Recently approved
Vocabria (cabotegravir)
Oral formulation of an integrase inhibitor mainly used for lead-in dose before long-acting formulation and possibly for bridging when injectable Cabenuva cannot be taken. It will not be available for other purposes. From ViiV/Janssen.
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. See drug page in this guide.
Rukobia (fostemsavir)
gp120 attachment inhibitor, twice daily oral antiretroviral taken in combination with other antiretrovirals. For multi-drug resistant HIV. From ViiV. See drug page this guide Phase 3
islatravir/3TC/doravirine
Fixed-dose combination of the NNRTI doravirine plus generic 3TC and new NRTI islatravir (EFdA). Current studies used triple combination for initial ART and switch to islatravir/doravirine for dual maintenance ART. From Merck.
islatravir/doravirine
Dual FDC with NNRTI doravirine. Current studies look at switch option after viral suppression with triple-drug ART. From Merck.
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.
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.
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.
Phase 1 and pre-clinical
Combinectin (GSK3732394)
A gp41 / CD4 entry inhibitor. Combined adnectin/fusion inhibitor that stops viral entry by targeting multiple sites of action; potential for self-administered once-weekly injections. From ViiV.
GS-1156
Once-daily unboosted protease inhibitor; high potency, long half-life, potential for fixed-dose combination single-tablet regimen. From Gilead.
MK-8583, MK-8504
Tenofovir prodrugs, both with completed Phase 1 studies. From Merck.
Adapted from HIV Pipeline 2020: New Drugs in Development, published by HIV i-Base, March 2020. For the full report, go to i-base.info/htb/3722
Abbreviations:
- 3TC: lamivudine
- ART: antiretroviral therapy
- bNAb: broadly neutralizing antibody
- FDC: fixed-dose combination
- INSTI: integrase inhibitor
- mAb: monoclonal antibody
- NNRTI: non-nucleoside reverse transcriptase inhibitor
- NRTI: nucleoside reverse transcriptase inhibitor
- PI: protease inhibitor