Sofosbuvir

SOVALDI

What it isA nucleotide-analog HCV NS5B polymerase inhibitor that acts as a chain terminator of viral RNA synthesis.

Why this oneIt is the 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.

⚠ BOXED WARNING

Principal riskBoxed warning: risk of hepatitis B virus reactivation, which can be fatal, in patients coinfected with HCV and HBV.

Cost, est. cash$300–$2,000/month

Generic entry2022

Classes and tags

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryUnknown / historical label unavailable

Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.