CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

microbiologic confirmation. Among 117 persons with known outcome, in-hospital mortality was associated with increasing DLL1 levels (Odds Ratio=2.0 per two-fold increase, 95% CI: 1.2-3.6; P=.008) and decreasing fetuin (Odds Ratio=0.67 per two-fold increase, 95% CI: 0.47-0.96; P=0.030) in CSF. Table 1: Median (IQR) CSF concentrations of delta-like 1 protein (DLL1), vitamin D binding protein (VDBP), and fetuin by diagnosis

P values calculated from mean log2 transformed biomarker values analyzed by ANOVA. Conclusions: CSF DLL1 exhibited reasonable diagnostic performance, and may have a role as low cost adjunctive TBM diagnostic tools and may perform better in combination. Misclassification bias (of non-detection of TBM classified as ‘other’) hampers diagnostic studies, and future larger studies are required. 827LB Adherence to Once-Weekly Self-Administered INH and Rifapentine for Latent TB: iAdhere Robert Belknap 1 ; Andrey Borisov 2 ; David Holland 3 ; Pei-Jean Feng 2 ; Joan-Pau Millet 4 ; Neil Martinson 5 ; AliciaWright 6 ; Michael Chen 2 ; Joan Cayla 4 ; Jose M. Mida 7 and theTuberculosisTrials Consortium (TBTC) 1 Denver Health and Hospital Authority, Denver, CO, US; 2 US Centers for Disease Control and Prevention, Altanta, GA, US; 3 Emory University, Atlanta, GA, US; 4 Tuberculosis Investigation Unit of Barcelona, Barcelona, Spain; 5 University of Witwatersrand, Johannesburg, South Africa; 6 Vanderbilt University, Nashville, TN, US; 7 Hospital Clinic–IDIBAPS, University of Barcelona, Barcelona, Spain Background: Once-weekly isoniazid and rifapentine for 3 months (3HP) by directly observed therapy (DOT) is safe and effective for treating latent tuberculosis infection (LTBI). Treatment completion with 3HP by DOT was 82.1% in the TBTC Prevent TB study. Implementation of 3HP is limited by the requirement for DOT. Models show that treatment completion by self-administered therapy (SAT) could be lower and still be cost-effective. The iAdhere study compared 3HP completion rates by DOT versus SAT or enhanced SAT with weekly text reminders (eSAT). Methods: The study was an international clinical trial among adults with LTBI and no contraindications for 3HP or SAT. Randomization was 1:1:1, stratified by site. A non-inferiority margin of 15%was used based on cost-effectiveness modeling in the US, and enrollment targeted >75% from the US to have power for a pre-planned sub-analysis. The primary outcome was completion of > 11 doses within 16 weeks, as determined by clinic dose records and pill counts for DOT, and by self-reports, pill counts, and medication event monitoring system (MEMS) data for SAT and eSAT. Results: Of 1,002 patients enrolled, 4 were excluded as contacts to drug-resistant TB, 998 were eligible to complete treatment, and 772 (77%) were enrolled in the US. The study arms were demographically similar. Median age was 37 years [IQR 27, 49]. Participants included 482 (48%) women, 344 (34%) contacts to active TB, and 141 (14%) LTBI test converters; 85 (8%) had diabetes, 11 (1%) were HIV positive, 776 (78%) HIV negative, and 215 (21%) HIV unknown. Overall treatment completion was 87.2% [95%CI 83.1%-90.5%] by DOT, 74.0% [68.9%-78.6%] by SAT, and 76.4% [71.3%-80.8%] by eSAT. Treatment completion in US participants was 85.4% [80.4%-89.4%], 77.9% [77.2%-82.6%], and 76.7% [70.9%-81.7%] respectively. SAT was non-inferior to DOT in the US but not overall and eSAT did not achieve non-inferiority (figure). Discontinuation rates due to adverse effects were similar by arm, 3.6% DOT, 5.4% SAT, 4.3% eSAT (P=0.52).

Poster Abstracts

Conclusions: Our findings support the use of 3HP by SAT in the US. Non-inferiority was not established for SAT or eSAT overall due to higher than predicted DOT completion rates and variability in SAT and eSAT completion outside the US. Further cost-effectiveness analyses and evaluation of the role of text reminders are needed. 828LB Wirelessly Observed Therapy (WOT): A New Paradigm in TB Therapy Monitoring Sara Browne 1 ; Richard Haubrich 1 ; Kathleen S. Moser 2 ; Lorenzo DiCarlo 3 ; Charles A. Peloquin 4 ; Constance A. Benson 1 1 University of California San Diego, San Diego, CA, US; 2 San Diego County Health and Human Services Agency, San Diego, CA, US; 3 Proteus Digital Health Inc, Redwood City, CA, US; 4 University of Florida College of Pharmacy, Gainesville, FL, US Background: Directly Observed Therapy (DOT) is universally recommended for TB treatment adherence, but DOT is resource intensive, expensive and unfeasible in resource- limited settings. Novel WOT technology provides date- & time-stamped recording of medication ingestions via an ingestible sensor and monitor patch worn on the patient’s torso. Ingestion data is transmitted to a paired mobile device and then uploaded to a secure Internet server, where healthcare workers can confirm ingestions remotely.

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CROI 2015