- A new study suggests that a once-daily single-tablet HIV treatment could effectively replace more complex, multi-tablet regimens.
- Nearly 96% of participants who switched to the simplified single-pill regimen maintained viral control, with no new drug resistance detected and improved lipid profiles.
- Participants reported that taking a single pill once a day was easier and more convenient, which may help support consistent adherence to treatment.
Although single-tablet regimens have been available for HIV over the past two decades, they are not suitable for everyone. A subset of individuals, particularly those diagnosed early in the HIV epidemic, still rely on complex regimens, which may involve multiple pills or injections.
The researchers suggest that a new single-pill combination treatment could be as effective as multi-tablet therapy, with similar safety outcomes in this cohort, which may support consistent adherence to this regimen.
BIC is an integrase inhibitor that prevents HIV from inserting its genetic material into immune cells, thereby preventing viral multiplication. LEN is a first-in-class capsid inhibitor that disrupts the virus and prevents it from properly delivering and assembling its genetic material.
Both drugs are already established agents in HIV care, but this trial represents one of the first to test them together in a simplified, fixed-dose formulation.
More than 550 people with HIV across 15 countries participated in the ARTISTRY-1 trial, switching from complex regimens to the single tablet.
Importantly, the median age of participants was 60, representing one of the oldest populations in a registration HIV treatment trial. Additionally, the majority had been on HIV therapy for nearly three decades and were taking a median of 3 antiretroviral pills per day, with some taking up to 11.
Yvonne Gilleece, MB, BCh, BAO, FRCP, honorary clinical professor and consultant in HIV medicine & sexual health at Brighton and Sussex Medical School, who was not involved in the study, highlighted the importance of investigating this cohort:
“Since 2022 the majority of people living with HIV accessing care in England are aged 50 years and over…reflecting an aging HIV population. In addition, more older people are being diagnosed with HIV.”
“By age 65 years, around 70% of those living with HIV for 20 years or more are living with multiple other conditions or comorbidities, compared with around 40% for those not living without HIV. We see a similar trend [f]or polypharmacy in those living with HIV.”
“The larger comorbidity prevalence in people living with HIV on effective antiretroviral is associated with an increased risk of death, particularly of non-AIDS malignancies,” Gilleece told Medical News Today.
Notably, the trial showed that roughly 96% of participants maintained viral suppression after switching to the single tablet, a rate similar to their previous multi-pill treatments.
Additionally, no new drug resistance emerged during the study period, and no significant safety concerns were identified. CD4 cell counts, a key measure of immune health, also remained stable.
Another notable difference was in lipid profiles, which may be particularly relevant for older adults living with HIV who experience cardiometabolic complications.
Participants reported that the simplified treatment was easier to take, potentially improving adherence and retention in care, both of which are essential for preventing resistance and maintaining viral suppression.
Gilleece noted that a reduction in polypharmacy could help to improve therapy adherence:
“Based on this study, BIC-LEN may benefit treatment experienced people living with HIV who are struggling with pill burden, from HIV or other treatments, and adherence.”
— Yvonne Gilleece
“Pill burden affects people in different ways. For people who have been treated for HIV and who may be requiring multiple tablets for HIV or other comorbidities, reduction in tablet burden can have a very positive impact on both mental and physical well-being,” she said.
Adverse events were common in both groups but were mostly mild to moderate, with 82% of participants taking the simplified treatment reporting at least one adverse event, and 84% of those continuing complex regimens reported the same.
Serious adverse events were infrequent and occurred at similar rates in both groups, with 2% discontinuing the single-pill regimen due to side effects, compared with 1% in the complex regimen group.
During the study, 5 deaths occurred in the simplified treatment group, but none were considered related to the study drug. One participant developed newly diagnosed diabetes that was considered drug-related. The condition resolved after switching back to the prior regimen.
The researchers concluded that the study drug could provide an effective and generally well-tolerated new option for those unable to use currently available single-tablet regimens.
As the population of people aging with HIV grows, treatment strategies that reduce pill burden, minimize drug interactions, and address cardiometabolic risks are becoming increasingly important.
“Some individuals cannot tolerate any pill burden, either because of difficulties in swallowing pills or re-stigmatisation of HIV, leading to the development of injectable HIV treatment. Increasing choice of HIV treatment options, therefore, is important.”
— Yvonne Gilleece
While these findings are promising, additional studies are ongoing to confirm the long-term safety and effectiveness of this combination tablet.
These findings suggest that switching from a complex regimen to a single-tablet option could simplify therapy without compromising viral control. For people who have spent decades navigating multi-pill regimens, that simplification could represent a meaningful step forward in HIV care.
Gilleece adds that the availability of different regimen options could help change conversations between clinicians and aging populations with HIV:
“The model of HIV care is shifting from purely management of HIV to medical and preventative care as people live and age with HIV. More than ever HIV physicians need general as well as specialist expertise in common non HIV-comorbidities, prevention, and treatments to enable comprehensive, holistic care.”
