/1.73m2) or ESRD
Hepatic No adjustment for mild, moderate, or severe hepatic impairment (Child-Pugh A, B, or C); not established in decompensated cirrhosis
Genotype 1 interferon-ineligible adults: SOVALDI + ribavirin for 24 weeks can be considered. Hepatocellular carcinoma awaiting liver transplantation: with ribavirin for up to 48 weeks or until transplantation.
Instructions
- Take orally once daily with or without food
- Always in combination (ribavirin, or peginterferon alfa + ribavirin); discontinue if the other agents are permanently discontinued
- Dosage reduction of SOVALDI is not recommended
- Test all patients for HBV (HBsAg and anti-HBc) before initiating
- Pellets: do not chew; may sprinkle on non-acidic soft food and take within 30 minutes
- Coadministration of amiodarone is not recommended (serious symptomatic bradycardia)
Contraindications
- When used with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to those agents also apply to SOVALDI combination therapy
Cautions
- Risk of HBV reactivation in HCV/HBV coinfected patients
- Serious symptomatic bradycardia when coadministered with amiodarone
- Reduced therapeutic effect with P-gp inducers
- Risks associated with combination treatment
Adverse reactions
- Fatigue
- Headache
- Nausea
- Insomnia
- Pruritus
- Anemia
- Decreased appetite (pediatric)
Pregnancy No adequate human data for SOVALDI; no adverse developmental outcomes in animals. With ribavirin or peginterferon alfa/ribavirin the regimen is contraindicated in pregnant women and in men whose female partners are pregnant.
Lactation Unknown whether present in human milk; the main metabolite is present in rat milk. If given with ribavirin, the ribavirin nursing information also applies.
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Self-check
- Which HCV polymerase does sofosbuvir inhibit?
NS5B. - What can occur when sofosbuvir is combined with amiodarone?
Serious symptomatic bradycardia.