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Last Updated: May 25, 2025

CLINICAL TRIALS PROFILE FOR GLECAPREVIR; PIBRENTASVIR


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All Clinical Trials for Glecaprevir; Pibrentasvir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02441283 ↗ A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530 Completed AbbVie Phase 2/Phase 3 2015-06-22 This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.
NCT02634008 ↗ Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P Recruiting AbbVie Phase 3 2016-06-01 An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.
NCT02634008 ↗ Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P Recruiting Kirby Institute Phase 3 2016-06-01 An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.
NCT02692703 ↗ A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2) Completed AbbVie Phase 3 2016-04-22 The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C virus (HCV) infection.
NCT02743897 ↗ Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients Active, not recruiting Merck Sharp & Dohme Corp. Phase 1/Phase 2 2016-05-01 This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with the appropriate direct-acting antiviral (DAA) after the single kidney transplantation.
NCT02743897 ↗ Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients Active, not recruiting University of Pennsylvania Phase 1/Phase 2 2016-05-01 This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with the appropriate direct-acting antiviral (DAA) after the single kidney transplantation.
NCT02946034 ↗ Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C Completed AbbVie Phase 4 2017-02-01 Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Glecaprevir; Pibrentasvir

Condition Name

Condition Name for Glecaprevir; Pibrentasvir
Intervention Trials
Hepatitis C 12
Hepatitis C Virus (HCV) 9
End Stage Renal Disease 4
Chronic Hepatitis c 3
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Condition MeSH

Condition MeSH for Glecaprevir; Pibrentasvir
Intervention Trials
Hepatitis C 29
Hepatitis 26
Hepatitis A 23
Hepatitis C, Chronic 12
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Clinical Trial Locations for Glecaprevir; Pibrentasvir

Trials by Country

Trials by Country for Glecaprevir; Pibrentasvir
Location Trials
United States 146
Canada 27
Australia 21
China 17
Korea, Republic of 15
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Trials by US State

Trials by US State for Glecaprevir; Pibrentasvir
Location Trials
California 10
Massachusetts 10
New York 10
Maryland 9
Pennsylvania 9
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Clinical Trial Progress for Glecaprevir; Pibrentasvir

Clinical Trial Phase

Clinical Trial Phase for Glecaprevir; Pibrentasvir
Clinical Trial Phase Trials
Phase 4 9
Phase 3 13
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Glecaprevir; Pibrentasvir
Clinical Trial Phase Trials
Completed 13
Recruiting 8
Not yet recruiting 4
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Clinical Trial Sponsors for Glecaprevir; Pibrentasvir

Sponsor Name

Sponsor Name for Glecaprevir; Pibrentasvir
Sponsor Trials
AbbVie 16
Kirby Institute 4
Massachusetts General Hospital 3
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Sponsor Type

Sponsor Type for Glecaprevir; Pibrentasvir
Sponsor Trials
Other 28
Industry 17
NIH 2
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Glecaprevir/Pibrentasvir: Clinical Trials, Market Analysis, and Projections

Introduction

Glecaprevir/pibrentasvir, marketed as Mavyret, is a groundbreaking combination therapy for the treatment of chronic hepatitis C virus (HCV) infection. This article delves into the clinical trials, market analysis, and future projections for this drug, highlighting its efficacy, safety, and cost-effectiveness.

Clinical Trials Overview

EXPEDITION-5 Trial

The EXPEDITION-5 trial, a Phase 3b, open-label, non-randomized, multicenter study, evaluated the efficacy and safety of glecaprevir/pibrentasvir in adults with chronic HCV genotype 1-6 infection, including those with chronic renal impairment and compensated liver cirrhosis. The study involved a 42-day screening period, followed by treatment durations of 8, 12, or 16 weeks, and a 24-week post-treatment period. The results showed high sustained virologic response (SVR) rates across various patient groups, including treatment-naive and treatment-experienced patients[1].

Other Clinical Studies

Additional studies have reinforced the efficacy of glecaprevir/pibrentasvir. For instance, a Phase 3b single-arm, open-label study focused on treatment-naive adults with chronic HCV infection and compensated cirrhosis, further confirming the safety and efficacy of this regimen[3].

Efficacy and Safety

Sustained Virologic Response

Glecaprevir/pibrentasvir has demonstrated exceptional efficacy across all six HCV genotypes. Studies have shown that between 93% and 100% of patients achieve SVR, which is a proxy for cure, with this therapy. This includes patients with and without cirrhosis, as well as those who have been previously treated with other antiviral regimens[4].

Safety Profile

The safety profile of glecaprevir/pibrentasvir is relatively favorable. However, a significant concern is the potential reactivation of hepatitis B virus (HBV) in coinfected patients, which can lead to severe complications. Therefore, patients must be tested for HBV infection before starting treatment[4].

