Recently approved
Cabenuva
(cabotegravir LA/rilpivirine LA)
Two long-acting drugs from INSTI and NNRTI families that are given by intramuscular injection and that have very long half-lives—detectable after more than one year following single dose. CAB LA + RPV LA injections were studied for treatment, and CAB LA is being studied for prevention as single INSTI injection. From ViiV/Janssen.
Phase 3
islatravir/3TC/doravirine
Fixed-dose combination of the NNRTI doravirine plus generic 3TC and NRTI islatravir (EFdA). From Merck. On partial clinical hold (see Investigational new drugs).
islatravir/doravirine
Dual FDC with NNRTI doravirine. From Merck. On clinical hold (see Investigational new drugs).
leronlimab (PRO 140)
Monoclonal antibody CCR5 target. Once-weekly (350–700 mg) subcutaneous injection being studied in addition to oral ART for multi-drug resistance and as monotherapy maintenance therapy (without oral ART). From CytoDyn.
Phase 2/3
islatravir (EFdA)
A new NRTI, highly potent, low dose, active against NRTI resistance. Long half-life, potential as oral (daily, weekly dose for treatment; perhaps monthly for PrEP) and implant (annual implant for PrEP). From Merck. On full and partial clinical hold (see Investigational new drugs).
lenacapavir (GS-6207)
New drug class (capsid inhibitor) with activity at multiple stages of viral lifecycle. Subcutaneous injection every six months. It is being studied simultaneously for treatment and prevention. From Gilead. Submitted for approval in U.S. in July 2021 (see page 32). On clinical hold (see Investigational new drugs).
Phase 2
GSK3640254
A maturation inhibitor with Phase 2a results in HIV-positive participants. From ViiV.
Phase 1–3 and pre-clinical
3BNC117, 10-1074, PGDM1400, PGT121, 10E8, UB-421, etc.
Many bNAbs (broadly neutralizing antibodies) are in development for HIV prevention, treatment, and cure, often in dual or triple combination (see “Scenes from the bNAb Revolution” in the January+February 2020 issue). Potential as switch option without ART and in current studies for use as PrEP.
Albuvirtide + 3BNC117
Albuvirtide is a fusion inhibitor, approved in China, that is being developed in the U.S. by Frontier Biotechnologies in combination with the bNAb 3BNC117 for use in treatment-experienced patients.
GS-1156
Once-daily unboosted protease inhibitor; high potency, long half-life, potential for fixed-dose combination single-tablet regimen. From Gilead.
GS-9883
Long-acting formulation of the integrase inhibitor bictegravir. From Gilead.
Adapted in part from HIV Pipeline 2021: New Drugs in Development, published by HIV i-Base, September 2021. Accessed online January 27, 2022. For the full report, go to i-base.info/htb/41142.
Also see HIV life cycle.