On december 19, 2014, fda approved viekira pak ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets for use with or without ribavirin for the treatment of patients with genotype 1 chronic hepatitis c virus hcv infection including those with compensated cirrhosis. Criteria for prior approval of viekira pak ombitasvir. Viekira pakviekira xr is indicated for the treatment of adult patients with chronic hepatitis c virus hcv. Ombitasvirparitaprevirritonavir plus dasabuvir fda. Viekira pak medicare coverage and copay details goodrx. Centrifuge specimen within six hours of collection, remove serumplasma, transfer specimen to polypropylene screwcapped tubes, and freeze. Ombitasvir, paritaprevir, ritonavir and dasabuvir viekira. Ombitasvir, paritaprevirritonavir plus dasabuvir viekira pak national drug monograph january 2015 va pharmacy benefits management services, medical advisory panel, visn pharmacist executives and office of public health. Compare harvoni vs viekira pak comprehensive analysis by treato. In the early 1990s, treatment included interferon monotherapy for 48 weeks, resulting in an approximate 10% sustained virologic response svr rates for genotype 1. These are packaged in bottles and blister cards of 3 tablets tripaks. Ombitasvir, paritaprevirritonavir plus dasabuvir viekira pak.
Viekiraxinnombitasvir, paritaprevir, ritonavir european medicines. Page 1 of 5 louisiana medicaid hepatitis c directacting antiviral daa agents to request authorization for nonpreferred daa agents, the prescriber must submit the following documents which must be completed, dated and signed by the prescriber signature stamps and. Dosing and drug interactions dovato official hcp website. Viekira pak is a combination of drugs used to treat patients with hepatitis c virus genotype 1. Viekira pak with ribavirin was assessed in 380 subjects with genotype 1 infection and compensated cirrhosis who were treated with viekira pak plus ribavirin for 12 n208 or 24 n172 weeks duration turquoiseii see clinical studies 14. Viekira pak ombitasvir, paritaprevir, ritonavir, and. Viekira pak is a new directacting antiviral agent that has an excellent efficacy in treating patients with chronic hcv. Viekira pak ombitasvir, paritaprevir, and ritonavir. Pharmacy prior authorization hepatitis c clinical guideline. Dec 23, 2014 on december 19, 2014, fda approved viekira pak ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets for use with or without ribavirin for the treatment of patients with genotype 1 chronic hepatitis c virus hcv infection including those with compensated cirrhosis. Coadministration of amiodarone with sovaldi is not recommended. Measure cyclosporine blood concentrations to determine subsequent dose modifications. Highlights of prescribing information vosevi is not.
Zithromax for oral suspension is supplied to provide 100 mg5 ml or 200 mg5 ml suspension in bottles. When administered with viekira pak, the recommended dosage of rbv is based on weight. Viekira pak or technivie can be used with these hiv drugs. Genotype 1 is the most common in the us, affecting around 75% of americans with the virus. Collect specimen in two ppt tubes, gelbarrier tubes, or lavendertop edta tubes. Viekira pak fda prescribing information, side effects and uses. The patient must have documented clinical evidence supporting use of viekira pak over preferred agents. Caspofungin is indicated for febrile neutropenia suspected to be caused by a fungal infection, and for the treatment. Viekira pakviekira xr with or without ribavirin is indicated for the treatment of adult patients with genotype 1. Highlights of prescribing information these highlights do not include all the information needed to use viekira pak safely and effectively. Ns5a inhibitor, ns34a protease inhibitor, cyp3a inhibitor, and nonnucleoside. If patient is female, she must not currently be pregnant and may not become pregnant while taking above combinations.
Abbvies viekira pak sales plummet in q3 the motley fool. Food and drug administration fda has approved abbvies nyse. Ribavirin is routinely recommended for use with all 3 combination products unless viekira pak or viekira xr is being used for the treatment of genotype 1b. Viekira pak ombitasvir, paritaprevir, and ritonavir tablets.
