Biktarvy was approved by the FDA in the US in February 2018. It is not yet approved in Europe.
- Biktarvy is a 3-in-1 single combination pill that is taken once-daily.
- Biktarvy can be taken with or without food.
- In research studies, side effects were not common and were generally mild. The most reported side effects were diarrhoea, nausea and tiredness, but less than 1 in 100 people (<1%) stopped Biktarvy in studies.
- Details for each of the drugs are available in the full prescribing information.
- Biktarvy is not recommended with advanced kidney disease defined as estimated creatinine clearance is below 30 mL per minute.
- A decision on EU approval is expected later in 2018, with UK access unlikely to be before 2019.
The Patient Information is a simplified summary: what the drug is, why it is used, results from studies and cautions including side effects.
The Product Information is a detailed technical summary that you can access as a PDF file by clicking the ‘Product Information’ tab. It describes more precisely how the drug works and how it is processed by your body. This includes, for example, reported food interaction studies in terms of calories or fat content. It includes more details of the study results and a full list of side effects and drug interactions.
Link to US prescribing information. (PDF document)