“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
Sunday, November 13
INVESTIGATIONAL TRIPLE-THERAPY REGIMEN
Sunday, November 13
Monday, November 14
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 andCanada. 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.pdfand the Patient Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf
|1||MK-3682 is an HCV nucleotide analogue NS5B polymerase inhibitor|
|2||Rusazvir (MK-8408) is an HCV NS5A inhibitor|
Doris Li, 908-740-1903
Ian McConnell, 908-740-1921
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898
Click here to download a printable PDF of the Full Report – February 2016 Version
Naggie is the first physician in her family, so she describes her path to infectious disease as “an adventure” in which she followed her instincts and her patients’ leads to her final destination. Along her path, Naggie encountered many patients with HIV and subsequently found her niche in infectious disease.
To this day, she values working with patients with HIV and now viral hepatitis through their introduction to and education in the disease space. Naggie wants them to live without either disease defining their parameters. To this end, she considers herself a clinician first and researcher second, with her research driven by her patients — their questions and their need for improved care. Bedside medicine, she said, is something to be treasured.
Currently, Naggie also holds an appointment within the section of GI/Hepatology Research at the Duke Clinical Research Institute where she is principal investigator on several clinical trials of direct-acting antivirals for the treatment of HCV in HIV-infected patients and she staffs two HIV/HCV coinfection multidisciplinary clinics at Duke and the Durham VA Medical Center. She also has active roles with the International Antiviral Society-USA’s Viral Hepatitis Committee and the HCV Guidelines committee through AASLD.
This issue marks HCV Advocate’s completion of 18 years of serving the hepatitis C community. It has been a year of frustration and celebration.
On the minus side, the number of new hepatitis C cases is rising. The largest increase occurred among persons aged 20–39 years. The acute infection rate among young women is approximately that of men. Pregnant HCV-positive women have about a 6 percent risk of passing the virus to their offspring, with an increased risk for those who are co-infected with HIV.
Baby boomers and other at-risk people are still largely undiagnosed. Those who do know they have hepatitis C, often face roadblocks while trying to access treatment. The hepatitis C death rate continues to climb, along with the incidence of liver cancer.
On the plus side, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) revised the HCV Guidelines, clearly recommending treatment for everyone, except those who are terminally ill and might not be helped by hep C treatment. The biggest cause for celebration occurred last month when the Centers for Medicare and Medicaid Services (CMS) stepped into the act. CMS:
•Sent letters to the CEOs of several drug manufacturers about providing access to therapy for hepatitis C patients, telling them to assist states with making high-price drugs affordable.
•CMS also sent notices to state Medicaid programs reminding them of their obligation to provide access to medications.
•On their blog, CMS issued a strong statement affirming the agency’s commitment to provide prescription drugs, specifically naming Medicaid recipients who have hepatitis C.
Also on the plus side are advances in research. Traditionally, Alan Franciscus and I provide some highlights from AASLD’s annual Liver Meeting in December’s HCV Advocate. This year’s meeting was late, so we could not make our press deadline and cover the abstracts with as much depth as we usually do. I will mention a few here, and Alan will cover some in this issue and more in an upcoming issue, so stay tuned.
The Liver Meeting
This year there was more patient advocacy presence than ever before. Two rallies drew attention to the tragic fact that many patients cannot get access to hepatitis C treatment. The first rally was to demand that Gilead reinstate medication coverage for all high risk patients to help end the hep C epidemic. The second rally was to urge physicians to be advocates for treating all people with hepatitis C, in other words, to following the HCV Guidelines.
On Monday evening, rather than the usual corporate-sponsored symposium, there was an opportunity to attend a community event. Project Inform and five other hepatitis advocacy organizations hosted, “Beyond the Walls of the Clinic.” This gathering of providers and community advocates discussed building partnerships to increase access to vital services and health care. The substantial number of posters presented at the Liver Meeting that addressed access to care issues further illustrated the depth of the problem.
