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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR INCIVEK


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505(b)(2) Clinical Trials for Incivek

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01511432 ↗ A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects Completed Vertex Pharmaceuticals Incorporated Phase 1 2012-01-01 The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Incivek

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01355289 ↗ Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501 Completed Eisai Inc. Phase 2 2011-11-01 To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment.
NCT01459913 ↗ 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 Vertex Pharmaceuticals Incorporated Phase 3 2011-11-01 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.
NCT01511432 ↗ A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects Completed Vertex Pharmaceuticals Incorporated Phase 1 2012-01-01 The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
NCT01581138 ↗ VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C Completed Vertex Pharmaceuticals Incorporated Phase 2 2012-07-01 The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Incivek

Condition Name

Condition Name for Incivek
Intervention Trials
Hepatitis C 3
Hepatitis C, Chronic 3
Chronic Hepatitis C 2
Infection 1
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Condition MeSH

Condition MeSH for Incivek
Intervention Trials
Hepatitis C 11
Hepatitis 10
Hepatitis C, Chronic 7
Hepatitis A 7
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Clinical Trial Locations for Incivek

Trials by Country

Trials by Country for Incivek
Location Trials
United States 60
Canada 8
Brazil 5
Austria 2
Poland 2
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Trials by US State

Trials by US State for Incivek
Location Trials
Texas 6
California 5
Virginia 4
Pennsylvania 3
North Carolina 3
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Clinical Trial Progress for Incivek

Clinical Trial Phase

Clinical Trial Phase for Incivek
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Incivek
Clinical Trial Phase Trials
Completed 6
Terminated 3
Withdrawn 2
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Clinical Trial Sponsors for Incivek

Sponsor Name

Sponsor Name for Incivek
Sponsor Trials
Vertex Pharmaceuticals Incorporated 5
Santaris Pharma A/S 2
Massachusetts General Hospital 1
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Sponsor Type

Sponsor Type for Incivek
Sponsor Trials
Industry 9
Other 4
U.S. Fed 1
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Incivek (Telaprevir): A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Incivek, known generically as telaprevir, was a groundbreaking drug in the treatment of genotype 1 chronic hepatitis C. Developed by Vertex Pharmaceuticals, it marked a significant advancement in the fight against this debilitating disease. Here, we delve into the clinical trials, market performance, and the eventual decline of Incivek.

Clinical Trials and Approval

Phase III Trials

Incivek was approved by the FDA in May 2011 based on three pivotal Phase III trials: Advance, Illuminate, and Realize. These trials involved over 1,095 untreated patients with genotype 1 hepatitis C and demonstrated improved sustained viral response (SVR) rates when telaprevir was combined with pegylated-interferon and ribavirin[4][5].

  • Advance Trial: This trial showed that patients treated with telaprevir in combination with pegylated-interferon and ribavirin had significantly higher SVR rates compared to those treated with the standard therapy of pegylated-interferon and ribavirin alone[4].
  • Optimize Trial: Conducted to evaluate the twice-daily dosing of telaprevir, this trial enrolled 740 treatment-naive patients and showed SVR rates of 74% and 73% for the twice-daily and eight-hour dosing regimens, respectively[4].

Safety and Efficacy

The clinical trials highlighted the efficacy of Incivek in achieving viral cure, with SVR rates that were significantly higher than the standard therapy. However, the treatment was associated with side effects such as rash, anemia, fatigue, itching, and gastrointestinal issues, which led to treatment discontinuation in some cases[1][4].

Market Performance

Launch and Initial Success

Incivek was launched in May 2011 and quickly became one of the fastest-selling drugs in history, generating $494.1 million in sales in the first five months after its launch. It was projected to reach $1 billion in sales by the end of 2011, a feat that would have set a record for the fastest drug launch ever[3].

