Bictegravir/FTC/TAF (Biktarvy) approved in Europe

11 July 2018. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 25 June 2018, the European Medicines Agency (EMA) approved a new integrase inhibitor-based fixed dose combination (FDC) of bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; B/F/TAF).

This is a single pill, once-daily, low milligram formulation that can be taken with or without food and has no baseline CD4 count or viral load restrictions.

The indication is for starting or switching treatment in HIV positive adults who do not have mutations associated with integrase inhibitors and although resistance testing is rarely routinely provided, this caution would be interpreted from treatment history that included viral failure with other drugs in this class.

Approval is based on results from four phase 3 studies: two in treatment-naive participants and two switch studies in people already on stable ART with undetectable viral load. Viral efficacy was high with no cases of drug resistance to bictegravir over 48 weeks in the limited number of cases with viral failure.

No dose adjustment is required in patients with estimated creatinine clearance (CrCl) ≥ 30 mL/min.

Drug interactions include magnesium/aluminium-containing antacids or iron supplements under fasted conditions. These can be avoided by taking B/F/TAF at least two hours before, or with food two hours after antacids containing magnesium and/or aluminium. B/F/TAF should be administered at least two hours before iron supplements, or taken together with food.

Main drug interactions that are contraindicated include: atazanavir, carbamazepine, ciclosporin (IV or oral use), oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, or sucralfate

B/F/TAF is marketed by Gilead Sciences under the trade name Biktarvy.

For more details see the full prescribing information. [2]

Biktarvy was approved by the US FDA in February 2018. [3]

References

1. European Commission grants marketing authorization for Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 Infection. (25 June 2018).
   http://www.gilead.com/news/press-releases
2. EMA website. Biktarvy EPAR prescribing infromation..
   http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004449/human_med_002263.jsp&mid=WC0b01ac058001d124
3. Bictegravir approved in the US in new integrase-inhibitor based FDC (Biktarvy). HTB February 2018).
   https://i-base.info/htb/33422