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daclatasvir (Daklinza)

Indications: - treatment of refractory hepatitis C, including those with HCV genotype 1 infection [1] - hepatitis C genotype 3 - for use in combination with sofosbuvir [2] Contraindications: - coadministration of daclatasvir, sofosbuvir & amiodarone Dosage: - 60 mg QD Adverse effects: - fatigue, headache, nausea, diarrhea* - reactivation of hepatitis B in patients with current or previous hepatitis B infection [3] - 24% of patients with chronic hepatitis B [4] - 1.4% with resolved hepatitis B infection [4] * in combination with sofosbuvir Drug interactions: - coadministration of daclatasvir, sofosbuvir & amiodarone increases risk of symptomatic bradycardia [2] - cases requiring pacemaker intervention have been reported Mechanism of action: - NS5A replication complex inhibitor

General

antiviral agent

Database Correlations

PUBCHEM cid=25154714

References

  1. Lok AS et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012 Jan 19; 366:216. PMID: 22256805 - Chung RT. A watershed moment in the treatment of hepatitis C. N Engl J Med 2012 Jan 19; 366:273. PMID: 22256811
  2. Brooks M FDA Clears Two New Oral Drugs for Hepatitis C. Medscape Oncology. July 24, 2015 http://www.medscape.com/viewarticle/848650
  3. FDA Drug Safety Communication: Oct 4, 2016 FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm
  4. Mucke MM, Backus LI, Mucke VT et al Hepatitis B virus reactivation during direct-acting antiviral therapy for hepatitis C: a systematic review and meta-analysis. Lancet Gastroenterology & Hepatology. Jan 19, 2018 PMID: 29371017 http://www.thelancet.com/journals/langas/article/PIIS2468-1253(18)30002-5/fulltext