- ACRONYMS AND DEFINITIONS
- DRUGS IN CLASS
- Technivie is part of a new generation of antiviral medications that are highly effective against hepatitis C
- Technivie is a combination pill that contains 3 medications - ombitasvir, paritaprevir, and ritonavir
- See Hepatitis C treatment for a list of other HCV drugs
- NOTE: Technivie is the same as Viekira Pak except that it does not contain dasabuvir. Dasabuvir has no activity against HCV genotype 4.
- MECHANISM OF ACTION
- Ombitasvir is an inhibitor of the HCV NS5A protein which is essential for viral replication and virion assembly
- Paritaprevir is HCV NS3/4A protease inhibitor
- HCV NS3/4A protease cleaves HCV-encoded polyprotein into the individual proteins NS3, NS4A, NS4B, NS5A, and NS5B. These proteins form a complex that is necessary for viral replication.
- Ritonavir has no activity against hepatitis C virus. Ritonavir is a strong CYP3A4 inhibitor that is added to the formulation to inhibit paritaprevir metabolism and increase its blood levels
- FDA-APPROVED INDICATION
- Treatment of hepatitis C genotype 4 in combination with ribavirin - in patients without cirrhosis or with Child-Pugh A
- HCV genotype 4
- In trials, Technivie was > 90% effective in eradicating HCV genotype 4 in patients without cirrhosis or with Child-Pugh A
- HCV genotype 1b (not FDA-approved)
- Technivie was ≥ 90% effective in eradicating HCV genotype 1b in one trial. [PubMed abstract]
- SIDE EFFECTS
- The table below shows side effects reported in the PEARL-I GT4 trial
- One arm of the trial received Technivie with ribavirin and the other arm received Technivie without ribavirin
- Since there was no placebo arm, strength of association is unknown
- Only side effects that occurred at an incidence of ≥ 5% are listed
|Side effect||Technivie + RBV for 12 weeks
|Technivie for 12 weeks
- Liver enzyme elevations
- None of the patients in the PEARL-I GT4 trial experienced liver enzyme elevations > 5 X ULN
- Bilirubin elevations
- In the PEARL-I GT4 trial, 5% (7/134) of patients experienced bilirubin elevations ≥ 2 X ULN. All of the elevations occurred in the ribavirin group.
- The elevations were mostly indirect and related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and possibly ribavirin-induced hemolysis
- Bilirubin elevations occurred early, peaked by Week 1, and generally resolved with ongoing therapy
- Anemia/Decreased hemoglobin
- In patients without cirrhosis, Technivie in combination with ribavirin caused an average decrease in hemoglobin of 2.1 g/dL from baseline. Patients treated with Technivie alone had an average decrease of 0.4 g/dL.
- Hemolytic anemia is a well-documented side effect of ribavirin. See ribavirin for more.
- Known hypersensitivity to ritonavir
- Child-Pugh B or C
- Concomitant use with drugs that are highly dependent on CYP3A4 for clearance and for which elevated levels are potentially toxic
- Moderate and strong inducers of CYP3A4. CYP3A4 inducers may lead to decreased effectiveness.
- See the Technivie PI sec 4 for a list of drugs that are contraindicated with Technivie
- Kidney disease
- No dose adjustment is necessary in mild, moderate, or severe kidney disease 
- Liver disease
- Child-Pugh A: no dose adjustment necessary
- Child-Pugh B or C - DO NOT USE 
- In October 2015, the FDA issued a drug safety warning regarding cases of liver failure that have occurred in patients taking Viekira Pak and Technivie. Most cases occurred in patients with advanced cirrhosis who were receiving Viekira Pak. See FDA communication for more.
- HIV coinfection
- The ritonavir component of Technivie is also an HIV-1 protease inhibitor and may select for protease inhibitor-resistant HIV strains
- Patients with HIV should be on suppressive therapy when taking Technivie
- Hepatitis B coinfection
- In October 2016, the FDA placed a boxed warning on all new hepatitis C drugs about the possible reactivation of hepatitis B infection in coinfected patients who are taking direct-acting antiviral hepatitis C drugs
- At the time of the warning, the FDA had identified 24 cases of hepatitis B reactivation in patients taking these drugs. Reactivation occurred in patients who were HBsAg positive and in those who were HBsAg negative and anti-HBc positive (see hepatitis B serology for more).
