FDA Approves New HIV Treatment Option Studied at Georgetown
Media Contact
Karen Teber, km463@georgetown.edu
WASHINGTON (April 21, 2026) — The U.S. Food and Drug Administration has approved a new once-daily HIV treatment that offers an additional option for people living with the virus. Researchers at Georgetown University and MedStar Health played a key role in the clinical trials that supported the therapy’s development.
The newly approved complete regimen combines two antiretroviral medications — doravirine and islatravir — into a single daily tablet. The treatment is approved for adults with HIV who have already achieved viral suppression. The drug will be marketed with the brand name Idvynso®.
Princy Kumar, MD
At Georgetown, the clinical trial was led by Princy Kumar, MD, professor of medicine at Georgetown University School of Medicine and chief of the Division of Infectious Diseases at MedStar Georgetown University Hospital.
“With this approval, we now have an additional option to help maintain viral suppression and support long-term health for people living with HIV,” said Kumar. “As the needs of people living with HIV evolve, factors like tolerability, toxicity, and drug-drug interactions are key considerations for switching HIV treatment.”
The approval is based on results from two pivotal Phase 3 clinical trials — Trial 051 Trial 052 — including an international study conducted at 53 research sites in eight countries with participation from Georgetown. Together, these studies evaluated the safety and efficacy of switching to the doravirine-islatravir combination in adults who were already virologically suppressed on existing oral therapies.
In the open-label Trial 051, which enrolled 553 participants, individuals were randomly assigned either to switch to the doravirine-islatravir regimen or to continue their current treatment. After 48 weeks, the new regimen maintained viral suppression similar to as existing therapy. The treatment was also generally well-tolerated, with similar rates of serious adverse events and very low discontinuation rates. Results from this study were published in The Lancet in February.
In the double-blind Trial 052, participants were switched from BIKTARVY [bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)], the current three-drug standard of care to the two-drug, DOR/ISL regimen. At Week 48, participants maintained viral suppression at a similar rate to BIC/FTC/TAF. Across both trials, the safety profile of DOR/ISL was generally comparable to the comparator antiretroviral regimens.
The approval marks an important development in HIV treatment. The doravirine-islatravir combination is the first two-drug regimen for HIV that does not rely on integrase strand-transfer inhibitors (INSTIs), a class of medications widely used in current treatment strategies, Additional treatment approaches like the doravirine-islatravir combination provide valuable flexibility in managing long-term care.
Georgetown’s role in the study reflects the institution’s commitment to advancing HIV research and care, and addressing health disparities in the communities we serve. Faculty investigators and clinical teams at Georgetown University Medical Center have contributed to clinical trials and therapeutic developments that have transformed HIV into a manageable chronic condition for many people.
Top Image: Artwork featuring colorized 3D prints of HIV virus particles. The virus surface (red) is covered with proteins (dark blue) that enable the virus to enter and infect human cells, and additional proteins (teal spheres) that disguise the virus from the immune system. A colorized transmission micrograph of an H9 T cell (blue) appears in the background. Photo by National Institute of Allergy and Infectious Diseases on Unsplash.