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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR MAVYRET


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All Clinical Trials for Mavyret

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02243293 ↗ A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection Completed AbbVie Phase 2/Phase 3 2014-09-19 The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.
NCT02446717 ↗ A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy Completed AbbVie Phase 2/Phase 3 2015-04-01 The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.
NCT02604017 ↗ A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection Completed AbbVie Phase 3 2015-10-01 This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis
NCT02636595 ↗ The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4) Completed AbbVie Phase 3 2015-11-01 The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
NCT02640157 ↗ A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection Completed AbbVie Phase 3 2015-12-01 The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.
NCT02640482 ↗ A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection Completed AbbVie Phase 3 2015-11-01 The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults with genotype 2 chronic hepatitis C virus (HCV) infection.
NCT02642432 ↗ A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis Completed AbbVie Phase 3 2015-12-07 The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mavyret

Condition Name

Condition Name for Mavyret
Intervention Trials
Hepatitis C 10
Chronic Hepatitis C 8
Hepatitis C Virus 6
HCV 4
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Condition MeSH

Condition MeSH for Mavyret
Intervention Trials
Hepatitis C 27
Hepatitis 26
Hepatitis A 23
Hepatitis C, Chronic 14
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Clinical Trial Locations for Mavyret

Trials by Country

Trials by Country for Mavyret
Location Trials
United States 155
Canada 17
Italy 14
Australia 12
France 11
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Trials by US State

Trials by US State for Mavyret
Location Trials
North Carolina 11
California 10
Texas 10
New York 10
Washington 9
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Clinical Trial Progress for Mavyret

Clinical Trial Phase

Clinical Trial Phase for Mavyret
Clinical Trial Phase Trials
Phase 4 8
Phase 3 12
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Mavyret
Clinical Trial Phase Trials
Completed 17
Not yet recruiting 4
Recruiting 3
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Clinical Trial Sponsors for Mavyret

Sponsor Name

Sponsor Name for Mavyret
Sponsor Trials
AbbVie 14
Massachusetts General Hospital 3
White River Junction Veterans Affairs Medical Center 2
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Sponsor Type

Sponsor Type for Mavyret
Sponsor Trials
Other 16
Industry 15
U.S. Fed 2
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MAVYRET: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to MAVYRET

MAVYRET, a fixed-dose combination of glecaprevir and pibrentasvir, is a groundbreaking treatment for chronic hepatitis C virus (HCV) infection. Developed by AbbVie, this pan-genotypic regimen has revolutionized the treatment landscape for HCV, offering a high cure rate and a shorter treatment duration.

Clinical Trial Overview

Efficacy and Safety

MAVYRET's efficacy and safety were evaluated in a series of clinical trials, including nine registrational studies that involved more than 2,300 patients across 27 countries. These studies encompassed all major HCV genotypes (GT 1-6) and various patient populations, including treatment-naive and treatment-experienced patients, as well as those with and without cirrhosis[3][5].

  • Treatment-Naive Patients: In treatment-naive non-cirrhotic patients, MAVYRET demonstrated a remarkable 98% cure rate (SVR12) over an 8-week treatment period. This was based on an integrated, pooled analysis of GT 1-6 patients from several phase 2 and 3 clinical trials, including ENDURANCE-1, -3, -5, and -6, EXPEDITION-2, -5, and -8, and SURVEYOR-1 and -2[1].
  • Virologic Failure and Relapse: The on-treatment virologic failure rate was exceptionally low at 0.1%, and the relapse rate was 0.6% among patients who completed the treatment[1].

Real-World Effectiveness

Real-world studies further reinforced the efficacy of MAVYRET. A meta-analysis of 18 real-world cohorts from various regions, including Europe, Japan, and the United States, showed a high SVR12 rate. For example, in GT 1-4 treatment-naive non-cirrhotic patients treated for 8 weeks, the cure rate was 99%[1].

Special Populations

MAVYRET has also been evaluated in special populations, including patients with chronic kidney disease and those with compensated cirrhosis. It is approved for use across all stages of chronic kidney disease and can be used in up to 95% of HCV patients, depending on the stage of liver disease and prior treatment history[3].

Market Analysis

Market Position and Opportunity

MAVYRET's approval and subsequent market performance have been significant. Given its pan-genotypic coverage and high cure rates, it has become a preferred treatment option for HCV.

  • Global Reach: MAVYRET has been granted marketing authorization in multiple regions, including the U.S. and Europe, expanding its global reach and market potential[3].
  • Patient Base: The drug is indicated for adults and children aged 3 years and older with chronic HCV infection, including those with compensated cirrhosis and across all major genotypes (GT 1-6)[2].

