Daclatasvir: A NS5A Replication Complex Inhibitor for Hepatitis C Infection.

Article Details

Citation

Copy to clipboard

Smith MA, Regal RE, Mohammad RA

Daclatasvir: A NS5A Replication Complex Inhibitor for Hepatitis C Infection.

Ann Pharmacother. 2016 Jan;50(1):39-46. doi: 10.1177/1060028015610342. Epub 2015 Oct 20.

PubMed ID

26486762 [ View in PubMed

]

Abstract

OBJECTIVES: To review the pharmacology, efficacy, and safety of daclatasvir in the treatment of patients with chronic hepatitis C virus (HCV) infection. DATA SOURCES: A literature search through EMBASE and PubMed was conducted (January 1966 to August 2015) using the terms BMS-790052, daclatasvir, and hepatitis C. References from retrieved articles were reviewed for any additional material. Additionally, the new drug application and prescribing information were retrieved. STUDY SELECTION/DATA EXTRACTION: The literature search was limited to human studies published in English. Phase 1, 2, and 3 studies describing the pharmacology, pharmacokinetics, efficacy, and safety of daclatasvir for HCV were identified. DATA SYNTHESIS: Daclatasvir, a nonstructural 5A protein inhibitor, combined with sofosbuvir, is indicated for adult patients with chronic HCV genotype 3 regardless of treatment or cirrhosis status. The phase III ALLY-3 trial (n = 152) demonstrated that daclatasvir taken once daily with sofosbuvir for 12 weeks was effective at achieving sustained virological response (SVR) rates in treatment-naive (97%) and treatment-experienced (94%) patients without cirrhosis. Patients with cirrhosis had significantly lower SVR rates (58 and 69%, respectively). The most common adverse drug events associated with daclatasvir and sofosbuvir in ALLY-3 were headache (20%), fatigue (19%), and nausea (12%). CONCLUSIONS: Daclatasvir, when combined with sofosbuvir, is an effective agent to treat HCV genotype 3, with SVR rates above 90% for patients without cirrhosis who are treatment naive or experienced. SVR rates for treatment-naive or -experienced patients with cirrhosis are not as robust (58%-69%).

DrugBank Data that Cites this Article

Drugs

Daclatasvir

Drug Enzymes

Drug	Enzyme	Kind	Organism	Pharmacological Action	Actions
Daclatasvir	Cytochrome P450 3A4	Protein	Humans	Unknown	Substrate	Details
Daclatasvir	Cytochrome P450 3A43	Protein	Humans	Unknown	Substrate	Details
Daclatasvir	Cytochrome P450 3A5	Protein	Humans	Unknown	Substrate	Details
Daclatasvir	Cytochrome P450 3A7	Protein	Humans	Unknown	Substrate	Details

Drug Transporters

Drug	Transporter	Kind	Organism	Pharmacological Action	Actions
Daclatasvir	ATP-binding cassette sub-family G member 2	Protein	Humans	Unknown	Inhibitor	Details
Daclatasvir	P-glycoprotein 1	Protein	Humans	Unknown	Substrate Inhibitor	Details
Daclatasvir	Solute carrier organic anion transporter family member 1B1	Protein	Humans	Unknown	Inhibitor	Details
Daclatasvir	Solute carrier organic anion transporter family member 1B3	Protein	Humans	Unknown	Inhibitor	Details