Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today upcoming presentations from its HIV
clinical development programs that will be featured during the 2021
Conference on Retroviruses and Opportunistic Infections (CROI
2021), taking place virtually from March 6 – 10, 2021.
Presentations will include new data for islatravir, the company’s
investigational nucleoside reverse transcriptase translocation
inhibitor (NRTTI), which is being developed for HIV treatment and
prevention. Merck will share late-breaking Phase 1 study results
evaluating a new prototype subdermal drug-eluting implant for
extended administration of islatravir for pre-exposure prophylaxis
(PrEP). This data will also be featured in the CROI virtual press
conference. Throughout the conference, Merck will also share
pharmacokinetic (PK) threshold and dose selection data for
once-monthly oral islatravir for PrEP and model-informed dose
selection data for the Phase 2b study of islatravir administered
with MK-8507, the company’s investigational non-nucleoside reverse
transcriptase inhibitor (NNRTI), for oral once-weekly treatment of
HIV-1 infection in adults. There will also be updates from the
International Maternal Pediatric Adolescent AIDS Clinical Trials
(IMPAACT) Network evaluating DELSTRIGO™ (doravirine 100
mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg) in
HIV-infected adolescents ages 12 to 18 years and weighing at least
45 kg.
“We recognize that new strategies for HIV treatment and
prevention continue to be needed to address this global epidemic.
We look forward to sharing updates from our broad HIV program at
CROI,” said Dr. Joan Butterton, vice president, global clinical
development, infectious diseases, Merck Research Laboratories. “Our
steadfast commitment to the global HIV community is reflected in
our exploration of different modalities and combinations and
extended duration alternatives for treatment and/or prevention.
Merck has been at the forefront of innovation in HIV for decades,
and we are excited to continue contributing to HIV research by
exploring the development of longer-acting treatment and prevention
options that may help address the evolving needs of people living
with or at risk for HIV.”
Select abstracts in the CROI 2021 program include:
- Next-Generation Islatravir Implants Projected to Provide Yearly
HIV Prophylaxis. Late Breaking Oral Presentation. R. Matthews et
al.
- Islatravir PK Threshold & Dose Selection for Monthly Oral
HIV-1 PrEP. Oral Presentation. M. Patel et al.
- Resistance Profile of MK-8507, a Novel NNRTI Suitable for
Weekly Oral HIV Treatment. Oral Presentation. T. Diamond et
al.
- Model Informed Dose Selection for Islatravir/MK-8507 Oral
Once-Weekly Phase 2b Study. Science Spotlight Presentation. B.
Kandala et al.
- IMPAACT 2014 24-Week PK and Safety of Doravirine/3TC/TDF in
Adolescents with HIV-1. Science Spotlight Presentation. A. Melvin
et al.
- Week 96 Analysis of Viral Blips from a Phase 2B Trial of
Islatravir and Doravirine. Science Spotlight Presentation. C. Orkin
et al.
- Comorbidity Burden in People Living with HIV in the United
States. Science Spotlight Presentation. P. Kumar et al.
- Improved Detection of HIV Gag p24 Protein from Patient-Derived
Samples. Science Spotlight Presentation. P. Zuck et al.
For more information, including details around the virtual
programming, please visit the CROI 2021 website.
Indications and Usage for DELSTRIGO
DELSTRIGO is indicated as a complete regimen for the treatment
of HIV-1 infection in adult patients with no prior ARV treatment
history or to replace the current ARV regimen in those who are
virologically suppressed (HIV-1 RNA less than 50 copies per mL) on
a stable ARV regimen with no history of treatment failure and no
known substitutions associated with resistance to the individual
components of DELSTRIGO.
Selected Safety Information about DELSTRIGO
Warning: Posttreatment Acute Exacerbation of Hepatitis B
(HBV)
All patients with HIV-1 should be tested for the presence of HBV
before initiating ARV therapy. Severe acute exacerbations of HBV
have been reported in patients who are coinfected with HIV-1 and
HBV and have discontinued products containing lamivudine or
tenofovir disoproxil fumarate (TDF), which are components of
DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue
DELSTRIGO should be monitored with both clinical and laboratory
follow-up for at least several months after stopping DELSTRIGO. If
appropriate, initiation of anti-HBV therapy may be warranted.
DELSTRIGO is contraindicated when co-administered with drugs
that are strong cytochrome P450 (CYP)3A enzyme inducers (including
the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital,
and phenytoin; the androgen receptor inhibitor enzalutamide; the
antimycobacterials rifampin and rifapentine; the cytotoxic agent
mitotane; and the herbal product St. John’s wort (Hypericum
perforatum)), as significant decreases in doravirine plasma
concentrations may occur, which may decrease the effectiveness of
DELSTRIGO.
DELSTRIGO is contraindicated in patients with a previous
hypersensitivity reaction to lamivudine.
Renal impairment, including cases of acute renal failure and
Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO
should be avoided with concurrent or recent use of a nephrotoxic
agent (eg, high-dose or multiple NSAIDs). Cases of acute renal
failure after initiation of high-dose or multiple NSAIDs have been
reported in patients with risk factors for renal dysfunction who
appeared stable on TDF.
