TECHNIVIE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TECHNIVIE (TECHNIVIE).
Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir. Ombitasvir is an NS5A inhibitor that inhibits HCV RNA replication and virion assembly. Paritaprevir is an NS3/4A serine protease inhibitor that prevents cleavage of the HCV polyprotein. Ritonavir is a pharmacokinetic enhancer that inhibits CYP3A-mediated metabolism of paritaprevir, increasing its plasma levels.
| Metabolism | Ombitasvir: Primarily metabolized by amide hydrolysis followed by oxidative metabolism. Paritaprevir: Primarily metabolized by CYP3A4. Ritonavir: Primarily metabolized by CYP3A4 and to a lesser extent by CYP2D6. |
| Excretion | Biliary/fecal (majority, >90% as unchanged drug); renal (<1%) |
| Half-life | Terminal half-life approximately 40 hours, supporting once-daily dosing |
| Protein binding | >99.9%, primarily to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 0.2 L/kg, indicating distribution largely confined to plasma and extracellular fluid |
| Bioavailability | Oral: not determined; absorption is rapid with Tmax of 4-5 hours post-dose |
| Onset of Action | Oral: clinical viral load reduction observed within 24-48 hours |
| Duration of Action | Sustained viral suppression for the duration of treatment (12-24 weeks); effective half-life supports daily dosing interval |
TECHNIVIE (ombitasvir, paritaprevir, and ritonavir) is administered orally as two fixed-dose combination tablets (each containing ombitasvir 12.5 mg, paritaprevir 75 mg, and ritonavir 50 mg) taken once daily in the morning with food, in combination with dasabuvir (250 mg twice daily with food) for genotype 1b or with ribavirin for genotype 1a.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment of TECHNIVIE is required for patients with any degree of renal impairment, including those on dialysis. However, if used with ribavirin, refer to ribavirin dosing adjustments for renal impairment. |
| Liver impairment | TECHNIVIE is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh class B or C). No dose adjustment is needed for mild hepatic impairment (Child-Pugh class A). |
| Pediatric use | Safety and efficacy in pediatric patients below 18 years of age have not been established; therefore, no dosing recommendations are available. |
| Geriatric use | No dose adjustment of TECHNIVIE is required in elderly patients. Clinical studies included patients aged 65 and older, with no overall differences in safety or efficacy observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TECHNIVIE (TECHNIVIE).
| Breastfeeding | No data on presence in human milk; risk to infant cannot be excluded. M/P ratio unknown. |
| Teratogenic Risk | Insufficient human data; animal studies show no teratogenicity at clinically relevant doses. Avoid in pregnancy unless benefit outweighs risk. |
| Fetal Monitoring | Monitor liver function tests and INR before and during therapy; assess for fetal growth via ultrasound if used in pregnancy. |
■ FDA Black Box Warning
Boxed Warning: Risk of Hepatitis B Virus (HBV) Reactivation. HBV reactivation has been reported in patients co-infected with HCV and HBV who were treated with direct-acting antivirals for HCV. Some cases resulted in fulminant hepatitis, hepatic failure, and death. Test all patients for evidence of current or prior HBV infection before starting Technivie. Monitor patients for HBV reactivation during treatment and post-treatment follow-up.
| Serious Effects |
["Severe hepatic impairment (Child-Pugh B or C) or decompensated cirrhosis.","Concomitant use with drugs that are strong CYP3A inducers (e.g., rifampin, St. John's wort).","Known hypersensitivity to ombitasvir, paritaprevir, ritonavir, or any excipients.","Concomitant use with drugs highly dependent on CYP3A for clearance (e.g., alfuzosin, ergot derivatives, lovastatin, simvastatin, etc.).","Concomitant use with ethinyl estradiol-containing contraceptives."]
| Precautions | ["HBV reactivation: Screen for HBV before initiation.","Hepatic decompensation/hepatic failure in patients with cirrhosis: Discontinue if signs of hepatic decompensation occur.","Increases in transaminases: Monitor hepatic function, especially during first 4 weeks of therapy.","Use with estrogen-containing contraceptives: May increase ALT levels; discontinue estrogens if ALT elevation occurs.","Drug interactions: Technivie is a CYP3A4 inhibitor; consider dose adjustments of sensitive CYP3A4 substrates.","Ribavirin: Use with caution in patients with creatinine clearance <50 mL/min."] |
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| Fertility Effects | No effects on fertility reported in animal studies; human data lacking. |