Bictegravir-Lenacapavir Single Pill Non-Inferior to Complex Regimens in Heavily Treatment-Experienced HIV Patients

A phase-three study published in February found a single daily pill combining bictegravir and lenacapavir performed as well as nine complex HIV regimens in adults who had taken treatment for decades. AllAfrica reported the results of the ARTISTRY 1 trial, which enrolled 557 participants across 15 countries, including South Africa.

The bictegravir-lenacapavir pill showed no drug resistance among those switched to it and produced higher treatment satisfaction scores than continued use of existing regimens.

Side effects were similar in both arms, with upper-respiratory symptoms and headache the most common complaints. Five deaths occurred in the bictegravir-lenacapavir group, none attributed to the drug. Chloe Orkin, principal investigator and Professor of Infection and Inequities at Queen Mary University of London, said most people living with HIV now take single-tablet regimens, yet many still require complex, multi-tablet schedules because of viral resistance, intolerance or contraindications.

She noted that these patients are often elders diagnosed early in the pandemic and face high pill burdens, adherence difficulties and drug-interaction risks. The study population averaged 28 years on treatment and was described as the oldest ever enrolled in a registrational HIV-treatment programme.

More than half of participants had at least two comorbidities, and 60 percent took two or more additional medicines for those conditions.

Participants had been stable on regimens that included older drugs, more than two pills daily, twice-daily dosing or an injectable plus tablets. Professor Graeme Meintjes, an infectious-diseases specialist at the University of Cape Town and Clinical Professor at Queen Mary University of London, called the findings a breakthrough for a small but important group.

He said most such patients in South Africa receive care in the private sector, where earlier access to antiretrovirals increased the likelihood of multi-drug resistance.

Over five million people in South Africa take the standard TLD combination of tenofovir disoproxil fumarate, lamivudine and dolutegravir each day. The World Health Organisation recommends TLD for nearly all people living with HIV, and most children aged one to four in the country have already switched to dolutegravir.

Meintjes added that the trial demonstrates continuing innovation even when the new option will not affect millions of patients.

The results were also presented at the 2026 Conference on Retroviruses and Opportunistic Infections.