2019 Ryan White HIV/AIDS Program CLINICAL CONFERENCE

ISL + DOR

• Phase 3 treatment program being launched: ▫ Trial for treatment-experienced participants. ▫ Two trials for participants switching therapy. ▫ Trial for treatment naïve participants.

Future possibilities: • Based on pharmacokinetics (PK), ISL has potential for once weekly dosing for treatment. • Also being considered for PrEP (promising PK results with ISL implant).

Molina J-M IAS2019WEAB0402LB Molina J-M,EACS2019,PE3/21

Slide31of 44FromRTGandhi, MD atNewOrleans, LA,December 4-7, 2019, Ryan WhiteHIV/AIDS ProgramCLINICAL CONFERENCE, IAS  USA.

HIV Capsid Inhibitor: Sustained levels for >24 weeks after single subcutaneous injection

Ganser-PornillosBK,YeagerM, SundquistWI,CurrOpinStructBiol,2008 SageretalCROI2019abstract141

Slide32of 44FromRTGandhi, MD atNewOrleans, LA,December 4-7, 2019, Ryan WhiteHIV/AIDS ProgramCLINICAL CONFERENCE, IAS  USA.

HIV Capsid Inhibitor: Antiviral activity after single subcutaneous dose in people with HIV

SingleSC GS-6207 dose

Start ofB/F/TAF

-3 -2.5 -2 -1.5 -1 -0.5 0 0.5 1 2 3 4 5 6 7 8 9 10 Mean Change in HIV-1 RNA, Log 10 copies/mL (95% CI) Day Placebo (n=6) GS-620750mg (n=6) GS-6207150mg (n=6) GS-6207450mg (n=6)

Recently announced 2 : • Phase 2/3 study in treatment experienced/multi-drug resistant HIV • Phase 2 trial in treatment naïve • Capsid inhibitor: two-week oral lead- in followed by subcutaneous injection every6mo.

1 DaarE IAS2019LBPEB13;DaarEEACS2019PE3/17

Mean reductionof HIV RNA:

2 clinical trials.gov: NCT04150068;NCT04143594

c/mL over 10 days 1

-1.4 to 2.2 log 10

Slide33of 44FromRTGandhi, MD atNewOrleans, LA,December 4-7, 2019, Ryan WhiteHIV/AIDS ProgramCLINICAL CONFERENCE, IAS  USA.