CROI 2019 Abstract eBook
46 BICTEGRAVIR/FTC/TAF SINGLE-TABLET REGIMEN IN ADOLESCENTS AND CHILDREN: WEEK 48 RESULTS Aditya Gaur 1 , Mark Cotton 2 , Carina Rodriguez 3 , Eric J. McGrath 4 , Elizabeth Hellstrom 5 , Afaaf Liberty 6 , Eva Natukunda 7 , Pope Kosalaraksa 8 , Kulkanya Chokephaibulkit 9 , Heather Maxwell 10 , Sophia R. Majeed 10 , Danielle Porter 10 , Pamela Wong 10 , Hiba Graham 10 , Cheryl Pikora 10 1 St. Jude Children’s Research Hospital, Memphis, TN, USA, 2 Stellenbosch University, Cape Town, South Africa, 3 University of South Florida, Tampa, FL, USA, 4 Children’s Hospital of Michigan, Detroit, MI, USA, 5 Be Part Yoluntu Centre, Paarl, South Africa, 6 Chris Hani Baragwanath Hospital, Johannesburg, South Africa, 7 Joint Clinical Research Centre, Kampala, Uganda, 8 Khon Kaen Hospital, Khon Kaen, Thailand, 9 Mahidol University, Bangkok, Thailand, 10 Gilead Sciences, Inc, Foster City, CA, USA Background: B/F/TAF, approved for adults living with HIV-1, is a single-tablet regimen (STR) containing the novel integrase strand transfer inhibitor (INSTI) bictegravir (B) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg. B/F/TAF has a high barrier to resistance and no food restriction. Short-term safety and pharmacokinetics (PK) of B/F/TAF in children and adolescents, reported previously, support the use of the full adult strength tablet in this population. The 48-week (W) safety and efficacy data for 6- to <18-year-olds receiving B/F/TAF are reported. Methods: Virologically suppressed adolescents (12 to <18 yrs) weighing ≥35 kg (Cohort 1) and children (6 to <12 yrs) weighing ≥25 kg (Cohort 2) with HIV-1 RNA <50 c/mL for ≥6 months before screening and CD4 ≥200 cells/μL received B/F/TAF once daily, in a prospective, 48-week, single-arm, open-label trial. Adverse events (AEs), laboratory results, and HIV-1 RNA <50 c/mL were assessed. Results: Fifty adolescents and fifty children (total n=100) were enrolled. At baseline for Cohort 1, median age was 15 yrs (range 12-17 yrs), weight 44.7 kg (range 35-123 kg), 64% female, 65% Black, median CD4 count 751 cells/μL, 90% vertically infected. For Cohort 2, median age was 10 yrs (range 6-11 yrs), median weight 29 kg (range 25-69 kg), 54% female, 72% Black, median CD4 count 930 cells/μL, and 96% vertically infected. All 100 participants (100%, 100/100) had HIV-1 RNA <50 c/mL at W24 and 98% (74/75) at W48 by US FDA Snapshot Algorithm; no participant had treatment-emergent resistance. CD4 count remained stable to W48. With a 50-week (range 20-93 wks) median duration of exposure to study drug, the only study drug-related AE reported with greater than single participant incidence was abdominal discomfort (2%, 2 participants; grade 1). One participant discontinued after W16 due to an AE (grade 2 insomnia and anxiety). All participants reported B/F/TAF size and shape as acceptable and taste as palatable; median percent adherence (pill counts) to study drug was high at 99% (range 80-100%). Conclusion: This 48-week efficacy, safety, acceptability, and palatability data, combined with the previously reported PK data, support the use of the first, unboosted, INSTI-based STR of B/F/TAF 50/200/25 mg for the treatment of adolescents and children (6 to <18 years of age and weighing ≥25 kg) living with HIV-1 and prompts further pediatric studies of appropriate formulations of B/F/TAF for children weighing <25 kg. 47 INCIDENT SYPHILIS RATES AND PREDICTORS IN US WOMEN WITH HIV, 2005-2016 Jodie Dionne-Odom 1 , AndrewWestfall 1 , Michael J. Mugavero 1 , Sonia Napravnik 2 , Julia C. Dombrowski 3 , Mari Kitahata 3 , Richard D. Moore 4 , Benigno Rodriguez 5 , Maile Y. Karris 6 , Elvin Geng 7 , Kenneth H. Mayer 8 , Jeanne M. Marrazzo 1 1 University of Alabama at Birmingham, Birmingham, AL, USA, 2 