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HPTN 076: TMC278 LA Safe, Tolerable and Acceptable
for HIV Pre-Exposure Prophylaxis
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Reported by Jules Levin
CROI 2017 Feb 14-16 Seattle, WA
Linda-Gail Bekker1, Sue Li2, Elizabeth Tolley3, Mark Marzinke4, Nyaradzo Mgodi5, Jessica Justman6, Shobha Swaminathan7, Adeola Adeyeye8, Jennifer Farrior3, Nirupama Sista3
1University of Cape Town, SA; 2Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, US; 3FHI 360,Durham, NC, US; 4Johns Hopkins University, Baltimore, MD, US; 5University of Zimbabwe,Harare, Zimbabwe; 6ICAP at Columbia University, New York, NY, US; 7Rutgers, New Jersey Medical School, Newark, NJ, US; 8DAIDS/NIAID/NIH, Rockville, MD, US
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Long Acting HIV ART - is this the future?
talk at CROI by Flexner: LONG-ACTING ANTIRETROVIRAL THERAPY: A SHOT IN THE DARK OR A PARADIGM SHIFT? [for HIV & HCV ?]
- they have formed LEAP - Long Acting Extended Release ART Resource Program with researchers/community and pharmaceutical industry me members including Flexner
http://longactinghiv.org/
Charles W Flexner
Johns Hopkins University, Baltimore, MD, USA
http://www.croiwebcasts.org/console/player/33659?mediaType=slideVideo&
⋅ Albuvertide is long acting T20 -Presented at Glasgow2016 : Efficacy and safety of long acting HIV fusion inhibitor albuvirtide in antiretroviral-experienced adults with HIV-1: interim 48 week results from the randomized, controlled, phase 3, non-inferiority TALENT study http://www.natap.org/2016/GLASGOW/GLASGOW_38.htm
⋅ EFdA/MK8591 is new Merck NRTI - data suggest potential for up to 1 year /implant - http://natap.org/2016/CROI/croi_14.htm
-CROI: MK-8591 Concentrations at Sites of HIV Transmission and Replication
http://www.natap.org/2016/HIV/080516_03.htm
⋅ CROI: LONG-ACTING IBALIZUMAB IN PATIENTS WITH MULTI-DRUG RESISTANT HIV-1: A 24-WEEK STUDY
⋅ New Gilead Capsid Inhibitor for HIV - (02/16/17) CROI: Discovery of Novel Potent HIV Capsid Inhibitors with Long-Acting Potential
⋅ - Injectable Cabotegravir+Rilpivirine - CROI: Long-term Safety and Efficacy of CAB and RPV as 2-Drug Oral Maintenance Therapy
⋅ CROI: A LONG-ACTING NANOFORMULATED CABOTEGRAVIR PRODRUG FOR IMPROVED ANTIRETROVIRAL THERAPY - (02/23/17)
⋅ TAF IMPLANT - CROI: In Vitro -In Vivo Evaluation of a Biodegradable Implant Containing TAF for HIV PrEP
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⋅RPV drug concentrations were determined via a validated liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method with a lower limit of quantification of 1 ng/mL.
⋅Participants identified one or more attributes of injectable prevention they liked and disliked at baseline. Participants’ interest in future injectable PrEP use was measured at Week 44 by level of agreement with six items. Comparisons by arm were made between participants who “agreed a lot” to each statement.
RESULTS
PARTICIPANT DISPOSITION
⋅A total of 136 (100 African, 36 US) women were enrolled.
⋅During the Oral Run-in Phase, ten women withdrew (8 active arm, 2 placebo arm) and four had product discontinued (3 active arm, 1 placebo arm).
⋅During the Injection Phase, one woman withdrew (placebo arm) and 16 product discontinuations occurred (10 active arm, 6 placebo arm).
INJECTION PHASE: SAFETY DATA
⋅A total of 122 (80 active arm, 42 placebo arm) women received >one injection;
64 active arm and 34 placebo arm participants received all six injections.
⋅Of the 16 product discontinuations during Injection Phase, six (8%) active arm and two (5%) placebo arm were due to AEs
including one placebo arm participant with prolonged QTcinterval.
⋅Transient Gr >2 liver abnormalities occurred in nine (11%) of active arm participants compared with four (10%) in the placebo arm.
⋅Three active arm participants developed Gr >3 injection site reactions compared with none in the placebo arm.
⋅The differences in AEs observed between the two arms were not statistically significant.
INJECTION PHASE:DRUG CONCENTRATION
⋅In participants receiving at least one injection:
⋅The median plasma trough concentration (CTrough) of RPV during the injection phase was 68.2 ng/mL.
⋅The concentration two weeks (C2WK) after the first and second injections (at Weeks 6 and 14) was 85.5 ng/mL and 113 ng/mL, respectively.
⋅At Week 52 (eight weeks after last injection), the CTroughwas 91.9 ng/mL.
⋅In participants receiving all six injections, less than 2% had RPV concentrations below the protein-adjusted 90% inhibitory concentration (PA-IC90) at any given time point after Week 4 when injections began.
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