  • Market Share: Incivek dominated the market, capturing 75% of the US prescriptions for hepatitis C treatment. Its sales were significantly higher than its competitor, Merck's Victrelis, with Incivek averaging 1,000 new prescriptions per week compared to Victrelis's 300 per week[3].

Peak Sales and Projections

At its peak, Incivek was expected to generate annual sales exceeding $4 billion, with analysts estimating peak sales up to $5 billion. The drug's success propelled Vertex Pharmaceuticals from a promising biotech company to a major biopharma player[3][5].

Market Decline and Discontinuation

Impact of Sovaldi

The launch of Gilead Sciences' Sovaldi in 2013 marked a significant turning point for Incivek. Sovaldi, with its 90% cure rate and simpler 12-week treatment regimen, quickly captured the market, leading to a drastic decline in Incivek sales. By 2014, Incivek's revenues had dropped to just 8% of Vertex's total revenue, down from being the majority contributor in previous years[2].

  • Sales Drop: In the first six months of 2014, Incivek sales plummeted to $13.2 million, a 96% drop from the $361.4 million generated in the same period the previous year[2].

Discontinuation

Due to the significant decline in market share and the availability of more effective and convenient treatments like Sovaldi, Vertex decided to discontinue the sales and distribution of Incivek by October 2014[2].

Regulatory Discussions and Future Plans

Phase 3 Studies

Before its discontinuation, Vertex was in discussions with regulatory agencies to initiate Phase 3 studies evaluating a 12-week treatment regimen for genotype 1 hepatitis C patients using a four-drug combination including Incivek. These studies aimed to assess the efficacy and safety of shorter treatment durations and response-guided therapies[1].

  • Four-Drug Regimens: The planned studies included evaluating 24- and 48-week response-guided, four-drug regimens for patients with cirrhosis and those who had not responded to prior treatments[1].

Key Takeaways

  • Clinical Success: Incivek demonstrated high SVR rates in clinical trials, significantly improving the standard of care for genotype 1 hepatitis C patients.
  • Market Dominance: Initially, Incivek dominated the market, achieving record-breaking sales and becoming one of the fastest-selling drugs in history.
  • Decline and Discontinuation: The introduction of Sovaldi led to a rapid decline in Incivek sales, resulting in its discontinuation by Vertex Pharmaceuticals.
  • Regulatory Efforts: Despite its discontinuation, the drug was part of ongoing discussions for future Phase 3 studies aimed at optimizing treatment regimens.

FAQs

What was the primary indication for Incivek?

Incivek was primarily indicated for the treatment of genotype 1 chronic hepatitis C in combination with pegylated-interferon and ribavirin.

How did Incivek perform in clinical trials?

Incivek showed significant efficacy in clinical trials, achieving high SVR rates when combined with pegylated-interferon and ribavirin, compared to the standard therapy.

What were the common side effects associated with Incivek?

Common side effects included rash, anemia, fatigue, itching, nausea, diarrhea, vomiting, and taste changes.

Why was Incivek discontinued?

Incivek was discontinued due to the significant decline in market share following the launch of Gilead Sciences' Sovaldi, which offered a more effective and convenient treatment option.

What were the peak sales projections for Incivek?

Analysts estimated peak sales for Incivek up to $5 billion annually.

Sources

  1. Vertex Pharmaceuticals. Interim Data from Phase 2 Study Showed 93% of People with Hepatitis C Who Received a Total of 12 Weeks of a Combination Regimen Including INCIVEKā„¢ (telaprevir) and VX-222 (400mg) Achieved a Viral Cure (SVR)[1].
  2. FiercePharma. Sovaldi forces Incivek off the hep C market as Vertex calls it quits[2].
  3. MMM-Online. Incivek's $1 bil. in sales this year would set record for fastest launch, analyst says[3].
  4. Clinical Trials Arena. Incivek / Telaprevir - Treatment for Chronic Hepatitis C[4].
  5. FierceBiotech. FDA approves mega-blockbuster Vertex hep C drug Incivek[5].

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