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 3 University of Washington, Seattle, WA, USA, 4 Johns Hopkins University, Baltimore, MD, USA, 5 Case Western Reserve University, Cleveland, OH, USA, 6 University of California San Diego, San Diego, CA, USA, 7 University of California San Francisco, San Francisco, CA, USA, 8 The Fenway Institute, Boston, MA, USA Background: Early syphilis rates in the US have increased 76% since 2013 and congenital syphilis rates are at a 20-year peak. Although defined as high-risk for STI screening, rates and predictors of syphilis in US women with HIV are not well described. We aimed to determine unique predictors of incident syphilis in a longitudinal US cohort of women living with HIV. Methods: This retrospective study included women enrolled in the US CFAR Clinical Network of Integrated Clinical Systems (CNICS) Cohort with at least one HIV clinic visit between 2005 and 2016. Data were extracted from the electronic
medical record and patient reported outcomes (PRO) were collected every 6 months. Incident syphilis was defined as a newly positive nontreponemal serologic test after a previously negative test or a 4-fold increase in titer, both with positive confirmatory testing. Each year in care was analyzed separately and more than one incident syphilis infection was allowed. Univariate (UV) and multivariable (MV) logistic regression with auto-regressive correlation structure and generalized estimating equations (GEE) were used to model the incident syphilis outcome. Variables were chosen for the MV model based on prior studies, statistical significance in the UV model (p<0.05), and data completeness. Results: A total of 4,795 women in the CNICS cohort were included with 27,249 woman-years in care. Median age was 47, 63% of women were Black and 75% had acquired HIV from heterosexual sex. Overall, 4219 (88%) were tested for syphilis and 119 women (2.8%) had 125 incident infections (7.6 cases per 1000 person-years). In the unadjusted model, active drug abuse, prior IVDA, hepatitis C (HCV Ab+), HIV viral load >1000 copies/mL, black race and later year of entry to care predicted incident syphilis. In the adjusted model, independent predictors were prior IVDA (aOR 2.3, 95% CI 1.3-3.9), HCV Ab+ (aOR 2.1, CI 1.3-3.7), later year of entry to care (aOR 2.3, CI 1.4-3.9 for 2011-2016 compared to 1994-2004), and black race (aOR 2.3, CI 1.4-3.9 compared to white). Age and HIV VL were not predictors. (see Table) Conclusion: In a large national cohort of US women with HIV, history of IV drug use and hepatitis C infection were the best predictors of incident syphilis infection. Further studies are needed to determine if this association is mediated via transactional sex or high-risk sex partners. Guidelines should prioritize women with HIV and IVDA for syphilis screening and the prevention of congenital syphilis.
48 PREPARING FOR PrEP IN ENGLAND: PREVALENCE AND INCIDENCE OF HIV AND BACTERIAL STIs Dana Ogaz , Ada R. Miltz, Sarika Desai, John Saunders, Andre Charlett, Owen N. Gill, Hamish Mohammed Public Health England, London, UK Background: In England, the recent decline in new HIV diagnoses among men who have sex with men (MSM) attending sexual health clinics (SHCs) has been attributed to HIV combination prevention including HIV pre-exposure prophylaxis (PrEP). To evaluate recent trends in HIV and STI diagnoses, we determined the prevalence of bacterial sexually transmitted infections (STIs) and annual incidence of HIV in MSM attending SHCs in England. Methods: Using GUMCAD, England’s national STI surveillance system, we extracted data on HIV (from 2012 to 2017) and bacterial STI (from 2017: chlamydia, gonorrhoea, and primary, secondary, early latent syphilis) diagnoses
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