~ Buy the ZEPATIER (elbasvir; grazoprevir) Drug Profile, 2024 PDF Report in the Report Store ~

CLINICAL TRIALS PROFILE FOR ZEPATIER

All Clinical Trials for Zepatier

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT02781649 ↗	Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients	Completed	Merck Sharp & Dohme Corp.	Phase 4	2016-07-20	In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100 mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant procedure and continued for 12 weeks post-renal transplant.
NCT02781649 ↗	Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients	Completed	Johns Hopkins University	Phase 4	2016-07-20	In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100 mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant procedure and continued for 12 weeks post-renal transplant.
NCT02786537 ↗	Study of Oral Treatments for Hepatitis C	Completed	AbbVie	Phase 4	2016-06-01	Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.

Clinical Trial Conditions for Zepatier

Condition Name

Condition Name for Zepatier
Intervention	Trials
Hepatitis C	13
Hepatitis C, Chronic	3
Chronic Hepatitis c	2
Renal Failure	1

Condition MeSH

Condition MeSH for Zepatier
Intervention	Trials
Hepatitis C	24
Hepatitis	20
Hepatitis A	10
Hepatitis C, Chronic	6

Clinical Trial Locations for Zepatier

Trials by Country

Trials by Country for Zepatier
Location	Trials
United States	35
United Kingdom	3
Taiwan	3
France	1
Spain	1

Trials by US State

Trials by US State for Zepatier
Location	Trials
Pennsylvania	5
Massachusetts	4
Maryland	3
Texas	3
Michigan	1

Clinical Trial Progress for Zepatier

Clinical Trial Phase

Clinical Trial Phase for Zepatier
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Zepatier
Clinical Trial Phase	Trials
Completed	12
Terminated	4
Active, not recruiting	4

Clinical Trial Sponsors for Zepatier

Sponsor Name

Sponsor Name for Zepatier
Sponsor	Trials
Merck Sharp & Dohme Corp.	16
University of Pennsylvania	4
Massachusetts General Hospital	2

Sponsor Type

Sponsor Type for Zepatier
Sponsor	Trials
Other	29
Industry	18
U.S. Fed	1

Zepatier: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Zepatier

Zepatier, a combination drug comprising 50mg of elbasvir (a non-structural protein 5A replication complex inhibitor) and 100mg of grazoprevir (an NS3/4A protease inhibitor), has been a significant addition to the treatment arsenal for chronic hepatitis C virus (HCV) genotypes 1 and 4. Approved by the FDA on January 28, 2016, Zepatier has been making waves in the hepatitis C market with its impressive clinical profile and competitive pricing[1][2][4].

Clinical Trials Overview

The approval of Zepatier was based on a robust clinical trial program that included several Phase II and Phase III studies. Here are some key trials:

• C-SCAPE, C-SALVAGE, C-SUFFER, C-EDGE, C-EDGE TN, C-EDGE CO-INFXN, and C-EDGE TE: These trials enrolled 1,373 patients with chronic HCV genotype 1 or 4 infections. The studies evaluated the safety and efficacy of Zepatier with or without ribavirin, assessing the sustained virologic response 12 weeks after completion of treatment (SVR12). The overall SVR rates ranged from 94% to 97% in genotype 1-infected subjects and from 97% to 100% in genotype 4-infected subjects[1][4].

• Additional Phase II Trials: Merck also conducted trials named C-CREAST 1, C-CREAST 2, and C-WORTHY on HCV genotypes 1, 2, and 3, respectively, further expanding the drug's clinical data[1].

Efficacy and Safety

The clinical trials demonstrated that Zepatier is highly effective in treating chronic HCV infections. Here are some key findings:

• SVR Rates: The trials showed high SVR rates, indicating that the virus was no longer detected in the blood 12 weeks after finishing treatment. For genotype 1, SVR rates were between 94% and 97%, and for genotype 4, they were between 97% and 100%[1][4].

• Side Effects: The most common side effects of Zepatier without ribavirin were fatigue, headache, and nausea. When used with ribavirin, the most common side effects were anemia and headache[4].

