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Direct-acting antiviral (HCV NS5A inhibitor) Pregnancy: Avoid — limited data. If ribavirin co-administered: contraindicated 6 months before, during, and after for both partners (severe teratogen).

Daclatasvir

Brand names: Daklinza

Adult dose

Dose: 60 mg OD for 12 weeks, in combination with sofosbuvir 400 mg OD (± ribavirin in cirrhotic / treatment-experienced).
Route: Oral
Frequency: Once daily
Max: 60 mg/day (90 mg if used with strong CYP3A4 inducer)
Take with or without food. Specialist hepatology/ID prescribing only. Largely superseded in UK by pangenotypic regimens (sofosbuvir/velpatasvir, glecaprevir/pibrentasvir).

Dose adjustments

Renal

No adjustment needed — minimal renal excretion. Useful in CKD/dialysis.

Hepatic

No adjustment for Child-Pugh A or B. Limited data Child-Pugh C — usually used with caution.

Clinical pearls

  • Pan-genotypic NS5A inhibitor for chronic hepatitis C — used in combination with sofosbuvir achieves SVR12 >95%.
  • UK first-line HCV regimens are now pangenotypic combinations (sofosbuvir/velpatasvir = Epclusa, glecaprevir/pibrentasvir = Maviret) — daclatasvir use is niche.
  • Specific niche: HCV genotype 3 (especially with cirrhosis) before pangenotypic regimens were available. Now largely replaced.
  • Most important interaction: amiodarone + sofosbuvir combinations have caused fatal bradycardia — always check current and recent (within 6 months) amiodarone use.
  • HBV screening (HBsAg, anti-HBc) before all DAA HCV therapy — HBV reactivation can be fulminant.
  • Specialist hepatology/HIV-HCV coinfection clinic prescribing.

Contraindications

  • Concurrent strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St John's wort) without dose increase
  • Hypersensitivity

Side effects

  • Headache, fatigue (very common)
  • Nausea
  • Insomnia
  • Anaemia (especially when ribavirin co-administered)
  • Bradycardia / heart block — RARE but serious when combined with sofosbuvir AND amiodarone (FDA black-box; deaths reported)
  • Diarrhoea
  • HBV reactivation (in patients with HBV/HCV co-infection — screen and prophylax)

Interactions

  • Amiodarone + sofosbuvir + daclatasvir: severe symptomatic bradycardia/heart block — AVOID combination; if essential, monitor in hospital
  • Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St John's wort): ↓ daclatasvir — increase to 90 mg OD (or avoid)
  • Strong CYP3A4 inhibitors (clarithromycin, ritonavir, ketoconazole): ↑ daclatasvir — reduce to 30 mg OD
  • Statins: ↑ statin levels (rosuvastatin specifically increased)
  • Digoxin: ↑ digoxin levels via P-gp inhibition — monitor levels
  • OAT/PrEP, oral contraceptives: minimal effect

Monitoring

  • HCV RNA at week 4, end of treatment, and 12 weeks post-treatment (SVR12)
  • ECG and HR if amiodarone exposure within 6 months
  • HBV markers throughout treatment if co-infected
  • LFTs

Reference: BNF 90; SmPC Daklinza; EASL HCV Guidelines 2020; AASLD/IDSA HCV Guidance; FDA Drug Safety Communication Mar 2015 (amiodarone + sofosbuvir). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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