• For use in combination with ribavirin for treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis.

• Diagnosis of hepatitis C virus (HCV) genotype 4 infection confirmed by detectable serum HCV RNA by quantitative assay. Genotype is required to determine length of approval.

AND

• A trial of Harvoni is required (Member must meet prior authorization criteria for and use Harvoni unless contraindicated)

AND

• Must be used in combination with ribavirin (RBV)

AND

• Chart note documentation and copies of lab results are required

AND

• Prescribed by or in consultation with a gastroenterologist, hepatologist or infectious disease physician.

AND

• One of the following clinical states to identify candidates for treatment:
• Evidence of Stage 2 or greater hepatic fibrosis defined by one of the following:
• Liver biopsy confirming a METAVIR score F2 or greater
• Transient elastography (Fibroscan) score greater than or equal to 7.5 kPa
• FibroSure (also known as FibroTest) score of greater than or equal to 0.48
• APRI score greater than 0.7
• FIB greater than 3.25
• ARFI score of greater than 1.34 m/s
• MRE score of greater than 3.20 kilopascals
• HepaScore ≥0.55
• FibroMeter ≥ 0.411
• 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).
• 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) Fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest, and causes a substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months]
• Men who have sex with men with high-risk sexual practices
• Patients with a current injectable substance abuse disorder and actively participating in treatment
• Persons on long-term hemodialysis
• Women of childbearing age who wish to get pregnant
• HCV-infected health care workers who perform exposure-prone procedures

• 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.
• Patients who have failed to respond to previous protease inhibitor (Olysio, Victrelis, Viekira Pak) based therapy.
• Patients with decompensated cirrhosis (Child-Pugh Class B or C).

• Technivie has not been studied in patients with HCV genotypes other than genotype 4.
• Technivie is contraindicated in patients with severe hepatic impairment (Child-Pugh C) due to potential risk of toxicity. Technivie is not recommended for use in patients with moderate hepatic impairment (Child-Pugh class B).
• In the SYNERGY trial, 21 patients (40% treatment experienced and 43% with advanced fibrosisF3 or F4 Metavir) with genotype 4 CHC began 12 weeks of treatment with Harvoni. One patient withdrew consent after taking the first dose. All 20 of the remaining patients achieved SVR-12. In a second trial, 21 /22 (95%) of treatment naove patients achieved SVR-12.
• The American Association for the Study of Liver Disease (AASLD) recommendations for treatment of genotype 4 HCV infection includes treatment with Harvoni for 12 weeks including Harvoni in combination with RBV for patients with infection in the HCV infection in the allograft and cirrhosis.
• The combination of Sovaldi (sofosbuvir) plus pegylated interferon and ribavirin produced SVR-12 in 27/28 (96%) patients with CHC genotype 4 infection.
• In a phase II study, patients with HCV genotype 4 infection received daily Sovaldi plus weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 12 weeks or 24 weeks; among treatment-naive patients SVR12 rates were 84% (21/25) and 92% (22/24), respectively. The PHOTON-2 trial, an open-label study of HIV/HCV-coinfected patients, included 31 treatment-naive patients with HCV genotype 4 infection who received daily Sovaldi plus weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 24 weeks. In this study, 84% of patients (26/31) achieved SVR12.
• 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.
• Viekira Pak and Technivie are contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C).

Technivie Tablets containing paritaprevir 75 mg, ritonavir 50 mg, ombitasvir 12.5 mg