SOFOSBUVIR/ VELPATASVIR/ VOXILAPREVIR 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/VOX (e.g., rifamycins, amiodarone, dabigatran, CYP450 inducers, cyclosporine, some antineoplastics, efavirenz, etravirine, lovastatin or simvastatin)
- Decompensated cirrhosis (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
Inclusion Criteria
- Care 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
- 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
- GT 1, 2, 4, 5 or 6, NS5A-experienced, with or without compensated cirrhosis
- GT 1-6, SOF experienced, NS3/4A PI naïve, with or without compensated cirrhosis
Ribavirin (RBV) Specific Considerations
- Contraindications to RBV include history of significant cardiac disease, significant anemia, pregnancy, and men whose female partner is pregnant or plans to become pregnant
- For GT 3, add RBV if cirrhosis and no contraindication, or extend duration to 24 weeks