Efficacy, safety and tolerability of Biktarvy in HIV-1 infection: A scoping review.
Ellen PetersAnd Collins IwujiPublished in: Antiviral therapy (2023)
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.
Keyphrases
- open label
- phase iii
- clinical practice
- case control
- clinical trial
- double blind
- placebo controlled
- randomized controlled trial
- antiretroviral therapy
- phase ii
- type diabetes
- pregnant women
- physical activity
- metabolic syndrome
- insulin resistance
- study protocol
- polycystic ovary syndrome
- drug induced
- deep learning
- adverse drug