Clinical Findings Support Initiation of
C-EDGE Phase 3 Program
Merck (NYSE:MRK), known as MSD outside of the United States and
Canada, today announced interim results from the ongoing C-WORTHy
study, a multi-arm Phase 2 clinical trial evaluating the efficacy
and safety of an all-oral, once-daily regimen combining MK-5172, an
investigational hepatitis C virus (HCV) NS3/4A protease inhibitor,
and MK-8742, an investigational HCV NS5A replication complex
inhibitor, among patients with chronic HCV Genotype 1 infection
(GT1). Interim analysis of hard-to-cure1 patients administered
MK-5172/MK-8742 with and without ribavirin (RBV) for 12 or 18 weeks
showed sustained viral response2 (SVR), 4 to 8 weeks after the
completion of therapy (SVR4/8):
- HCV GT1 infected, treatment-naïve
cirrhotic patients, MK-5172/MK-8742 treated - 97 percent (28/29 and
29/30) for 12 and 18 weeks, and MK-5172/MK-8742 plus RBV - 90
percent (28/31) and 97 percent (30/31) for 12 and 18 weeks,
respectively.
- HCV GT1 infected prior-null responder
patients (with or without cirrhosis), MK-5172/MK-8742 treated - 91
percent (30/33) and 97 percent (29/30) for 12 and 18 weeks,
respectively, and MK-5172/MK-8742 plus RBV treated 94 percent
(30/32) and 100 percent (32/32) for the 12 and 18 weeks,
respectively.
- Treatment-naïve, non-cirrhotic patients
with HCV/HIV co-infection, MK-5172/MK-8742 treated for 12 weeks -
90 percent (26/29) and MK-5172/MK-8742 plus RBV for 12 weeks 97
percent (28/29).
These data were presented at the 49th Annual Meeting of the
European Association for the Study of the Liver (EASL), also known
as The International Liver Congress™ 2014 in London, UK.
“There is still a need for further options for the most
difficult-to-cure patients, including those with cirrhosis and
HCV/HIV co-infection,” said Dr. Eric Lawitz, MD, vice president,
Scientific and Research Development, The Texas Liver Institute, and
clinical professor of medicine, University of Texas Health Science
Center in San Antonio. “These findings provide additional clinical
evidence regarding the potential of MK-5172/MK-8742 in treating a
broad spectrum of HCV patients.”
C-WORTHy Study Design
C-WORTHy is a randomized, dose-responsive, parallel-group,
multiple-site, double-blind clinical trial comparing different
patient populations exposed to different durations of treatment of
MK-5172 (100 mg once daily) in combination with MK-8742 (50 mg once
daily) with or without RBV in subjects with chronic HCV infection.
A total of 471 patients with chronic HCV GT1 and HCV RNA levels of
≥10,000 IU/mL were enrolled in C-WORTHy and randomized across 16
arms. These results examine hard-to-cure subpopulations, including
treatment-naïve patients with liver cirrhosis (12- and 18-week
arms, with and without RBV), prior-null responder patients with and
without cirrhosis (12- and 18-week arms, with and without RBV) and
patients with HIV/HCV co-infection (12-week arms).
Key Findings for MK-5172/MK-8742
Viral suppression (HCV RNA levels less than 25 IU/mL) was
demonstrated for treatment-naïve patients with cirrhosis,
prior-null responder patients with and without cirrhosis and
HIV/HCV co-infected patients by Treatment Week (TW)12. These levels
were maintained at rates between 90 and 100 percent across patient
subgroups through the completion of dosing and at the four-week
treatment follow-up time point (FU4).
Table 1
Interim Analysis of the C-WORTHy Trial:
Treatment-Naïve, Cirrhotic Patients with HCV
GT1 Infection (Intention-to-Treat
Analysis (ITT), Excluding Patients Yet to Reach FU4)
Parameter
MK-5172 + MK-8742 +RBV(12
Weeks)(N = 31)
MK-5172 + MK-8742(NO RBV)(12
Weeks)(N = 29) MK-5172 + MK-8742
+RBV(18 Weeks)(N = 32) MK-5172 +
MK-8742(NO RBV)(18 weeks)(N = 31)
SVR4/8, % (n/m†)
90% (28/31) 97% (28/29) 97%
(30/31) 97% (29/30) No SVR, % (n)
Breakthrough 3% (1) 0% (0)
0% (0) 0% (0) Relapse
7% (2) 3% (1) 0% (0)
3% (1) Non-virologic Discontinuation 0%
(0) 0% (0) 3% (1) 0%
(0)
† m = patients who have reached the FU4
visits (all patients in the 12-week arms, and 61/63 patients in the
18-week arms have reached FU4).
