Single daily pill shows promise as replacement for complex, multi-tablet HIV treatment regimens

A new, daily oral tablet that combines two current HIV treatment medications, bictegravir and lenacapavir (BIC/LEN), could 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 published in The Lancet.

The trial, which 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 a rate of 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.