My Favorite Posters and Presentations
The research presented here was gathered from conference posters, presentations and abstracts. They represent part of the story, and unless and until these studies are published in a peer-reviewed journal, these data and conclusions are considered preliminary.
Abstract #85 A Highly Specific and Sensitive Hepatitis C Virus Antigens Enzyme Immunoassay (HCV-Ags EIA) for One-step Diagnosis of HCV Infection Mutual Inhibition between Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
Abstract #1785 Application of a Novel Hepatitis C Virus Antigens Enzyme Immunoassay (HCV-Ags EIA) for One-step Diagnosis of Active HCV Infection Using Urine Specimens
Authors Ke-Qin Hu, Wei Cui
Results and Conclusion Diagnosing an HCV infection is a two-step process. Currently, the first step checks for the presence of HCV-antibodies. If that test is positive, then a viral load test (HCV RNA) is performed. These two small studies (138/110 subjects each) set out to test a one-step process using chemicals that detect HCV antigens (HCV-Ags). One study used serum samples, the other study tested urine. These University of California, Irvine researchers were able to screen and diagnosis HCV infection in a single step with both testing systems.
Editorial Comments Although these are small studies, the potential implications are huge, especially the urine test. First, the one-step process puts to rest that anxious waiting period of wondering, do I or don’t I have hep C? It would also eliminate the misdiagnoses, those people who had a positive hep C-antibody test who were told they have hep C, but who later were tested correctly with a viral load test, and found out they didn’t have the virus.
The non-invasive feature of the urine test is especially attractive, and opens the door to global application. A press release issued by UC Irvine suggested that this testing system would be cost-effective. Hope to see more research on this in the near future.
Abstract # 89 Rectal Shedding of HCV in HCV/HIV Co-infected Men
Authors Andrew L. Foster, et al.
Results and Conclusion Looking at the HCV epidemic among HIV-infected men who have sex with men (MSM), this research sought to understand how HCV is transmitted.
Researchers obtained blood and rectal fluid specimens from 43 HCV/HIV positive MSM. Although blood was not visible on any of the samples, HCV was detected in 20 of the specimens of rectal fluid. Those whose blood tests showed higher viral load were both more likely to shed HCV into the rectum and to shed at higher levels. In short, sexual transmission via body fluid or other abrasions may lead to rectal transmission of HCV in HIV-infected MSM.
Editorial Comments Presumably, the use of condoms would reduce risk of HCV transmission in MSM.
Abstract # 313 The Need for Improved Liver Literacy in the US Population
Authors Tracy J. Mayne, Herbert Swanson
Results and Conclusion This sample of 511 U.S. participants assessed the level of awareness, knowledge, attitudes and behaviors surrounding liver health and liver disease and found it to be limited. Most respondents do not perceive themselves to be at risk for liver disease. They do not think about or discuss it with friends, family or their physician. Almost half had some belief that a person can live without a liver.
•Almost half believed that a person can live without a liver.
•Most of the respondents didn’t perceive themselves to be at risk for liver disease, and don’t think about or discuss it with friends, family or their medical providers.
•Most were unaware that liver function testing is part of routine blood work, but were aware of tests and values for blood pressure, blood sugar, cholesterol, and BMI.
•Respondents were more likely to worry about other diseases than liver-related ones.
•Cirrhosis was more likely to be stigmatized than other diseases.
Editorial Comments Liver disease needs more press. How about an Ice Bucket Challenge or an “I Liver New York” campaign?
The public’s lack of knowledge about the liver illustrates how much work we have to do as we enter our 19th year of increasing public awareness about hep C. You can be a part of it by donating money to your favorite advocacy group. Naturally, the HCV Advocate hopes you will consider them when you plan your charitable giving. Truly, no amount is too small, especially if we all give a little.
Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. She blogs at www.LucindaPorterRN.com and HepMag.comShare This Page