Completed Phase 3 Study or submitted for approval
Dovato (dolutegravir/3TC)
FDA-approved in April 2019. Single-tablet regimen comprised of an INSTI and an NRTI. Phase 3 Gemini studies as initial ART complete; TANGO switch study ongoing; regulatory decision expected third quarter of 2019. From ViiV. See drug page in this guide.
fostemsavir (GSK3684934)
An ap120 attachment inhibitor. 48-week results from the Phase 3 BRIGHTE study in heavily treatment-experienced with extensive drug resistance; not yet submitted. From ViiV. See drug page in this guide.
Phase 3
cabotegravir
Oral formulation of an integrase inhibitor mainly used for lead-in dose before long-acting formulation. From ViiV.
cabotegravir LA/rilpivirine LA
An INSTI/NNRTI injection with very long half-life—detectable after more than one year following single injection. Studied as both treatment with rilpivirine CAB LAstudied as both treatment with rilpivirine LA and prevention as single INSTI injection. From ViiV. See drug page in this guide.
PRO 140
Monoclonal antibody CCR5 target. Once-weekly (350 mg) subcutaneous injection being studied in addition to ART for multi-drug resistance and as monotherapy maintenance therapy (without ART). From CytoDyn.
UB-421
Monoclonal antibody CD4 binding. Infusion dosed either weekly or every two weeks as alternative to ART during treatment interruption. From United BioPharma.
Phase 1–2
MK-8591 (EFdA)
A first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), highly potent, low dose, expected to suppress viruses with common NRTI resistance mutations. Long half-life, potential as oral (weekly dose) and implant (annual implant for PrEP). From Merck.
MK-8591/3TC/doravirine
Fixed-dose combination with NNRTI doravirine plus generic 3TC. From Merck.
GS-9131
A new NRTI active against NRTI resistance. Synergy reported with AZT, FTC, abacavir, efavirenz, bictegravir, dolutegravir and lopinavir; additive activity with TDF and TAF. Will be co-formulated with other Gilead drugs. Phase 2 dose-finding study in Ugandan women. From Gilead.
GSK3640254
A maturation inhibitor acquired by ViiV from BMS.
3BNC117 and 10-1074
Monoclonal antibodies.
Phase 1 open-label dose-ranging studies include studying these two antibodies in HIV-positive and HIV-negative participants. Both also have longer-acting (LA) formulations. From Rockefeller University.
PGDM1400 and PGT121
Another dual monoclonal antibody combination in a Phase 1 study with the potential for both treatment and prevention. From the Ragon Institute and IAVI.
Selected pre-clinical compounds not in human studies
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-PS1
New once-daily unboosted protease inhibitor; high potency, long half-life, potential for fixed-dose combination single-tablet regimen. From Gilead.
GS-CA1
Early stage for a new drug class with activity at multiple stages of viral lifecycle. Subcutaneous injection with monthly or less frequent dosing. From Gilead.
ABBREVIATIONS
3TC: lamivudine
AZT: zidovudine
FDC: fixed-dose combination
FTC: emtricitabine
INSTI: integrase inhibitor
mAb: monoclonal antibody
NNRTI: non-nucleoside reverse transcriptase inhibitor
NRTI: nucleoside reverse transcriptase inhibitor
PI: protease inhibitor
STR: single-tablet regimen
TAF: tenofovir alafenamide
TDF: tenofovir disoproxil fumarate
Adapted from HIV Pipeline 2018: New Drugs in Development, published by HIV i-Base, July 2018. For the full report, go to http://www.http://i-base.info/htb/34488.