Incivek | telaprevir

Drug Class: Direct Acting Antiviral Agent; Protease Inhibitor
Similar Drugs: Olysio, Victrelis, Sovaldi
Manufacturer: Vertex
Approval Date: May 2011

What is Incivek

Incivek is a protease inhibitor used for treating chronic hepatitis C virus (HCV) infections. It is a direct acting antiviral agent. Incivek reduces the activity of hepatitis C virus protease enzymes which leads to the formation of defective viruses that are unable to multiply in the liver. As a result the hepatitis C viral load decreases.

What is Incivek used for

Incivek is used for treatment of chronic hepatitis C infection in adults with compensated liver disease, including cirrhosis. Patients may be treatment naive (previously untreated) or have been previously treated and were none responders, partial responders, or relapsed. It must be combined with peginterferon alfa and ribavirin.

How well does Incivek work

The efficacy and safety was evaluated in 4 clinical studies. Studies compared the addition of Incivek (2250 mg total daily) or placebo for 8/12 weeks to standard therapy with peginterferon alfa-2a (Peg-IFNa, 180 mcg/week) plus ribavirin (RBV, 1000/1200 mg/day) for 24/48 weeks.

• In previously untreated subjects, hepatitis C virus levels were undetectable in 79% of Incivek treated subjects versus 46% of subjects that only received peginterferon alfa and ribavirin.
• In previously untreated subjects with liver cirrhosis at baseline, hepatitis C virus levels were undetectable in 61% of the group receiving Incivek for 12 weeks + Peg-IFNa/RBV for 24 weeks versus 92% of the group receiving Incivek for 12 weeks + Peg-IFNa/RBV for 48 weeks.
• In comparing Incivek dosing regimens in previously untreated subjects, response rates were similar between the group receiving Incivek 1125 mg twice daily (74%) and the group receiving Incivek 750 mg every 8 hours (73%).
• In subjects who relapsed after previous therapy, virus levels were undetectable in 86% of Incivek treated subjects versus 22% of subjects that only received peginterferon alfa and ribavirin. In prior partial responders, it was undetectable in 59% and 15%, respectively; in prior null responders, it was undetectable in 32% and 5%, respectively.

How is Incivek different from peginterferon alfa and ribavarin

• Incivek is a direct-acting hepatitis C virus protease inhibitor.
• It reduces the hepatitis C virus to undetectable levels in more patients.

What is the dosing of Incivek

It is supplied as Incivek 375 mg tablets. Dosing is 1125 mg administered orally 2 times daily (10-14 hours apart) with a meal or snack. It is administered in combination with peginterferon alfa and ribavirin.

What are the side effects of Incivek

Common: rash, pruritus, anemia, nausea, hemorrhoids, diarrhea, anorectal discomfort, dysgeusia, fatigue, vomiting and anal pruritus.

Serious: Fatal skin reactions/rash (e.g., Stevens Johnson Syndrome), anemia, birth defects.

Incivek Drug interactions

Incivek interacts with various drugs. Here are some of the significant interactions.

These drugs decrease the breakdown of Incivek in the liver, increasing blood levels of Incivek

Antifungals (ketoconazole, itraconazole, posaconazole, voriconazole): Oral or intravenous administration of some antifungals may increase blood levels of Incivek and the antifungal. High doses of interacting antifungals are not recommended. 

These drugs decrease the breakdown of Incivek in the liver

HIV-Antiviral Agents (atazanavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir, efavirenz): blood concentrations of Incivek may be decreased through induction of metabolism. Blood levels of the antiviral agent may also be altered. 

Antimycobacterial: concentrations of Incivek may be decreased, and rifabutin concentrations may be increased

Incivek decreases metabolism of some co-administered drugs

Benzodiazepines: exposure to midazolam may be increased. Co-administration of oral midazolam is contraindicated

Corticosteroids (prednisone, methylprednisolone, fluticasone, budesonide): blood concentrations of corticosteroids given by mouth or injection can be significantly increased. Alternatives should be considered. 

HMG-CoA Reductase Inhibitors ― Statins (atorvastatin, lovastatin, simvastatin): blood concentrations of these agents may be markedly increased through inhibition of metabolism by Incivek. such combinations should be avoided.  

PDE5 Inhibitors (Viagra, Cialis, Levitra): blood concentrations of PDE5 inhibitors may be increased when combined with Incivek. Co-administration of these agents with Incivek in the treatment of pulmonary arterial hypertension is contraindicated. 

What is the price of Incivek

$945.07 for 6 tablets which is the dose for one day. The cost of Incivek for 30 days without insurance is $26,462.04.

How to obtain prescription assistance for Incivek

Use these resources for Incivek cost assistance.

 VERTEX GPS Co-Pay Assistance  and Patient Assistance Program

References

INCIVEK prescribing information and medication guide. Cambridge, MA: Vertex Pharmaceuticals, Inc.; 2013.

RED BOOK Online. INCIVEK. Truven Health Analytics, Inc.; 2014

Also Read

Are New Hepatitis C Virus (HCV) Treatments Too Expensive? 

New Drugs for Treatment of Hepatitis C: Victrelis, Incivek, Olysio, Sovaldi

The material on this site is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider.