Viekira Pak

VIEKIRA PAK- dasabuvir and ombitasvir and paritaprevir and ritonavir
AbbVie Inc.

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with VIEKIRA PAK. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

VIEKIRA PAK is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2) and Clinical Studies (14)]:

  • genotype 1b without cirrhosis or with compensated cirrhosis
  • genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

2 DOSAGE AND ADMINISTRATION

2.1 Testing Prior to the Initiation of Therapy

  • Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with VIEKIRA PAK [see Warnings and Precautions (5.1)].
  • Prior to initiation of VIEKIRA PAK, assess for laboratory and clinical evidence of hepatic decompensation [see Warnings and Precautions (5.2 and 5.3)].

2.2 Recommended Dosage in Adults

VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.

The recommended oral dosage of VIEKIRA PAK is two ombitasvir, paritaprevir, ritonavir tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening). Take VIEKIRA PAK with a meal without regard to fat or calorie content [see Clinical Pharmacology (12.3)].

VIEKIRA PAK is used in combination with ribavirin (RBV) in certain patient populations (see Table 1). When administered with VIEKIRA PAK, the recommended dosage of RBV is based on weight: 1000 mg/day for subjects <75 kg and 1200 mg/day for those ≥75 kg, divided and administered twice-daily with food. For ribavirin dosage modifications, refer to the ribavirin prescribing information.

For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in Table 1. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 1 shows the recommended VIEKIRA PAK treatment regimen and duration based on patient population.

Table 1. Treatment Regimen and Duration by Patient Population (Treatment-Naïve or Interferon-Experienced)
Patient Population Treatment* Duration
Genotype 1a, without cirrhosis VIEKIRA PAK + ribavirin 12 weeks
Genotype 1a, with compensated cirrhosis (Child-Pugh A) VIEKIRA PAK + ribavirin 24 weeks**
Genotype 1b, with or without compensated cirrhosis (Child-Pugh A) VIEKIRA PAK 12 weeks
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.**VIEKIRA PAK administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history [see Clinical Studies (14.3)].

2.3 Use in Liver Transplant Recipients

In liver transplant recipients with normal hepatic function and mild fibrosis (Metavir fibrosis score 2 or lower), the recommended duration of VIEKIRA PAK with ribavirin is 24 weeks, irrespective of HCV genotype 1 subtype [see Clinical Studies (14.6)]. When VIEKIRA PAK is administered with calcineurin inhibitors in liver transplant recipients, dosage adjustment of calcineurin inhibitors is needed [see Drug Interactions (7)].

2.4 Hepatic Impairment

VIEKIRA PAK is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) [see Contraindications (4), Warnings and Precautions (5.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.

  • Ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “AV1” on one side.
  • Dasabuvir 250 mg tablets are beige-colored, film-coated, oval-shaped, debossed with “AV2” on one side. Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir.

4 CONTRAINDICATIONS

  • If VIEKIRA PAK is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.
  • VIEKIRA PAK is contraindicated:
    • In patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
    • With drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events [see Drug Interactions (7) and Clinical Pharmacology (12.3)]:
      • Alpha1-adrenoreceptor antagonist: alfuzosin HCL
      • Anti-anginal: ranolazine
      • Antiarrhythmic: dronedarone
      • Anti-gout: colchicine in patients with renal and/or hepatic impairment
      • Antipsychotic: lurasidone, pimozide
      • Ergot derivatives: ergotamine, dihydroergotamine, methylergonovine
      • Ethinyl estradiol-containing products such as combined oral contraceptives
      • GI Motility Agent: cisapride
      • HMG-CoA Reductase Inhibitors: atorvastatin, lovastatin, simvastatin
      • Immunosuppressants: everolimus, sirolimus, tacrolimus
      • Microsomal triglyceride transfer protein inhibitor: lomitapide
      • Non-nucleoside reverse transcriptase inhibitor: efavirenz
      • Phosphodiesterase-5(PDE5) inhibitor: sildenafil when dosed as Revatio for the treatment of pulmonary arterial hypertension (PAH)
      • Sedatives/hypnotics: triazolam, orally administered midazolam
    • With drugs that are moderate or strong inducers of CYP3A and strong inducers of CYP2C8 and may lead to reduced efficacy of VIEKIRA PAK [see Drug Interactions (7) and Clinical Pharmacology (12.3)]:
      • Anticonvulsants: carbamazepine, phenytoin, phenobarbital
      • Androgen receptor inhibitor: apalutamide
      • Antimycobacterial: rifampin
      • Herbal Product: St. John’s Wort (Hypericum perforatum)
    • With drugs that are strong inhibitors of CYP2C8 and may increase dasabuvir plasma concentrations and the risk of QT prolongation [see Drug Interactions (7) and Clinical Pharmacology (12.3)]:
      • Antihyperlipidemic agent: gemfibrozil
    • In patients with known hypersensitivity to ritonavir (e.g. toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome).

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