Daclatasvir Dosage

Applies to the following strengths: 90 mg; 30 mg; 60 mg

Usual Adult Dose for:

Chronic Hepatitis C

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Chronic Hepatitis C

60 mg orally once a day

Recommended Regimen and Duration of Therapy:
Genotype 1:

Without cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
Compensated (Child-Pugh A) cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
Decompensated (Child-Pugh B or C) cirrhosis: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks
Posttransplant: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

Genotype 3:

Without cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks
Posttransplant: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

Comments:

Dose recommendations also apply to HCV/HIV-1-coinfected patients.
Optimal duration of therapy has not been established for HCV genotype 3-infected patients with cirrhosis or for HCV genotype 1-infected patients with Child-Pugh C cirrhosis.
The manufacturer product information for sofosbuvir should be consulted regarding dosing. The manufacturer product information should be consulted regarding ribavirin dosing and dose adjustments (if applicable).

Use: With sofosbuvir (with or without ribavirin), for the treatment chronic HCV genotype 1 or 3 infection

Renal Dose Adjustments

No adjustment recommended.

Comments:

The manufacturer product information for sofosbuvir and ribavirin should be consulted regarding use in patients with renal dysfunction.

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.

Comments:

Based on liver dysfunction study in non-HCV-infected subjects

Dose Adjustments

Coadministration with strong CYP450 3A inhibitors and certain HIV antiviral agents: 30 mg orally once a day
Coadministration with moderate CYP450 3A inducers and nevirapine: 90 mg orally once a day
Coadministration with strong CYP450 3A inducers: Contraindicated

The dose of this drug should not be reduced for side effects.

If sofosbuvir is permanently discontinued, this drug should also be discontinued.

Precautions

US BOXED WARNING:

RISK OF HBV REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: All patients should be tested for evidence of current/prior HBV infection before starting this drug. HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. HCV/HBV-coinfected patients should be monitored for hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

Significant removal via dialysis is not likely (highly protein bound).

Other Comments

Administration advice:

Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
Use in combination with sofosbuvir (with or without ribavirin); do not use alone.
Before starting this drug and sofosbuvir (with or without ribavirin), consider screening HCV genotype 1a-infected patients with cirrhosis for nonstructural protein 5A (NS5A) polymorphisms at amino acid positions M28, Q30, L31, and Y93.
May administer without regard to food
Consult the manufacturer product information regarding missed doses.

General:

Limitations of use: Sustained virologic response (SVR12) rates were reduced in HCV genotype 3-infected patients with cirrhosis using this drug with sofosbuvir for 12 weeks.
Before starting therapy, the manufacturer product information for coadministered HCV antiviral drugs should be consulted for additional information.

Patient advice: