Ombitasvir & Paritaprevir & Ritonavir

Ombitasvir/paritaprevir/ritonavir is a prescription medication used to treat genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. It is given in combination with ribavirin for 12 weeks. 

It is a single product containing 3 ingredients: ombitasvir, paritaprevir and ritonavir.

Ombitasvir belongs to a group of drugs called NS5A inhibitors. Paritaprevir belongs to a group of drugs called NS3/4A protease inhibitor. Ritonavir is in a class of medications called protease inhibitors. Together these help to stop the virus that causes hepatitis C from spreading inside the body.

This medication comes in tablet form and is taken once a day, with a meal without regard to fat or calorie content. 

Common side effects of ombitasvir/paritaprevir/ritonavir include feeling weak, tiredness, nausea, and sleep problems. Do not drive or operate heavy machinery until you know how this medication affects you. 

Ombitasvir/paritaprevir/ritonavir is a prescription medication used to treat genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. It is given in combination with ribavirin for 12 weeks. It is not known if this medication is safe and effective in children under 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ombitasvir & Paritaprevir & Ritonavir may be found in some form under the following brand names:

• Technivie

Serious side effects have been reported with ombitasvir/paritaprevir/ritonavir. See the "Drug Precautions" section. 

Common side effects of ombitasvir/paritaprevir/ritonavir include the following:

• feeling weak
• tiredness
• nausea
• sleep problems

Do not drive or operate heavy machinery until you know how this medication will affect you.

This is not a complete list of ombitasvir/paritaprevir/ritonavir side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alfuzosin hydrochloride (Uroxatral)
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• efavirenz (Atripla, Sustiva)
• ergot-containing medicines including: ergotamine tartrate (Cafergot, Ergomar, Ergostat, Medihaler, Migergot, Wigraine, Wigrettes), dihydroergotamine mesylate (D.H.E. 45, Migranal), and methylergonovine (Ergotrate, Methergine)
• ethinyl estradiol-containing medicines: combination birth control pills or patches (such as Lo Loestrin FE, Norinyl, Ortho TriCyclen Lo, and Ortho Evra), hormonal vaginal rings (such as NuvaRing), and the hormone replacement therapy medicine, Fem HRT 
• cholesterol lowering medications such as lovastatin (Advicor, Altoprev, Mevacor) and simvastatin (Simcor, Vytorin, Zocor)
• midazolam, when taken by mouth
• triazolam (Halcion) when taken by mouth
• phenytoin, (Dilantin, Phenytek)
• phenobarbital (Luminal)
• pimozide (Orap)
• rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• sildenafil citrate (Revatio), when taken for pulmonary artery hypertension (PAH)
• St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort
• warfarin (International normalized ratio (INR) values may rise and fall irregularly in those taking warfarin. As a result, frequent monitoring of INR values is recommended in patients taking warfarin)

This is not a complete list of ombitasvir/paritaprevir/ritonavir drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with ombitasvir/paritaprevir/ritonavir including the following:

• can cause increases in your liver function blood test results, especially if you use ethinyl estradiol-containing medicines (such as some birth control products).
  • You must stop using ethinyl estradiol-containing medicines before you start treatment with this medication.
  • If you use these medicines as a method of birth control, you must use another method of birth control during treatment with ombitasvir/paritaprevir/ritonavir, and for about 2 weeks after you finish treatment with this medication. Your healthcare provider will tell you when you may begin taking ethinyl estradiol containing medicines.
  • Your healthcare provider should do blood tests to check your liver function during the first 4 weeks and then as needed, during treatment with ombitasvir/paritaprevir/ritonavir.
• Serious liver injury. This may occur mostly in patients with underlying advanced liver disease. Your healthcare provider may tell you to stop taking this medication if you develop signs or symptoms of liver problems. Tell your healthcare provider right away if you develop any of the following symptoms, or if they worsen during treatment with this medication:
  • tiredness
  • weakness
  • loss of appetite
  • nausea and vomiting
  • yellowing of your skin or eyes
  • color changes in your stools
• Multiple Drug Interactions. Ombitasvir/paritaprevir/ritonavir can interact with many medications.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Keep a list of your medicines to show your healthcare provider and pharmacist. 
  • Ask your healthcare provider or pharmacist for a list of medicines that interact with ombitasvir/paritaprevir/ritonavir.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take this medication with other medicines.
  • When you finish treatment with ombitasvir/paritaprevir/ritonavir:
    • If your doctor changed the dose of one of your usual medicines during treatment with ombitasvir/paritaprevir/ritonavir: Ask your healthcare provider about when you should change back to your original dose after you finish treatment with ombitasvir/paritaprevir/ritonavir.
    • If your doctor told you to stop taking one of your usual medicines during treatment with ombitasvir/paritaprevir/ritonavir: Ask your healthcare provider if you should start taking these medicines again after you finished treatment with ombitasvir/paritaprevir/ritonavir.

