Shots:

• The submission is based on P-II/III CAPELLA trial evaluating the safety & efficacy of lenacapavir (SC- every 6mos.) in combination with other antiretroviral agents vs PBO in 36 THE patients with multi-drug resistant HIV-1 infection
• The study demonstrated viral load reduction of ≥ 0.5 log10 copies/mL from baseline for 14days functional monothx. period (88% vs 17%)- was well-tolerated with no serious AEs & no therapy discontinuations @14-day period. The data will be presented at IAS 2021
• If approved- therapy will be the 1st capsid inhibitor & the only long acting HIV-1 treatment option. The company plans to submit MAA for lenacapavir to EMA & other global agencies in the coming mos.

  | Ref: Gilead | Image:Gilead