Results from MSD’s Phase 3 Study of Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir in Patients with Advanced Chronic Kidney Disease Published in The Lancet
5.10.2015 23:01 | Business Wire
MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced the publication of results from C-SURFER, the first Phase 31 clinical trial to investigate an all-oral, ribavirin-free chronic hepatitis C virus (HCV) treatment regimen in treatment-naïve and treatment-experienced patients with advanced chronic kidney disease (CKD) stages 4 or 5 and chronic HCV genotype 1 (GT1) infection. Data from the Phase 3 clinical trial evaluating the investigational, once-daily treatment regimen of elbasvir (50mg)2 and grazoprevir (100mg)3 in patients with advanced CKD were published online in the medical journal The Lancet. Data from this study were initially presented at The International Liver CongressTM 2015 in April 2015; additional information about that presentation and the design of the study can be found in the MSD news release of 24 April 2015.
“People with advanced chronic kidney disease represent an important segment of the chronic hepatitis C patient population,” said Dr. Howard Monsour, Jr., chief of hepatology, Houston Methodist Hospital, Houston, Texas, U.S.A. “The publication of this study details the evidence supporting a potential future treatment option for these patients who are currently underserved.”
The peer-reviewed, published results show that 12 weeks of therapy with elbasvir plus grazoprevir in patients with chronic HCV GT1 infection and advanced CKD resulted in high rates of sustained virologic response 12 weeks after the completion of treatment (SVR12). High rates of SVR were achieved regardless of patient characteristics in this study, including African-American patients, patients receiving hemodialysis and patients with the IL28B non-CC genotype. Among those receiving elbasvir plus grazoprevir in the primary analysis population, 99 percent (115/116) achieved SVR12, with one relapse 12 weeks after the end of treatment. In a secondary analysis that included six additional patients excluded from the primary efficacy analysis for non-virologic reasons (study discontinuation unrelated to study drug, loss to follow-up, noncompliance, etc.), 94 percent (115/122) achieved SVR12. Adverse events reported at or above 10 percent frequency in the active and placebo treatment groups included headache, nausea and fatigue; rates in the active treatment group were comparable to those in the group that received placebo for the first 12 weeks.
About Chronic HCV Infection and Chronic Kidney Disease
Chronic HCV infection is both a cause and complication of the treatment of CKD. In patients with CKD, chronic HCV infection is associated with an increased risk of accelerated loss of remaining kidney function, kidney transplant failure and death. Furthermore, patients with chronic HCV infection and advanced CKD represent an unmet need due to a lack of demonstrated HCV treatment options for this group.
Elbasvir/grazoprevir is MSD’s investigational, once-daily, fixed-dose combination therapy containing elbasvir (HCV NS5A replication complex inhibitor) and grazoprevir (HCV NS3/4A protease inhibitor). Evaluations of elbasvir/grazoprevir for multiple HCV genotypes as part of MSD’s broad clinical trials programme include patients with difficult-to-treat conditions such as cirrhosis, advanced chronic kidney disease, HIV/HCV co-infection, inherited blood disorders and those on opiate substitution therapy. In July 2015, the European Medicines Agency (EMA) accepted the Marketing Authorisation Application (MAA) for elbasvir/grazoprevir, with an accelerated assessment timeline. Additionally, in July 2015, the U.S. Food and Drug Administration (FDA) granted Priority Review for the New Drug Application for elbasvir/grazoprevir, with a Prescription Drug User Fee Act (PDUFA) action date of 28 Jan., 2016.
In April 2015, the FDA granted Breakthrough Therapy designation status for elbasvir/grazoprevir for the treatment of patients with chronic HCV GT1 infection with end stage renal disease on hemodialysis, and Breakthrough Therapy designation status for elbasvir/grazoprevir for the treatment of patients with chronic HCV GT4 infection. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
MSD’s Commitment to HCV
For nearly 30 years, MSD has been at the forefront of the response to the HCV epidemic. MSD employees are dedicated to applying their scientific expertise, resources and global reach to deliver innovative health care solutions that support people living with HCV worldwide.
Today's MSD is a global health care leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programmes and partnerships.
Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
1 Included small Phase 2 pharmacokinetic assessment
2 Elbasvir is an HCV NS5A replication complex inhibitor
3 Grazoprevir is an HCV NS3/4A protease inhibitor
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