Key Takeaways
• DOR/ISL offers a once-daily, two-drug regimen simplifying treatment protocols for HIV-1 patients.
• The non-inferiority results support DOR/ISL as a viable alternative to existing antiretroviral therapies.
• Safety profiles comparable to standard treatments enhance its potential for widespread clinical use.
Merck has unveiled top-line results from two pivotal Phase 3 clinical trials, demonstrating that its investigational doravirine/islatravir (DOR/ISL) regimen meets efficacy criteria for non-inferiority compared to established antiretroviral therapies in adults with HIV-1 who have achieved viral suppression.
In both trials, participants maintained HIV-1 RNA levels below 50 copies/mL at the 48-week mark when treated with DOR/ISL. The regimen proved non-inferior to baseline antiretroviral therapy (bART) in the open-label MK-8591A-051 study and to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in the double-blind MK-8591A-052 study. Although the criteria for superiority were not achieved in the latter trial, the safety profiles of DOR/ISL remained comparable to other therapies, ensuring its viability as a treatment option.
Future Plans and Studies
Merck intends to present detailed data from these trials at upcoming scientific congresses and submit regulatory filings. Additionally, ongoing Phase 3 studies are assessing DOR/ISL in treatment-naïve individuals and those switching from previous DOR/ISL trials, aiming to expand its potential applications in HIV management.
The introduction of a single-tablet regimen like DOR/ISL could significantly improve adherence rates among patients, reducing the complexity of daily HIV management. By minimizing the number of pills and dosing frequency, Merck addresses a critical barrier in long-term HIV treatment, potentially leading to better health outcomes and enhanced quality of life for those living with the virus.
Merck’s continued investment in islatravir and its combination with doravirine underscores the company’s dedication to expanding effective HIV treatment options. Healthcare providers may soon have access to a new regimen that not only maintains viral suppression but also aligns with the goal of reducing treatment complexity for patients. This advancement could play a pivotal role in improving adherence and overall quality of life for those living with HIV.

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