Do not take ombitasvir/paritaprevir/ritonavir if you:

• are allergic to ombitasvir/paritaprevir/ritonavir or any of its ingredients
• have had a severe skin rash after taking ritonavir (Norvir)
• have severe liver problems
• you take any of the medications listed in Drug Interactions. 

Your doctor will want to monitor your liver function closely and may discontinue this medication if your liver function worsens.  

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ombitasvir/paritaprevir/ritonavir, there are no specific foods that you must exclude from your diet when receiving ombitasvir/paritaprevir/ritonavir.

Before taking ombitasvir/paritaprevir/ritonavir, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to ombitasvir/paritaprevir/ritonavir or any of its ingredients
• have had a severe skin rash after taking ritonavir (Norvir)
• if you have a history of hepatitis B infection
• have liver problems other than hepatitis C infection
• have had a liver transplant. If you take the medicines tacrolimus (Prograf) or cyclosporine (Gengraf, Neoral, Sandimmune) to help prevent rejection of your transplanted liver, the amount of these medicines in your blood may increase during treatment with ombitasvir/paritaprevir/ritonavir.
  • Your healthcare provider should check the level of tacrolimus or cyclosporine in your blood, and if needed may change your dose of these medicines or how often you take them. When you finish taking ombitasvir/paritaprevir/ritonavir or if you have to stop ombitasvir/paritaprevir/ritonavir for any reason, your healthcare provider should tell you what dose of tacrolimus or cyclosporine to take and how often you should take it.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• you take any of the listed medications in Drug Interactions Section

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ombitasvir/paritaprevir/ritonavir falls into category B. There are no well-done studies that have been done in humans with ombitasvir/paritaprevir/ritonavir. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. It is not known if ombitasvir/paritaprevir/ritonavir will harm your unborn baby. Ombitasvir/paritaprevir/ritonavir should not be given to pregnant women or in men whose female partners are pregnant. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if ombitasvir/paritaprevir/ritonavir is excreted in human breast milk or if it will harm your nursing baby. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from ombitasvir/paritaprevir/ritonavir, your doctor will determine the risk versus benefit of using this medication. Talk to your healthcare provider about the best way to feed your baby if you take ombitasvir/paritaprevir/ritonavir.

Take ombitasvir/paritaprevir/ritonavir exactly as your healthcare provider tells you to take it.

• Do not change your dose unless your healthcare provider tells you to.
• Do not stop taking ombitasvir/paritaprevir/ritonavir without first talking with your healthcare provider.
• Take 2 ombitasvir/paritaprevir/ritonavir tablets every day in the morning, with a meal.
• Ombitasvir/paritaprevir/ritonavir is given in combination with ribavirin for 12 weeks.
• Ombitasvir/paritaprevir/ritonavir is supplied in monthly cartons that contain enough medicine for 28 days. Each monthly carton contains 4 smaller cartons. Each of the 4 smaller cartons contains enough child resistant daily dose packs of medicine to last for 7 days (1 week). Each daily dose pack contains all of your medicine for 1 day (2 tablets). Follow the instructions on each daily dose pack about how to remove the tablets.
• If you miss a dose of this medication, and it is less than 12 hours from the time you usually take your dose, take the missed dose with a meal as soon as possible. Then take your next dose at your usual time with a meal.
• If you miss a dose of this medication, and it is more than 12 hours from the time you usually take your dose, skip the missed dose. Then take your next dose at your usual time with a meal.
• Do not take more than your prescribed dose of ombitasvir/paritaprevir/ritonavir to make up for a missed dose.
• When you finish treatment with ombitasvir/paritaprevir/ritonavir:
  • If your doctor changed the dose of one of your usual medicines during treatment with this medication: Ask your healthcare provider about when you should change back to your original dose after you finish treatment with ombitasvir/paritaprevir/ritonavir.
  • If your doctor told you to stop taking one of your usual medicines during treatment with this medication: Ask your healthcare provider if you should start taking these medicines again after you finished treatment with ombitasvir/paritaprevir/ritonavir.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose and duration your doctor recommends may be based on the following:

• how you respond to this medication
• the condition of your liver

The recommended dose of ombitasvir/paritaprevir/ritonavir to treat hepatitis C virus is two tablets taken orally once daily (in the morning) with a meal without regard to fat or calorie content. Ombitasvir/paritaprevir/ritonavir is recommended to be used in combination with ribavirin.

If you take too much ombitasvir/paritaprevir/ritonavir call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store ombitasvir/paritaprevir/ritonavir at or below 86°F (30°C).
• Keep this and all medications out of the reach of children. 

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C.