Merck to Present New Data from Studies of Investigational HIV Therapy Doravirine, Including Pivotal DRIVE-FORWARD Trial, at AIDS 2018


July 2, 2018 5:30 am ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that new data from the company are scheduled to be
presented at the 22nd
International AIDS Conference
(AIDS 2018) taking place July 23-27 in
Amsterdam. Presentations include Week 96 data from the Phase 3
DRIVE-FORWARD clinical trial for doravirine (DOR) and additional
analyses for DOR and investigational therapy MK-8591. DOR is a
non-nucleoside reverse transcriptase inhibitor (NNRTI) under
investigation as a single tablet for use in combination with other
antiretroviral (ARV) agents and as a fixed-dose combination with
lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) for the
treatment of HIV-1 infection in adult patients with no prior ARV
treatment history (treatment-naïve). MK-8591 is an investigational
nucleoside reverse transcriptase translocation inhibitor (NRTTI)
currently being evaluated in clinical trials for the treatment of HIV

“While enormous progress has been made in the fight against HIV/AIDS,
continued scientific innovation is needed given the unmet need that
continues to exist in HIV,” said Dr. George Hanna, vice president and
therapeutic area head of infectious diseases, global clinical
development, Merck Research Laboratories. “Merck looks forward to
presenting these new data from our HIV pipeline at AIDS 2018.”

Presentations include a late-breaking poster of the Week 96 data from
the pivotal Phase 3 DRIVE-FORWARD clinical trial evaluating the safety
and efficacy of once-daily DOR compared to once-daily ritonavir-boosted
darunavir (DRV+r), each administered with either emtricitabine/tenofovir
disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC), in
treatment-naïve adults with HIV-1 infection. In addition, analyses of
the resistance profiles of DOR and MK-8591 will be presented.

Data to be presented include:

  • Doravirine Versus Ritonavir-Boosted Darunavir: 96-Week Results of
    the Randomized, Double-Blind, Phase 3 DRIVE-FORWARD Noninferiority
    Trial. Abstract LBPEB017. K. Squires. Late-breaking Poster Exhibition:
    Wednesday, July 25, 12:30-14:30 CET, Poster Exhibition Area, Hall 1
  • Understanding the Resistance Profile of the HIV-1 NNRTI Doravirine
    in Combination with the Novel NRTTI MK-8591. Abstract THPEB068. D.
    Hazuda. Poster Exhibition: Thursday, July 26, 12:30-14:30 CET, Poster
    Exhibition Area, Hall 1
  • Characterization of Doravirine-Selected Resistance Patterns from
    Participants in Treatment-Naïve Phase 3 Clinical Trials. Abstract
    THPDB0101. M. Lai. Poster Discussion: Thursday, July 26, 13:00-14:00
    CET, Emerald Room

Earlier this year, the U.S. Food and Drug Administration (FDA) accepted
for review New Drug Applications for DOR and DOR/3TC/TDF for the
treatment of HIV-1 infection in treatment-naïve adults. The FDA has set
a target action date of October 23, 2018 for both applications.

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

news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”)
includes “forward-looking statements” within the meaning of the safe
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Pamela Eisele, 267-305-3558
Carmen de Gourville, 267-305-4195
Teri Loxam, 908-740-1986
Michael DeCarbo, 908-740-1807

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