One of my key learnings from this session was the number of new molecules and combinations for HIV infection that had been granted FDA approval in 2018. These were:
- Symtuza (Darunavir/cobicistat/tenofovir alafenamide/emtricitabine) – first PI-based 3-in-1 combination
- Dolutegravir – tenofovir disoproxil fumarate – emtricitabine (dolutegravir -tenofovir alafenamide-emtricitabine) – a 3-in-1 attractive combination, WHO recommended, in generic formulation (FDA tentative approval)
- Juluca (dolutegravir + rilpivirine) – first 2-in-1 combination approved for maintenance
- Trogarzo (Ibalizumab) – first monoclonal antibody against HIV-1 to receive FDA approval, and currently indicated for use as salvage therapy
- Biktarvy (bictegravir/tenofovir alafenamide/emtricitabine) – a new low-milligram integrase-based Fixed Dose Combination
- Delstrigo (doravirine + tenofovir disoproxil fumarate + lamivudine) – new once daily NNRTI with TDF and 3TC (generics)
In summary, in 2018 several new drugs have been approved by the FDA. Currently only two of these, Juluca and Biktarvy, are TGA approved in Australia and both are pending addition to the Pharmaceutical Benefits Scheme. There are however many more drugs in the pipeline. There is a lot of research currently underway and the challenge is going to be keeping up with the developments in terms of both our existing treatment options and the new therapeutic options that become available, and their place in therapy. Due to the recent issues that have arisen with antiretroviral use in pregnancy it is going to be important to record our pregnancy data in the Antiretroviral Pregnancy Registry (APR) on an ongoing basis.
Author bio:
Fiona trained as a pharmacist in UK prior to moving to Australia in 1997. She has been working as a clinical pharmacist in the area of HIV/Sexual Health on the Gold Coast since 1998. She was involved in a pilot of pharmacist prescribing for patients with HIV infection in 2009-2010. She is contacted for advice by health professionals external to the Gold Coast, and has provided advice in relation to adults, adolescents and children with HIV infection.
