CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

60 days. Per protocol, no dPrEP patients with contraindications (N=7) initiated PrEP. Conclusion: Immediate PrEP initiation is a promising model for walk-in settings; PrEP was rarely discontinued (0.2%) among iPrEP patients due to absolute contraindications. There was a substantial loss to follow up among patients who delayed PrEP due to contraindications concerns.

1 University of Washington, Seattle, WA, USA, 2 University of Washington in Kenya, Nairobi, Kenya, 3 Kenyatta National Hospital, Nairobi, Kenya Background: Creatinine (Cr) testing is recommended as part of PrEP delivery to identify pre-existing renal disease prior to PrEP initiation. Whether Cr testing is essential to assure safe use of PrEP is not yet known. We evaluated implementation of point-of-care (POC) Cr testing within a large-scale PrEP program in Western Kenya. Methods: From June 2017 to August 2018, HIV-uninfected women seeking routine antenatal (ANC), postnatal (PNC), and family planning (FP) services were screened per national PrEP guidelines at 16 facilities in Kisumu, Kenya. Kenyan national PrEP guidelines currently recommend, but do not require, assessment of Cr clearance (CrCl) prior to PrEP initiation and annually thereafter when Cr testing is available. Prior to PrEP initiation, nurses measured height and weight, conducted Cr serum testing using validated Xpress StatSensor® POC machines (Nova Biomedical Cooperation, Waltham, MA, USA), and calculated CrCl by Cockcroft-Gault equation using a mobile application. If a single estimated CrCl measurement was below the normal range (<50mL/min according to Kenyan guidelines), the test was repeated before excluding that client from PrEP services. In a subset, we evaluated the cost and time required per test of the POC test compared to standard laboratory methods when a laboratory was present. Results: In total, 4007 women were evaluated for PrEP eligibility and received POC Cr testing; 41% from ANC, 50% PNC, and 10% FP. The median age was 24 years (IQR 21-28) and 200 (5%) women were ≤18 years. The median CrCl was 113 mL/min (IQR 97-132) for ANC clients, 111 mL/min (IQR 93-130) for PNC, and 99 mL/min (IQR 82-120) for FP. Overall, 8/4007 (0.2%) women had estimated CrCL <50mL/min; 1 (0.06%) from ANC, 5 (0.2%) PNC, and 2 (0.5%) FP. POC Cr testing added a median of 3 minutes to PrEP eligibility assessments and cost USD 4.5 per test; in contrast, laboratory-based results took 3 hours and cost USD 5 per test. Conclusion: It was feasible to implement POC Cr testing during PrEP delivery within MCH and FP settings and low CrCl was very rare among screened women. Given the rarity of medical ineligibility and safety of short-term PrEP, our data support the recommendation of not mandating Cr testing at PrEP initiation. PrEP programs could consider conducting Cr testing at one to three months post-initiation to reduce Cr testing-related time, costs and inconvenience. 962 IMMEDIATE PrEP INITIATION AT NEW YORK CITY SEXUAL HEALTH CLINICS Tarek Mikati , Kelly Jamison, Demetre C. Daskalakis New York City Department of Health and Mental Hygiene, Long Island City, NY, USA Background: New York City (NYC) Sexual Health Clinics (SHC) patients are at increased risk of HIV acquisition. Immediate PrEP initiation (iPrEP) can increase PrEP uptake at walk-in settings where patient visits may be sporadic. At NYC SHC, tenofovir/emtricitabine is offered after a negative rapid HIV test but before results of other lab testing recommended for PrEP initiation are available. PrEP initiation is delayed (dPrEP) if patients report symptoms consistent with acute HIV (AHI), history of kidney disease (KD) and/or history of active hepatitis B virus infection (HBV). We determined the prevalence of PrEP-related medical contraindications among candidates evaluated for iPrEP at NYC SHC. Methods: Using medical record data, we examined demographics and PrEP- related laboratory testing outcomes among patients evaluated for PrEP initiation. Patients were included in the analysis if they were cis- gender men or women, age>18 years, and had no prior HBV serology and serum creatinine testing at NYC SHC. Patients were considered to have PrEP medical contraindications if they had a positive HIV viral load test (absolute contraindication), glomerular filtration rate < 60 ml/min (absolute), and/or a positive Hepatitis B surface antigen (relative). Results: From January 2017- June 2018, 1437 patients were evaluated for iPrEP; 1387 (97%) qualified and 50 (3%) were delayed. Median age was 28 years (IQR 25-33) and the majority (95%; 1361/1437) were men who have sex with men. Of all 1437 patients, 33%were non-Hispanic (NH) white, 30% Hispanic, and 23% NH Black. One third were foreign born (32%; 456/1437). Inconsistent condom use for vaginal/anal sex in the prior three months was reported by 76% (1059/1437) of patients. The prevalence of any PrEP contraindication was more common among dPrEP than iPrEP patients (14% vs 0.7%; p< 0.001) (see table). Patients ≥ 40 years were more likely to have any PrEP contraindication (3.0% vs 0.5%; p=0.01). PrEP was discontinued within 10 days among iPrEP patients with subsequently identified absolute contraindications (N=4). Among dPrEP patients without any contraindication, only 35% (15/43) initiated PrEP within

