GSK744 CAB For PrEP INI ViiV Topical microbicide Oral Longacting LA parenteral 1 Fostemsavir BMS663068 Prodrug of BMS626529 Attachment inhibitor BMS ViiV MK8591 EFdA ID: 751991
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Slide1
HIV Pipeline
Cabotegravir-LA
(GSK-744; CAB)For PrEPINIViiV
Topical microbicide
Oral
Long-acting (LA) parenteral
1
Fostemsavir
(BMS-663068)
Prodrug of BMS-626529Attachment inhibitorBMS ViiV
MK-8591 (EFdA)NRTTI6Merck
Dapivirine(TMC120; DPV)IVR for PrEPNNRTIJanssen IPMFiled with EMA
Other parenteral
Cenicriviroc
7(TBR-652; CVC)Not for X4-tropic HIVEntry inhibitorTakeda Tobira
PC-1005(MIV-150+zinc acetate) Multipurpose gel including for PrEPNNRTIPopulation Council; NIH
GSK3640254 Maturation InhibitorGSK
PRO-140 (PA14)3Not for X4-tropic HIVEntry inhibitor; mAb(not an ARV) CytoDyn
ABX464Rev inhibitor5Abivax
Potential first-in-class to reach market
Cabotegravir-LA + Rilpivirine-LA
Maintenance strategy
ViiV + Janssen
Vicriviroc (MK-4176)
± MK-2048
IVR for PrEP10Entry Inhibitor ± INI NIH; Merck
GSK2838232Requires a boosterMaturation InhibitorGSK
TMB-60711(MK-8122, PPL-100)Protease inhibitorAmbrilia TaiMed
UB-4214(TMB-355)mAb against CD4(not an ARV)United Biopharma
VRC018bNAb against gp120For preventionNIH
VRC family8 (VRC01LS, VRC07, VRC07-523LS, 10E8VLS, N6LS …)bNAbs against gp120For prevention or treatmentNIH
MK-4250MOA unknownMerck
MK-8504NRTI (TFV prodrug)Merck
P
Being studied in adolescents and/or children
P
P
P
Vesatolimod
(GS-9620)9TLR7 agonist / Immunomodulator(not an ARV)Gilead
GS-9131NRTIGilead
GS-620712(GS-CA2)Capsid inhibitorGilead
GS-972213bNAb against gp120Gilead
10-1074(LS) + 3BNC117(LS)
14bNAbs against gp120For prevention or treatmentRockefeller; NIH
PGDM1400 + PGT121bNAbs against gp120For prevention or treatmentIAVI
Medicines Patent PoolList not exhaustive. Last updated on: 10/2018
MK-8527MOA unknownMerck
MK-8583
NRTI
MerckSlide2
Child & Adolescent HIV Pipeline
Medicines Patent Pool
List not exhaustive. Last updated on: 11/19/2018§TAF is also being studied in children with chronic hepatitis B in Ph2/3 studyDolutegravirIntegrase inhibitor
ViiV[down to 4w]
Cabotegravir-LAI +
Rilpivirine-LAI
Maintenance strategy
ViiV + Janssen[12-17y]
Oral
Long-acting (LA) parenteral1Other parenteral
VRC01, VRC01-LSbNAb against gp120As maintenanceNIH[up to 5y]
DoravirineNNRTIMSD[12-17y]DapivirineIVR for PrEP
NNRTI
Janssen IPM
Filed with EMA[15-17y]Topical microbicide
Licensed to MPPBictegravirIntegrase inhibitorGilead[2-17y, VS]
VS Virologically suppressed
TAF§NRTIGilead[1m-17y, VS]
Also Ph2/3Also Ph1/2
Microneedle Patch (of RAL, or EfdA?)
