ELBASVIR/ GRAZOPREVIR TAB
Clinical Criteria Summary
Patient Eligibility & Characteristics
- Genotype (GT) 1 or 4, treatment naïve, with or without compensated cirrhosis
- Limited life expectancy
- Severe hepatic impairment (Child-Pugh B/C or history of hepatic decompensation)
- Prior hepatitis C virus (HCV) treatment failure to a non-structural protein 5A (NS5A) inhibitor containing regimen
Specialist Consultation & Regimen Planning
- Care provided by and/or in consultation with a VA/VA Community Care Hepatitis C Specialist
- Treatment regimen and duration consistent with HCV genotype (GT) and patient characteristics
Screening & Laboratory Requirements
- Completed hepatitis B screening: at minimum HBsAg, HBV core antibody (anti-HBc) and HBV surface antibody (anti-HBs)
- Hepatitis B surface antigen (HBsAg) positive and not on antiviral treatment with entecavir or tenofovir
Adherence & Counseling
- Documented ongoing nonadherence to prescribed medications or medical treatment
- Adherence counseling performed including laboratory follow-up and documented understanding by patient
Drug Interactions & Contraindications
- Concurrent use of drugs not recommended with EBR/GZR (e.g., rifamycins, strong CYP3A inducers, cobicistat, cyclosporine, boosted HIV protease inhibitors, efavirenz) Recommend full drug-drug interaction check.