Efficacy, safety and tolerability of Biktarvy in HIV-1 infection: A scoping review

Abstract

Background: Biktarvy is approved for use in HIV-1 infection in both treatment-naïve and treatment-experienced individuals, after a series of successful phase III trials. However, studies on real-world evidence on its efficacy, safety and tolerability are limited. Purpose: The study aims to collate real-world evidence on the use of Biktarvy in clinical practice to identify gaps in knowledge. Research Design: Scoping review was undertaken using PRISMA guidelines and a systematic search strategy. The final search strategy used was (Bictegravir* OR biktarvy) AND (efficac* OR safe* OR effect* OR tolerab* OR ‘side effect*’ OR ‘adverse effect*’). The last search was performed on the 12th of August 2021. Study Sample: Studies were eligible if they reported on the efficacy, effectiveness, safety or tolerability of bictegravir-based ART. Data Collection and/or Analysis: Data were collected from 17 studies that met the inclusion and exclusion criteria and summarised using a narrative synthesis. Results: The efficacy of Biktarvy in clinical practice is comparable to phase III trials. However, adverse effects and discontinuation rates were found to be higher in real-world studies. Conclusions: The cohorts in the included real-world studies showed more demographic diversity when compared to the drug approval trials, further prospective studies are required on under-represented groups such as women, pregnant people, ethnic minorities and older adults.

Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials

“…For both studies included in this analysis, it is unclear whether similar efficacy would be seen in real-world populations initiating HIV treatment, including individuals who have eGFR <30 mL/min where B/F/TAF is not recommended except in those with end-stage renal disease on hemodialysis; however, analyses of real-world studies indicate effectiveness of B/F/TAF is similar in clinical practice as in phase 3 studies. 20 In comparison to the blinded phase, the open-label phase was optional for investigators and participants, leading to the potential for selection bias. Most participants (79.8%, 506/634) completed the blinded phase and enrolled in the open-label extension, and there were high rates of continued study follow-up throughout despite the concurrent COVID-19 pandemic, which occurred in the final year of the protocol and triggered restrictions that affected clinical services.…”

Assessment of Gastrointestinal Adverse Effects during the First Six Months of “Biktarvy” Antiretroviral Therapy: Age-Related Patterns and Their Relation with Changes of 5 kg Weight Loss/Gain in the Initial Treatment Period

“…Together, bictegravir, emtricitabine, and tenofovir alafenamide make a potent and well tolerated option for managing HIV-1 infection, simplifying treatment regimens and improving patient adherence. Its effectiveness and relatively low risk of drug interactions have made it a valuable addition to the armamentarium of HIV therapies [20].…”

Current drugs for HIV-1: from challenges to potential in HIV/AIDS

“…CAB/RPV therapy was non-inferior to oral DTG/ABC/3TC therapy in sustaining HIV-1 suppression, and patients reported improved satisfaction with treatment (Orkin et al, 2020a). BIC/FTC/TAF (Biktarvy) is approved for use in HIV-1 infection in both treatment-naive and treatment-experienced individuals after a series of successful phase III trials, and its clinical efficacy has also been confirmed (Peters and Iwuji, 2023). In March 2020, a CAB/RPV (Cabenuva) including a secondgeneration INSTI and NNRT was introduced, administered intramuscularly monthly (Howe et al, 2021), and viral failure was infrequent (Cutrell et al, 2021).…”