- The FDA recommends that providers check all patients for hepatitis B coinfection (HBsAg and anti-HBc) before starting therapy and that they monitor patients for reactivation during and after therapy
- See AASLD guidelines for HBV coinfected patients for more
- MONITORING THERAPY
- Manufacturer's recommendations
- The manufacturer recommends monitoring liver function tests during the first 4 weeks of therapy and as clinically indicated thereafter. During the first 4 treatment weeks of the PEARL trials, monitoring was done at 0, 1, 2, and 4 weeks.
- If ALT levels remain persistently elevated greater than 10 X ULN, then consider stopping therapy
- Discontinue Technivie if ALT elevations are accompanied by signs or symptoms of liver inflammation or increasing direct bilirubin, alkaline phosphatase, or INR
- Patients should notify their doctor if they develop signs of liver toxicity (fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces)
- AASLD recommendations
- DRUG INTERACTIONS
- NOTE: The drug interactions presented here are NOT A COMPREHENSIVE LIST of all known interactions. Other interactions exist. The interactions below are meant to encompass commonly prescribed medications and/or interactions that are well-documented. Always consult your physician or pharmacist before taking medications concurrently. CLICK HERE for more information on drug interactions.
- HIGH ALERT INTERACTIONS
- Numerous drugs and drug classes
- The three drugs in Technivie™ are metabolized and eliminated through a number of pathways that can lead to significant drug interactions (see metabolism and elimination below)
- Technivie™ is contraindicated with a number of medications, and it has the potential to interact with many others
- See Technivie PI for a list of potential drug interactions [sec 7] and medications that are contraindicated with Technivie [sec 4]
- METABOLISM AND ELIMINATION
- NOTE: Drugs can be metabolized by more than one enzyme. Drugs may be metabolized by an enzyme and inhibit/induce the enzyme at the same time. Drug transporters (ex. p-glycoprotein) can play a role in drug metabolism. Not all drug interactions are clinically significant. Consult your physician or pharmacist if you are taking medications together and are concerned about a possible interaction.
- Primarily metabolized by amide hydrolysis
- UGT1A1 - inhibitor
- P-glycoprotein - substrate
- BCRP - substrate
- CYP3A4 - sensitive substrate
- UGT1A1 - inhibitor
- OATP1B1 - OATP1B1/P1B3 substrate and inhibitor
- BCRP - substrate and inhibitor
- P-glycoprotein - substrate and inhibitor
- Dosage form
- Technivie™ comes in a carton that has 28 days of therapy. Each monthly carton has 4 weekly cartons that contain 7 daily dosage packs.
- Each Technivie tablet contains the following:
- Ombitasvir 12.5 mg
- Paritaprevir 75 mg
- Ritonavir 50 mg
- Two Technivie tablets once daily in the morning with food
- Take with food. Food increases absorption
- Treatment regimens
- HCV Genotype 4 (in combination with ribavirin)
- Without cirrhosis or with Child-Pugh A: Technivie + ribavirin for 12 weeks. Ribavirin dosing should be weight-based.
- Treatment-naïve patients without cirrhosis may consider Technivie for 12 weeks without ribavirin
- HEPATITIS C TREATMENT RECOMMENDATIONS
- See Hepatitis C treatment recommendations for complete treatment guidelines
- LONG TERM SAFETY
- Technivie™ was FDA-approved in 2015
- There is no long-term safety data for the medication
- GENERIC AVAILABILITY
- Possible generic:
NOTE: Drug companies typically file multiple patents on their drugs in order to protect them from competition. The patent expiration listed here is the date that the earliest patent on the drug expires (accounting for pediatric exclusivity). Because drug companies use numerous techniques to extend the life of their patents, it does not necessarily mean a generic will become available around this date.
- What is PMID?
- PI = Manufacturer's Package Insert
- 1 - Technivie™ PI
- 2 - PMID 25837829 - PEARL-I GT4
- 3 - PMID 26170136 - PEARL-I GT1b