New 5-Year Data Show Biktarvy is Effective, Improves QoL in People with HIV

The combination HIV treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; Biktarvy, Gilead) continues to be effective and well-tolerated five years after starting the regimen, according to new data from the BICSTaR trial presented at EACS 2025, in Paris (abstract MeP05.3).

Positive quality-of-life measures also were reported by study participants five years out.

“The five-year outcomes presented at EACS 2025 are consistent with the results observed from multiple phase 3 clinical trials evaluating the treatment responses of people with HIV on Biktarvy,” Gilead spokesperson Brian Plummer told Infectious Disease Special Edition. “In the group of BICSTaR study participants with 5 years of real-world follow-up who were enrolled in Canada, France, and Germany, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. These benefits were seen in both treatment-naive and treatment-experienced people with HIV who have a high burden of comorbidities.”

A large portion of the study population had comorbidities: 63.6% of treatment-naive participants and 84.1% of treatment-experienced participants. Even so, at five years, 97.9% (47/48) of treatment-naive and 96.8% (306/316) of -experienced participants were virologically suppressed, and in both groups, the median CD4+ cell count and CD4+/CD8+ ratio increased from baseline.

Maintaining Quality of Life

Using the HIV Symptom Index (HIV-SI) and the Short Form Health Survey mental and physical component summary scores (M/PCS) and the HIV Treatment Satisfaction Questionnaire (HIVTSQ), the investigators found the quality-of-life measures remained steady through the study period. At five years, HIV-SI overall bothersome symptom count stayed low. MCS and PCS scores improved from baseline; however, treatment experienced participants saw a small decrease in PCS scores. Finally, HIVTSQ scores were high. 

The investigators also reported that changes in metabolic and renal parameters were small.

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Low Rates of Adverse Events

Drug-related adverse events occurred in 18.9% (25/132) of naive participants and 14.6% (101/691) of experienced participants, which correlated with regimen discontinuation in 5.3% and 7.7%, respectively. However, the investigators did not find any treatment-emergent resistance.

“The results underscore the importance of patient-reported outcomes as a person-centered approach to HIV research and can help us to better understand the impact on health-related quality of life and specifically, mental health status of people with HIV,” Mr. Plummer told IDSE. “This could help inform treatment strategies for these groups.”

Mr. Plummer and several of the study investigators are employees of Gilead, the maker of Biktarvy.