New Studies for Longtime HIV Therapy Reinforce Efficacy, Safety Profile


Five-year cumulative data from 2 phase 3 studies looked at 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF (Biktarvy).

Two phase 3 studies provide long term data demonstrating the sustained efficacy and clinical safety of B/F/TAF. Specifically, the Week 240 results reinforce the antiretroviral’s role as a guidelines recommended treatment option for a broad range of people with HIV and demonstrated the sustained efficacy and durable viral suppression. The data support the long-term use of Biktarvy, with no significant changes to metabolic, bone, and renal health markers through five years.

The data was published in eClinicalMedicine.

The 2 phase 3 studies (Study 1489 and Study 1490) sustained efficacy and safety profile, durable viral suppression, and high barrier to resistance are clinically important because most studies of HIV therapies generally follow participants through to standard primary and secondary endpoints, i.e., 48 and 96 weeks, respectively.

The ART maintained a high level of efficacy.Of those with available virologic data, 98.6% (95% CI [97.0%–99.5%], 426/432) maintained HIV-1 RNA <50 copies/mL at Week 240 (missing = excluded); when missing virologic data were considered as failure, 67.2% (95% CI [63.4%–70.8%], 426/634) maintained HIV-1 RNA <50 copies/mL. Mean (SD) change in CD4+ count from baseline was +338 (236.2) cells/μL,” the study authors wrote.

The investigators also reported there were no cases of treatment failure due to emergent resistance were detected among the final resistance analysis population of both studies.

“Through 5 years of follow-up, B/F/TAF maintained high rates of virologic suppression with no treatment-emergent resistance and rare drug discontinuations due to adverse events. These results demonstrate the durability and safety of B/F/TAF in people with HIV,” the study authors concluded.

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