Merck to Present New Data from Clinical Trials Evaluating ISENTRESS® HD (raltegravir) and Investigational HIV Therapies Doravirine and MK-8591 at IAS 2017


July 6, 2017 6:00 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that new data from the company’s HIV portfolio and
pipeline are scheduled to be presented at the 9th
IAS Conference on HIV Science
(IAS 2017). Presentations include
late-breaker abstracts from two Phase 3 pivotal clinical trials – Week
96 data from ONCEMRK, a study evaluating once-daily ISENTRESS
(raltegravir) in combination with other antiretroviral agents in
previously untreated adult patients with HIV-1 infection, and Week 48
data from DRIVE-AHEAD, a study evaluating doravirine (MK-1439), an
investigational non-nucleoside reverse transcriptase inhibitor (NNRTI)
as part of a fixed dose regimen containing doravirine (DOR), lamivudine
(3TC), and tenofovir disoproxil fumarate (TDF) compared to a regimen
containing efavirenz (EFV), emtricitabine (FTC), and TDF in previously
untreated adult patients with HIV-1 infection. In addition, a
late-breaker abstract will be presented of a Phase 1 study of MK-8591,
Merck’s investigational nucleoside reverse transcriptase translocation
inhibitor (NRTTI) in adult patients with HIV-1 infection. IAS 2017 is
taking place in Paris, France, from July 23-26, 2017.

“Merck has never wavered in our commitment to addressing the treatment
needs of people living with HIV, and the data to be presented at IAS
2017 on our portfolio and our pipeline reflect that commitment,” said
Dr. George Hanna, associate vice president, clinical research, Merck
Research Laboratories.

In the United States, once-daily ISENTRESS HD was approved by the Food
and Drug Administration (FDA) on May 26, 2017, in combination with other
antiretroviral agents, for the treatment of HIV-1 infection in adults,
and pediatric patients weighing at least 40 kg, who are treatment-naïve
or whose virus has been suppressed on an initial regimen of ISENTRESS
400 mg given twice daily. ISENTRESS HD is administered as a 1200 mg
once-daily dose, given orally as two 600 mg film-coated tablets. On May
18, 2017, the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) adopted a positive opinion
recommending approval of the once-daily dose of ISENTRESS (ISENTRESS 600
mg as it will be known outside the United States) in combination with
other antiretroviral medicinal products, for the treatment of HIV-1
infection in adults and pediatric patients weighing at least 40 kg. The
recommendation is under review by the European Commission for marketing
authorization in the European Union with a decision on approval expected
in the second half of 2017.

Select Late-Breaker Abstracts at IAS 2017:

  • Abstract # TULBPEB20: Raltegravir (RAL) 1200 mg once daily (QD)
    versus RAL 400 mg twice daily (BID), in combination with tenofovir
    disoproxil fumarate/emtricitabine (TDF/FTC), in previously untreated
    HIV-1 infection through week 96

    • Late-breaker poster, Tuesday, July 25, 12:30 – 14:30 CET,
      Poster Exhibition
  • Abstract # TUPDB0202LB: Single doses as low as 0.5 mg of the novel
    NRTTI MK-8591 suppress HIV for at least seven days

    • Late-breaker poster discussion, Tuesday, July 25, 13:00 – 14:00
      CET, Havana Amphitheater
  • Abstract # TUAB0104LB: Fixed dose combination of
    doravirine/lamivudine/TDF is non-inferior to
    efavirenz/emtricitabine/TDF in treatment-naïve adults with HIV-1
    infection: week 48 results of the Phase 3 DRIVE-AHEAD study

    • Late-breaker oral presentation, Antiretroviral Therapy – ART:
      Season Two, Tuesday, July 25, 14:30 – 16:00 CET, Le Grand

About Doravirine

Doravirine (MK-1439) is an investigational NNRTI being evaluated by
Merck for the treatment of HIV-1 infection. Doravirine is being
evaluated in several ongoing studies as a once-daily fixed dose
combination with 3TC and TDF or individually for use in combination with
other antiretroviral agents. Phase 3 studies include DRIVE-AHEAD, a
trial comparing DOR/3TC/TDF to EFV/FTC/TDF in previously untreated adult
patients; DRIVE-FORWARD, a trial comparing doravirine (DOR) to
once-daily ritonavir-boosted darunavir (DRV+r), each administered in
combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
or abacavir/lamivudine (ABC/3TC), in previously untreated adult
patients; and DRIVE-SHIFT, a trial evaluating a switch to DOR/3TC/TDF in
people who are currently virologically suppressed on another
antiretroviral regimen. Other ongoing Phase 2 studies include an
evaluation of DOR/3TC/TDF in previously untreated patients with
transmitted resistance to NNRTIs and in people switching from efavirenz
due to intolerability.

About MK-8591

MK-8591 (formerly known as EFdA) is Merck’s investigational nucleoside
reverse transcriptase translocation inhibitor (NRTTI) currently being
evaluated in early stage clinical trials for the treatment of HIV
infection. It inhibits HIV reverse transcriptase through multiple
mechanisms that are different from any approved anti-HIV medicines,
including traditional nucleoside reverse transcriptase inhibitors
(NRTIs). MK-8591 is being evaluated for its potential to be administered
as part of a daily or an extended duration dosing regimen.