Table 2
Interim Analysis of the C-WORTHy Trial:
Prior Null Responders (~50% Cirrhotics),
Cirrhotic Patients with HCV GT1
Infection (ITT, Excluding Patients Yet to Reach FU4)
Parameter
MK-5172 + MK-8742 +RBV(12
Weeks)(N = 32)
MK-5172 + MK-8742(NO RBV)(12
Weeks)(N = 33)
MK-5172 + MK-8742 +RBV(18
Weeks)(N = 33)
MK-5172 + MK-8742(NO RBV)(18
weeks)(N = 32)
SVR4/8, % (n/m†)
94% (30/32) 91% (30/33) 100%
(32/32) 97% (29/30) No SVR, % (n)
Breakthrough 0% (0) 0% (0)
0% (0) 3% (1) Relapse
0% (0) 9% (3) 0% (0)
0% (0) Non-virologic Discontinuation 6%
(2) 0% (0) 0% (0) 0%
(0) † m = patients who have reached the FU4 visits (all
patients in the 12-week arms, and 62/65 patients in the 18-week
arms have reached FU4).
Table 3
Interim Analysis of the C-WORTHy
Trial:Treatment-Naïve Non-Cirrhotic HCV GT1-InfectedPatients
with HIV Co-Infection (ITT, Excluding Patients Yet to Reach
FU4)
Parameter
MK-5172 + MK-8742 +RBV(12
Weeks)(N = 29)
MK-5172 + MK-8742(NO RBV)(12
Weeks)(N = 30)
SVR4/8, % (n/m†)
97% (28/29) 90% (26/29) No SVR, %
(n) Breakthrough 0% (0) 7%
(2) Relapse 3% (1) 0% (0)
Non-virologic Discontinuation 0% (0)
3% (1) † m = patients who have reached the FU4 visits (only
one patient in the RBV-free arm has not yet reached FU4).
The most common adverse events observed among treatment-naïve
patients with cirrhosis and prior-null responder patients with and
without cirrhosis were fatigue (23% and 28%, respectively),
headache (24% and 24%, respectively), and asthenia (8% and 19%,
respectively). The most common adverse events observed among HIV
co-infected patients were headache (8%), asthenia (8%), fatigue
(7%), and sleep disorder (7%). There were no early discontinuations
due to drug-related adverse events and no clinically significant
abnormalities observed in routine laboratory analysis of
hematologic markers.
About Merck’s Phase 3 HCV Program: C-EDGE
Based on the results of the Phase 2 clinical program, Merck has
initiated Phase 3 clinical trials for MK-5172/MK-8742. The Phase 3
program, called C-EDGE, will evaluate the safety and efficacy of
MK-5172/MK-8742 with and without ribavirin in various genotypes and
across a broad range of patient populations with chronic HCV. Study
cohorts will include: C-EDGE TN (GT1, GT4-6; treatment-naive ±
cirrhosis), C-EDGE CO-INFXN (GT1, GT4-6; treatment-naive ±
cirrhosis with HIV/HCV co-infection), C-EDGE RECOVERY (GT1, GT4-6;
treatment-naive ± cirrhosis; ± HIV/HCV co-infection on opiate
substitution therapy), and C-EDGE TE (GT1, GT4-6; prior failed
treatment with peginterferon/ribavirin; ± HIV/HCV co-infection).
Study information can be found at www.clinicaltrials.gov.
Merck’s Commitment to HCV
For more than 25 years, Merck has been at the forefront of the
response to the HCV epidemic. Merck employees are dedicated to
applying their scientific expertise, resources and global reach to
deliver healthcare solutions that support people living with HCV
worldwide.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside of the United States
and Canada. Through our prescription medicines, vaccines, biologic
therapies, and consumer care 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 healthcare through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook and
YouTube.
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Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
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results to differ materially from those described in the
forward-looking statements can be found in Merck’s 2013 Annual
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Internet site (www.sec.gov).
1 Defined as treatment-naïve patients with liver cirrhosis,
prior-null responder patients with and without cirrhosis and
patients with HIV/HCV co-infection
2 Defined as HCV RNA below the limit of quantification or below
the limit of detection at the last visit on record – 4, 8, 12, or
24 weeks after the completion of therapy
MerckMedia Contacts:Caroline Lappetito, 267-305-7639Sarra
Herzog, 201-669-6570orInvestor Contacts:Carol Ferguson,
908-500-1101Justin Holko, 908-423-5088
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