Innovation benefits of cabotegravir LA injections for HIV PrEP will enable a closer FDA review
On 17 November 2020, ViiV Healthcare issued a press release noting that the US FDA had given cabotegravir LA injections a ‘breakthrough therapy’ designation for use as HIV PrEP, due to offering at least one significant benefit over existing treatment options. 
This was based on early results from the HPTN 083 study in gay men and transgender women that were presented at the IAS virtual conference in July. The injectable formulation showed greater coverage with fewer problems linked to low adherence compared to oral PrEP.
More recently, results from the HPTN 084 study reported similar efficacy in heterosexual women in seven sub-Saharan African countries. 
Importantly, the press release refers to including both studies in regulatory submissions in the hope that any approval simultaneously covers all populations.
- ViiV press statement. ViiV Healthcare receives FDA breakthrough therapy designation for investigational, long-acting cabotegravir for HIV prevention. (17 November 2020).
- Two-monthly cabotegravir injections prevent HIV infection in African women: HPTN 084 study recommends early unblinding. HTB (11 November 2020).