Sofosbuvir + Daclatasvir

Indications

Sofosbuvir + Daclatasvir is used for: Sofosbuvir and Daclatasvir combination indicated for the treatment of, chronic hepatitis C (CHC) infection, as a component of a combination antiviral treatment regimen. Sofosbuvir and Daclatasvir combination should be used in combination with or without ribavirin for the treatment of CHC in adults.

Adult Dose

Oral Adult Tablet: 1 tab once daily.

Child Dose

Safety and efficacy not established

Renal Dose

Renal impairment (any degree): No dose adjustment required

Administration

Can be taken with or without food.

Contra Indications

When Sofosbuvir and Daclatasvir is used in combination with Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Sofosbuvir and Daclatasvir combination treatment with Ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant because of the risks for birth defects and fetal death associated with Ribavirin.

Precautions

Pregnancy: If Ribavirin is used with this combination it may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective non-hormonal methods of contraception and have monthly pregnancy tests.

Pregnancy-Lactation

Interactions

Reduced therapeutic effect w/ drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/oxcarbazepine, rifabutin/rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered w/ amiodarone in combination w/ another direct acting antiviral.

Adverse Effects

Side effects of Sofosbuvir + Daclatasvir : The most common adverse events observed with Sofosbuvir and Daclatasvir in combination with Ribavirin were fatigue and headache. There are some rare side effects, such as Insomnia, Nausea, Pruritus, Anemia, Asthenia, Rash, Anorexia, Chills, Infulenza Like Illness

Mechanism of Action

Daclatasvir Inhibits NS5A, a nonstructural protein encoded by HCV. Binds to the N-terminus within domain 1 of NS5A, which may cause structural distortions that interfere with NS5A functions, and thereby inhibits both viral RNA replication and virion assembly. Sofosbuvir Nucleotide prodrug that undergoes metabolism to the active uridine analog triphosphate, an inhibitor of HCV NS5B RNA-dependent polymerase; its inhibition in turn suppresses viral replication .