Competitive Landscape

The HCV treatment market is highly competitive, with several direct-acting antivirals (DAAs) available. However, MAVYRET's unique profile, including its short treatment duration and high efficacy across all genotypes, positions it favorably.

  • Competitors: Other notable DAAs include Epclusa and sofosbuvir-based regimens. However, MAVYRET's 8-week treatment duration for many patients and its broad genotypic coverage give it a competitive edge[4].

Economic Impact

The economic impact of MAVYRET is substantial, considering the high cure rates and reduced treatment duration, which can lead to lower healthcare costs in the long term.

  • Cost Savings: By achieving high SVR12 rates, MAVYRET reduces the need for prolonged treatment and follow-up care, potentially leading to significant cost savings for healthcare systems[1].

Projections and Future Outlook

Market Projections

Given its strong clinical performance and favorable market position, MAVYRET is expected to continue to dominate the HCV treatment market.

  • Market Growth: The global HCV treatment market is projected to grow, driven by increasing awareness, improved diagnostics, and the availability of effective treatments like MAVYRET[2].

Patent and Intellectual Property

MAVYRET's patent protection extends until 2036, providing AbbVie with a significant period of market exclusivity. This protection is crucial for maintaining market share and generating revenue[4].

Future Developments

While MAVYRET remains a leading treatment, ongoing research and development in the HCV space may introduce new competitors or complementary treatments.

  • Emerging Treatments: Other companies, such as Atea Pharmaceuticals, are developing new HCV treatments with potential "best-in-class" profiles, which could impact the market dynamics in the future[4].

Real-World Impact

Patient Outcomes

The real-world effectiveness of MAVYRET has been consistently high, mirroring the results from clinical trials. This has led to improved patient outcomes, including higher cure rates and better quality of life.

  • Patient Adherence: The shorter treatment duration and once-daily dosing of MAVYRET enhance patient adherence, which is critical for achieving optimal treatment outcomes[1].

Healthcare System Benefits

The high efficacy and short treatment duration of MAVYRET also benefit healthcare systems by reducing the overall burden of HCV care.

  • Resource Allocation: By curing HCV in a shorter period, healthcare resources can be more efficiently allocated, reducing the long-term costs associated with managing chronic HCV infection[3].

Key Takeaways

  • High Efficacy: MAVYRET has demonstrated a high cure rate (SVR12) across all major HCV genotypes in clinical trials and real-world studies.
  • Short Treatment Duration: The 8-week treatment duration for many patients is a significant advantage, improving patient adherence and reducing healthcare costs.
  • Broad Indications: MAVYRET is approved for use in adults and children aged 3 years and older, including those with compensated cirrhosis and across all stages of chronic kidney disease.
  • Market Dominance: With its favorable clinical profile and broad market authorization, MAVYRET is expected to continue dominating the HCV treatment market.
  • Future Outlook: While new treatments are in development, MAVYRET's patent protection until 2036 ensures its market position for the foreseeable future.

FAQs

What is MAVYRET used for?

MAVYRET is used for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older, including those with compensated cirrhosis and across all major HCV genotypes (GT 1-6)[2].

How effective is MAVYRET in treating HCV?

MAVYRET has shown a high cure rate (SVR12) of up to 99% in clinical trials and real-world studies, with a low on-treatment virologic failure rate and relapse rate[1][3].

What is the typical treatment duration for MAVYRET?

For many patients, especially those who are treatment-naive and non-cirrhotic, the typical treatment duration with MAVYRET is 8 weeks[1][3].

Is MAVYRET safe for patients with chronic kidney disease?

Yes, MAVYRET is approved for use across all stages of chronic kidney disease, making it a versatile treatment option for a wide range of patients[3].

What are the common adverse reactions associated with MAVYRET?

The most common adverse reactions to MAVYRET include headache (13%) and fatigue (11%), with most adverse reactions being mild in severity[1].

Sources

  1. MAVYRET (glecaprevir/pibrentasvir) | Official HCP Site. Retrieved from https://www.mavyret.com/hcp
  2. Net Present Value Model: Mavyret - GlobalData. Retrieved from https://www.globaldata.com/store/report/mavyret-npv-drug-analysis/
  3. Enanta Announces U.S. FDA Approval of AbbVie's MAVYRET. Retrieved from https://ir.enanta.com/news-releases/news-release-details/enanta-announces-us-fda-approval-abbvies-mavyrettm
  4. Third Quarter Financial and Business Update. Retrieved from https://ir.ateapharma.com/static-files/83baba6a-8ad6-495a-8988-4b735a085599
  5. MAVYRET Drug Trials Snapshot - FDA. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/mavyret-drug-trials-snapshot

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