• For the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection:
• without cirrhosis or with compensated cirrhosis
• with decompensated cirrhosis for use in combination with ribavirin
  

• Diagnosis of hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection confirmed by detectable serum HCV RNA by quantitative assay. Baseline viral load by quantitative assay including genotype and treatment status of patient (treatment naive or treatment-experienced) are required.

AND

• For genotype 1 and 4: Failure or clinically significant adverse effects to Zepatier (grazoprevir/elbasvir)

AND

• Patient is 18 years of age or older

AND

• Any of the following clinical states identify candidates for treatment:
• Evidence of Stage 2 or greater hepatic fibrosis including one of the following: Liver biopsy confirming a METAVIR score F2 or greater OR Transient elastography (Fibroscan), score greater than or equal to 7.5 kPa; OR FibroSure (also known as FibroTest) score of greater than or equal to 0.48; OR APRI score greater than 0.7; OR FIB greater than 3.25.
• Evidence of extra-hepatic manifestation of hepatitis C virus, such as type 2 or 3 essential mixed cryoglobulinemia with end- organ manifestations (e.g. vasculitis), or kidney disease (e.g., proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis).
• Persons with hepatocellular carcinoma with life expectancy greater than 12 months
• Pre- and post-liver transplant, or other solid organ transplant
• HIV-1 co-infection
• Hepatitis B co-infection
• Other coexistent liver disease (e.g. nonalcoholic steatohepatitis)
• Type 2 diabetes mellitus (insulin resistant)
• Porphyria cutanea tarda
• Debilitating fatigue impacting quality of life (e.g., secondary to extra-hepatic manifestations and/or liver disease)
• Men who have sex with men with high-risk sexual practices
• Active injection drug users
• Persons on long-term hemodialysis
• Women of childbearing age who wish to get pregnant
• HCV-infected health care workers who perform exposure-prone procedures
• Criteria for Reauthorization/Continuation of Therapy:
• Initial authorization criteria have been met, and
• Evidence of lack of adherence may result in denial of treatment reauthorization.
• Missed medical appointments related to the hepatitis C virus may result in denial of treatment authorization.

• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
• Dual therapy (Epclusa + (Sovaldi, Harvoni or Olysio)

• No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2) or with end stage renal disease (ESRD), due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite.
• Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with daclatasvir or simeprevir. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir-containing regimen (Harvoni (ledipasvir/sofosbuvir)).
• Child-Pugh Score:

Child-Pugh class is determined by the total number of points: A = 5-6 points; B = 7-9 points; C = 10-15 points

• Diagnostic criteria for chronic fatigue syndrome was developed by an expert committee convened by the Institute of Medicine on the basis of a comprehensive literature review and input from patient, advocacy, and research communities. These diagnostic criteria state that symptoms should persist for at least 6 months and be present at least half the time with moderate, substantial, or severe intensity to distinguish chronic fatigue syndrome from other diseases.
  
  

Tablets each containing sofosbuvir 400 mg and velpatasvir 100 mg

1. Epclusa [Prescribing Information]. Foster City, CA: Gilead Sciences, Inc.; June 2016.
2. American Association for the Study of Liver Disease Recommendations for Testing, Managing, and Treating Hepatitis C; April 2016. (accessed at: http://www.hcvguidelines.org)
3. Curry MP. OLeary JG, Bzowej N et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. NEJM November 19, 2015 373;21:.
4. Foster GR, Afdahl N, Roberts SK et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. NEJM November 19, 2015 373;21:
5. Feld JJ, Jacobson IM, Hezode C et al. Sofosbuvir and velpatasvie for HCV genotype 1, 2, 4, 5 and 6 infection. NEJM November 19, 2015 373;21: