Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir

It is very important that your doctor check your progress at regular visits to make sure ombitasvir, paritaprevir, ritonavir and dasabuvir is working properly. Blood tests may be needed to check for unwanted effects.

Using ombitasvir, paritaprevir, ritonavir and dasabuvir together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Avoid pregnancy during combination treatment with ombitasvir, paritaprevir, ritonavir and dasabuvir and ribavirin for 6 months of stopping treatment. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

Do not use the following medicines while you are using ombitasvir, paritaprevir, ritonavir and dasabuvir: alfuzosin (Uroxatral®), cisapride (Propulsid®), colchicine (Colcrys®), dronedarone (Multaq®), efavirenz (Sustiva®), ethinyl estradiol (Norinyl®, Ortho Evra®), everolimus (Afinitor®), gemfibrozil (Lopid®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), sirolimus (Rapamune®), St. John's wort, tacrolimus (Prograf®), triazolam (Halcion®), certain medicines to lower cholesterol (such as atorvastatin, lovastatin, simvastatin, Mevacor®, Zocor®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Tegretol®), or ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Using Viekira Pak® with any of these medicines can cause very serious medical problems.

Check with your doctor right away if you are weak or tired, have onset of confusion, have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

(om BIT as vir, par i TA pre vir, ri TOE na vir, & da SA bue vir)

• Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir
• Paritaprevir, Ombitasvir, Ritonavir, and Dasabuvir
• Ritonavir, Ombitasvir, Paritaprevir, and Dasabuvir
• Viekira XR

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Combination package:

Viekira Pak [28 day supply]:

Tablet, oral: Ombitasvir 12.5 mg, paritaprevir 75 mg, and ritonavir 50 mg (56s)

Tablet, oral: Dasabuvir 250 mg (56s)

Tablet Extended Release, Oral:

Viekira XR: Ombitasvir 8.33 mg, paritaprevir 50 mg, ritonavir 33.33 mg, and dasabuvir 200 mg

• Viekira Pak
• Viekira XR

Hepatic impairment prior to treatment initiation:

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate to severe impairment (Child-Pugh class B or C): Use is contraindicated.

Hepatotoxicity during treatment:

ALT >10 times ULN (persistent): Consider therapy discontinuation.

ALT increased along with signs or symptoms of hepatic inflammation, increasing direct bilirubin, alkaline phosphatase, or INR: Discontinue therapy.

Evidence of hepatic decompensation: Discontinue therapy.

Immediate release: Administer with meals; administer ombitasvir/paritaprevir/ritonavir tablet once daily in the morning; administer dasabuvir tablet twice daily (morning and evening).

Extended release: Administer with a meal. Swallow whole; do not split, crush, or chew. Avoid consumption of alcohol within 4 hours before or after administration of ER tablet (may alter release of dasabuvir).

Store at or below 30°C (86°F). Dispense in original carton.

Manufacturer’s labeling: Baseline hepatic function tests and during the first 4 weeks of therapy, then periodically during therapy; serum HCV-RNA at baseline and at the end of treatment, during treatment follow-up, and when clinically indicated. In patients with cirrhosis, monitor for clinical signs and symptoms of hepatic decompensation (eg, ascites, hepatic encephalopathy, variceal hemorrhage).

Hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) prior to initiation; in patients with serologic evidence of hepatitis B virus (HBV) infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during treatment and during post-treatment follow-up.

Alternate recommendations (AASLD/IDSA 2015):

Baseline (within 12 weeks prior to starting antiviral therapy): CBC, INR, hepatic function panel (albumin, total and direct bilirubin, ALT, AST, and alkaline phosphatase), calculated GFR

Baseline (at any time prior to starting antiviral therapy): HCV genotype and subtype, quantitative HCV viral load

During therapy: CBC, serum creatinine, calculated GFR, hepatic function panel (after 4 weeks of therapy and as clinically indicated); quantitative HCV viral load testing (after 4 weeks of therapy and at 12 weeks after completion of therapy). If quantitative HCV viral load is detectable at treatment week 4, repeat testing is recommended after 2 additional weeks of treatment (treatment week 6).