Nuevos Fármacos y Enfoques Terapéuticos

Arkaitz Imaz

Unidad de VIH e ITS - Servicio de Enfermedades InfecciosasHospital Universitari de Bellvitge

Pregnancy Scarce information on efficacy and safety of the newer ARV agents used during pregnancy

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Nuevos fármacos antirretrovirales en desarrollo

TAR “long-acting”. EC fase 3 con CAB + RPV

Biterapia

Nuevos datos con ARV de reciente incorporación: BIC/FTC/TAF

TAR en embarazo

Daar E, et al. CROI 2020 #469

Daar E, et al. CROI 2020 #469

• At doses of 20 to 750 mg SC, mean GS-6207 concentrations on Day 10 were 0.7- to 20.5-fold higher than the protein-adjusted EC95 for wild type HIV-1

• Mean GS-6207 concentrations ≥4.4 ng/mL are predicted to provide near maximal antiviral activity

• The most common AEs were mild to moderate reactions at injection site which were self-limiting and resolved in a fewdays after dosing.

2 ongoing clinical trials in PLWH evaluating GS-6207 900 mg, with a 6-month dosing interval:– In treatment-naive PLWH (NCT04143594)– In heavily treatment-experienced PLWH (NCT04150068)

Daar E, et al. CROI 2020 #469

Margot NA. CROI 2020 #529

GCSM: gag cleaveage site mutations

Yakubova E, et al. CROI 2020 #473LB

DeJesus E, et al. CROI 2020 #507

Orkin C, et al. CROI 2020 #482LB

Orkin C, et al. CROI 2020 #482LB

Orkin C, et al. CROI 2020 #482LB

Orkin C, et al. CROI 2020 #482LB

Overton ET, et al. CROI 2020 #34

• Primary endpoint: Proportion with plasma HIV-1 RNA ≥50 c/mL at Week 48 (Snapshot, ITT-E) (Noninferiority margin: 4%)

• Key secondary endpoint: Proportion with HIV-1 RNA <50 c/mL at Week 48 (Snapshot, ITT-E)

• Additional secondary endpoints: Safety and tolerability; Incidence of confirmed VF; Incidence of viral resistance in participants experiencing CVF; Participants’ treatment preference for LA regimen

• Randomization was stratified by prior CAB + RPV exposure

Overton ET, et al. CROI 2020 #34

Overton ET, et al. CROI 2020 #34

Overton ET, et al. CROI 2020 #34

Overton ET, et al. CROI 2020 #34

Overton ET, et al. CROI 2020 #34

Underwood M, et al. CROI 2020 #484

Tiraboschi J, et al. CROI 2020 #435

Palich R, et al. CROI 2020 #494

First VF: W24, pVL=7,950 copies/mL, concomitant low plasma concentrations of RAL and ETR. New resistance mutations associated to INSTI (L74I, G140A and Q148H). Previous NNRTI resistance mutations (K103N and 100I).Second VF: W48, pVL=156 copies/mL, concomitant adequate plasma concentrations of RAL and ETR. No acquisition of resistance mutations associated to INSTI. Previous NNRTI resistance mutations (A98G, K101R and G190E/Q)

Hagins DP, et al. CROI 2020 #36

Hagins DP, et al. CROI 2020 #36

Hagins DP, et al. CROI 2020 #36

Hagins DP, et al. CROI 2020 #36

Hagins DP, et al. CROI 2020 #36

Hagins DP, et al. CROI 2020 #36

Hagins DP, et al. CROI 2020 #36

Chinula L, et al. CROI 2020 #LB 130

Chinula L, et al. CROI 2020 #LB 130

Chinula L, et al. CROI 2020 #LB 130

Chinula L, et al. CROI 2020 #LB 130

Chinula L, et al. CROI 2020 #LB 130

Chinula L, et al. CROI 2020 #LB 130

Chinula L, et al. CROI 2020 #LB 130

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