IAS 2016 Towards an HIV Cure Symposium Durban, South Africa.
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1 Effect of vorinostat, hydroxychloroquine and maraviroc combination therapy on viremia following treatment interruption in individuals treated during acute HIV infection Eugène Kroon, Jintanat Ananworanich, Keith Eubanks, Jintana Intasan, Suteeraporn Pinyakorn, Nicolas Chomont, Sharon R Lewin, Sarah Palmer, Lydie Trautmann, Hua Yang, Nitiya Chomchey, Nittaya Phanuphak, Ken Cooper, Praphan Phanuphak, Mark de Souza on behalf of the SEARCH 019 study group IAS 2016 Towards an HIV Cure Symposium Durban, South Africa The views expressed are those of the authors and should not be construed to represent the positions of the U.S. Army or the Department of Defense or other institutions involved.
2 Conflict of Interest JA has received travel support from Cooper Human Systems, honoraria from ViiV Healthcare and Merck KE, HY, KC and MdS are employees of Cooper Human Systems The presentation will include discussion of off-label products
3 Background Multifaceted approach using drugs with different modes of action informed by mathematical modelling Vorinostat: Latency reversal Maraviroc: Entry inhibitor Hydroxychloroquine: Immune modulator Acutely treated participants with low HIV reservoir size Objective Frequency of participants with VL < 50 copies/ml at 24 weeks post treatment interruption with VHM+ART vs. ART alone
4 Study Design Adults treated in Fiebig III/IV acute HIV VL < 50 for > 2 yrs ART only (n=5) VHM+ ART (n=10) ART ART if VL only > 1000 Weekly VL monitoring ART if VL > 1000 Viral load post interruption Wk 0 start VHM Wk 10 Stop VHM, Begin interruption Wk 34 End of study Vorinostat 400mg/day 14 days on/off 3 cycles (10 weeks) Hydroxychloroquine 200mg/dose 2 times/day 10 weeks Maraviroc 600mg/dose 2 times/day 10 weeks
5 Characteristics Median (range) VHM+ART ART At randomization Age, years 28 (22-51) 26 (24-34) Male:Female 9:1 4:1 ART duration, weeks 224 (79-294) 155 ( ) CD4 count, cells/mm ( ) 1079 ( ) Total HIV DNA in PBMC, c/10 6 cells 44 (0 93) 27 (3 86) P > 0.05 for all
6 Safety Two participants with serious adverse events in the VHM arm One discontinued the study from renal insufficiency and low platelets from VHM One with diarrhea possibly from food poisoning/vhm Non-serious adverse events 81 events in 10 VHM vs. 37 events in 5 ART participants Significantly more participants in VHM vs. control with thrombocytopenia (7 vs. 0) and high creatinine (7 vs. 0) Treatment interruption No acute retroviral syndrome No new resistance mutations by genotyping No virological failure after ART resumption
7 Viral Load after ART Interruption Median time to first VL detection: 22 days (range 14 to 77 days) ART resume at VL > 1000 c/ml Two of 8 had detected CSF VL during plasma viremia post interruption (Kroon, Valcour, Spudich, Abstract 10588)
8 Post-treatment Interruption Median (range) VHM+ART ART Time from treatment interruption to 3 (2 5) 3.1 (3-11) VL detection, weeks VL levels at first detection, c/ml 222 ( ) 156 (52 395) Peak VL levels, c/ml ( ) 4717 ( ) Time from first VL detection to ART 1 ( ) 2 (1 5.3) resumption, weeks Time from ART resumption to VL 2.9 ( ) 2 ( ) suppression, weeks CD4 change from pre interruption to ART resumption, cells/mm 3 2 (-376 to 549) 16 (-284 to 474)
9 No Changes in Total HIV DNA in PBMCs VHM ATI ART After ART resumption (20 weeks) ATI After ART resumption (19 weeks) No significant changes in total HIV DNA in PBMCs from week 34 to week 0 - VHM: median -4 (range -49 to 0) - ART: median -1 (range -19 to 0) Amélie Pagliuzza, Nicolas Chomont (U Montreal)
10 VHM Induces Low Level Plasma Viremia RNA copies/ml *** p= VHM C1 C2 C3 ATI After ART resumption (20 weeks) ART C1 C2 C3 ATI After ART resumption (19 weeks) Time (weeks) Assay cut-off = 0.5 copies/ml Time (weeks) Frank Maldarelli (NCI), Robert Gorelick, Jeff Lifson (ACVP, Leidos Biomed Res)
11 No Changes in Immune Activation Markers VHM ART Week 10 ATI After ART resumption (7 weeks) Week 10 ATI After ART resumption (4 weeks) CD4+CD38+HLA-DR+ No changes in frequencies of activated CD4+ and CD8+ T cells No changes in IP10, MCP1, scd14, scd163 Serena Spudich (Yale), Lydie Trautmann (MHRP)
12 Summary Proof-of-concept study of vorinostat/hydroxychloroquine/maraviroc + ART vs. ART alone in treated acutely infected persons Closely monitored treatment interruption was safe VHM Well tolerated in the majority No changes in total HIV DNA in PBMCs Increases low level plasma viremia in some participants No changes in T cell and soluble immune activation markers All Fiebig III/IV treated individuals had viral rebound after ATI Time to VL rebound did not differ significantly to published chronic HIV cohorts In this small study, ART duration, total HIV DNA in PBMCs, single copy VL, CD4/CD8 ratio did not predict time to viral rebound
13 Conclusion Treatment in Fiebig III/IV with or without VHM did not result in delayed time to viral rebound Alternative strategies to reduce or eliminate HIV reservoirs are needed
14 Thai Red Cross James Fletcher Donn Colby Carlo Sacdalan Thidarat Jupimai Chulalongkorn Kiat Ruxrungtham Sukalya Lerdlum Sunee Sirivichayakul U Montréal Amelie Pagliuzza Remi Fromentin U Melbourne Ajantha Rhodes J. Judy Chang The Westmead Institute/ U Syd Vincent Morcilla UNC Gail Henderson Jean Cadigan RTI Holly Peay U Minnesota Timothy Schacker Kapson Analytics MHRP Nelson Michael Merlin Robb Hiroshi Takata Supranee Buranapraditkun Julie Mitchell AFRIMS Alexandra Schuetz Yuwadee Phuang-ngern Rapee Trichavaroj Siriwat Akapirat NIAD Irini Sereti Daniel Douek NCI Frank Maldarelli ACVP, Leidos Biomed Res Jacob Estes Claire Deleage Robert Gorelick Robin Dewar Jeff Lifson UCSF Victor Valcour Joanna Hellmuth Yale IAS 2016 Towards an HIV Cure Serena Symposium Spudich John Kapson Leah Le Durban, South Africa U Pittsburgh John Mellors Acknowledgements The SEARCH 019 and RV254 study participants Thai GPO ViiV Healthcare Gilead Merck Monogram
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