LEDIPASVIR/ SOFOSBUVIR 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 LDV/SOF (e.g., cytochrome P450 inducers, amiodarone/dronaderone, rosuvastatin > 10mg/day, high-dose proton pump inhibitors)
- 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 specialist
- HCV genotype (GT) 1, 4, 5 or 6
- 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, 4, 5 or 6, treatment-naïve with or without compensated cirrhosis
- GT 1, 4, 5 or 6, treatment-naïve with decompensated cirrhosis and no contraindication to ribavirin
- GT 1, treatment-experienced (pegylated interferon or NS3/4A inhibitor only) with decompensated cirrhosis and no contraindication to ribavirin
Ribavirin Contraindications
- History of significant cardiac disease
- Significant anemia
- Pregnancy
- Men whose female partner is pregnant or plans to become pregnant