sofosbuvir
Regulatory sources consulted
Approved indications
- Treatment of chronic hepatitis C in adults and adolescents aged 12 to under 18 years, always with other medicines.
Contraindications
Absolute
- Hypersensitivity to sofosbuvir.
- Use of strong intestinal P-gp inducers such as rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, or St John’s wort.
Clinical warnings
- Before starting a direct-acting antiviral, assess current or prior HBV infection and monitor for reactivation during and after treatment. — CIMA/AEMPS, ficha técnica 113894001
- Combination with amiodarone may cause severe bradycardia or heart block; use only when no alternative exists and with intensive monitoring. — CIMA/AEMPS, ficha técnica 113894001
Drug interactions
- HighAmiodarone
Mechanism: It may cause severe symptomatic bradycardia and heart block.
Recommendation: Use only when no alternative exists; also consider amiodarone stopped months earlier, monitor continuously for 48 hours at initiation in high-risk patients, and continue clinical monitoring afterward.
CIMA/AEMPS, ficha técnica 113894001
- ModerateP-gp inducers
Mechanism: They reduce sofosbuvir and may cause loss of efficacy.
Recommendation: Do not combine with strong inducers; also avoid moderate inducers.
CIMA/AEMPS, ficha técnica 113894001
- HighVitamin K antagonists
Mechanism: Liver function may change during antiviral treatment and alter INR.
Recommendation: Monitor INR closely during and after treatment.
CIMA/AEMPS, ficha técnica 113894001
Adverse events
Common (≥1%)
Fatigue, headache, nausea, and insomnia in studied combination regimens
Rare but serious
Severe bradycardia, heart block, and HBV reactivation
Pregnancy and lactation
It is preferable to avoid sofosbuvir during pregnancy; if combined with ribavirin, its strict contraindications apply. It should not be used during breastfeeding.