What's Happening?
Merck has announced new data from Phase 3 trials evaluating the investigational, once-daily, oral two-drug regimen of doravirine/islatravir (DOR/ISL) in adults with virologically suppressed HIV-1 infection. The trials demonstrated that DOR/ISL maintained
viral suppression and showed non-inferiority to the three-drug regimen BIC/FTC/TAF, with no observed treatment-emergent resistance. The data, presented at the 20th European AIDS Conference, highlighted minimal changes in weight and body composition, and no clinically meaningful effect on fasting lipids and insulin resistance. The U.S. FDA has accepted the New Drug Application for DOR/ISL, with a target action date set for April 28, 2026.
Why It's Important?
The findings from Merck's trials are crucial for advancing HIV treatment options, offering a potentially simpler regimen for patients with virologically suppressed HIV-1 infection. The minimal impact on weight and body composition is particularly important for individuals living with HIV, who may face obesity and other weight-related issues. The acceptance of the New Drug Application by the FDA signifies progress in HIV treatment, potentially improving patient adherence and quality of life. This development underscores Merck's commitment to HIV research and its role in addressing the global HIV epidemic.
What's Next?
With the FDA's target action date set for April 2026, Merck's DOR/ISL regimen could soon become a viable treatment option for HIV patients. The company will continue to monitor trial participants and gather data to ensure the regimen's efficacy and safety. Healthcare providers and patients may anticipate new guidelines and recommendations based on the trial outcomes, potentially influencing treatment strategies for HIV-1 infection.
