Daclatasvir Dihydrochloride and Migalastat Hydrochloride

• Generic Name: daclatasvir
• Dosage Forms: n.a.
• Other Brand Names: Daklinza

Treatment of chronic HCV genotype 1 or genotype 3 infection in treatment-naive (previously untreated) or previously treated adults, including those with cirrhosis (compensated or decompensated), liver transplant recipients, and those with HIV coinfection.

Treatment of chronic HCV genotype 2 or genotype 4 infection; only limited data available.

Must be used in conjunction with other antivirals; do not use alone.

Usually used in a multiple-drug regimen that includes sofosbuvir (with or without ribavirin).

Efficacy of daclatasvir and sofosbuvir (with or without ribavirin) for treatment of HCV genotype 1a infection is reduced in cirrhotic patients with NS5A polymorphisms M28, Q30, L31, or Y93 at baseline. Consider screening for NS5A polymorphisms prior to initiation of treatment in cirrhotic patients with HCV genotype 1a infection. (See General under Dosage and Administration.)

Efficacy of daclatasvir and sofosbuvir (with or without ribavirin) is reduced in cirrhotic patients with HCV genotype 3 infection compared with those without cirrhosis.

Treatment of chronic HCV infection is complex and rapidly evolving; consult a specialist to obtain the most up-to-date information.

• Generic Name: migalastat
• Dosage Forms: n.a.
• Other Brand Names: Galafold

Migalastat hydrochloride is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.