People living with HIV could soon benefit from a markedly less frequent medication schedule. A regulatory trial shows that a weekly tablet taken once a week is just as reliable as the traditional therapy in which patients must take a pill daily. The study tested the combination of the drugs Islatravir and Lenacapavir in adults whose HIV infection was already well controlled.
In this global study, more than 600 people from twelve countries participated. By random assignment, they received either the new weekly tablet or their current daily triple therapy of Bictegravir, Emtricitabine, and Tenofovir Alafenamide. Such drug combinations are designed to generally prevent the HIV virus from developing resistance. Since the study was double-blind, all participants also received placebos.
After 48 weeks, the results in both groups were nearly identical, as a team led by Jürgen Rockstroh from the University Hospital Bonn reported in the New England Journal of Medicine. In both study arms, viral load remained suppressed in 93 percent of participants over the study period.
No resistance observed
Equally important: with the new regimen, no virologic failure occurred in any participant. “There was no development of resistance,” Rockstroh told the German Press Agency. He had presented the results previously at the World AIDS Conference in Rio de Janeiro and described the absence of resistance as “a very important goal.” Additionally, the dropout rate and the frequency of serious side effects differed little between the two groups: five participants dropped out in the weekly arm versus six in the daily arm, and serious adverse events occurred in about 5 percent of participants in both groups.
Funding for the study came from the pharmaceutical companies Gilead Sciences and Merck Sharp & Dohme (MSD), which both manufacture the active drugs. Rockstroh said a regulatory filing would likely be submitted first in the United States, with approval in Europe expected to follow later. If the U.S. regulatory agency approves, the treatment could hit the market in the second half of 2027.
For people who struggle with a daily pill regimen, the new therapy could be a real relief, Rockstroh noted. He pointed out that when antiviral combination therapy was introduced in 1996, HIV medications had to be taken three times a day.
Depot injections already in use
Norbert Brockmeyer, president of the German STI Society, called the development highly positive. While there are already depot injections approved that can be given monthly, every two months, or every six months, “for those who prefer a tablet, the new development is fantastic,” the expert said. Patients would not have to remember to take a dose every day—and thus would not be reminded of their infection on a daily basis.
Brockmeyer expects the newly tested regimen to be approved. Lenacapavir, which was first approved in Europe in 2022, belongs to the relatively new class of so-called capsid inhibitors. Islatravir is one of the so-called NRTTI (nucleoside reverse-transcriptase translocation inhibitors).
