Generic Name: ombitasvir/paritaprevir/ritonavir and dasabuvir
Abbreviation: OBV/PTV/r + DSV or PrOD
Other Market Name: Holkira Pak (Canada); Viekirax (Europe) and Exviera (Europe)
Drug Class: Multi-Class Combination Drugs
Approval Status: Approved
Generic Version Available: No
Experimental Code: ABT-267 + ABT-450/r + ABT-333
FDA-approved for the treatment of chronic hepatitis C genotype 1 infection in adults. Ribavirin may be prescribed with Viekira Pak. Viekira Pak is not recommended for people with advanced (decompensated) cirrhosis.
- Ombitasvir is an HCV NS5A inhibitor. Paritaprevir is an HCV NS3/4A protease inhibitor. Ritonavir is a CYP3A4 inhibitor, which boosts paritaprevir, and does not have specific activity against HCV. Dasabuvir is a non-nucleoside NS5B polymerase inhibitor.
- Viekira Pak was approved by the U.S. Food and Drug Administration for use by people living with hepatitis C on December 19, 2014.
- In clinical trials, 95 to 100 percent of participants were cured with 12 weeks of therapy.
- Lab testing in the first four weeks of treatment is recommended as Viekira Pak may cause liver enzymes to elevate.
Adult Dose: Viekira Pak consists of two pills: Ombitasvir, paritaprevir and ritonavir are combined into one tablet, and dasabuvir is a separate tablet. Two ombitasvir/paritaprevir/ritonavir tablets taken orally once daily (in the morning) and one dasabuvir tablet taken orally twice daily (morning and evening) with a meal. If ribavirin is prescribed, follow additional dosing instructions for that drug.
Pediatric Dose: N/A
Dosing Info: Treatment varies from 12 to 24 weeks. Duration of treatment and whether Viekira Pak is prescribed with ribavirin are determined by genotype subtype and the presence of cirrhosis. For specific treatment recommendations, see Hepatitis C Treatment-Naive Recommendations or Hepatitis C Re-treatment Recommendations.
The side effects associated with Viekira Pak are considered mild. The most common are nausea, itching and insomnia. When taken with ribavirin, the most common side effects are fatigue, nausea, itching and other skin reactions, insomnia, and weakness. Taking ribavirin increases the type, frequency and intensity of side effects.
- Before taking this medication, tell your medical provider and pharmacist about any drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit.
- Do not use this product if you use ethinyl estradiol-containing medicines (such as some birth control products).
- Viekira Pak may interact with drugs and herbs that are metabolized in the liver and intestines, such as phenytoin, rifampin, St. John’s wort and certain contraceptives. Additional drug-drug interactions may occur and these are listed in Viekira Pak’s full prescribing information. Potential interactions are listed at hep-druginteractions.org.
- Warning: Patients who are coinfected with hepatitis B and C who take this medication may be at risk of hepatitis B virus (HBV) reactivation. Before taking this medication, be sure your doctor has tested you for evidence of current or prior hepatitis B virus infection. 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 serious hepatitis flares, liver failure, and death.
- When Viekira Pak is prescribed with ribavirin, a drug that may harm fetuses, it should not be taken by pregnant women or those who are trying to become pregnant. Women of childbearing age and their male sexual partners must use two forms of birth control throughout treatment and for six months after treatment if ribavirin is prescribed.
- When not taken with ribavirin, the effects of Viekira Pak on the developing fetus during pregnancy or on babies during breast-feeding are not well-studied.
For More Info: https://www.rxabbvie.com/pdf/viekirapak_pi.pdf
Co-Pay Program Info: http://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment
Patient Assistance Program Info: http://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment
Last Reviewed: January 4, 2019