Drug Summary
Adverse Effects
Class and Mechanism
Indications
Elbasvir-Grazoprevir for Genotypes 1 or 4 (with or without cirrhosis)
- Genotype 1a, treatment-naïve or peginterferon/ribavirin-experienced* (without baseline NS5A polymorphisms^): Elbasvir-grazoprevir for 12 weeks
- Genotype 1a, treatment-naïve or peginterferon/ribavirin-experienced* (with baseline NS5A polymorphisms^): Elbasvir-grazoprevir plus ribavirin for 16 weeks
- Genotype 1b, treatment-naïve or peginterferon/ribavirin-experienced*: Elbasvir-grazoprevir for 12 weeks
- Genotype 1a# or 1b, peginterferon/ribavirin/protease inhibitor-experienced+: Elbasvir-grazoprevir plus ribavirin for 12 weeks
- Genotype 4, treatment-naïve: Elbasvir-grazoprevir for 12 weeks
- Genotype 4, peginterferon/ribavirin-experienced*: Elbasvir-grazoprevir plus ribavirin for 16 weeks
*Patients who have failed therapy with peginterferon alfa plus ribavirin
^One or more polymorphisms at the amino acid positions 28, 30, 31, or 93.
#The optimal treatment duration for peginterferon/ribavirin/protease inhibitor-experienced patients with genotype 1a and one or more baseline NS5A resistance-associated polymorphisms has not been established.
+Patients who have failed therapy with peginterferon alfa plus ribavirin plus an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir)
Dosing
- The recommended dose is one tablet taken orally once daily, with or without food.
- No dosage adjustment is recommended for elbasvir-grazoprevir in patients with renal insufficiency, including patients with end-stage renal disease or persons on hemodialysis.
- For patients with mild hepatic impairment (Child-Pugh Class A), no dose adjustment of elbasvir-grazoprevir is recommended. Elbasvir-grazoprevir is contraindicated for use in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C).
- When ribavirin is used with elbasvir-grazoprevir in patients with a CrCl greater than 50 mL/min, it should be given as weight-based dosing in two divided doses with food (weight less than 66 kg=800 mg/day; 66 to 80 kg=1000 mg/day; 81 to 105 kg=1200 mg/day; greater than 105 kg=1,400 mg/day). For patients with CrCl less than 50 mL/min, the dose of ribavirin should be adjusted to be consistent with the recommendations in the ribavirin package insert.
Cost and Medication Access
- Merck has an active Patient Assistance Program for patients who cannot obtain or afford elbasvir-grazoprevir. Information on the program can be obtained at Merck Patient Assistance Program (Merck Helps) website or by calling 1-800-405-5810.
- Merck has also developed a copay assistance program. There are specific conditions that apply. Information to help patients get access and support to elbasvir-grazoprevir is available on the Merck Access and Support Services website.