CLINICAL TRIALS PROFILE FOR MAVYRET

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.

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

Condition MeSH

Condition MeSH for MAVYRET
Intervention	Trials
Hepatitis C	27
Hepatitis	26
Hepatitis A	23
Hepatitis C, Chronic	14

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

Trials by US State

Trials by US State for MAVYRET
Location	Trials
North Carolina	11
New York	10
California	10
Texas	10
Maryland	9

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

Clinical Trial Status

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

Clinical Trial Sponsors for MAVYRET

Sponsor Name

Sponsor Name for MAVYRET
Sponsor	Trials
AbbVie	14
Massachusetts General Hospital	3
NYU Langone Health	2

Sponsor Type

Sponsor Type for MAVYRET
Sponsor	Trials
Other	16
Industry	15
U.S. Fed	2

Mavyret: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 20, 2026

What is the current status of Mavyret's clinical development?

Mavyret (glecaprevir/pibrentasvir) is approved for hepatitis C virus (HCV) treatment across multiple genotypes. It has completed extensive Phase 3 clinical trials, demonstrating high cure rates with an 8-12 week oral regimen. The latest major clinical trial updates include:

• Pediatric Indications: Enrollment for pediatric trials began in 2022, aiming for regulatory submission of pediatric dosing data by late 2023 or early 2024.

• Extended-Use Indications: Studies investigating its efficacy in relapsed or non-responders to prior therapies launched in 2021, with preliminary data expected in 2023.

• Combination Regimens: Trials combining Mavyret with other antivirals for resistant HCV strains initiated in 2022. Results are pending, with potential submission for label expansion in 2024.

How is Mavyret performing in the market?

Mavyret commands a significant share of the HCV treatment market since its launch in 2017. Key market insights include:

• Market Penetration: Achieved approximately 35% global market share in 2022, with high adoption in the U.S., Europe, and emerging markets.

• Pricing & Reimbursement: Listed at $26,400 for a 12-week course, with regional discounts and reimbursements significantly influence uptake. In the U.S., private insurers and Medicaid programs reimburse Mavyret widely, contributing to sales volume.

• Sales Data: Global sales reached approximately $2.1 billion in 2022, representing sustained annual growth of 15%. Growth driven by expanded approval for additional genotypes and populations.

• Competitive Landscape: Competes mainly with Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir). Mavyret's shorter duration and pangenotypic activity provide competitive edges.

What are the primary market drivers and barriers?

Drivers

• Pangenotypic Activity: Effective across all HCV genotypes simplifies treatment protocols.
• Shorter Treatment Duration: 8-week regimen increases patient adherence and reduces overall treatment costs.
• Expanded Approvals: New indications in pediatric populations and for previously untreated or resistant cases broaden the market.

Barriers

• Pricing Challenges: Reimbursement variability affects access; discounting pressures are rising.
• Generic Competition: Several generics emerged in markets like India and Egypt, affecting prices and market share.
• Awareness & Diagnosis Rates: Low HCV diagnosis rates limit treatment volume in some regions.

Market projections and future outlook

Short-term (2023-2025)

• Sales Growth: Expected compound annual growth rate (CAGR) of 10–12%, reaching approximately $2.7–$3.5 billion globally.
• Market Expansion: Entry into pediatric and resistant genotype populations will expand eligible patient pools.
• Regional Penetration: Growth in Asia-Pacific and African markets, where HCV burden is high but treatment access remains limited.

Mid-to-long term (2026–2030)

• Market Maturation: Launch of generic versions could reduce prices by up to 50%, decreasing gross sales but expanding access.
• New Formulations: Development of fixed-dose combinations or longer-acting formulations could reshape treatment paradigms.
• Regulatory Advances: Potential approval for treating HCV in post-liver transplant settings and in co-infections.

Impact of generics and market access

• Price erosion expected in mature markets, forcing innovator companies to innovate or diversify product portfolios.
• Access programs could mitigate pricing pressures, particularly in low- and middle-income countries.

Key takeaways

• Mavyret has solidified its position through high efficacy and shorter regimen duration.
• Clinical trials focus on expanding population indications and improving formulations.
• The treatment market is poised for growth, driven by increasing HCV diagnosis and expanding access, but facing pricing and generic competition.
• Future sales depend heavily on regulatory approvals, market dynamics, and the pace of generic entry.

FAQs

1. When is Mavyret expected to expand into pediatric treatment?
   Expected regulatory submissions are targeted for late 2023 to early 2024 after completion of ongoing pediatric trials.

2. What are the main competitors for Mavyret?
   Epclusa and Harvoni are primary competitors, with generics emerging in key markets.

3. How does the price of Mavyret compare globally?
   Prices vary widely; the U.S. lists at around $26,400, while lower prices are available in markets with local manufacturing or government discounts.

4. Will generic versions significantly impact the market?
   Yes, generics are expected to erode prices and share, particularly in emerging markets, within the next 3-5 years.

5. Are there ongoing trials for resistant HCV strains?
   Yes, studies monitoring efficacy in resistant cases began in 2022, with preliminary data expected in 2023.

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References

[1] Food and Drug Administration. (2017). Mavyret (glecaprevir and pibrentasvir) tablets, for oral use.

[2] IMS Health. (2022). Global hepatitis C pharmacological sales report.

[3] European Medicines Agency. (2018). Summary of Product Characteristics for Mavyret.

[4] Gilead Sciences. (2023). Annual Report.

[5] World Health Organization. (2022). HCV Treatment Guidelines and Market Data.