Merck Applauds the U.S. Department of Veterans Affairs (VA) for Broadening Treatment Access for Veterans with Chronic Hepatitis C Infection


March 9, 2016 4:00 pm ET

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)

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,

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.

Patient Population       Treatment       Duration

Treatment-naïve or PegIFN/RBV-experienced* without baseline NS5A

      ZEPATIER       12 weeks

Treatment-naïve or PegIFN/RBV-experienced* with baseline NS5A

      ZEPATIER with RBV       16 weeks

Treatment-naïve or PegIFN/RBV-experienced*

      ZEPATIER       12 weeks
GT1a or GT1b:


      ZEPATIER with RBV       12 weeks


      ZEPATIER       12 weeks


      ZEPATIER with RBV       16 weeks

*Patients who have failed treatment with peginterferon alfa (PegIFN) +
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.

About Merck

Today’s Merck is 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,
and connect with us on Twitter,
and LinkedIn.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA

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.

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 (

Please see Prescribing Information for ZEPATIER (elbasvir and
grazoprevir) at
and the Patient Information for ZEPATIER at

Pam Eisele, 267-305-3558
Sarra Herzog, 201-669-6570
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898

Unsubscribe from email alerts