Merck to Present New Data from Studies of Investigational HIV Therapies Doravirine and MK-8591 at CROI 2018

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March 1, 2018 7:00 am ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that data from studies of Merck’s robust HIV pipeline,
including doravirine, a late-stage investigational non-nucleoside
reverse transcriptase inhibitor (NNRTI), and MK-8591, an investigational
nucleoside reverse transcriptase translocation inhibitor (NRTTI), a
“first of its kind” mechanism to enter clinical trials, are scheduled to
be presented at the Conference on Retroviruses and Opportunistic
Infections (CROI 2018). In addition, Merck scientists will present data
from experiments investigating the mechanisms of formation and
maintenance of HIV reservoirs and the impact of HIV persistence in the
gut on immune recovery during antiretroviral therapy. CROI
2018
is taking place in Boston, Massachusetts, from March 4-7, 2018.

“Merck’s commitment to HIV has never wavered, and we are very excited
about the progress being made in our labs today to both better
understand HIV and to bring forward the next generation of potential
treatments,” said Dr. George Hanna, associate vice president, clinical
research, Merck Research Laboratories.

Presentations include Week 48 subgroup analysis from the pivotal Phase 3
DRIVE-AHEAD trial evaluating the efficacy and safety of doravirine
(DOR), lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a
once-daily fixed-dose combination single tablet as a complete regimen
(DOR/3TC/TDF) for the treatment of HIV-1 infection in treatment-naïve
adults. In addition, results from a Phase 1 study evaluating MK-8591, an
investigational nucleoside reverse transcriptase translocation inhibitor
(NRTTI) that potentially inhibits HIV reverse transcriptase through
multiple mechanisms will be presented in a late breaking abstract
session.

Merck Abstracts at CROI 2018:

  • Abstract # 491: Similar Efficacy and Safety by Subgroup in
    DRIVE-AHEAD: DOR/3TC/TDF versus EFV/FTC/TDF

    • Chloe Orkin
    • Poster presentation, Monday, March 5, 2:30 – 4:00 PM, Poster
      Hall D
  • Abstract # 89LB: Low Dose MK-8591 Protects Rhesus Macaques Against
    Rectal SHIV Infection

    • Martin Markowitz
    • Late-breaker oral presentation, Tuesday, March 6, 11:45 AM,
      Ballroom B
  • Abstract # 26: Multiple Daily Doses of MK-8591 as Low as 0.25 mg
    Are Expected to Suppress HIV

    • Randolph P. Matthews
    • Oral presentation, Monday, March 5, 11:00 AM, Auditorium
  • Abstract # 158: CD32+ CD4+ T Cells Are HIV Transcriptionally Active
    Rather Than a Resting Reservoir

    • Mohamed Abdel-Mohsen
    • Oral presentation, Wednesday, March 7, 5:45 PM, Ballroom A
  • Abstract # 730: Validation of a Chronic Kidney Disease Risk Score
    in HIV+ Patients in the US

    • Anthony Mills
    • Poster presentation, Tuesday, March 6, 2:30 – 4:00 PM, Poster
      Hall D
  • Abstract # 316: A Bispecific Approach for Targeting Negative
    Checkpoint Receptors in HIV-1 Latency

    • Daniel Gorman
    • Poster presentation, Tuesday, March 6, 2:30 – 4:00 PM, Poster
      Hall A
  • Abstract # 383: Higher Rectal p24 Levels Correlate with Poor CD4
    Recovery in Treated HIV Infection

    • Bonnie J. Howell
    • Poster presentation, Wednesday, March 7, 2:30 – 4:00 PM, Poster
      Hall A
  • Abstract # 376: IL-10 Signaling Is a Key Mechanism of SIV
    Persistence in ART-Treated Rhesus Macaques

    • Maria Pino
    • Poster presentation, Wednesday, March 7, 2:30 – 4:00 PM, Poster
      Hall A
  • Abstract # 393: Blinded Evaluation of Ultrasensitive Assays of HIV
    in Plasma

    • Sheila M. Keating
    • Poster presentation, Wednesday, March 7, 2:30 – 4:00 PM, Poster
      Hall A

About Doravirine

Doravirine (MK-1439, DOR) is an investigational NNRTI being evaluated by
Merck for the treatment of HIV-1 infection. DOR is being evaluated in
several ongoing clinical trials both as a once-daily single-entity
tablet in combination with other antiretroviral agents in a tailored
regimen, and as a once-daily fixed-dose combination (DOR/3TC/TDF) in a
complete single tablet regimen. Phase 3 trials include DRIVE-FORWARD, a
trial comparing DOR to once-daily ritonavir-boosted darunavir (DRV+r),
each administered in combination with emtricitabine (FTC)/TDF or
abacavir (ABC)/3TC, in treatment-naïve adults; DRIVE-AHEAD, a trial
comparing DOR/3TC/TDF to efavirenz (EFV)/FTC/TDF in treatment-naïve
adults; and DRIVE-SHIFT, a trial evaluating a switch to DOR/3TC/TDF in
HIV-1 infected adults who are currently virologically suppressed on
another antiretroviral regimen. Other ongoing Phase 2 clinical trials
include an evaluation of DOR/3TC/TDF in treatment-naïve adults with
transmitted resistance to NNRTIs and in people switching from EFV due to
intolerability.

Earlier this year, the U.S. Food and Drug Administration (FDA) accepted
for review two New Drug Applications (NDAs) for DOR for the treatment of
HIV-1 infection in treatment-naïve adults. The submission includes a
once-daily single-entity tablet in combination with other antiretroviral
agents in a tailored regimen, and a once-daily fixed-dose combination
(DOR/3TC/TDF) in a complete single tablet regimen. The FDA has set a
target action date of October 23, 2018, for both applications.

About MK-8591

MK-8591 is Merck’s investigational nucleoside reverse transcriptase
translocation inhibitor (NRTTI) currently being evaluated in clinical
trials for the treatment of HIV infection. Preclinical evidence
indicates that MK-8591 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 in a 3-part Phase 2b
dose-ranging trial, DRIVE2SIMPLIFY, a study of MK-8591 in combination
with doravirine.

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,
visit www.merck.com
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Merck
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or
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or
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