Ombitasvir, paritaprevirritonavir technivie pharmacy benefits. Technivie should be administered with ribavirin rbv. Highlights of prescribing information these highlights do not include all the information needed to use viekira pak safely and effectively. Lactic acidosissevere hepatomegaly with steatosis and post treatment severe acute exacerbation of hepatitis b lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs see warnings and precautions 5. Alaska medicaid prior authorization clinical criteria for use hcv daa pa clinical criteria for use changes approved. Ombitasvirparitaprevirritonavir technivie contraindications patients with severe hepatic impairment concomitantly taking medications that are. Serious skin reactions fatal and nonfatal serious skin reactions, including stevens johnson syndrome sjs, drug reaction with eosinophilia and systemic symptoms dress.
Paritaprevir is an acylsulfonamide inhibitor of the ns34a serine protease manufactured by. Technivie fda prescribing information, side effects and uses. Discontinuation of therapy is recommended in all patients with 1 hcv rna levels of greater than iuml at treatment week 4 or 12. Ombitasvirparitaprevirritonavir and dasabuvir ombptv rtv and dbv viekira pak and viekira xr 57 are fda approved for hcv genotype 1. The paradigm of hepatitis c virus hcv treatment has changed drastically in the past 20 years. Aetna better health pharmacy prior authorization hepatitis. Technivie is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis c virus hcv infection without cirrhosis or with compensated cirrhosis. Ritonavir does not have activity against hepatitis c virus hcv. The combination of two directacting antivirals, each with distinct mechanisms of action, targets and inhibits specific hcv proteins in the viral replication process. Technivie, ombitasvir, paritaprevir and ritonavir centerwatch. See full prescribing information for complete boxed. Dec 01, 2020 technivie is used to treat genotype 4 chronic hepatitis ca in adults without cirrhosis or with a certain type of cirrhosis compensated cirrhosis.
Acceptable tests for determination of fibrosis in hcv. In the early 1990s, treatment included interferon monotherapy for 48 weeks, resulting in an approximate 10% sustained virologic response svr rates for genotype 1. Technivie ombitasvir, paritaprevir, and ritonavir tablets. Pmda summary of investigation results and revisions of precautions for prescription products, 20 october 2015. An assessment by the statin liver safety task force. Technivie ombitasvir, paritaprevir and ritonavir tablets fda. Pmda summary of investigation results and revisions of precautions for overthecounter laxatives, 20 october 2015. Per prescribing information, this combination may be administered without ribavirin in treatmentnaive patients who cannot tolerate ribavirin. Navigating clinically significant drug interactions between. These highlights do not include all the information needed to use biktarvy safely and effectively. Oct 21, 2015 and patient counseling information sections of the package insert and medication guide with information on postmarketing cases of hepatic decompensation and hepatic failure with technivie. Added step requirement for harvoni and ag 8 weeks therapy. Technivie is a fixeddose combination of ombitasvir, paritaprevir, and ritonavir. Department of health and human services silver spring md 20993.
Paritaprevir was a component of viekira pak and technivie. Genotyping hepatitis c viruses from southeast asia by a novel line probe assay that simultaneously detects core and 5 untranslated regions. Based on the week 96 analysis, the most common adverse reaction all grades. Tavalisse is an oral medicine that can help you manage chronic immune thrombocytopenia itp by protecting your platelets from destruction. All of the above information was adapted from the abbvie inc. Jul 24, 2015 about technivie technivie is an alloral antiviral treatment consisting of the fixeddose combination of paritaprevirritonavir 150100mg coformulated with ombitasvir 25mg dosed once daily and taken with a meal, which is coadministered with weightbased rbv mg or 1200mg in divided doses, twice daily, taken with food.
American association for the study of liver diseases and the infectious diseases society. Office of pharmacy services prior authorization criteria. Abbvie, revised 72015 9 viekira pak package insert. Ombptvrtv technivie is approved for genotype 4 because dbv is not active against genotype 4. For ribavirin dosage modifications, refer to the ribavirin prescribing information. Inject the sterile water slowly, so that it drips down the side of the vial into the fuzeon powder. Removed daklinza as product was withdrawn from the market. Risk of hepatitis b virus reactivation in patients coinfected with hcv and hbv test all patients for evidence of current or prior hepatitis b virus hbv infection before initiating. Harvoni package insert, foster city, ca, gilead pharmaceuticals. Risk of hepatitis b virus reactivation in patients coinfected with hcv and hbv see full prescribing information for complete boxed warning. Criteria for prior approval of technivie ombitasvir, paritaprevir and ritonavir 1. Acceptable tests for determination of fibrosis in hcv noninvasive methods for determination of liver disease numerous noninvasive methodologies have been developed to.
