MedPath

Islatravir

Generic Name
Islatravir
Drug Type
Small Molecule
Chemical Formula
C12H12FN5O3
CAS Number
865363-93-5
Unique Ingredient Identifier
QPQ082R25D
Background

Islatravir is under investigation in clinical trial NCT04233216 (Doravirine/islatravir (DOR/ISL) in Heavily Treatment-experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)).

Clinical Trials
Related News

Merck's Doravirine/Islatravir Combo Shows Promise in Phase 3 HIV-1 Trials

• Merck's doravirine/islatravir (DOR/ISL) regimen demonstrated non-inferiority compared to current antiretroviral therapies in Phase 3 trials for HIV-1. • The DOR/ISL combination met primary efficacy endpoints, maintaining viral suppression in adults with virologically suppressed HIV-1 infection. • Merck plans to submit detailed findings from these trials to regulatory authorities for review and potential approval. • The ongoing Phase 3 trials are also evaluating DOR/ISL in treatment-naïve individuals, expanding its potential application.

FDA Accepts Gilead's Lenacapavir for HIV Prevention with Priority Review

• The FDA has accepted Gilead's NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP). • Lenacapavir demonstrated 100% risk reduction in cisgender women and 96% risk reduction in a diverse population, compared to background HIV incidence. • The FDA has granted priority review with a target action date of June 19, 2025, potentially making it the first twice-yearly HIV prevention option. • Gilead is also pursuing global access, including submissions to the EMA and voluntary licensing agreements to facilitate availability in low- and middle-income countries.

Gilead and Merck's Once-Weekly HIV Treatment Shows Promise in Phase 2 Trial

• A Phase 2 trial of a once-weekly oral combination of islatravir and lenacapavir demonstrated sustained viral suppression in adults living with HIV. • 94.2% of participants switching from a daily regimen of Biktarvy maintained viral suppression after 48 weeks on the new treatment. • The investigational regimen showed a favorable safety and tolerability profile, with mostly mild adverse events reported. • Gilead and Merck are collaborating to advance this treatment, which has the potential to become the first once-weekly oral HIV therapy.

Gilead Presents New HIV Treatment and Prevention Data at HIV Glasgow 2024

• Gilead's PURPOSE 2 trial results show lenacapavir's potential as a twice-yearly HIV prevention option for cisgender men and gender-diverse individuals. • Four-year outcomes from the BICSTaR study confirm the consistent efficacy and safety of Biktarvy in diverse HIV patients with comorbidities. • Phase 2 study data highlights a promising once-weekly oral combination of islatravir and lenacapavir for HIV treatment. • Gilead's research at HIV Glasgow 2024 underscores its commitment to innovative HIV therapies and prevention strategies.

HIVR4P Highlights: PrEP Advances, Vaccine Strategies, and HIV Reservoir Insights

• The dapivirine vaginal ring was found safe for use in early pregnancy, adding to evidence supporting its use throughout pregnancy. • Injectable cabotegravir (CAB-LA) PrEP showed no drug interactions with long-acting reversible contraceptives in cisgender women. • Early-stage HIV vaccine studies show promising immune responses, informing the development of next-generation broadly neutralizing antibody vaccines. • A novel refillable implant shows promise for ultra-long-acting delivery of antiretrovirals for HIV prevention and treatment.

Merck Highlights Infectious Disease Advances at IDWeek 2024

• Merck will present Phase 2b/3 trial results for clesrovimab, a preventative monoclonal antibody against respiratory syncytial virus (RSV) in infants. • Data from the Phase 3 STRIDE-8 trial of CAPVAXIVE, a pneumococcal 21-valent conjugate vaccine, in adults at increased risk of pneumococcal disease will be shared. • Week 48 data from a Phase 2 study of a once-weekly oral combination of islatravir and lenacapavir for HIV-1 treatment will be presented. • Merck's presentations at IDWeek 2024 underscore its commitment to addressing global health needs through innovative vaccines and infectious disease therapies.

Gilead's Lenacapavir Shows Promise in HIV Prevention and Treatment

• Gilead's twice-yearly injectable lenacapavir reduced HIV infections by 96% in a Phase 3 trial, demonstrating superiority to daily oral Truvada for PrEP. • The PURPOSE 2 trial included cisgender men, transgender individuals, and gender non-binary people, showing broad efficacy across diverse populations. • Gilead plans to begin regulatory filings for lenacapavir for PrEP by the end of 2024, with potential launch in 2025, prioritizing access in high-incidence, resource-limited countries. • A Phase 2 trial of once-weekly oral islatravir and lenacapavir maintained viral suppression in adults with HIV, paving the way for Phase 3 trials.
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