Ombitasvir & Paritaprevir & Ritonavir & Dasabuvir

Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir is a prescription medication used to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

This combination medication contains three antiviral drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. The regimen also contains ritonavir, which is used to increase blood levels of paritaprevir.

The recommended dosing is 2 ombitasvir/paritaprevir/ritonavir 12.5 mg/75 mg/50 mg tablets once daily and 1 dasabuvir 250 mg tablet twice daily. Take this drug regimen with a meal. This regimen may be administered with ribavirin.

Common side effects include feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.

Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir is used to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

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

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

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

• the condition being treated
• other medical conditions you have

The recommended dosing of the combination regimen is 2 ombitasvir/paritaprevir/ritonavir 12.5 mg/75 mg/50 mg tablets once daily in the morning and 1 dasabuvir 250 mg tablet twice daily in the morning and evening.

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. 

Serious side effects have been reported with Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir including the following:

• Changes in liver function (especially if you use ethinyl estradiol-containing medicines (such as some birth control products). Tell your healthcare provider right away if you have some or all of the following symptoms of changes in liver function:
  • fatigue
  • lack or appetite
  • weakness
  • vomiting
  • nausea
  • yellowing of the skin or eyes (jaundice)
  • discolored feces

You must stop using ethinyl estradiol-containing medicines before you start taking ombitasvir/paritaprevir/ritonavir/dasabuvir. If you use these medicines as a method of birth control, it is recommended you use another method of birth control during treatment with ombitasvir/paritaprevir/ritonavir/dasabuvir and for about 2 weeks after you finish your treatment with ombitasvir/paritaprevir/ritonavir/dasabuvir. 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/dasabuvir.

• Serious liver injury. This may occur mostly in patients with underlying advanced liver disease. Tell your healthcare provider right away if you develop:
  • fatigue
  • weakness 
  • loss of appetite
  • nausea and vomiting
  • yellow eyes or skin
  • light-colored stools

Do not take this medication if you:

• are allergic to ombitasvir, paritaprevir, ritonavir, and/or dasabuvir
• have severe liver dysfunction
• have had a severe reaction to ritonavir
• are taking drugs that are metabolized by or affect the activity of certain liver enzymes

Serious side effects have been reported with Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir. See the “Precautions” section.

Common side effects include:

• feeling tired
• itching
• feeling weak or lacking energy
• nausea
• trouble sleeping

This is not a complete list of Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir 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:

• Antiarrhythmics, including amiodarone (Cordarone, Pacerone)bepridil (Vascor), disopyramide (Norpace), flecainide, systemic lidocaine (Xylocaine), mexiletine (Mexitil), propafenone (Rythmol), and quinidine
• Antifungals, including ketoconazole (Nizoral) and voriconazole (Vfend)
• Calcium channel blockers, including amlodipine (Norvasc)
• Corticosteroids, including fluticasone (Flonase, Veramyst)
• Diuretics, including furosemide (Lasix)
• Antiviral agents, including atazanavir (Reyataz, in Evotaz), darunavir (Prezista, in Prezcobix), lopinavir (Aluvia, in Kaletra), and rilpivirine (Edurant, in Complera)
• Cholesterol-reducing medications, including rosuvastatin (Crestor) and pravastatin (Pravachol)
• Immunosuppressants, including cyclosporine (Sandimmune, Neoral, Restasis, Gengraf) and tacrolimus (Protopic, Hecoria, Prograf)
• Salmeterol (Serevent)
• Buprenorphine/naloxone (Suboxone)
• Omeprazole (Prilosec)
• Alprazolam (Xanax)
• Ethinyl estradiol (in combined oral contraceptives, contraceptive vaginal rings, and contraceptive patches)
• 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/Dasabuvir drug interactions. Ask your doctor or pharmacist for more information.

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/Dasabuvir falls into category B. There are no well-done studies that have been done in humans with this medication. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

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

It is not known if Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using  Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir.