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.

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
United Kingdom	3
Netherlands	3
France	3

Trials by US State

Trials by US State for Elbasvir; Grazoprevir
Location	Trials
Pennsylvania	5
Massachusetts	3
Texas	3
Maryland	2
California	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
University of Maryland, Baltimore	2

Sponsor Type

Sponsor Type for Elbasvir; Grazoprevir
Sponsor	Trials
Other	49
Industry	48
NIH	1

Elbasvir and Grazoprevir: Clinical Trials, Market Analysis, and Projections

Introduction to Elbasvir and Grazoprevir

Elbasvir and grazoprevir, marketed under the brand name ZEPATIER, are a combination of antiviral drugs used to treat chronic hepatitis C virus (HCV) infection. This article will delve into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Phase III Clinical Trials

One of the significant Phase III clinical trials for elbasvir and grazoprevir involved treatment-naïve subjects with chronic HCV genotypes 1, 4, and 6 who were co-infected with HIV. The trial, identified by the EudraCT number 2014-000342-30, aimed to assess the efficacy and safety of the combination regimen. The primary hypothesis was that the percentage of participants achieving Sustained Virologic Response after 12 weeks of therapy (SVR12) would be greater than 70%[1].

Efficacy and Safety Results

The trials demonstrated impressive results, with SVR12 rates significantly higher than those achieved by alternative regimens. For instance, in patients treated with ZEPATIER, the SVR12 rate was 99%, compared to 90% for the combination therapy of sofosbuvir plus peginterferon and ribavirin, particularly in patients with chronic HCV genotypes 1 and 4[2].

Special Populations

Another notable trial, C-EDGE CO-STAR, evaluated the efficacy and safety of elbasvir/grazoprevir in people with chronic HCV genotypes 1, 4, or 6 infection who inject drugs and are on opioid agonist therapy. This study showed high sustained virologic response rates after 12 weeks of treatment, with 96% of GT1a patients, 97% of GT1b patients, and 100% of GT4 patients achieving SVR12[5].

Market Analysis

Current Market Trends

The viral hepatitis market, driven by the increasing adoption of innovative antiviral medications, is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.69% during 2024-2034. Merck & Co., the manufacturer of ZEPATIER, has been a key player in this market, advancing its hepatitis C treatment portfolio significantly[2].

Market Drivers

The widespread adoption of antiviral medications, particularly those with high efficacy and safety profiles like ZEPATIER, is a major driver of the market. The superior results of ZEPATIER in clinical trials, especially in treating chronic HCV genotypes 1 and 4, have contributed to its market presence[2].

Cost-Effectiveness

Economic Evaluations

A systematic review of economic evaluations of elbasvir/grazoprevir for chronic hepatitis C highlighted the cost-effectiveness of this treatment. The study assessed the reporting quality of various articles and summarized the results, indicating that elbasvir/grazoprevir is a cost-effective option for treating CHC, especially considering its high SVR rates and reduced need for subsequent treatments[3].

Real-World Data and Presentations

International Liver Congress

Merck has presented real-world data and clinical trial results for ZEPATIER at significant medical conferences, such as the International Liver Congress. These presentations have included data on the efficacy and safety of ZEPATIER in various patient populations, further solidifying its position in the market[4].

Future Projections

Market Growth

Given the current trends and the ongoing need for effective HCV treatments, the market for elbasvir and grazoprevir is expected to continue growing. The CAGR of 2.69% for the viral hepatitis market indicates a steady demand for innovative antiviral therapies like ZEPATIER.

Competitive Landscape

As new treatments and combination therapies emerge, the competitive landscape may evolve. However, ZEPATIER's established efficacy and safety profile, along with its cost-effectiveness, position it strongly in the market.

Key Takeaways

• High Efficacy Rates: ZEPATIER has demonstrated high SVR12 rates in clinical trials, particularly in patients with chronic HCV genotypes 1 and 4.
• Safety and Tolerability: The combination regimen has shown a favorable safety profile in various patient populations.
• Cost-Effectiveness: Economic evaluations indicate that elbasvir/grazoprevir is a cost-effective treatment for chronic hepatitis C.
• Market Growth: The viral hepatitis market is expected to grow at a CAGR of 2.69% during 2024-2034, driven by the adoption of innovative antiviral medications.
• Real-World Data: Real-world studies and presentations at medical conferences continue to support the efficacy and safety of ZEPATIER.

FAQs

What are the primary components of ZEPATIER?

ZEPATIER is a combination of two antiviral drugs: elbasvir and grazoprevir.

What are the main indications for ZEPATIER?

ZEPATIER is indicated for the treatment of chronic hepatitis C virus (HCV) genotypes 1, 4, and 6.

What are the SVR12 rates for ZEPATIER in clinical trials?

In clinical trials, ZEPATIER has demonstrated SVR12 rates of up to 99% in patients with chronic HCV genotypes 1 and 4[2].

Is ZEPATIER cost-effective?

Yes, economic evaluations have shown that elbasvir/grazoprevir is a cost-effective treatment for chronic hepatitis C[3].

What is the expected market growth for ZEPATIER and similar antiviral medications?

The viral hepatitis market, which includes ZEPATIER, is expected to grow at a CAGR of 2.69% during 2024-2034[2].

Sources

1. EudraCT Number 2014-000342-30 - Clinical trial results. Retrieved from Clinical Trials Register.
2. Viral Hepatitis Market Estimated to Reach a CAGR of 2.69% during 2024-2034. Retrieved from BioSpace.
3. Cost-Effectiveness of Elbasvir/Grazoprevir for the Treatment of Chronic Hepatitis C. Retrieved from Frontiers in Public Health.
4. Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) and Investigational Combination Therapy MK-3682B for the Treatment of Chronic Hepatitis C Infection at The International Liver Congress™ 2017. Retrieved from Merck.
5. Merck Announces Presentation of Phase 3 Results of Investigational Elbasvir/Grazoprevir in People with Chronic Hepatitis C Genotypes 1, 4 or 6 Infection Who Inject Drugs and Are on Opioid Agonist Therapy. Retrieved from Merck.