Prior to or when initiating DELSTRIGO, and during treatment,
assess serum creatinine, estimated creatinine clearance, urine
glucose, and urine protein in all patients. In patients with
chronic kidney disease, also assess serum phosphorus. Discontinue
DELSTRIGO in patients who develop clinically significant decreases
in renal function or evidence of Fanconi syndrome. Discontinue
DELSTRIGO if estimated creatinine clearance declines below 50
mL/min.
In clinical trials in HIV-1 infected adults, TDF was associated
with slightly greater decreases in bone mineral density (BMD) and
increases in biochemical markers of bone metabolism. Serum
parathyroid hormone levels and 1,25 Vitamin D levels were also
higher. Cases of osteomalacia associated with proximal renal
tubulopathy have been reported with the use of TDF.
Immune reconstitution syndrome can occur, including the
occurrence of autoimmune disorders with variable time to onset,
which may necessitate further evaluation and treatment.
Because DELSTRIGO is a complete regimen, co-administration with
other antiretroviral medications for the treatment of HIV-1
infection is not recommended.
Consult the full Prescribing Information prior to and during
treatment for more information on potential drug-drug
interactions.
If co-administered with rifabutin, take one tablet of DELSTRIGO
once daily, followed by one tablet of doravirine (PIFELTRO)
approximately 12 hours after the dose of DELSTRIGO.
Because DELSTRIGO is a fixed-dose combination tablet and the
dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not
recommended in patients with estimated creatinine clearance less
than 50 mL/min.
The most common adverse reactions with DELSTRIGO (incidence ≥5%,
all intensities) were dizziness (7%), nausea (5%), and abnormal
dreams (5%).
By Week 96 in DRIVE-AHEAD, 3% of adult subjects in the DELSTRIGO
group and 7% in the EFV/FTC/TDF group had adverse events leading to
discontinuation of study medication.
In DRIVE-AHEAD, mean changes from baseline at Week 48 in
LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were
pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3
mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the
DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The
clinical benefits of these findings have not been demonstrated.
In DRIVE-AHEAD, neuropsychiatric adverse events were reported in
the three pre-specified categories of sleep disorders and
disturbances, dizziness, and altered sensorium. Twelve percent of
adult subjects in the DELSTRIGO group and 26% in the EFV/FTC/TDF
group reported neuropsychiatric adverse events of sleep disorders
and disturbances; 9% in the DELSTRIGO group and 37% in the
EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group
and 8% in the EFV/FTC/TDF group reported altered sensorium.
The safety of DELSTRIGO in virologically-suppressed adults was
based on Week 48 data from subjects in the DRIVE-SHIFT trial.
Overall, the safety profile in virologically-suppressed adult
subjects was similar to that in subjects with no ARV treatment
history.
In DRIVE-SHIFT, mean changes from baseline at Week 48 in
LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were
pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6
mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL DELSTRIGO
group vs -2.1 mg/dL in the PI + ritonavir group. The clinical
benefits of these findings have not been demonstrated.
There is a pregnancy exposure registry that monitors pregnancy
outcomes in individuals exposed to PIFELTRO or DELSTRIGO during
pregnancy. Healthcare providers are encouraged to register patients
by calling the Antiretroviral Pregnancy Registry (APR) at
1-800-258-4263.
Mothers infected with HIV-1 should be instructed not to
breastfeed if they are receiving DELSTRIGO due to the potential for
HIV-1 transmission.
About Islatravir (MK-8591)
Islatravir (formerly MK-8591) is Merck’s investigational
nucleoside reverse transcriptase translocation inhibitor (NRTTI)
under evaluation in clinical trials for the treatment of HIV-1
infection in combination with other antiretrovirals, including the
ILLUMINATE clinical trials program for once-daily treatment, as
well as for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a
single agent, across a variety of formulations.
Our Commitment to HIV
For more than 35 years, Merck has been committed to scientific
research and discovery in HIV, and we continue to be driven by the
conviction that more medical advances are still to come. Our focus
is on pursuing research that addresses unmet medical needs and
helps people living with HIV and their communities. We remain
committed to working hand-in-hand with our partners in the global
HIV community to address the complex challenges that hinder
continued progress toward ending the epidemic.
Our Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
vaccines and antibacterial, antiviral and antifungal medicines,
Merck has multiple programs that span discovery through late-stage
development. To learn more about Merck’s infectious diseases
pipeline, visit www.merck.com.
About Merck
For 130 years, Merck, 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 in
pursuit of our mission to save and improve lives. We demonstrate
our commitment to patients and population health by increasing
access to health care through far-reaching policies, programs and
partnerships. Today, Merck continues to be at the forefront of
research to prevent and treat diseases that threaten people and
animals – including cancer, infectious diseases such as HIV and
Ebola, and emerging animal diseases – as we aspire to be the
premier research-intensive biopharmaceutical company in the world.
For more information, visit www.merck.com and connect with us on
Twitter, Facebook, Instagram, YouTube 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 the global outbreak of novel coronavirus disease
(COVID-19); 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 2020
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 (www.sec.gov).
Please see Prescribing Information for DELSTRIGO
(doravirine/3TC/TDF) at:
https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf
and Patient Information for DELSTRIGO (doravirine/3TC/TDF) at:
https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_ppi.pdf
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