Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today the presentation of new data from its
ongoing HIV research programs at the Conference on Retroviruses and
Opportunistic Infections (CROI 2020) taking place March 8 – 11,
2020 in Boston, Massachusetts. At the conference, data from several
studies will be shared, including an analysis of the efficacy of
weekly oral doses of the investigational nucleoside reverse
transcriptase translocation inhibitor (NRTTI) islatravir as
postexposure prophylaxis (PEP) in the SIV/rhesus macaque IV
challenge model; metabolic outcomes from a Phase 2b trial of
islatravir with doravirine (100 mg) and lamivudine (3TC, 300 mg) or
with a fixed dose combination of doravirine, 3TC and tenofovir
disoproxil fumarate (TDF, 300 mg) in previously untreated adults;
and ongoing research into ways to target HIV viral reservoirs. The
islatravir as PEP study will be featured in an official CROI press
conference.
“Merck’s commitment to HIV spans exploratory research to Phase 3
trials and is fueled by our goal to develop meaningful scientific
innovations that someday may help people living with HIV,” said Dr.
George Hanna, vice president and therapeutic area head of
infectious diseases, Global Clinical Development, Merck Research
Laboratories. “We look forward to discussing the latest evidence
for the clinical potential of our investigational candidates,
including islatravir.”
Select abstracts in the CROI 2020 program include:
- Weekly Oral Islatravir Provides Effective PEP Against IV
Challenge with SIVmac251. Oral Presentation. Session 89 Late
Breaker (Abstract 4468). M. Markowitz et al.
- Discussion at official CROI press conference: Tuesday, March
10, 7:30 a.m., Room 210, Hynes Convention Center
- Islatravir Metabolic Outcomes in Phase 2B Trial of
Treatment-Naïve Adults with HIV-1. Poster Presentation. Session 686
(Abstract 1166). G. McComsey et al.
- MK-8504 and MK-8583 (Tenofovir Prodrugs) Single-Dose PK and
Antiviral Activity in HIV Infection. Poster Presentation and Themed
Discussion. Session 468 (Abstract 1066). R. Matthews et al.
- Distinct HIV Reservoir Measures Correlate with Defective But
Not Intact Pro-Viral DNA. Poster Presentation. Session 309
(Abstract 2343). E. Papasavvaset al.
- HIV Gag p24 Persists in Tissue and Correlates with Immune
Response. Poster Presentation. Session 316 (Abstract 3388). P. Zuck
et al.
For more information, please visit the CROI 2020 website.
Indications and Usage for PIFELTRO and DELSTRIGO PIFELTRO
is indicated in combination with other antiretroviral (ARV) agents
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
doravirine.
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 PIFELTRO and 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.
PIFELTRO and DELSTRIGO are 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 and PIFELTRO.
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.
Co-administration of PIFELTRO with efavirenz, etravirine, or
nevirapine is not recommended.
If DELSTRIGO is 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.
If PIFELTRO is co-administered with rifabutin, increase PIFELTRO
dosage to one tablet twice daily (approximately 12 hours
apart).
Consult the full Prescribing Information prior to and during
treatment for more information on potential drug-drug
interactions.
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%). The most common adverse reactions with PIFELTRO
(incidence ≥5%, all intensities) were nausea (7%), dizziness (7%),
headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%),
and abnormal dreams (5%).
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.
Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and
16% of subjects in the immediate switch group experienced ALT and
AST elevations greater than 1.25 X ULN, respectively, through 48
weeks on DELSTRIGO. For these ALT and AST elevations, no apparent
patterns with regard to time to onset relative to switch were
observed. One percent of subjects had ALT or AST elevations greater
than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST
elevations were generally asymptomatic, and not associated with
bilirubin elevations. In comparison, 4% and 4% of subjects in the
delayed switch group experienced ALT and AST elevations of greater
than 1.25 X ULN through 24 weeks on their baseline regimen.
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 PIFELTRO or DELSTRIGO due to the
potential for HIV-1 transmission.
About Islatravir (MK-8591) Islatravir is Merck’s
investigational nucleoside reverse transcriptase translocation
inhibitor (NRTTI) currently being evaluated in clinical trials for
the treatment of HIV-1 infection in combination with other
antiretrovirals, as well as for pre-exposure prophylaxis of HIV-1
infection as a single investigational agent, across a variety of
formulations.
Our Commitment to HIV For more than 30 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.
About Merck For more than 125 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 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 2019
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 PIFELTRO (doravirine)
at:
https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf;
and Patient Information for PIFELTRO (doravirine) at:
https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf
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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