SOFOSBUVIR/ VELPATASVIR TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Limited life expectancy
- Documented ongoing nonadherence to prescribed medications or medical treatment
- Concurrent use of drugs not recommended with SOF/VEL (e.g., amiodarone, apalutamide, modafinil, rifamycins, CYP450 inducers, St John’s Wort, > 10mg/day of rosuvastatin, efavirenz, etravirine)
- Hepatitis B surface antigen (HBsAg) positive and not on antiviral treatment with entecavir or tenofovir
- Contraindication to ribavirin (RBV) if RBV is indicated
Inclusion Criteria
- Care provided by and/or in consultation with a VA/VA Community Care Hepatitis C virus (HCV) specialist
- HCV Genotype (GT) 1-6 or ungenotyped with detectable HCV RNA
- Treatment regimen and duration consistent with HCV GT and patient characteristics
- 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 met)
- GT 1-6 or ungenotyped with detectable HCV RNA and treatment naïve with or without compensated cirrhosis (CTP A)
- GT 1-6 and treatment experienced (PEG-IFN/RBV +/- NS3/4A inhibitor but NS5A and SOF naïve) with or without compensated cirrhosis (CTP A)
- GT 1b, treatment-experienced (NS5A naïve and SOF-experienced)
- GT 1-6 with decompensated cirrhosis (CTP B or C): 12 weeks with RBV or 24 weeks without RBV if NS5A naïve; 24 weeks with RBV if NS5A-experienced
Specific Clinical & Regimen Notes
- Contraindication to RBV includes history of significant cardiac disease, significant anemia, pregnancy, and men whose female partner is pregnant or plans to become pregnant
- Ribavirin should be added if GT 3 with compensated cirrhosis and Y93H is present
- If GT 1a, add RBV or use SOF/VEL/VOX