About ISENTRESS (raltegravir)

Approved in 2007, ISENTRESS was the first integrase inhibitor developed
for the treatment of HIV-1 infection. ISENTRESS is one of the regimen
options recommended by the Department of Health and Human Services – in
combination with other antiretroviral agents – as a first-line therapy
in treatment-naïve HIV-1 infected adults. ISENTRESS chewable tablets and
oral suspension, each in combination therapy, are approved to treat
pediatric patients aged at least four weeks of age, and weighing less
than 20 kg.

ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA
by the integrase enzyme and has demonstrated rapid antiviral activity.
Inhibiting integrase from performing this essential function limits the
ability of the virus to replicate and infect new cells.

ISENTRESS is approved as part of combination therapy in 112 countries
for treatment of HIV-1 infection in adult patients. ISENTRESS, in
combination therapy, for use in children and adolescents with HIV-1 aged
two years and older has also been approved for use in 69 countries, and
ISENTRESS oral suspension for infants at least four weeks of age is
approved for use in 33 countries.

Selected Safety Information about ISENTRESS HD (raltegravir) and
ISENTRESS (raltegravir)

Severe, potentially life-threatening and fatal skin reactions have been
reported. This includes cases of Stevens-Johnson syndrome,
hypersensitivity reaction and toxic epidermal necrolysis. Immediately
discontinue treatment with ISENTRESS or ISENTRESS HD and other suspect
agents if severe hypersensitivity, severe rash, or rash with systemic
symptoms or liver aminotransferase elevations develops and monitor
clinical status, including liver aminotransferases closely.

Immune reconstitution syndrome can occur, including the occurrence of
autoimmune disorders with variable time to onset, which may necessitate
further evaluation and treatment.

ISENTRESS chewable tablets contain phenylalanine, a component of
aspartame, which may be harmful to patients with phenylketonuria.

Co-administration of ISENTRESS or ISENTRESS HD with drugs that induce
uridine diphosphate glucuronosyltransferase (UGT) 1A1 may result in
reduced plasma concentrations of raltegravir. Co-administration of
ISENTRESS or ISENTRESS HD with drugs that inhibit UGT1A1 may increase
plasma levels of raltegravir.

Co-administration of ISENTRESS or ISENTRESS HD and other drugs may alter
the plasma concentration of raltegravir. The potential for drug-drug
interactions must be considered prior to and during therapy.
Co-administration or staggered administration of aluminum and/or
magnesium hydroxide-containing antacids and ISENTRESS or ISENTRESS HD is
not recommended. Co-administration of ISENTRESS HD with calcium
carbonate antacids, tipranavir/ritonavir, or etravirine is also not

During co-administration with rifampin, the recommended dosage of
ISENTRESS in adults is 800 mg twice daily. Rifampin, a strong inducer of
UGT1A1, reduces plasma concentrations of ISENTRESS. There are no data to
guide co-administration of ISENTRESS with rifampin in patients below 18
years of age.

Co-administration with rifampin is not recommended with ISENTRESS HD.

The impact of other strong inducers of drug metabolizing enzymes on
raltegravir is unknown (e.g., Carbamazepine, Phenobarbital, and
Phenytoin). Co-administration of ISENTRESS or ISENTRESS HD with other
strong inducers is not recommended.

The most commonly reported (≥2 percent) drug-related clinical adverse
reactions of moderate to severe intensity in treatment-naïve adult
patients receiving ISENTRESS compared with efavirenz were headache (4
percent vs. 5 percent), insomnia (4 percent vs. 4 percent), nausea (3
percent vs. 4 percent), dizziness (2 percent vs. 6 percent), and fatigue
(2 percent vs. 3 percent), respectively. The most commonly reported (≥2
percent) clinical adverse reactions of all intensities (Mild, Moderate,
and Severe) in treatment-naïve adult patients receiving ISENTRESS HD
compared with ISENTRESS through 48 weeks included abdominal pain,
diarrhea, vomiting, and decreased appetite. Intensities were defined as
follows: Mild (awareness of sign or symptom, but easily tolerated);
Moderate (discomfort enough to cause interference with usual activity);
or Severe (incapacitating with inability to work or do usual activity).

Grade 2–4 creatine kinase laboratory abnormalities were observed in
subjects treated with ISENTRESS or ISENTRESS HD. Myopathy and
rhabdomyolysis have been reported with ISENTRESS. Use with caution in
patients at increased risk of myopathy or rhabdomyolysis, such as
patients receiving concomitant medications known to cause these
conditions and patients with a history of rhabdomyolysis, myopathy, or
increased serum creatine kinase.

There is a pregnancy exposure registry that monitors pregnancy outcomes
in women exposed to ISENTRESS or ISENTRESS HD during pregnancy.
Healthcare providers are encouraged to register patients by calling the
Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Women infected with HIV-1 should be instructed not to breastfeed if they
are receiving ISENTRESS or ISENTRESS HD due to the potential for HIV

About Merck

For more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. 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. Today, Merck continues to be at the forefront of
research to advance the prevention and treatment of diseases that
threaten people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease
and infectious diseases including HIV and Ebola. For more information,
and connect with us on Twitter,
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
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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 2016 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 ISENTRESS (raltegravir) and
ISENTRESS HD (raltegravir) at

Patient Information for ISENTRESS and ISENTRESS HD (raltegravir) at

The Instructions for Use also are available at

Pam Eisele, 267-305-3558
Carmen de Gourville, 267-305-4195
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898

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