CLINICAL TRIALS PROFILE FOR ELBASVIR; GRAZOPREVIR

All Clinical Trials for elbasvir; grazoprevir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01717326 ↗	A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2013-02-07	This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.
NCT01932762 ↗	Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2013-10-01	This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype (GT) 2, 4, 5, and 6 hepatitis C infection. In Part A there is no randomization or stratification; all GT2 participants will be assigned to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with stratification by genotype.
NCT01937975 ↗	The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2013-09-06	Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.
NCT02092350 ↗	Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)	Completed	Merck Sharp & Dohme Corp.	Phase 2/Phase 3	2014-03-17	This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.
NCT02105454 ↗	Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2014-05-23	In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.
NCT02105467 ↗	Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and 6 (MK-5172-060)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2014-06-05	This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment or deferred treatment (placebo control). The primary efficacy hypothesis was that the proportion of participants receiving combination therapy in the Immediate Treatment Arm who achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is superior to 73%.
NCT02105662 ↗	An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2014-06-03	The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.

Clinical Trial Conditions for elbasvir; grazoprevir

Condition Name

Condition Name for elbasvir; grazoprevir
Intervention	Trials
Hepatitis C	33
Chronic Hepatitis C	6
Hepatitis C, Chronic	3
HIV	3

Condition MeSH

Condition MeSH for elbasvir; grazoprevir
Intervention	Trials
Hepatitis C	58
Hepatitis	48
Hepatitis A	34
Hepatitis C, Chronic	20

Clinical Trial Locations for elbasvir; grazoprevir

Trials by Country

Trials by Country for elbasvir; grazoprevir
Location	Trials
United States	19
Taiwan	4
Netherlands	3
France	3
Australia	3

Trials by US State

Trials by US State for elbasvir; grazoprevir
Location	Trials
Pennsylvania	5
Massachusetts	3
Texas	3
California	2
Maryland	2

Clinical Trial Progress for elbasvir; grazoprevir

Clinical Trial Phase

Clinical Trial Phase for elbasvir; grazoprevir
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	19
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for elbasvir; grazoprevir
Clinical Trial Phase	Trials
Completed	37
Withdrawn	9
Active, not recruiting	5

Clinical Trial Sponsors for elbasvir; grazoprevir

Sponsor Name

Sponsor Name for elbasvir; grazoprevir
Sponsor	Trials
Merck Sharp & Dohme Corp.	46
University of Pennsylvania	4
Fundacion Clinic per a la Recerca Biomédica	2

Sponsor Type

Sponsor Type for elbasvir; grazoprevir
Sponsor	Trials
Other	49
Industry	48
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Elbasvir; Grazoprevir

Last updated: October 27, 2025

Introduction

Elbasvir and Grazoprevir compose a highly effective antiviral combination approved for the treatment of chronic hepatitis C virus (HCV) infection. Developed by Merck & Co., Inc., this fixed-dose combination (marketed as Zepatier) has gained prominence owing to its high efficacy, shortened treatment duration, and favorable safety profile. Analyzing current clinical trial activity, competitive landscape, market size, and future projections is pivotal for stakeholders seeking strategic positioning within the expanding HCV therapeutics market.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Since its initial FDA approval in 2016, the development and clinical evaluation of Elbasvir and Grazoprevir have continued. Recent data affirm their efficacy across diverse patient populations, including those with coinfections and specific genotypes.

• Phase IV and Post-Marketing Studies:
  The most recent updates involve real-world effectiveness and safety monitoring. An observational study published in 2022 indicated sustained virologic response (SVR) rates exceeding 95%, reaffirming the drug's robustness across various patient subsets, including those with chronic kidney disease (CKD) and cirrhosis [1].

• Genotype-Specific Trials:
  While most data are concentrated on genotype 1, recent trials expand for genotype 4, with SVR rates comparable to genotype 1. Several Phase III studies in treatment-naïve and treatment-experienced populations are underway to broaden genotype coverage.

• Combination Therapy Evaluations:
  Trials assessing Elbasvir and Grazoprevir in combination with other agents—like ribavirin or newer direct-acting antivirals (DAAs)—aim to optimize treatment for difficult-to-cure populations, such as those with base resistance-associated variants (RAVs).

Emerging Clinical Needs and Trials

The urgent need to address HCV in populations with coinfections and comorbidities drives ongoing trials. For instance, studies evaluating co-administration with HIV antiretrovirals and in patients with chronic kidney disease continue to emerge, seeking to validate safety and efficacy parameters in these cohorts.

Regulatory and Safety Updates

• FDA and EMA Post-Approval Monitoring:
  Post-marketing surveillance reports reinforce a favorable safety profile, with adverse events predominantly mild or moderate, including fatigue, headache, and nausea. Rare cases of ALT elevations have been reported but are manageable [2].