Cost-Effectiveness Analysis

Comparative Analysis

A cost-effectiveness analysis conducted in Japan compared glecaprevir/pibrentasvir with other direct-acting antivirals (DAAs). The study found that glecaprevir/pibrentasvir was dominant, offering higher quality-adjusted life years (QALYs) and lower lifetime costs compared to other DAAs. The analysis also indicated that the glecaprevir/pibrentasvir portfolio was cost-effective in a wide range of scenarios, including treatment-naive and treatment-experienced patients across various genotypes[2].

Economic Impact

The cost-effectiveness of glecaprevir/pibrentasvir is a significant factor in its market appeal. It is substantially less expensive than many other available treatments, making it an attractive option for healthcare systems and patients alike. This economic advantage, combined with its high efficacy rates, positions glecaprevir/pibrentasvir as a preferred treatment option[4].

Market Analysis

Market Positioning

Glecaprevir/pibrentasvir has quickly become a leading treatment for chronic HCV due to its pan-genotypic efficacy, simplicity of dosing, and cost-effectiveness. The drug's ability to treat all six HCV genotypes over a shorter treatment duration (8-16 weeks) enhances its market position. Additionally, the absence of a need for ribavirin and the lack of dosage adjustment for patients with renal impairment further contribute to its appeal[4].

Competitive Landscape

In the competitive landscape of HCV treatments, glecaprevir/pibrentasvir stands out due to its broad genotypic coverage and favorable safety profile. It competes with other DAAs such as sofosbuvir/ledipasvir and daclatasvir/asunaprevir/beclabuvir, but its cost-effectiveness and high SVR rates give it a competitive edge[2].

Future Projections

Continued Dominance

Given its strong clinical trial results, cost-effectiveness, and market positioning, glecaprevir/pibrentasvir is expected to continue dominating the HCV treatment market. As healthcare systems increasingly prioritize cost-effective treatments with high efficacy rates, the demand for this drug is likely to remain strong.

Expansion into New Markets

AbbVie's ongoing efforts to expand the availability of glecaprevir/pibrentasvir into new markets, including regions with high HCV prevalence, are expected to drive further growth. The drug's approval in various countries and its inclusion in national treatment guidelines will also contribute to its market expansion.

Ongoing Research and Development

While glecaprevir/pibrentasvir has established itself as a leading HCV treatment, ongoing research and development may lead to further improvements or new indications. Continuous monitoring of real-world outcomes and potential new uses will help maintain its market relevance.

Key Takeaways

  • High Efficacy: Glecaprevir/pibrentasvir achieves high SVR rates across all six HCV genotypes.
  • Cost-Effectiveness: The drug is cost-effective compared to other DAAs, offering higher QALYs and lower lifetime costs.
  • Safety Profile: It has a relatively favorable safety profile, although HBV reactivation is a concern.
  • Market Positioning: The drug's pan-genotypic efficacy, simplicity of dosing, and cost-effectiveness make it a preferred treatment option.
  • Future Projections: Expected to continue dominating the HCV treatment market with potential expansion into new markets.

FAQs

Q: What are the main components of the glecaprevir/pibrentasvir regimen?

A: Glecaprevir/pibrentasvir is a combination of a hepatitis C virus (HCV) NS3/4A protease inhibitor (glecaprevir) and an HCV NS5A inhibitor (pibrentasvir)[4].

Q: How long does the treatment with glecaprevir/pibrentasvir typically last?

A: The treatment duration is 8 weeks for patients without cirrhosis who are treatment-naive, and 12 to 16 weeks for other patient groups[4].

Q: What is the primary safety concern associated with glecaprevir/pibrentasvir?

A: The primary safety concern is the potential reactivation of hepatitis B virus (HBV) in coinfected patients, which can lead to severe complications[4].

Q: Is glecaprevir/pibrentasvir cost-effective compared to other HCV treatments?

A: Yes, glecaprevir/pibrentasvir has been shown to be cost-effective, offering higher QALYs and lower lifetime costs compared to other direct-acting antivirals[2].

Q: Can glecaprevir/pibrentasvir be used in patients with renal impairment?

A: Yes, no dosage adjustment is needed for patients with renal impairment, making it a versatile treatment option[4].

Sources

  1. Clinical Trial Results: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (EXPEDITION-5)[1].
  2. Cost-Effectiveness Analysis: A Cost-Effectiveness Analysis of Glecaprevir/Pibrentasvir Versus Other Direct-Acting Antivirals for Treating Chronic Hepatitis C Virus Infections in Japan[2].
  3. AbbVie Clinical Trials: A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults with Chronic HCV Infection and Compensated Cirrhosis[3].
  4. American Academy of Family Physicians: Glecaprevir/Pibrentasvir (Mavyret) for the Treatment of Chronic Hepatitis C[4].
  5. PR Newswire: AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir Achieved 99% SVR12 Rate in Chronic Hepatitis C Patients with Compensated Cirrhosis[5].
Last updated: 2025-01-01

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