Daily single-pill HIV regimen promises result

Across the world, millions of HIV patients take multiple pills daily to keep a check on the virus. Many of them diagnosed in the 1980s or 1990s developed resistance to medicines, resulting in complex treatment options. A single daily pill now shows promise as a replacement for such complex, multi-tablet HIV treatment regimens.

The new, daily oral tablet that combines two current HIV treatment medications, bictegravir and lenacapavir (BIC/LEN), may be able to effectively replace more complicated HIV treatment regimens used by people living with HIV who are long-term survivors, according to the results of a new phase 3 clinical trial.

Single-tablet regimens have been the standard of care for people with HIV-1 for the last two decades, offering simplicity, reduced pill burden, improved adherence, and better clinical outcomes compared with complex multi-tablet regimens. But older adults diagnosed early during the HIV-1 epidemic or people born with HIV-1 faced decades of antiretroviral therapy. They continue to rely on regimens consisting of multiple pills per day. These regimens usually require pharmacological boosting agents and can result in higher drug concentrations.

Led by Chloe Orkin at Queen Mary University of London, the ARTISTRY-1 trial evaluated the efficacy and safety of switching to a single-pill option for such people with HIV-1 with virological suppression on a complex regimen.

The trial that included more than 550 people living with HIV across 15 countries showed that the new single-pill treatment was highly effective in maintaining HIV suppression (HIV virus levels below 50 copies/mL).

Nearly 96% of participants who switched to this simplified regimen maintained viral suppression with no new drug resistance reported. In comparison, participants who continued their existing complex, multi-pill treatments showed similar results, also maintaining viral suppression at about 94-96%.

Participants’ median age was 60 years (age ranges were between 22 and 84), which is considerably older than people who are usually included in HIV medication trials. Most trial participants had been taking between two and 11 pills per day for their HIV treatment, with approximately 40% of participants taking antiretrovirals more than once a day. Many participants also reported other health conditions, such as cardiovascular or kidney disease, and most had resistance to prior HIV therapy.

In the study, no significant or novel safety concerns were identified, and most participants experienced fewer lipid-related side effects, such as increased cholesterol levels, suggesting an additional potential benefit for those at risk of heart disease.

Participants reported that the new treatment option was easier and more convenient to take, which can help support consistent adherence to daily medication. The authors say this is especially important for older adults living with HIV, people with a previous history of developing resistance to HIV treatments, or those who are taking additional medications to help manage age-related health conditions along with HIV medication.

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

The results of the trial have appeared in a recent issue of The Lancet.

—Kalyan Ray