Queens’ Univ. of Belfast; PATH
PIP Confirmed
Preclinical or
Formulation Development
Ibalizumab
(Trogarzo®, TMB355)mAb against CD4TaiMed
Biologics; TheratechnologiesSolid Drug Nanoparticles (SDN of DRV/r, LPV/r…)Univ. LiverpoolVRC01, VRC01-LS
bNAb against gp120As prophylaxisNIH[Neonates]Slide3
Paritaprevir
/r (ABT-450/r)NS3/4A inhibitorEnanta + AbbVie
HCV Direct-Acting Antivirals (DAAs) Marketed or under active clinical developmentSofosbuvir(GS-7977/PSI-7977; SOF) NS5B inhibitor – nuc 2GileadGlecaprevir(ABT-493; GLE) 5NS3/4A inhibitorEnanta + AbbVie
Daclatasvir(BMS-790052; DCV)NS5A inhibitorBMS
Pibrentasvir(ABT-530; PIB) NS5A inhibitor
AbbVieDasabuvir
(ABT-333)NS5B inhibitor – non-nucAbbVie
Asunaprevir 3 (BMS-650032)NS3/4A inhibitorBMS
Ombitasvir(ABT-267; OBV)NS5A inhibitorAbbVie
Voxilaprevir(GS-9857; VOX)NS3/4A inhibitorGileadLedipasvir (GS-5885; LDV)NS5A inhibitorGileadVelpatasvir(GS-5816; VEL)NS5A inhibitorGileadSimeprevir(TMC435; SIM; SMV)NS3/4A inhibitorJanssenOdalasvir(ACH-3102)NS5A inhibitor
Achillion JanssenBoceprevir(SCH-503034)NS3/4A inhibitorMerckVaniprevir 4(MK-7009)NS3/4A inhibitorMerckGrazoprevir (MK-5172; GZR)NS3/4A inhibitorMerck
Elbasvir(MK-8742; EBR)NS5A inhibitorMerckRuzasvir(MK-8408; RZR) NS5A inhibitor MerckUprifosbuvir(MK-3682; UPR)NS5B inhibitor – nuc MerckRavidasvir 9 (PPI-668; ASC16; RDV) NS5A inhibitor Presidio
Pharco; Ascletis
Filed with CFDA Danoprevir/ritonavir
6 (ITMN-191, ASC08)NS3/4A inhibitorRoche; Ascletis TD-6450NS5A inhibitorTheravance TREKtxTelaprevir(VX-950)NS3/4A inhibitorVertex Janssen AL-335
NS5B inhibitor – nuc Alios (now Janssen)Not pangenotypicPangenotypicIndividual pangenotypic potential per published in vitro data:1Pangenotypic coverage not verifiable
Faldaprevir 7(BI 201335)NS3/4A inhibitorBI TREKtxGSK2878175 8Oral & LAPNS5B inhibitor – non-nuc GSKFuraprevir (TG-2349)
NS3/4A inhibitorTaiGen MB-110NS5A inhibitorMicrobio Co.CC-31244NS5B inhibitor – non-nuc Cocrystal PharmaList not exhaustive. Host-targeting agents are not included Medicines Patent Pool. Last updated on: 8/2018
NUCAT-527NS5B inhibitor - nucAtea Pharmaceuticals
Discontinued9
SH229
NS5B inhibitor
Nanjing
Sanhome PharmaceuticalsSlide4
Paritaprevir
/r (ABT-450/r)NS3/4A AbbVieSofosbuvir(GS-7977) NS5B – nucGileadGlecaprevir(ABT-493) NS3/4AAbbVie
Pibrentasvir(ABT-530) NS5AAbbVieDasabuvir (ABT-333)NS5B – non-nucAbbVieOmbitasvir(ABT-267)NS5A AbbVie
Voxilaprevir(GS-9857)NS3/4A Gilead
Ledipasvir (GS-5885)
NS5AGileadVelpatasvir
(GS-5816)NS5A Gilead
Simeprevir(TMC435)NS3/4A Janssen
Grazoprevir (MK-5172)NS3/4A Merck
Elbasvir(MK-8742)NS5AMerckRavidasvir (PPI-668; RDV) NS5A Presidio Pharco, AscletisSofosbuvir(GS-7977) NS5B – nucGileadDaclatasvir(BMS-790052)NS5A BMSGT1~4b
Sofosbuvir(GS-7977) NS5B – nucGilead Sofosbuvir(GS-7977) NS5B – nucGilead
MarketedPhase III+Velpatasvir(GS-5816)NS5A Gilead
Sofosbuvir(GS-7977) NS5B – nucGilead
Sofosbuvir
(GS-7977) NS5B – nucGilead+GT1, ± RBV for GT1, 4dGT1GT1, 4, 5, 6; + RBV for GT3aParitaprevir
/r (ABT-450/r)NS3/4A Ombitasvir(ABT-267)NS5A± RBV for GT4Medicines Patent PoolList not exhaustive. Last updated on: 8/2018± RBV GT1, 4; + SOF for GT3c GT1~6
GT1~6eGT1~6fPFDA-approved for age 12+
HCV DAA Combination RegimensFixed-dose combinationPPaediatric investigation underwayP
PPPP
PRavidasvir (PPI-668; RDV) NS5A Presidio
Pharco, Ascletis
Danoprevir/ritonavir (ITMN-191, ASC08)
NS3/4A inhibitorRoche; Ascletis
+P+RBVgSlide5
Regimen
Age 12+Age 6 to <12 yrsAge 3 to < 6 yrsSOF + RBV
Approved(GT2, 3; ≥35kg)Phase 2 (GT2, 3)1(small tablet or granules for young children)SOF/LDVApproved (GT1, 4-6; ≥35kg)Two Phase 2 studies
(1/2-dose tablet)
OBV/PTV/r ± DSV ± RBVPhase 3
SOF/LDV + RBV
Phase 2
(GT3 only)(Tablet or “age-appropriate dose or formulation”) GRZ/EBR
Phase 2 (GT1, 4 only)(Tablet or granules for young children)
SOF/VELPhase 2 (Tablet of “age-appropriate dose”)SOF/VEL/VOXMay be covered in Registry for paediatric & adolescent patientsSOF + DCVPhase 3(Age 8-18, GT4 only, Egypt; 1 or ½ tablet)2
--GLE/PIBPhase 3, with Expanded Access Program(“Paediatric formulation” for 3 to <12 yrs)List not exhaustive. Some studies are investigator-initiated.Medicines Patent Pool. Last updated 11/2018
PangenotypicNot pangenotypic
Development Progress of Paediatric HCV Regimens