ombitsavir, paritaprevir, retrovir, and dasabuvir

ombitsavir, paritaprevir, retrovir, and dasabuvir (Viekira Pak®, Viekira XR®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

• Treatment of chronic hepatitis C, genotype 1a and 1b without cirrhosis or with compensated cirrhosis

All of the following must be met as a condition for coverage:

• Patient must have compensated liver disease by fibroscan ultrasound or biopsy, documenting stage 2, stage 3, or stage 4
• Resistance testing must be included with the prior authorization request for genotype 1.
  • Treatment failure associated with HCV resistance to newly developed direct-acting antiviral agents is not an uncommon occurrence and poses a substantial problem to clinicians trying to re-treat patients who have failed available interferon-free treatments.
• Trial and failure of preferred agent(s) Epclusa, Harvoni, Vosevi

This Medication is Not Approvable for the following condition(s):

• Patients with Stage 0 or stage 1 fibrosis
• Any condition not listed above as an approved indication

Fibrosis

• Stage 0 or 1 none or mild peri-portal fibrosis – not approvable
• Stage 2 peri-portal fibrosis with/without extension and portal-portal bridging – approvable
• Stage 3 portal-central bridges but no nodular formation - approvable
• Stage 4 definite cirrhosis – approvable

Dosing:

• Immediate-release (Viekira Pak):  Ombitasvir/paritaprevir/ritonavir tablet:  2 tablets every morning.  Dasabuvir tablet:  1 tablet twice daily.
• Extended-release:  3 tablets once daily

Duration of therapy:

• Genotype 1a, 12 weeks (without cirrhosis); 24 weeks (with compensated cirrhosis [Child-Pugh class A]).  Based on prior treatment history, some patients with compensated cirrhosis may be considered for a duration of therapy of 12 weeks.
• Genotype 1b, 12 weeks (with or without compensated cirrhosis [Child-Pugh class A])
• Genotype 1, unknown subtype or mixed infection:  12 weeks (without cirrhosis); 24 weeks (with compensated cirrhosis [Child-Pugh class A]).  Based on prior treatment history, some patients with compensated cirrhosis may be considered for a duration of therapy of 12 weeks.
• Liver transplant recipients (Metavir fibrosis score 2 or less), regardless of genotype 1 subtype:  24 weeks.

Concomitant therapy: 

• Use in combination with ribavirin for patients with genotype 1a (with or without compensated cirrhosis [Child-Pugh class A]), genotype 1 subtype unknown or mixed infection, and liver transplant recipients (Metavir fibrosis score 2 or less; regardless of genotype 1 subtype).