Bictegravir–Ienacapavir Single-Tablet Switch

A phase 3 randomized evaluated a once-daily bictegravir–lenacapavir single-tablet regimen as a switch option to reduce pill burden and dosing complexity in people living with HIV who were stable on complex multi-tablet regimens.

In the report’s framing, virologic control after switching was described as comparable to continuing existing regimens, without presenting the approach as a directive for practice.

More than 550 participants across 15 countries were enrolled, and the study focused on long-term survivors taking relatively complex antiretroviral regimens. Reported baseline characteristics included a median age of 60 years (range 22–84), with pre-trial pill burdens spanning 2 to 11 pills per day. Around 40% of participants were reported to take antiretrovirals more than once daily, indicating that dosing schedules were not uniformly once-daily at baseline. Most participants had resistance to prior HIV therapy, describing a cohort with substantial prior treatment complexity and high pill burden.

For the primary virologic outcome, the report defines maintenance of suppression as HIV RNA <50 copies/mL and states that nearly 96% of participants in the switch arm remained suppressed at the reported endpoint. Participants who continued their existing complex, multi-pill regimens were described as having similar suppression rates (about 94–96%) over the same window. In the same discussion of virologic outcomes, no new drug resistance was reported. Overall, the report presents suppression as comparable between switching and continuing strategies at the stated threshold and timepoint.

On tolerability and safety, no significant or novel safety concerns were identified in the trial. Most participants experienced fewer lipid-related side effects, including fewer cholesterol increases, while keeping the discussion at a high level. Participants were also described as finding the once-daily regimen easier and more convenient to take.

The authors emphasized potential relevance for older adults, people with a history of treatment resistance, and those taking additional medications for age-related health conditions. Additional clinical trials are underway to confirm the long-term safety and effectiveness of the bictegravir/lenacapavir combination tablet.

Key Takeaways:

• A multinational phase 3 switch trial in long-term survivors with substantial baseline regimen complexity and prior treatment challenges was conducted.
• It reports similar maintenance of HIV RNA suppression between switching and continuing strategies, and states that no new drug resistance was reported.
• It reports no significant or novel safety concerns, fewer lipid-related side effects for most participants, and participant-described ease and convenience with once-daily dosing.