Single daily pill shows promise as replacement for complex, multi-tablet HIV treatment regimens: Study

A phase 3 clinical trial, led by Professor Chloe Orkin of Queen Mary University of London, has shown that a new, daily oral tablet that combines two current HIV treatment medications – bictegravir and lenacapavir (BIC/LEN) – may simplify treatment significantly for people with HIV who currently take very complex treatments.

The findings were presented at the Conference on Retroviruses and Opportunistic Infections 2026 in Denver, Colorado on 25 February and published simultaneously in The Lancet.

While most people with HIV take a single daily pill or use two-monthly injections, some people whose virus harbours resistance have not benefitted from these simpler treatments. Instead, they remain on complex multi-tablet treatments which can put them at risk of harm from significant drug interactions. Most of the people who are in this situation were diagnosed towards the beginning of the HIV epidemic and have been living with HIV for 30 years or more.

This trial, led by Queen Mary researchers, included more than 550 people living with HIV across 15 countries, showed that the new single pill treatment was highly effective in controlling the HIV virus.

Nearly 96% of participants who switched to this simplified regimen maintained viral control with no new drug resistance reported, which was similar to the comparator. In addition, no significant or novel safety concerns were identified, and lipid profiles improved. Participants also reported that the new treatment option was easier and more convenient to take, which can help support consistent adherence to daily medication.

Professor Chloe Orkin MBE, Clinical Professor of Infection and Inequities at Queen Mary University of London said: “Simplifying HIV treatment from handfuls of pills at the start of the epidemic to one pill a day has improved clinical outcomes for most people living with HIV. However, until now, some people with resistant virus or clinical contraindications cannot take these simpler regimens and must instead take complex regimens which may place them at risk of drug interactions.“The ARTISTRY-1 trial results demonstrate that a single tablet containing the drugs bictegravir and lenacapavir works just as well as their complex multi-tablet regimen and improved participants’ lipid profile. The findings are game changing for this group of people, many of whom have lived with HIV for decades, and who have other cardiovascular conditions associated with aging.”

The median age of participants on the trial was 60 years – the oldest median age of any registration trial in HIV so far. The participants had been taking HIV treatment for a median of 28 years, and most were taking at least three pills per day with a maximum of 11 pills. Around 80% of participants had resistance to prior HIV therapy and most reported other health conditions, such as cardiovascular or kidney disease.

Additional clinical trials are underway to confirm the long-term safety and effectiveness of the BIC/LEN combination tablet.

Reference:

Orkin, ChloeSokhela, Simiso et al., Switch to single-tablet bictegravir–lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial, The Lancet, DOI:10.1016/S0140-6736(26)00307-7.