Includes dosage, cost, side effects, dug interactions, efficacy, fda approval date, and prescribing information. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for viekira pak ombitasvir, paritaprevir, ritonavir, and dasabuvir. Viekira pak is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged. Viekira pak 12 tablets per 28 days dispensing limits a 28day supply dispense limit applies to all targeted hepatitis c agents in order to better manage the therapy regimen. In fact, patients born between 1945 and 1965 represent the highest proportion 70% of hcvinfected individuals in the united states, 1 and the prevalence of this birth cohort is estimated to be 3. Ombitasvir, paritaprevir, ritonavir, and dasabuvir. Drugs contraindicated for use with ombitasvir, paritaprevir. Nov 01, 2017 viekira pak veekeerah pak ombitasvir, paritaprevir, and ritonavir tablets. Ombitasvirparitaprevirritonavir and dasabuvir viekira pak editors summary. Viekira pak is an antiviral treatment for hepatitis c its a combination therapy that includes the medicines ombitasvir, paritaprevir, dasabuvir, and ritonavir. Viekira xr and technivie fact sheet treatment action group. Antiviral therapy in elderly patients with hepatitis c.
Navigating clinically significant drug interactions. Zithromax is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria. Dec 12, 2019 testing prior to the initiation of therapy. Learn about norvir ritonavir as a part of your hiv1 antiretroviral therapy regimen. Ombitasvir, paritaprevirritonavir plus dasabuvir viekira pak national. Medicare coverage and pricing details for viekira pak. Specimens drawn into ppt tubes need to be centrifuged within six hours and frozen. The paradigm of hepatitis c virus hcv treatment has changed drastically in the past 20 years. Ombitasvir, paritaprevir, ritonavir and dasabuvir viekira pak drug interaction chart.
Rates of hepatitis c virus hcv infection are disproportionately higher in older patients. It contains four medicines, dasabuvir, ombitasvir, paritaprevir, and ritonavir. Com web site and connecting to a site that is not under the control of abbvie. Abbvie is not responsible for the contents of any such site or any further links from such site. Pharmacy prior authorization hepatitis c clinical guideline viekira pak xr ombitas vir, paritaprevir, ritonavir, dasubavir technivie ombitasvir, paritaprevir, ritonavir. Viekira pak ombitasvir, paritaprevir, ritonavir 12. Sensitivity analyses were also conducted on the subset of patients who received the. More information is available in the prescribing information for viekira xr and technivie and. Viekira pak are considered i nvestigational for patients that are under 18 years of age and for patients that do not meet the criteria for medical necessity. If viekira pak is administered with ribavirin rbv, refer to the prescribing information for ribavirin for a list of ribavirinassociated adverse reactions.
Navigating clinically significant drug interactions between hepatitis c direct acting antiviral agents and statins. Learn more about medicare prescription drug plans and savings with goodrx. Viekira pak viekira xr is indicated for the treatment of adult patients with chronic hepatitis c virus hcv. No alcohol or illicit drug use during the course of treatment.
Before taking viekira pak, tell your health care provider. Viekira pak contains ombitasvir, paritaprevir, and ritonavir as a fixeddose. When taking viekira pak in combination with ribavirin, you should also read the medication guide that comes with ribavirin. Viekira pak belongs to a class of drugs called directacting antiviral agents. Although it is not required that technivie, viekira xr, and viekira pak be taken with food, if prescribed with ribavirin, this is the recommendation because concentrations of ribavirin. Viekira pak is contraindicated in patients with severe hepatic impairment childpugh c see contraindications 4, use in specific populations 8. Viekira pak was approved by the fda on december 19, 2015 as the newest treatment for chronic hepatitis c genotype 1, and is already available to patients. Viekira pak with ribavirin in gt1infected subjects with compensated cirrhosis. Highlights of prescribing information these highlights do not. Viekira pak with ribavirin was assessed in 380 subjects with genotype 1 infection and compensated cirrhosis who were treated with viekira pak plus ribavirin. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Find patient medical information for viekira pak oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Dasabuvirombitasvirparitaprevirritonavir viekira xr, viekira pak. Drugs contraindicated for use with ombitasvir, paritaprevir, ritonavir and dasabuvir viekira pak drug class drugs within class that are contraindicated clinical comments alpha1adrenoreceptor antagonist alfuzosin hcl potential for hypotension.
