Mucosal Assays in Oral and Long Acting (LA) Antiretroviral PrEP Trials. Ian McGowan MD PhD FRCP University of Pittsburgh Pittsburgh, PA USA
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1 Mucosal Assays in Oral and Long Acting (LA) Antiretroviral PrEP Trials Ian McGowan MD PhD FRCP University of Pittsburgh Pittsburgh, PA USA
2 Overview A brief history of oral/la PrEP research Integration of mucosal assays into oral/la PrEP research Lessons learned about the performance and utility of mucosal assays in oral/la PrEP trials
3 Oral PrEP
4 Oral PrEP Oral PreP with either TDF or TDF/FTC has been evaluated in eight Phase 2B/3 trials with evidence of efficacy in multiple populations Limited mucosal sampling has focused primarily on compartmental PK assays Ongoing Phase 1/2 studies have more extensive mucosal sampling
5 Oral PrEP Timeline 2010 iprex (TDF/FTC) 2012 TDF2 (TDF/FTC) VOICE (TDF, TDF/FTC) PROUD (TDF/FTC) HPTN-069 (Maraviroc, FTC, TDF) 2012 FEM-PrEP (TDF/FTC) 2012 Partners PrEP (TDF TDF/FTC) 2013 Bangkok Tenofovir Study (TDF) Ipergay (TDF/FTC) CHARM-03 (Maraviroc)
6 Mucosal Assays in Oral PrEP RMP-02/MTN-006 (single dose TDF) Compartmental PK Mucosal safety including flow cytometry Explant infection HPTN-069 CCR5 genotype Compartmental PK GALT flow cytometry Explant infection
7 TFV and FTC Concentration in Rectal Tissue Concentration (ng/mg) TFV FTC Time (hours) Control Early detection of FTC in rectal tissue at high concentrations similar to HIVinfected patients on ART TFV is only detectable at 24h post drug intake at high concentrations
8 Long Acting (LA) PrEP
9 LA PrEP LA antiretrovirals are being developed for treatment and prevention indications Goal is to circumvent adherence challenges associated with the use of oral antiretrovirals LA Platforms Injectable agents (rilpivirine and cabotegravir) Implantable device (multiple preclinical leads)
10 LA PrEP Candidate Agents Candidate Class of Drug Current Stage of development NNRTI Licensed for treatment of HIV infection Dapivirine NNRTI Phase 3 Tenofovir alafenamide NRTI Phase 3 Cabotegravir INSTI Phase 2 Elvitegravir INSTI Licensed for treatment of HIV infection VRC01 Monoclonal antibody Phase 1 5P12-RANTES CCR5 antagonist Preclinical Griffithsin Lectin Preclinical
11 LA Timeline 2007 (Phase 1) 2011 (Phase 1) 2013 Cabotegravir (Phase 1) LATTE-2 Cabotegravir (Phase 2B) 2009 (Phase 1) 2012 SSAT040 (Phase 1) MWRI-01 (Phase 1) HPTN-076 (Phase 2)
12 Cabotegravir LA Timeline 2013 Cabotegravir (Phase 1) ÉCLAIR Cabotegravir (Phase 2A) HPTN-077 Cabotegravir (Phase 2A) 2012 Cabotegravir (Phase 1) 2014 Cabotegravir (Phase 1) LATTE-2 Cabotegravir (Phase 2B) HPTN-083 Cabotegravir (Phase 2B/3)
13 Cabotegravir Compartmental PK GSK Plasma or Tissue (ng/ml or ng/g) Week 2 Week 8 Week 4 Week 12 Overall Plasma Rectal Tissue Tissue Tissue / Plasma Ratio Unsplit, Split Cervical 0.16, 0.20 Vaginal 0.19, 0.28 Rectal NQ, 0.08 Unsplit Split
14 NHP Cabotegravir Data Andrews CD et al. Science 2014
15 Mucosal Assays in LA PrEP studies SSAT040 & MWRI-01 Compartmental PK Explant infection Rectal fluid PD Cabotegravir studies Compartmental PK
16 Implantable PrEP Products still in preclinical phase of development TAF implantable device. PK data in dogs. Gunawardana M et al. Antimicrob. Agents. Chemother. () Thin film polymer device. PK data in rats anticipated In Ariane van der Straten USAID grant
17 Lessons Learned
18 Lessons Learned Oral PrEP Very limited mucosal assays in completed oral PrEP studies More extensive data being generated in ongoing studies (HPTN-069 & CHARM-03) LA PrEP Compartmental PK and explant challenge data available for rilpivirine (SSAT040 & MWRI-01 Studies) Limited PK data for cabotegravir
19 Summary Oral PrEP established as safe and effective form of HIV prevention Mucosal assays of limited value unless evaluating new drug classes in Phase 1/2 studies Mucosal assays may be of significant benefit in the development of LA injectable and implantable PrEP Compartmental PK Explant infection studies
20 Acknowledgements The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.
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