Market Analysis

Competitive Landscape

Zepatier's entry into the market has significantly impacted the dominance of Gilead's Harvoni, a previously leading drug in the hepatitis C treatment space.

• Pricing Strategy: Merck priced Zepatier at $54,600 for a 12-week treatment regimen, which is over 40% lower than Harvoni's price of $94,500 for a similar duration. This competitive pricing has been a key factor in Zepatier's market penetration[2][3].

• Market Impact: Analysts predict that Zepatier will carve out a solid niche in the hepatitis C market due to its excellent clinical profile, safety, and cost-effectiveness. This is expected to lead to substantial changes in patient share and therapy costs, intensifying competition in the market[2].

Cost-Effectiveness

Studies have highlighted the cost-effectiveness of Zepatier:

• Lifetime Cumulative Incidence of Liver Cancer: Treatment with Zepatier reduced the lifetime cumulative incidence of liver cancer to less than 1% from an average of 23.2% compared to no treatment[3].

• Simulated Models: In a simulated model of 1,000 HCV-infected patients with chronic kidney disease, Zepatier was found to be cost-effective at typically used thresholds, further solidifying its position in the market[3].

Market Projections

Growth of the Viral Hepatitis Market

The viral hepatitis market is expected to grow at a CAGR of 2.69% from 2024 to 2034, driven by the increasing adoption of innovative antiviral therapies, including direct-acting antivirals (DAAs) like Zepatier[5].

Impact on the Hepatitis C Market

• Competition and Patient Share: Zepatier's competitive pricing and strong clinical performance are expected to challenge the market share of other drugs, including Harvoni and Sovaldi. The response of competitors, especially Gilead, in price negotiations with payers will influence the extent of Zepatier’s market penetration[2].

• Future Opportunities: The hepatitis C market still presents opportunities for improvement, particularly in treating niche and traditionally difficult-to-treat patient populations and reducing treatment durations below 12 weeks[2].

Key Takeaways

• Clinical Efficacy: Zepatier has demonstrated high SVR rates in clinical trials for HCV genotypes 1 and 4.
• Competitive Pricing: Zepatier is priced significantly lower than Harvoni, making it a cost-effective option.
• Market Impact: Zepatier is expected to challenge the dominance of Harvoni and other similar drugs in the hepatitis C market.
• Cost-Effectiveness: Zepatier reduces the lifetime cumulative incidence of liver cancer and is cost-effective in simulated models.
• Market Growth: The viral hepatitis market is projected to grow at a CAGR of 2.69% from 2024 to 2034.

FAQs

What is Zepatier and how is it used?

Zepatier is a once-daily oral medication combining elbasvir and grazoprevir, used for the treatment of chronic hepatitis C virus genotypes 1 and 4, with or without ribavirin.

What were the key findings from the clinical trials of Zepatier?

Clinical trials showed high SVR rates ranging from 94% to 97% for genotype 1 and from 97% to 100% for genotype 4, indicating effective treatment of HCV infections.

How does Zepatier compare to Harvoni in terms of pricing?

Zepatier is priced over 40% lower than Harvoni, making it a more cost-effective option for patients.

What is the expected impact of Zepatier on the hepatitis C market?

Zepatier is expected to challenge the dominance of Harvoni and other similar drugs, leading to changes in patient share and therapy costs.

What are the common side effects of Zepatier?

The most common side effects of Zepatier without ribavirin are fatigue, headache, and nausea, while with ribavirin, they are anemia and headache.

Sources

1. Clinical Trials Arena: Zepatier for the Treatment of Chronic Hepatitis C Genotype 1 and 4 Infection.
2. Biopharma Dive: Merck's Zepatier Will Threaten the Dominance of Gilead's Harvoni in Hepatitis C Market.
3. Biopharma Dive: New Analysis Boosts Cost-Effectiveness Argument for Merck's Zepatier.
4. FDA: FDA Approves Zepatier for Treatment of Chronic Hepatitis C Genotypes 1 and 4.
5. BioSpace: Viral Hepatitis Market Estimated to Reach a CAGR of 2.69% during 2024-2034.