One pill a day to keep HIV at bay. According to the results of a new phase III clinical trial published in The Lancet, a daily tablet combining two current HIV treatment medications, bictegravir and lenacapavir, could effectively replace more complicated treatment regimens used by people living with HIV who are long-term survivors.
For José Ignacio Bernardino, this announcement is significant because, "for the first time, we have a simple combination of a single tablet to treat people with complex regimens." The secretary of the GeSIDA study group, from the Spanish Society of Infectious Diseases (SEIMC), values these results, as he is familiar with the therapy because, from La Paz University Hospital, he is one of the five Spanish centers participating in the trial (along with Clínic, Ramón y Cajal, Clínico San Carlos, and Virgen del Rocío).
The results are being presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2026, held in Denver, USA. From there, the lead author, Chloe Orkin, from the Blizard Institute (Faculty of Medicine and Dentistry, Queen Mary University of London), explains via email to this medium that "the ARTISTRY-1 trial is ongoing" as it is a longitudinal study "to observe long-term effects." Therefore, she points out that "we will have even more solid data on global implications, for example, its effect on other associated pathologies."
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In total, more than 550 people living with HIV from 15 countries have been involved. This volume has shown that the new single-pill treatment was very effective in maintaining HIV suppression (virus levels below 50 copies/ml). The participant profile, as Bernardino explains, corresponds to a "person with a long history of HIV infection (average of 28 years), with an average age of 60 years (age ranging from 22 to 84), users of complex treatments, and with resistance to previous therapies."
Regarding resistances, the GeSIDA spokesperson details them: "Almost 70% had a history of resistance to nucleoside analogs, 55% to non-nucleoside reverse transcriptase inhibitors, and up to 40% had protease inhibitor resistance mutations." Orkin adds that, "at the time of entering the study, no resistances were present."
How effective will it be against HIV?
Almost 96% of participants who switched to this simplified regimen maintained viral suppression without new cases of medication resistance reported. In comparison, participants who continued with their current complex multi-pill regimens also showed similar results, maintaining viral suppression in a range of 94% to 96%.
In this scenario, as Bernardino points out, the emergence of the option to control HIV with a single daily pill "is of enormous relevance in a population where treatment regimens are complex." Therefore, he points to a clear beneficiary profile: over 60 years old, with over 30 years of infection, having used multiple previous therapies, and having additional concomitant diseases.
"It's not a common patient because it's not the majority of what we see in consultations. But it's a proportion of long-term survivor patients who have many issues that could be managed with this therapeutic option," says the GeSIDA spokesperson. Additionally, he emphasizes that the new advancements, besides aiming for "invisible" virus maintenance, also seek to "improve people's quality of life," although Bernardino notes that "specific data (questionnaires) have not yet been published."
Most participants in the trial had been taking between two and 11 daily pills in their HIV treatment, and almost 40% were taking antiretrovirals more than once a day. Over 55% also reported other conditions such as cardiovascular diseases (hypertension and diabetes) or renal issues.
Bernardino also highlights who are not candidates for the daily pill. "People with a history of mutations and failures with integrase inhibitors did not participate in the study."
What are the side effects of the daily HIV pill?
The study did not identify significant or new safety issues. Most participants experienced fewer lipid-related side effects, such as increased cholesterol levels, suggesting an additional potential benefit for individuals at risk of cardiometabolic diseases. The combination "has interactions as with other complex treatments, but there are some medications that need attention, such as clonazepam (benzodiazepine)," adds the GeSIDA expert.
Participants mentioned that the new treatment option was easier and more convenient to take, which would help maintain consistent adherence to daily medication. Researchers point out that additional clinical trials are being conducted to confirm the long-term safety and efficacy of the bictegravir and lenacapavir combination.