Ribavirin for 12 weeks from technivie prescribing information. Rebetol product information accessed 040420 at dailymed. Navigating clinically significant drug interactions. Sep 22, 2016 epidemiology, presentation, and natural history of hcv disease. For patients with hcvhiv1 coinfection, follow the dosage recommendations in table 1. Direct acting antiviral medications for treatment of hepatitis c hmsa. Download the pdf here technivie provides an opportunity to treat adults in the u. About technivie technivie is an alloral antiviral treatment consisting of the fixeddose combination of paritaprevirritonavir 150100mg coformulated with ombitasvir 25mg dosed once daily and taken with a meal, which is coadministered with weightbased rbv mg or 1200mg in divided doses, twice daily, taken with food. Drugs contraindicated for use with ombitasvirparitaprevirritonavir. If certain ugt1a or cyp3a inducers are coadministered, then adjust the weightbased dose of tivicay to twice daily. Treatment with technivie and ribavirin requires 6 scheduled visits over 6 months. This drug requires a written request for prior authorization.
Technivie ombitasvir, paritaprevir and ritonavir fda. Technivie is indicated in combination with ribavirin for the treatment of patients with. The patient must meet all general criteria for newer direct acting antivirals daa for hepatitis c in addition to drug specific criteria, to be considered eligible for prior approval. Cyp3a substrates evaluated in drug interaction studies which may require dose adjustment andor clinical monitoring include see table 2 ciclosporin, sirolimus.
Criteria for prior approval of technivie ombitasvir. Viekira xr dasabuvirombitasvirparitaprevirritonavir product information accessed 040420 at dailymed. Reference numbers 2184h specialty quantity limit hepatitis c medications 2184h p2019. New hcv treatments include more than one drug to prevent drug resistance from. It is a fixeddose combination tablet that is used to treat patients with hepatitis c, genotype 4. Technivie ombitasvirparitaprevirritonavir tablets with ribavirin is indicated for the treatment of adults with genotype 4 chronic hepatitis c virus.
Ribavirin is routinely recommended for use with all 3 combination products unless viekira pak or viekira xr. Technivie ombitasvirparitaprevirritonavir product information accessed 040420 at dailymed. Direct acting antivirals f or hepatitis c hcv therapeutic. American association for the study of liver diseases and the infectious diseases society of america. Hepatitis c viral rna genotype, lipa test summary quest. These tests will include a pregnancy test for female patients of childbearing age.
Highlights of prescribing information zepatier is recommended. Refer to the prescribing information for ribavirin for a list of ribavirinassociated. About hepatitis c hepatitis c is inflammation of the liver. Technivie was also granted a breakthrough therapy designation by the fda in 2014, a status given to investigational treatments for serious or lifethreatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy. Highlights of prescribing information severe skin reactions. Adverse effects associated with the use of technivie may include, but are not limited to, the. Direct acting antivirals for hepatitis c hcv therapeutic. No alcohol or illicit drug use during the course of treatment. Jun 08, 2020 o viekira pak, viekira xr, technivie, and zepatier in members with childpugh b or c o use in combination with other directacting antivirals daas unless indicated o any contraindications to any of the agents. Recommendations for testing, managing, and treating hepatitis c. These highlights do not include all the information needed to use reyataz safely and effectively. Technivie contains the antiviral medications ombitasvir, paritaprevir and. Chronic hepatitis c virus infection, in combination with technivie authorization of up to 12 weeks total may be granted for members prescribed rbv in combination with technivie who meet the criteria for approval for the requested regimen. Incivek telaprevir tablets, for oral use initial u.
Never shake the vial butgently tap the fuzeon vial with fingertip for 10 seconds to start dissolving the powder. Jul 24, 2015 this approval of technivie is based on data from the pearli study, which demonstrated 100 percent sustained virologic response rates at 12 weeks posttreatment svr 12 in patients who received. Homepage tavalisse fostamatinib disodium hexahydrate tablets. Technivie refer to package insert for a listing of interacting medications. Side effects of technivie ombitasvir, paritaprevir and ritonavir. Technivie is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic. Technivie is given together with another drug called ribavirin. Recommendations for testing, managing, and treating. Most people infected with hepatitis c virus hcv have no. Technivie ombitasvir, paritaprevir, and ritonavir tablets receives fda approval as the first and only alloral, interferonfree treatment for genotype 4 chronic hepatitis c in the u. Reference numbers 2140a ribavirin 2140a sgm p2019 2020 cvs caremark. Table 1 shows the recommended technivie treatment regimen and duration for. Highlights of prescribing information or below 15 ml per.
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