GLECAPREVIR/ PIBRENTASVIR PELLET
Clinical Criteria Summary
Exclusion Criteria
- Limited life expectancy
- Documented ongoing nonadherence to prescribed medications or medical treatment
- Concurrent use of drugs not recommended with GLE/PIB (e.g., rifampin, atazanavir, darunavir, efavirenz, etravirine or ritonavir)
- Severe hepatic impairment (Child-Pugh B/C or history of hepatic decompensation)
- Prior hepatitis C virus (HCV) treatment failure of both an NS3/4A protease inhibitor AND an NS5A inhibitor
- Hepatitis B surface antigen (HBsAg) positive and not on antiviral treatment with entecavir or tenofovir
- Contraindication to ribavirin (RBV) IF RBV is indicated (includes history of significant cardiac disease, significant anemia, pregnancy, and men whose female partner is pregnant or plans to become pregnant)
Inclusion Criteria
- Care is provided by or in consultation with a VA/VA Community Care Hepatitis C Specialist
- Treatment regimen and duration consistent with HCV genotype (GT) and patient characteristics according to VA HCV Treatment considerations
- HCV GT 1-6 or ungenotyped but detectable HCV RNA
- Completed hepatitis B screening: at minimum HBsAg, HBV core antibody (anti-HBc) and HBV surface antibody (anti-HBs)
- Adherence counseling performed including laboratory follow-up and documented understanding by patient
- Additional Inclusion Criteria (One of the following must be true)
- GT 1-6 or ungenotyped but detectable HCV RNA with or without compensated cirrhosis and are treatment naïve
- GT 1-6 with or without compensated cirrhosis with prior treatment experience with pegylated interferon, ribavirin +/- sofosbuvir (SOF)
- GT 1 with or without compensated cirrhosis and prior NS3/4A experience (but SOF and NS5A naïve)
- GT 1 with or without compensated cirrhosis and prior NS5A inhibitor experience but NS3/4A naïve
- With SOF and RBV for GT 1-6 with or without compensated cirrhosis and treatment experienced with sofosbuvir / velpatasvir / voxilaprevir or SOF plus GLE/PIB