Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced the presentation of data from the company’s
HIV clinical development program at the 11th International AIDS
Society Conference on HIV Science (IAS 2021) from July 18-21.
Presentations will feature new data for islatravir, an
investigational nucleoside reverse transcriptase translocation
inhibitor, which is currently being evaluated across a variety of
doses, formulations and frequencies for both the treatment of HIV-1
infection in combination with other antiretroviral agents and for
the prevention of HIV-1 infection as a monotherapy. These data
include results from a late-breaking presentation from a Phase 2a
study evaluating the safety and pharmacokinetics (PK) of
once-monthly (QM) oral islatravir for pre-exposure prophylaxis
(PrEP) through 24 weeks. Additionally, Merck will share 96-week
safety data for once-daily islatravir in combination with
doravirine in previously untreated adults with HIV-1 infection.
There will also be updates from the Phase 3 DRIVE-AHEAD trial
evaluating DELSTRIGO™ (doravirine 100 mg/lamivudine 300
mg/tenofovir disoproxil fumarate 300 mg) in previously untreated
participants with HIV-1.
“Our decades-long commitment to fighting the epidemic is
stronger than ever as we continue to build on our legacy of
research and innovation in HIV,” said Dr. Joan Butterton, vice
president, Global Clinical Development, Infectious Diseases, Merck
Research Laboratories. “We believe that islatravir has the
potential to serve as the foundation of future treatment and
prevention regimens, and we look forward to sharing new data from
our HIV portfolio and pipeline.”
An overview of the islatravir treatment and prevention
development program is available here.
Select abstracts in the IAS 2021 program include:
- Safety and Pharmacokinetics of Oral Islatravir Once Monthly for
HIV Pre-exposure Prophylaxis (PrEP): Week 24 Analysis of a Phase 2a
Trial. Late Breaking Oral Presentation OALC01LB03. Abstract 2361.
S. Hillier et al.
- Islatravir Safety Analysis Through Week 96 from a Phase 2 Trial
in Treatment Naïve Adults with HIV-1 Infection. On-Demand Oral
Presentation OAB0304. Abstract 744. D. Cunningham et al.
- Week 96 Metabolic and Bone Outcomes of a Phase 2b Trial of
Islatravir and Doravirine. E-poster Presentation PEB149. Abstract
1017. GA. McComsey et al.
- The Safety and Efficacy of Maintenance with
Doravirine/Lamivudine/Tenofovir through 192 Weeks in Adults with
HIV-1: Results from the DRIVE-AHEAD Clinical Trial. E-poster
Presentation PEB147. Abstract 709. C. Orkin et al.
- HIV Recent Infection Test-Based Incidence as a Counter-Factual
for New PrEP Trials. E-poster Presentation PEC307. Abstract 2322.
N. Parkin et al.
- Safety and Pharmacokinetics of Islatravir in Study Participants
with Severe Renal Insufficiency. E-poster Presentation PEB168.
Abstract 1914. RP. Matthews et al.
- No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and
Islatravir. E-poster Presentation PEB171. Abstract 1171. W. Ankrom
- NNRTI MK-8507 Does Not Alter the Pharmacokinetics of the
Combined Oral Contraceptive Levonorgestrel/Ethinyl Estradiol.
E-poster Presentation PEB169. Abstract 688. W. Ankrom et al.
- Higher Comorbidity and Comedication Burden in Women and Young
People Living with HIV. On-Demand Oral Presentation OAA0104.
Abstract 804. M. Paudel et al.
For more information, including details around the virtual
programming, please visit the IAS 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
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 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
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
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
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
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
Mothers infected with HIV-1 should be instructed not to
breastfeed if they are receiving DELSTRIGO due to the potential for
About Islatravir (MK-8591)
Islatravir (MK-8591) is Merck’s investigational nucleoside
reverse transcriptase translocation inhibitor 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. Islatravir is also being
studied for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a
single agent, across a variety of formulations, including the
IMPOWER clinical trials evaluating an oral, once-monthly
Our Commitment to HIV
For more than 35 years, Merck has been committed to scientific
research and discovery (R&D) in HIV. Today, we are developing a
series of antiviral options designed to help people manage HIV and
protect people from HIV, with the goal of reducing the growing
burden of infection worldwide. We remain committed to working
hand-in-hand with our partners in the global HIV community to
address the complex challenges that impede progress toward ending
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
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
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
and Patient Information for DELSTRIGO (doravirine/3TC/TDF) at:
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