MSD将在 HIV Glasgow 2026上展示其广谱口服抗病毒药物组合及研发管线最新数据

November 2, 2026--RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that new data across its HIV treatment and prevention pipeline and portfolio will be presented at HIV Drug Therapy Glasgow 2026 (HIV Glasgow 2026), taking place Nov 8–11, 2026, in Glasgow, Scotland. Presentations will highlight Merck’s strategy to expand oral options in both HIV treatment and prevention, including data on once-daily IDVYNSO® (doravirine/islatravir), the investigational once-weekly oral treatment regimens islatravir/lenacapavir (ISL/LEN) and islatravir/ulonivirine (ISL/ULO), and the investigational once-monthly oral pre-exposure prophylaxis (PrEP) alimatravir (AMI, MK-8527).

“The data being presented at HIV Glasgow reflect the breadth of our research across HIV treatment and prevention,” said Dr. Luisa Stamm, associate vice president and HIV section head at Merck Research Laboratories. “Our goal is to bring forward oral options, including daily and once-weekly HIV treatment regimens, as well as a once-monthly HIV prevention pill. Because no single medicine works for every person, we are committed to expanding choices that may help address the diverse needs and preferences of people living with HIV or those who could benefit from PrEP.”

At HIV Glasgow, Merck will present Phase 3 subgroup analyses of once-daily IDVYNSO, including Week 48 resistance and weight analyses from Trial 53 comparing IDVYNSO to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in adults with HIV-1 who had not previously received antiretroviral treatment, as well as Week 96 patient-reported outcomes for IDVYNSO in adults with virologically suppressed HIV-1. Separately, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications for IDVYNSO (doravirine and islatravir): one based on the Phase 3 Trial 053 in adults who had not previously received antiretroviral treatment and one based on the Phase 3 Trials 051 and 052 to include 96-week data in virologically suppressed adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) or target action date of April 22, 2027, for both applications.

IDVYNSO (doravirine/islatravir) is a two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir and is approved in the United States for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

The investigational once-weekly oral regimen of islatravir and lenacapavir pairs Merck’s islatravir, a potent nucleoside analog with multiple mechanisms of action including HIV-1 reverse transcriptase translocation inhibition, with Gilead’s lenacapavir, a first-in-class capsid inhibitor that disrupts HIV-1 at multiple stages of its lifecycle. Data to be presented at HIV Glasgow from the Phase 3 ISLEND-1 and ISLEND-2 trials will include Week 48 safety and efficacy subgroup analyses across diverse demographic populations. ISLEND-2 data will also include Week 48 patient-reported outcomes and a qualitative substudy of participant and provider experiences with once-weekly dosing. These data further characterize Phase 3 safety and efficacy findings first presented at AIDS 2026, providing additional insight across patient subgroups, treatment experiences, and preferences with once-weekly oral therapy.

Key presentations at HIV Glasgow 2026 by program:

• Doravirine/islatravir (once-daily oral treatment)

  DOR/ISL analyses: Week 48 resistance and weight analyses in adults with HIV-1 who had not previously received antiretroviral treatment and Week 96 patient-reported outcomes assessing treatment satisfaction in adults living with virologically suppressed HIV-1 (Abstract #P060, Abstract #P401, Abstract #P063).

• Islatravir/lenacapavir (investigational once-weekly oral treatment)

  ISLEND-1 (Phase 3): Week 48 subgroup analyses evaluating a switch to once-weekly ISL/LEN compared to continuing a daily regimen of BIC/FTC/TAF in adults living with virologically suppressed HIV-1 (Abstract #P050).

  ISLEND-2 (Phase 3): Week 48 subgroup analyses evaluating a switch to once-weekly ISL/LEN compared to continuing daily standard-of-care treatment in adults living with virologically suppressed HIV-1, accompanied by Week 48 patient-reported outcomes and a qualitative substudy detailing participant and provider experiences (Abstract #P049, Abstract #P057, Abstract #P056).

• Islatravir + ulonivirine (investigational once-weekly oral treatment)

  Week 24 data from the Phase 2b MK-8591B-060 ( NCT06891066) study that informed an updated population pharmacokinetic model of ulonivirine. The model characterizes exposure and activity over time to support dosing recommendations for the investigational once-weekly combination of ulonivirine 200 mg and islatravir 2 mg in adults living with virologically suppressed HIV-1 (Abstract #P038).

  Phase 1 clinical pharmacology data on the absorption, metabolism, and excretion profile of investigational ulonivirine (Abstract #P265).

• Alimatravir (AMI [MK-8527]; investigational once-monthly oral PrEP)

  AMI is being evaluated as a potential once-monthly oral prevention option for HIV-1 in two ongoing Phase 3 trials. Adult enrollment in both trials is now complete. Participant demographics will be presented from the adult cohorts of EXPrESSIVE-10 and EXPrESSIVE-11 (Abstract #P017, Abstract #P015).

• Merck symposia during HIV Glasgow 2026

  Policy symposium:Reimagining HIV elimination: Policy solutions for the next decade
  Date and time: Monday, Nov. 9, 18:15–19:30 GMT/UTC+0, Scottish Event Campus (Clyde Auditorium)

  Medical symposium:Considerations for individualizing HIV care: Cardiometabolic health, unmet needs and the older adult
  Date and time: Tuesday, Nov. 10, 12:45–13:45 GMT/UTC+0, Scottish Event Campus (Clyde Auditorium)
  
  Both events will be open to registered attendees, in person and virtually.

Details on abstracts listed above and select additional abstracts: