- Ombitasvir + paritaprevir + ritonavir (Technivie)
Acronyms and Definitions
- GT - Genotype
- HCV - Hepatitis C virus - see hepatitis C for more
- Hepatitis C genotype - See genotype for more
- PI - Package Insert
- SVR - Sustained Virological Response
- ULN - Upper limit of normal
- DRUGS IN CLASS
- Technivie is comprised of 3 medications:
- Paritaprevir (called ABT-450 in trials)
- 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
- Technivie contains 3 medications
- Ombitasvir - an inhibitor of hepatitis C virus NS5A protein
- Paritaprevir - an inhibitor of hepatitis C virus NS3/4A protease
- 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
- HCV genotype 4
- Technivie ± ribavirin - treatment regimens and trials
- HCV genotype 1b (not FDA-approved)
- Technivie - treatment regimens and trials
- 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
- *No serious skin reactions were reported
- Rib = ribavirin
- Reference 
- 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
- Ribavirin may cause hemolytic anemia
- The average change in hemoglobin levels in the Technivie + ribavirin group was -2.1 g/dL
- In the Technivie + ribavirin group, 4% of patients had their ribavirin dose reduced because of anemia. No patients received a blood transfusion or erythropoietin.
|Side effect||Technivie + Rib
for 12 weeks
for 12 weeks
- Known hypersensitivity to ritonavir
- Moderate to severe hepatic impairment (Child-Pugh B and 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 and 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 including technivie
- 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
- Coinfected patients should have a hepatitis B viral load drawn before starting therapy. During therapy, patients should be monitored for hepatitis B flare with appropriate labs (e.g. HBsAg, hepatitis B viral load, liver enzymes).
- Patients should contact their doctor if they experience signs of liver damage (e.g. fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools)
- See FDA drug safety communication for more
- MONITORING THERAPY
- LAB MONITORING FOR SIDE EFFECTS
- 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)
- See managing HCV treatment for recommendations on regimens that include ribavirin
- LAB MONITORING FOR STOPPING THERAPY DUE TO LACK OF EFFICACY
- Guidelines have not been established
- DRUG INTERACTIONS
NOTE: Drug interactions presented here are NOT all-inclusive. Other interactions may exist. The interactions presented here 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 for interactions with many others
- Because the list is quite extensive and will likely grow, we recommend consulting the Technivie package insert for an updated list of drug interactions
- Technivie PI - see section 4 for drug contraindications. See section 7 for drug interactions.
- 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 - major 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
- TREATMENT REGIMENS
- 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:
- What is PMID?
- PI = Manufacturer's Package Insert
- # PMID
1 - Technivie PI
2 - 25837829 - PEARL-I GT4
3 - 26170136 - PEARL-I GT1b