Incivek (Telaprevir) - Summary

INCIVEK SUMMARY

INCIVEK (telaprevir) is an inhibitor of the HCV NS3/4A protease.

INCIVEK™ (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment-naive or who have previously been treated with interferon-based treatment, including prior null responders, partial responders, and relapsers [see Clinical Studies (14.2 and 14.3), including definitions of these terms].

The following points should be considered when initiating treatment with INCIVEK:

• INCIVEK must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin [see Warnings and Precautions ].
• A high proportion of previous null responders (particularly those with cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK combination treatment [see Clinical Pharmacology (12.4) and Clinical Studies ].
• INCIVEK efficacy has not been established for patients who have previously failed therapy with a treatment regimen that includes INCIVEK or other HCV NS3/4A protease inhibitors [see Clinical Pharmacology ].

NEWS HIGHLIGHTS

Published Studies Related to Incivek (Telaprevir)

Telaprevir for previously treated chronic HCV infection. [2010]
likelihood of success with retreatment... CONCLUSIONS: In HCV-infected patients in whom initial peginterferon alfa and

Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. [2009]
rapidly reduced HCV RNA levels in early studies... CONCLUSIONS: Treatment with a telaprevir-based regimen significantly improved

Cost-effectiveness of telaprevir in patients with genotype 1 hepatitis C in Australia. [2014]
treatment with PR earlier... CONCLUSION: Telaprevir plus PR in the Australian setting is cost-effective when

VX-222, a non-nucleoside NS5B polymerase inhibitor, in telaprevir-based regimens for genotype 1 hepatitis C virus infection. [2014]
telaprevir-based regimens for treatment of genotype 1 HCV... CONCLUSION: These results provide valuable information regarding the safety,

Effect of fluvastatin on 24-week telaprevir-based combination therapy for hepatitis C virus genotype 1b-infected chronic hepatitis C. [2014]
randomized, controlled trial... CONCLUSION: In this trial, administration of fluvastatin with

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Clinical Trials Related to Incivek (Telaprevir)

A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection [Completed]
The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype [Terminated]
The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

A Study to Assess Safety and Pharmacokinetics of Telaprevir in Patients With Hepatic Impairment [Completed]
The purpose of this study is to determine whether the pharmacokinetic (what the body does to the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment, compared to the pharmacokinetic parameters in patients with normal liver function, and measure the relative unbound plasma concentrations of telaprevir.

Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects [Completed]
The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this study there will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK) sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit within 10 to 14 days of the last dose of study drugs. The total duration of the study from Screening to Follow-up will be approximately 9 weeks.

A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir [Completed]
The purpose of this study is to investigate the potential pharmacokinetic (what the body does to the drug) interactions between multiple doses of phenytoin 200 mg every 12 hours or carbamazepine 200 mg every 12 hours and telaprevir 750 mg every 8 hours at steady-state (constant concentration of medication in the blood) in healthy participants.

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Reports of Suspected Incivek (Telaprevir) Side Effects

Nausea (874),  Fatigue (733),  Rash (646),  Anaemia (627),  Pruritus (502),  Diarrhoea (490),  Vomiting (488),  Anorectal Discomfort (454),  Headache (366),  Dyspnoea (317), more >>