Abbvie is not responsible for the contents of any such site or any further. Ombitasvirparitaprevirritonavir plus dasabuvir fda label. Review of viekira pak ombitasvir, paritaprevir, and ritonavir. What is the most important information i should know about viekira pak. Consult the ribavirin prescribing information for detailed information on ribavirinrelated adverse effects and. Zithromax 500 mg tablets are engraved with pfizer on one side and ztm500 on the other. Centrifuge specimen within six hours of collection, remove serumplasma, and transfer specimen to polypropylene screwcapped tubes, and freeze. Fda released a safety warning that viekira pak can cause serious liver injury mostly in patients with underlying advanced liver disease. Prior authorization criteria viekira pak ombitasvir. Acute bacterial exacerbations of chronic bronchitis in adults acute bacterial sinusitis in adults uncomplicated skin and skin structure infections in adults urethritis and cervicitis in adults genital ulcer disease in men. Cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Norvir, a wellknown and approved treatment for more than 20 years. Viekira pak refer to package insert for a listing of interacting medications. Viekira pak is used in combination with ribavirin rbv in certain patient populations see table 1.
We report the first case of fatal lactic acidosis presenting 3 days after initiating therapy with viekira pak. Viekira pak side effects, dosage, interactions drugs. For more information, please see the viekira pak package insert pdf. Chronic hepatitis c virus infection, in combination with viekira pak viekira xr authorization of up to 24 weeks total as applicable may be granted for members prescribed rbv in combination with viekira pak viekira xr who meet the criteria for approval for the requested regimen. Viekira pak is not for people with advanced cirrhosis. Dec 02, 2019 pharmacy prior authorization hepatitis c clinical guideline viekira pak xr ombitas vir, paritaprevir, ritonavir, dasubavir technivie ombitasvir, paritaprevir, ritonavir. Daily dosage of ribavirin is weight based mg for members less than 75 kg and 1200 mg for those greater than or equal to 75 kg, administered orally in two divided doses with food. Viekira pak xr ombitas vir, paritaprevir, ritonavir. Common questions and answers about ritonavir package insert norvir found some additional information full prescribing information sheet for viekira pak ombitasvir, paritaprevir, and ritonavir tablets. Test all patients for evidence of current or prior hbv infection by measuring hepatitis b surface antigen hbsag and hepatitis b core antibody antihbc before initiating hcv treatment with viekira pak see warnings and precautions. June 24, 2016 viekira pak description viekira pak ombitasvir, paritaprevir, ritonavir and dasabuvir background hepatitis c is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Abbv viekira pak, an alloral, interferonfree treatment, with or without ribavirin rbv, for the treatment of patients with chronic genotype 1 gt1 hepatitis c virus hcv infection, including those with compensated cirrhosis. Ombitasvirparitaprevirritonavir plus dasabuvir uses. Pearl ii was a 12week openlabel, randomized trial which had a primary endpoint of cure svr 12 rate in noncirrhotic patients with hcv gt1b who had previously received treatment and were given either viekira pak and rbv or viekira pak alone.
Drug information on ombitasvirparitaprevirritonavir plus dasabuvir copackaged tablets film coated for health care professionals. Procedures and billing codes to report provider services, use appropriate cpt codes, alpha numeric hcpcs level 2 codes. Zithromax for oral suspension after constitution contains a flavored suspension. Viekira in combination with ribavirin is contraindicated in pregnancy. Viekira pak ombitasvirparitaprevirritonavirdasabuvir. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Aidsinfo provides the following drug label solely as an example of the labels available for viekira pak. If you are allergic to any of the medicines in viekira pak dasabuvir, ombitasvir, paritaprevir, and ritonavir or any other medicines. Highlights of prescribing information these highlights do not include all the information needed to use zepatiersafely and effectively. Page 1 of 5 louisiana medicaid hepatitis c directacting antiviral daa agents to request authorization for nonpreferred daa agents, the prescriber must submit the following.
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