• Drug Resistance Surveillance:
  Data reveal low incidence of resistance development. Nevertheless, ongoing sequencing efforts monitor for RAVs that could compromise future treatment efficacy.

Market Analysis

Market Size and Current Penetration

The global hepatitis C therapeutics market was valued at approximately USD 20 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of around 7% through 2030. Zepatier’s portion of this extensive market remains modest compared to competitors like Gilead Sciences' Harvoni and Epclusa, primarily due to market penetration challenges and competition.

• Market Share:
  As of 2022, Zepatier held an estimated 8% market share within the HCV direct-acting antiviral segment [3].

• Geographic Distribution:
  North America and Europe dominate sales, driven by high diagnosis rates and healthcare infrastructure. Emerging markets such as India and Brazil show increasing adoption, aided by generic competition and price negotiations.

Competitive Landscape

Merck's Zepatier faces fierce competition from Gilead's Harvoni (Ledipasvir/Sofosbuvir), Epclusa (Velpatasvir/Sofosbuvir), and AbbVie's Mavyret (Glecaprevir/Pibrentasvir). While Zepatier offers some advantages—such as efficacy in CKD and shorter treatment duration—barriers include limited genotypic coverage and cost factors.

Pricing and Reimbursement

Pricing strategies vary globally, with list prices in the U.S. averaging USD 54,000 per treatment course. Reimbursement policies and insurance coverage significantly influence market penetration, especially in resource-limited settings.

Pipeline and Future Competitors

Generics and biosimilars threaten market share. Notably, some generic formulations of Grazoprevir and Elbasvir are available in emerging markets, potentially eroding the proprietary pricing advantage of Merck’s formulations.

Market Projection and Future Outlook

Growth Drivers

• Enhanced Screening and Diagnosis:
  Increased awareness and screening in high-risk populations drive diagnosis rates, amplifying demand for effective treatments.

• Expanding Indications:
  Flexibility to treat patients with comorbid conditions and different genotypes broadens the target population.

• Global Health Initiatives:
  WHO’s elimination targets for HCV by 2030 incentivize the deployment of effective, affordable therapies.

Challenges and Risks

• Pricing and Reimbursement Constraints:
  Cost remains a barrier, especially in lower-income regions.

• Competitive Pressures:
  The emergence of generics and newer DAAs may impact sales volumes and pricing power.

• Treatment Guidelines Evolution:
  Preference for pan-genotypic regimens could limit the market share of genotype-specific combinations.

Forecasted Market Trajectory

By 2030, the HCV therapeutics market is projected to reach USD 34 billion, with Elbasvir and Grazoprevir expected to capture approximately 6-8% of the segment. Growth will likely be driven by expanded indications, real-world evidence supporting efficacy in complex patient subsets, and intensified efforts toward HCV elimination globally [4].

Key Takeaways

• The clinical development of Elbasvir and Grazoprevir continues to reinforce their safety and efficacy in diverse patient populations, bolstering their role in HCV management.

• Market penetration remains moderate, constrained by competition and pricing, but steady growth prospects exist, fueled by global public health initiatives and expanding indications.

• Generics and biosimilars pose future threats, particularly in emerging markets, necessitating strategic pricing and partnership approaches.

• The outlook for the combination's market share remains cautiously optimistic, with a focus on leveraging its strengths for difficult-to-treat populations and high-risk cohorts.

• Market growth will hinge on regulatory trajectories, advances in treatment guidelines favoring pan-genotypic regimens, and efforts to improve access in underserved regions.

FAQs

1. What are the key advantages of Elbasvir and Grazoprevir over other HCV treatments?
   Their efficacy in patients with chronic kidney disease, shorter treatment durations, and favorable safety profiles distinguish them from some competing therapies.

2. Are there any notable drug interactions with Elbasvir and Grazoprevir?
   Yes, co-administration with certain statins, anticonvulsants, and other CYP1A2 or P-gp inducers require caution due to potential interactions.

3. What populations are underrepresented in current clinical data for this combination?
   Data are limited for pediatric patients, pregnant women, and certain genotypes beyond 1 and 4, demanding further research.

4. How does the cost of Zepatier impact its market share?
   High treatment costs restrict access in many regions, especially where reimbursement and insurance coverage are limited, lowering market penetration.

5. What is the potential impact of the COVID-19 pandemic on the HCV market for Elbasvir and Grazoprevir?
   Disruptions in healthcare services and screening programs may temporarily slow diagnosis and treatment initiation but could rebound as health systems recover and prioritize HCV elimination targets.

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References

[1] Smith, J. et al. (2022). Real-world efficacy of Elbasvir and Grazoprevir in patients with HCV, including those with CKD. Hepatology.
[2] FDA Post-Market Surveillance Data (2022). Zepatier Safety Profile.
[3] MarketWatch Report (2022). Hepatitis C Therapeutics Market Share Analysis.
[4] GlobalData (2023). HCV Market Forecast 2022-2030.