Single HIV Pill Could Simplify Treatment for Drug-Resistant Patients

A new once-daily combination tablet could transform treatment for people living with drug-resistant HIV by replacing complex multi-tablet regimens with a single pill, according to findings from the Phase III ARTISTRY-1 clinical trial presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2026.

The international study, led by Professor Chloe Orkin of Queen Mary University of London, evaluated a fixed-dose oral combination of bictegravir and lenacapavir (BIC/LEN) in people with HIV who had limited treatment options because of drug resistance or other clinical factors.

Addressing an Unmet Need in HIV Care

While many people living with HIV now achieve viral suppression with a single daily tablet or long-acting injectable therapies, a small but important group continues to rely on complicated treatment regimens consisting of multiple medications each day.

Many of these individuals were diagnosed during the early years of the HIV epidemic and have lived with the virus for more than three decades. Long-term treatment can lead to drug resistance, while ageing-related conditions such as cardiovascular and kidney disease increase the risk of drug interactions.

The ARTISTRY-1 trial sought to determine whether combining bictegravir and lenacapavir into a single daily tablet could provide equivalent viral control while simplifying treatment.

High Rates of Viral Suppression Maintained

The Phase III study enrolled more than 550 participants across 15 countries.

Nearly 96% of those who switched to the once-daily BIC/LEN tablet maintained viral suppression, performing comparably to their existing complex treatment regimens. Researchers also reported no emergence of new drug resistance during the study and identified no significant or unexpected safety concerns.

In addition, participants experienced improvements in lipid profiles, suggesting the simplified regimen may offer broader metabolic benefits alongside effective HIV control.

Reducing Treatment Burden

The study population reflected individuals with longstanding HIV infection and complex medical needs.

Participants had a median age of 60 years, making ARTISTRY-1 the HIV registration trial with the oldest median participant age to date. They had been receiving HIV treatment for a median of 28 years, with most taking at least three tablets daily and some requiring as many as 11 pills.

Approximately 80% had resistance to previous HIV therapies, and many were also managing other chronic conditions, including cardiovascular and kidney disease.

Participants reported that the new single-tablet regimen was easier and more convenient to take, a factor that could improve long-term adherence to treatment.

Potential to Improve Long-Term HIV Management

The investigators say the findings represent an important advance for people who have been unable to benefit from the treatment simplification seen in modern HIV care.

By reducing pill burden without compromising viral suppression, the bictegravir/lenacapavir combination could offer a practical new option for patients with resistant HIV who remain on complex regimens.

Additional clinical trials are ongoing to further evaluate the long-term safety and effectiveness of the fixed-dose combination before it becomes more widely available.