Dosing
Dosing: For most patients, 1 tablet, once daily, for 12 weeks1
Genotype 12 | |||
---|---|---|---|
1a without RASsa | 1a with RASsa | 1b | |
Treatment-naïve | 12 weeks ZEPATIER | 16 weeks ZEPATIER+RBVb | 12 weeks ZEPATIER |
Treatment-experienced: pegIFN/RBVb | |||
Treatment-experienced: pegIFN/RBV/PIc | 12 weeks ZEPATIER + RBVb |
Genotype 42 | |
---|---|
Treatment-naïve | 12 weeks ZEPATIER |
Treatment-experienced: pegIFN/RBV | 16 weeks ZEPATIER + RBVb |
(a) Baseline NS5A RASs at positions 28, 30, 31, or 93. RASs=resistance-associated substitutions.2
(b) For patients with CrCl >50 mL per minute, the recommended dosage of RBV is weight-based (800 mg/day to 1,400 mg/day) administered in 2 divided doses with food. For patients with CrCl ≤50 mL per minute, including patients receiving hemodialysis, refer to the RBV tablet prescribing information for the correct RBV dosage.2
(c) Patients who have failed treatment with pegIFN + RBV + HCV NS3/4A protease inhibitor (PI): boceprevir, simeprevir, telaprevir. The optimal ZEPATIER-based regimen and duration of therapy for pegIFN/RBV/PI-experienced GT1a-infected patients with baseline NS5A RASs at positions 28, 30, 31, or 93 have not been established.2
For your GT1a patients, testing for baseline NS5A RASs identifies optimal dosing to maximize cure* rates.
- Testing patients with HCV GT1a infection for the presence of NS5A RASs at positions 28, 30, 31, or 93 is recommended prior to initiation of treatment with ZEPATIER to determine dosage regimen and duration.
- In clinical trials with ZEPATIER, the prevalence of baseline NS5A RASs at positions 28, 30, 31, or 93 was 12% (37/309) in patients in the United States.
- Among patients with these baseline RASs who received ZEPATIER + RBV for 16 weeks, 100% (6/6) achieved cure* vs 70% (39/56) among patients with these baseline RASs who received ZEPATIER for 12 weeks.
No dosage adjustment of ZEPATIER is recommended in patients with mild hepatic impairment (Child-Pugh A) or with any degree of renal impairment, including patients on hemodialysis.
- ZEPATIER can be taken with or without food.
- ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C).
* Cure=sustained virologic response, defined as HCV ribonucleic acid (RNA) <LLOQ at 12 weeks after completion of therapy (SVR12).2
Definitions
AASLD = American Association for the Study of Liver Diseases
CrCl = creatinine clearance
IDSA = Infectious Diseases Society of America
pegIFN = peginterferon alfa
PI = protease inhibitor
RASs = resistance-associated substitutions
RBV = ribavirin
References
1. Gower E, Estes C, Blach S, et al. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014;61:S45–S57.
2. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed March 20, 2020.