Could Investigational BIC/LEN Be a Future HIV Treatment for Patients With Comorbidities?

People living with HIV are aging, and a certain subset have multiple comorbidities. A novel drug combination, bictegravir and lenacapavir (BIC/LEN; Gilead Sciences), could one day be an option for those patients due to low amounts of drug–drug interactions, according to preliminary results from the phase 3 portion of the ARTISTRY-1 trial, presented at EACS 2025, in Paris (abstract eP.LB006).

Fewer Pills

BIC/LEN also could reduce patients’ daily pill count. In ARTISTRY, study participants were taking two to six pills per day, according to Brian Plummer, a Gilead spokesperson, who spoke with Infectious Disease Special Edition. Around 40% of study participants were taking antivirals twice daily, he said, and more than 75% were taking a protease inhibitor–based regimen. “The results presented at EACS 2025 contextualize the unmet need for people living with HIV on complex regimens who may benefit from a single-tablet regimen,” Mr. Plummer told IDSE. “Without effective new options, such as new single-tablet regimens, these individuals who are treatment experienced on complex regimens may experience pill fatigue/burden, as well as regimen and adherence challenges.”

Ease to Complex Regimens

Another possible benefit could be that BIC/LEN has the potential to be effective for patients who are treatment experienced, with some resistance to other medications, or those who are on other medications that could interact with HIV therapies. “A significant unmet need exists among PWH [people with HIV] who are virologically suppressed, treatment experienced on complex ART regimens,” Mr. Plummer said. “These individuals (representing a projected 6%-8% of PWH on treatment globally) can be more challenging to treat because of issues related to resistance, intolerance, toxicity, drug–drug interactions, or contraindications to currently available single-table regimens. Single-tablet regimens have helped bring radical change in the outlook for people living with HIV.”

This works because BIC/LEN works in different pathways than the older HIV therapies. The big difference is that other therapies may use pharmacokinetic boosters that are strong inhibitors of cytochrome P450 3A (CYP3A) and P-glycoprotein, Mr. Plummer explained. Bictegravir and lenacapavir are metabolized through different pathways or have more modest ejects on CYP3A, he said.

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Preliminary Data

In regard to the phase 3 study participants (N=557), the majority were on a regimen containing a boosted protease inhibitor and/or integrase strand transfer inhibitor. The researchers found more drug–drug interactions connected with antiretroviral therapy (ART) regimens containing boosted darunavir compared with BIC/LEN, due to strong inhibition of drug metabolism pathway components CYP3A and P-glycoprotein by pharmacokinetic enhancers cobicistat and ritonavir, compared with moderate CYP3A inhibition and weak P-glycoprotein inhibition by LEN.

Drug–drug interaction “liability of ART regimens varies, with advantages for BIC/LEN compared with pharmacokinetic enhancer–containing complex regimens,” the study authors wrote.

The study authors and Mr. Plummer are all employees of the drugmaker Gilead.