Merck to Present New Data on ZEPATIER™ (elbasvir and grazoprevir) and Chronic Hepatitis C Clinical Development Programs at The Liver Meeting® 2016
Monday, October 3, 2016 8:00 am EDT
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that new data from the company's chronic hepatitis C virus (HCV) clinical development programs will be presented at The Liver Meeting® 2016. Fifteen scientific abstracts, including seven oral and eight poster presentations, will highlight findings from Merck's HCV clinical development programs. The data include evaluations of ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg tablets and the company's investigational MK-3682B (MK-36821/grazoprevir2/rusazvir) in a broad range of patients with chronic HCV infection. The Liver Meeting® 2016 will take place in Boston, MA, from November 11-15, 2016.
"Merck has been a part of the fight against chronic hepatitis C infection for more than 30 years, and that fight continues. Chronic hepatitis C is a complex infectious disease that affects tens of millions of patients globally, each with their own personal circumstances, co-morbidities and challenges," said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories. "At AASLD this year, researchers will share data from numerous studies that are underway to better understand the potential of ZEPATIER and our investigational medicines in diverse patient populations."
Key presentations at The Liver Meeting® 2016 will include:
ZEPATIER (elbasvir and grazoprevir)
Saturday, November 12
⋅ HCV reinfection and injecting risk behavior following elbasvir/grazoprevir treatment in patients on opioid agonist therapy: CO-STAR Three Year Follow-up Study (Poster presentation, Abstract #871, 2:00 p.m.-7:30 p.m. EDT)
⋅ High Efficacy in Patients With Chronic Hepatitis C Virus (HCV) Genotype (GT)1b Infection Treatment With Elbasvir/Grazoprevir for 12 Weeks: An Integrated Analysis (Poster presentation, Abstract #874, 2:00 p.m.-7:30 p.m. EDT)
⋅ Concomitant Proton Pump Inhibitor Use Does Not Reduce the Efficacy of Elbasvir/Grazoprevir (Poster presentation, Abstract #869, 2:00 p.m.-7:30 p.m. EDT)
⋅ Elbasvir/Grazoprevir (EBR/GZR) Does Not Worsen Renal Function in Patients With Hepatitis C Virus (HCV) Infection and Pre-existing Renal Disease (Poster presentation, Abstract #889, 2:00 p.m.-7:30 p.m. EDT)
⋅ Final Results from Phase 3 Portion in Phase 2/3 Study of Elbasvir / Grazoprevir in Hepatitis C Genotype 1 Infected Japanese Patients (Poster presentation, Abstract #851, 2:00 p.m.-7:30 p.m. EDT)
Sunday, November 13
⋅ Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naïve Subjects with Chronic HCV GT1, GT4 and GT6 Infection ( C-CORAL ): A Phase III Randomized Multinational Clinical Trial (Oral presentation, Abstract #76, 3:45 p.m.-4:00 p.m. EDT)
⋅ C-ISLE : Grazoprevir/Elbasvir plus Sofosbuvir in Treatment-naïve and Treatment-experienced HCV GT3 Cirrhotic Patients Treated for 8, 12 or 16 weeks (Oral presentation, Abstract #74, 3:15 p.m.-3:30 p.m. EDT)
INVESTIGATIONAL TRIPLE-THERAPY REGIMEN
Sunday, November 13
⋅ Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 With or Without Ribavirin in Non-cirrhotic or Cirrhotic Patients with Chronic HCV GT1, 2 or 3 Infection (Part B of C-CREST 1 & 2 ) (Oral presentation, Abstract #110, 5:00 p.m.-5:15 p.m. EDT)
⋅ High Sustained Virologic Response (SVR) Rates in Patients with Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/MK-8408 Plus Ribavirin After Failure of 8 Weeks of Therapy (Part C of C-CREST 1 & 2 ) (Oral presentation, Abstract #112, 5:30 p.m.-5:45 p.m. EDT)
Monday, November 14
⋅ Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 in Cirrhotic or Non-cirrhotic Patients with Chronic HCV GT1 Infection who Previously Failed a Direct-acting Antiviral Regimen ( C-SURGE ) (Oral presentation, Abstract #193, 3:00 p.m.-3:15 p.m. EDT)
For more information, including a complete list of abstract titles at the meeting, please visit: http://www.aasld.org/events-professional-development/liver-meeting.
About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets
ZEPATIER is a fixed-dose combination product containing elbasvir, a HCV NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor. In the United States, ZEPATIER is indicated with or without ribavirin (RBV) for treatment of chronic HCV GT1 or 4 infection in adults. ZEPATIER is not indicated to treat chronic HCV GT3 or GT6 infection. ZEPATIER was approved in the United States on January 28, 2016 and is also approved in the European Union, Canada, Japan, Australia, Saudi Arabia, Israel and Switzerland, with additional regulatory approvals anticipated.
Selected Safety Information about ZEPATIER
ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). ZEPATIER is also not for use with organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's Wort), and efavirenz. If ZEPATIER is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen.
Elevations of alanine transaminase (ALT) to greater than 5 times the upper limit of normal (ULN) occurred in 1% of subjects, generally at or after treatment week 8. These late ALT elevations were typically asymptomatic and most resolved with ongoing or completion of therapy. Healthcare professionals should perform hepatic lab testing on patients prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic lab testing should be performed at treatment week 12.
Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces. Healthcare providers should consider discontinuing ZEPATIER if ALT levels remain persistently greater than 10 times ULN. ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalized ratio.
The concomitant use of ZEPATIER with certain drugs may lead to adverse reactions or reduced therapeutic effect due to drug interactions. Certain strong CYP3A inhibitors may increase the plasma concentration of ZEPATIER, leading to possibly clinically significant adverse reactions. Moderate CYP3A inducers may decrease the plasma concentration of ZEPATIER, leading to reduced therapeutic effect and possible development of resistance. Coadministration of ZEPATIER with these drugs is not recommended. Physicians should consult the Prescribing Information for potential drug interactions.
In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache and nausea. In subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache.
Selected Dosage and Administration Information for ZEPATIER (elbasvir and grazoprevir)
ZEPATIER is a single tablet taken once daily. The recommended dosing is 12 or 16 weeks with or without RBV, depending on HCV genotype, prior treatment history and, for patients with genotype 1a infection, presence of certain baseline NS5A resistance-associated polymorphisms. See Prescribing Information for ZEPATIER for specific dosage regimens and durations. Refer to RBV prescribing information for RBV dosing and dosage modifications when ZEPATIER is given with RBV. To determine dosage regimen and duration of ZEPATIER for genotype 1a patients, testing for the presence of virus with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, or 93 is recommended prior to initiating treatment.
Merck's Commitment to HCV
For more than 30 years, Merck has been at the forefront of the response to the HCV epidemic. Merck's chronic HCV clinical development programs have included more than 135 clinical trials in approximately 40 countries and have enrolled nearly 10,000 participants. As part of our longstanding leadership in infectious diseases, Merck collaborates with the scientific and patient communities to develop and deliver innovative solutions to support people living with chronic HCV worldwide.
For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. 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, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. 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 health care legislation in the United States and internationally; global trends toward health care 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 2015 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).
Please see Prescribing Information for ZEPATIER (elbasvir and grazoprevir) at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf and the Patient
Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf
MK-3682 is an HCV nucleotide analogue NS5B polymerase inhibitor
Rusazvir (MK-8408) is an HCV NS5A inhibitor