March 09, 2016 04:00 PM Eastern Standard Time
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, applauds the U.S. Department of Veterans Affairs (VA) for broadening access to treatment for Veterans with chronic hepatitis C virus (HCV) infection.
ZEPATIER (elbasvir and grazoprevir) was approved Jan. 28, 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic HCV genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA, and was recently added to the VA National Formulary.
Merck introduced ZEPATIER with a price and access strategy to broaden and accelerate access to treatment for patients covered in commercial or public plans, including our country's Veterans. The Veteran population is disproportionally affected by chronic HCV with an estimated 180,000 Veterans infected with the virus. Despite the availability of highly effective direct acting anti-viral (DAA) regimens for more than two years, the VA estimates that only about one in five of these Veterans have been treated with these DAA regimens over that period.
"As the single largest provider of chronic hepatitis C care in the United States, our goal has been to treat every Veteran with HCV infection," said Sloan Gibson, deputy secretary for the Department of Veterans Affairs. "We are grateful to Congress and to pharmaceutical leaders like Merck that are committed to our Veterans who have nobly served our nation."
ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child-Pugh B or C). ZEPATIER also is 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.
"This is a good example of how government and industry can work together toward a shared goal in the best interests of public health – particularly for our Veterans who are so deserving. We are thankful and privileged to have worked in partnership with the VA to help accelerate access to chronic hepatitis C treatment for America's Veterans," said Kenneth C. Frazier, chairman and CEO, Merck. "The VA is now leading the way for the U.S. in showing what is possible in the fight against chronic hepatitis C."
Selected Safety Information about ZEPATIER (elbasvir and grazoprevir)
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 possible clinically significant adverse reactions from greater exposure to ZEPATIER or concomitant drugs. Coadministration of ZEPATIER is not recommended with certain strong CYP3A inhibitors (e.g., ketoconazole or the cobicistat-containing regimens of elvitegravir/cobicistat/emtricitabine/tenofovir [disoproxil fumarate or alafenamide]). Healthcare professionals should not exceed atorvastatin 20mg/daily or rosuvastatin 10mg/daily when given with ZEPATIER. If ZEPATIER is given with fluvastatin, lovastatin or simvastatin, healthcare professionals should give the lowest statin dose necessary and closely monitor for statin-associated adverse events. If ZEPATIER and tacrolimus are coadministered, frequent monitoring of tacrolimus whole blood concentrations, changes in renal function and tacrolimus-associated adverse events is recommended.
The concomitant use of ZEPATIER and certain drugs may cause significant decrease of elbasvir and grazoprevir plasma concentrations, which may lead to reduced therapeutic effect of ZEPATIER and possible development of resistance. Coadministration of ZEPATIER is not recommended with moderate CYP3A inducers (e.g., nafcillin, bosentan, etravirine, modafinil).
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.
About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets
ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotype 1 or 4 infection in adults. The dosing regimens and durations for treatment with once-daily ZEPATIER for chronic HCV GT1 or GT4 infection in patients with or without cirrhosis, HIV-1 co-infection or renal impairment are as shown in the table below. For patients with chronic HCV GT1a infection, testing for the presence of NS5A resistance-associated polymorphisms (positions 28, 30, 31 or 93) is recommended prior to starting treatment with ZEPATIER to determine the optimal dosage regimen and duration.
Treatment-naïve or PegIFN/RBV-experienced* without baseline NS5A polymorphisms†
Treatment-naïve or PegIFN/RBV-experienced* with baseline NS5A polymorphisms†
ZEPATIER with RBV
Treatment-naïve or PegIFN/RBV-experienced*
GT1a or GT1b:
ZEPATIER with RBV
ZEPATIER with RBV
*Patients who have failed treatment with peginterferon alfa (PegIFN) + RBV.
†NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31 or 93.
§Patients who have failed treatment with PegIFN/RBV + HCV NS3/4A protease inhibitor (PI): boceprevir, simeprevir or telaprevir. For GT1a-infected PegIFN/RBV/PI-experienced patients with one or more baseline NS5A resistance-associated polymorphisms (positions 28, 30, 31 or 93), the optimal ZEPATIER-based treatment regimen and duration of therapy has not been established.
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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 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. 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.
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Please see Prescribing Information for ZEPATIER (elbasvir and grazoprevir) athttp://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
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