BICSTAR is a multicenter, international, observational cohort study evaluating B/F/TAF treatment in ART TN & TE people with HIV. This extension analysis gathers data from 435 participants (67 TN, 382 TE) from Germany, France & Canada.

The median age in the TN group was 40 years (32, 50), and 50 years (41, 56) in the TE group. 54% and 81% of participants had any ongoing comorbidity from the TN and TE groups, respectively, with neuropsychiatric conditions being the lead (TN 24%, TE 34%), followed by metabolic disorders (TN 19%, TE 37%) and hypertension (TN 6%, TE 20%).

97% from both groups were VS at the 3-year follow-up time, with no report of emergence resistance to B/F/TAF components. For TN participants, the most weight gain was reported in the first 6 months, with median weight gain being similar at 3 years, from baseline [6 months 3 kg (0.4, 6.0), 36 months 4.3 kg (-0.5, 7.3), both parameters present change from baseline]. Small numeric changes were seen in weight in the TE group [median at 6 months 0.7 kg (-1.0, 2.5), at 36 months 1.7 kg (-1.0, 4.3), both from baseline]. Drug-related adverse events declined during the years, with 2% in the TN and 0% in the TE group at the 36-months follow-up period.

To conclude, B/F/TAF was highly effective in the 3-year follow-up of a real-world setting, with no emergent resistance to treatment components and no new safety findings.