26 June 2018. Related: ARVs, Fixed dose combinations, Integrase inhibitors, Nukes.
Biktarvy is a pink/grey film-coated tablet (15 mm x 8 mm) with “GSI” on one side and “9883” on the other.
Biktarvy is a single pill that contains bictegravir (50 mg), emtricitabine (200 mg) and tenofovir alafenamide fumarate (25 mg).
Biktarvy was approved by the FDA in the US in February 2018 and in June 2018 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 generally mild. The most reported side effects were diarrhoea, nausea and tiredness, but less than 1 in 100 people (<1%) stopped Biktarvy in studies due to side effects.
- Mood changes (anxiety, dizziness, depression) and difficulty sleeping were reported by less than 1 in 20 people (5%).
- Since approval, weight gain has been reported with integrase inhibitors in general, including bictegravir.
- Details for each of the drugs are available in the full prescribing information.
Biktarvy should not be taken at the same time as magnesium/aluminium-containing antacids or iron supplements. This means leaving at least two hours gap before/after Biktarvy. Please aks your pharmacist for details.
- Drug interactions. Bictarvy should not be taken with rifampicin or St John’s Wort. It is also not recommended with atazanavir, carbamazepine, ciclosporin (IV or oral use), oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, or sucralfate.
- Biktarvy is not recommended with advanced kidney disease defined as estimated creatinine clearance is below 30 mL per minute.
- General access to Biktarvy in the UK is depends on how quickly the NHS commissioning reviews take, and will vary by country.
The European patient information and detailed Product Information for Biktarvy are available from this link on the European Medicines Agency (EMA) website.
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)