Interim results of C-SWIFT, a Phase 2 study evaluating ultra-short treatment durations of grazoprevir/elbasvir (MK-5172/MK-8742) plus sofosbuvir, to be presented
Results from the C-WORTHy study, a Phase 2 clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742) across multiple patient populations, including difficult-to-cure, to be presented
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data from clinical studies of the company's investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir (MK-5172/MK-8742) are scheduled to be presented at the 65th American Association for the Study of Liver Diseases (AASLD) Annual Meeting, also known as The Liver Meeting®. The meeting is scheduled to take place at the John B. Hynes Veterans Memorial Convention Center in Boston, Mass., from Nov. 7 - 11, 2014.
"Tremendous progress has been made in recent years in the understanding of chronic hepatitis C and its treatment, but it is important that we continue to advance the development of therapies to treat diverse populations of HCV-infected patients," said Dr. Eliav Barr, vice president, Infectious Diseases, Merck Research Laboratories. "Merck's broad and systematic hepatitis C clinical development program is designed with this goal in mind, and is generating important insights into the potential of grazoprevir/elbasvir across multiple viral genotypes and patient populations."
New data will also be presented for MK-3682 (formerly IDX21437), an investigational oral nucleotide prodrug NS5B inhibitor acquired earlier this year by Merck as part of its purchase of Idenix Pharmaceuticals.
Key Presentations of Grazoprevir/Elbasvir
Data from clinical trials evaluating grazoprevir/elbasvir will be the subject of two oral presentations, as well as three poster presentations, including a late-breaking abstract:
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, oral, once-daily, fixed-dose combination chronic HCV treatment, consisting of grazoprevir (MK-5172), an investigational oral, once-daily HCV NS3/4A protease inhibitor, and elbasvir (MK-8742), an investigational oral, once-daily HCV NS5A replication complex inhibitor. In October 2013, Merck announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to grazoprevir/elbasvir for treatment of chronic HCV infection. Breakthrough therapy 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.
Results from the C-WORTHy study, a Phase 2 clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742) across multiple patient populations, including difficult-to-cure, to be presented
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data from clinical studies of the company's investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir (MK-5172/MK-8742) are scheduled to be presented at the 65th American Association for the Study of Liver Diseases (AASLD) Annual Meeting, also known as The Liver Meeting®. The meeting is scheduled to take place at the John B. Hynes Veterans Memorial Convention Center in Boston, Mass., from Nov. 7 - 11, 2014.
"Tremendous progress has been made in recent years in the understanding of chronic hepatitis C and its treatment, but it is important that we continue to advance the development of therapies to treat diverse populations of HCV-infected patients," said Dr. Eliav Barr, vice president, Infectious Diseases, Merck Research Laboratories. "Merck's broad and systematic hepatitis C clinical development program is designed with this goal in mind, and is generating important insights into the potential of grazoprevir/elbasvir across multiple viral genotypes and patient populations."
New data will also be presented for MK-3682 (formerly IDX21437), an investigational oral nucleotide prodrug NS5B inhibitor acquired earlier this year by Merck as part of its purchase of Idenix Pharmaceuticals.
Key Presentations of Grazoprevir/Elbasvir
Data from clinical trials evaluating grazoprevir/elbasvir will be the subject of two oral presentations, as well as three poster presentations, including a late-breaking abstract:
- Monday, November 10: As part of the late-breaking abstract poster session, interim Phase 2 data from C-SWIFT, a clinical trial evaluating the efficacy and safety of ultra-short treatment durations with grazoprevir/elbasvir plus sofosbuvirwill be presented. C-SWIFT is the first study to report sustained viral responsei (SVR) data from regimens as short as four weeks in genotype 1 (GT1) treatment-naïve patients (Abstract #LB-33).
- Monday, November 10: Data from a clinical trial evaluating the health-related quality of life (HRQOL) impact of grazoprevir/elbasvir without the use of pegylated beta interferon (IFN) and ribavirin (RBV) versus grazoprevir/elbasvir treatment regimens containing RBV with or without IFN will be presented as part of a poster session (Abstract #1455).
- Tuesday, November 11: Final results (SVR24) from the C-WORTHy Study (Parts A and B) evaluating the efficacy and safety of grazoprevir/elbasvir with or without RBV in GT1 infected patients will be presented during two oral sessions.
- The first session will focus on cirrhotic and prior null-responder patients (Abstract #196).
- The second session will focus on mono-infected and HIV/HCV co-infected treatment-naïve, non-cirrhotic patients (Abstract #236).
- Tuesday, November 11: Results from a study evaluating the pharmacokinetics and safety of grazoprevir/elbasvir in patients with end-stage renal disease (ESRD), hemodialysis (HD) or severe renal impairment (SRI) will be presented as part of a poster session (Abstract #1940).
- Tuesday, November 11: results from a Phase 1/2a study assessing seven-day dosing of MK-3682 in subjects infected with HCV will be presented as an AASLD presidential poster of distinction during the Hepatitis C: Preclinical Development poster session (Abstract #1974).
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, oral, once-daily, fixed-dose combination chronic HCV treatment, consisting of grazoprevir (MK-5172), an investigational oral, once-daily HCV NS3/4A protease inhibitor, and elbasvir (MK-8742), an investigational oral, once-daily HCV NS5A replication complex inhibitor. In October 2013, Merck announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to grazoprevir/elbasvir for treatment of chronic HCV infection. Breakthrough therapy 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.
Thank you, Merck. I did the second part of the C-Worthy trial. I am cirrhotic and was 79 years old when I started my trial. Other trials were not available due to age and/or cirrhosis. My first UND was last October and SVR since July. A few side effects--probably because ribavirin was included in my arm of the study. Did my first follow-up last week. Also did an HCC scan. All is fine. I am very grateful to Merck.
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