WeeklySA_AdminALTERNATIVE: A new clinical trial suggests a once-daily tablet combining two antiretroviral drugs could safely replace complex multi-pill HIV regimens for many patients, maintaining viral suppression while reducing treatment burden…
By Peter Morales-Brown
A once-daily HIV pill may soon offer a simpler alternative for people who currently rely on complex, multi-tablet treatment regimens.
New research suggests that a single-tablet combination therapy could effectively replace complicated treatment schedules while maintaining viral suppression. Nearly 96% of participants who switched to the simplified pill maintained viral control, with no new drug resistance detected and improved lipid profiles observed during the trial.
The findings come from the ARTISTRY-1 phase 3 clinical trial, presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2026 in Denver, Colorado, and published in The Lancet. Researchers say the results highlight the potential for simplified therapy among patients who have long depended on multiple medications to manage HIV.
Simplifying long-term HIV treatment
Antiretroviral therapy (ART) has transformed HIV from a life-threatening infection into a manageable chronic condition. Most people living with HIV today can maintain viral suppression by taking combinations of medications on a regular schedule.
Although single-tablet regimens have been available for years, they are not suitable for everyone. A subset of patients — particularly those diagnosed during the early years of the HIV epidemic — still rely on complex regimens that involve multiple pills or injectable treatments.
These regimens are often necessary because of drug resistance or other medical considerations. However, taking several medications daily can increase the risk of side effects, drug interactions and treatment fatigue. The challenge becomes even greater for older adults living with additional conditions such as high blood pressure, diabetes or kidney disease.
The new study suggests that a once-daily tablet combining two antiretroviral drugs — bictegravir (BIC) and lenacapavir (LEN) — may provide a viable alternative for people who cannot currently use existing single-tablet regimens.
Inside the trial
The ARTISTRY-1 trial was led by researchers from Queen Mary University of London and involved more than 550 people living with HIV across 15 countries.
Participants switched from complex treatment regimens to the experimental single-tablet combination. The trial population represented one of the oldest groups ever enrolled in a registration study of HIV treatment.
The median age of participants was 60, reflecting the reality that HIV populations in many countries are aging as treatment improves survival. Many individuals in the trial had been receiving HIV therapy for nearly three decades.
Participants were taking a median of three antiretroviral pills per day, with some taking as many as 11 pills daily before switching to the simplified regimen.
Bictegravir works by blocking HIV from inserting its genetic material into immune cells, preventing the virus from replicating. Lenacapavir, a first-in-class capsid inhibitor, interferes with the virus’s protective shell, disrupting the virus’s ability to deliver and assemble its genetic material.
Both drugs are already established in HIV care, but the trial marks one of the first attempts to combine them in a single fixed-dose tablet.
Strong viral suppression
The study results were encouraging. Researchers found that approximately 96% of participants maintained viral suppression after switching to the single-tablet regimen — a rate comparable to their previous multi-drug therapies.
Importantly, no new drug resistance was detected, and participants’ CD4 cell counts, an important marker of immune health, remained stable throughout the study.
Another notable finding was an improvement in lipid profiles, which could be particularly significant for older adults living with HIV who face increased risks of cardiovascular and metabolic disease.
Participants also reported that the once-daily pill was easier and more convenient to take, suggesting that simplified therapy could help improve adherence — a critical factor in maintaining viral suppression and preventing drug resistance.
Aging populations and treatment
Experts say the study reflects a broader shift in HIV care as the global population living with the virus grows older.
Yvonne Gilleece, honorary clinical professor and consultant in HIV medicine and sexual health at Brighton and Sussex Medical School, who was not involved in the trial, noted that people with HIV are increasingly living into older age.
“Since 2022 the majority of people living with HIV accessing care in England are aged 50 years and over,” she said, reflecting the aging HIV population.
By age 65, around 70% of people who have lived with HIV for more than two decades have multiple other medical conditions, compared with roughly 40% in the general population.
These additional health challenges often lead to polypharmacy — the need to take multiple medications for different conditions — increasing the risk of drug interactions and complicating treatment routines.
Reducing pill burden could therefore play an important role in improving both adherence and overall well-being for long-term HIV survivors.
Safety and side effects
Adverse events occurred in both groups in the study but were generally mild to moderate. About 82% of participants taking the simplified treatment reported at least one adverse event, compared with 84% among those continuing complex regimens.
Serious adverse events were rare and occurred at similar rates in both groups. Only 2% of participants discontinued the single-tablet treatment due to side effects, compared with 1% in the multi-pill group. Five deaths occurred during the study in the simplified treatment group, but researchers determined that none were related to the study medication.
One participant developed newly diagnosed diabetes considered drug-related, but the condition resolved after the individual returned to their previous regimen.A potential step forward
Researchers concluded that the new combination tablet could offer an effective and well-tolerated option for people who cannot use existing single-tablet regimens.
As HIV care increasingly focuses on long-term health, aging and prevention of other chronic diseases, treatment strategies that reduce pill burden and drug interactions are becoming more important.
The availability of additional treatment options may also help physicians tailor therapy to the needs of an aging population living with HIV.
While the results are promising, scientists say long-term studies are still needed to confirm the durability and safety of the combination therapy.
For many patients who have spent decades managing complex treatment schedules, however, the possibility of simplifying therapy to a single daily pill could represent a meaningful improvement in quality of life and long-term HIV care. – NMT
