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.
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
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.
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.
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.
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.
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
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.
Once-daily unboosted protease inhibitor; high potency, long half-life, potential for fixed-dose combination single-tablet regimen. From Gilead.
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
- 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