963 PrEP PERSISTENCE AND DISCONTINUATIONS IN A COHORT OF YOUNG BLACK MSM IN ATLANTA, GA David P. Serota 1 , Eli Rosenberg 2 , Annie M. Lockard 1 , Carlos del Rio 1 , Nicole Luisi 1 , Scott R. Cutro 3 , Charlotte-Paige M. Rolle 4 , Aaron J. Siegler 1 , Travis Sanchez 1 , Patrick S. Sullivan 1 , Colleen F. Kelley 1 1 Emory University, Atlanta, GA, USA, 2 State University of New York at Albany, Rensselaer, NY, USA, 3 Kaiser Permanente, Atlanta, GA, USA, 4 Orlando Immunology Center, Orlando, FL, USA Background: HIV incidence is high among young black MSM (YBMSM) in the US, and effective implementation of pre-exposure prophylaxis (PrEP) has great potential to reduce new infections. Scale up of PrEP is ongoing in this key population; yet, we continue to observe high HIV incidence (interim estimate 6%/year) in our cohort of YBMSM with access to PrEP services. A better understanding of patterns of PrEP persistence and discontinuation among YBMSM is needed. Methods: The EleMENt study is an observational cohort examining relationships between substance use and HIV risk behavior among HIV-negative YBMSM (n=299) aged 18-29 in Atlanta, GA. All participants were offered optional PrEP at each study visit over the 24-month follow-up. Clinical visits, labs, transportation, and navigation services for manufacturer assistance plans (MAP) to obtain no/low cost TDF/FTC were provided by the study. For initiators, we recorded time on and off PrEP based on frequent study surveys, prescription records, dates of MAP approvals, counseling notes, and other participant contacts. PrEP discontinuation events were defined as a ≥2 week lapse in PrEP use. Time to first PrEP discontinuation was assessed with the Kaplan- Meier method, with a Cox proportional hazard model used to identify factors associated with discontinuation. Results: After 483 person-years of follow up, 42% (125/299) of YBMSM initiated PrEP through the EleMENt program. Overall, PrEP initiators were “on PrEP” for 69% of possible person-time after initiation. 63% (79/125) discontinued PrEP at least once during study follow-up, and 68% of discontinuers (54/79) subsequently restarted PrEP. 22% (27/125) discontinued two or more times. The median time to first PrEP discontinuation was 219 days (95% CI 181-280). In a multivariable model, marijuana use (adjusted hazard ratio [aHR] 2.07, 95% CI 1.24-3.47), age <22 years (aHR 3.63, 95% CI 1.95-6.74) and having fewer than 3 sex partners (aHR 2.16, 95% CI 1.30-3.58) were associated with PrEP discontinuation. Conclusion: Persistent PrEP coverage in this cohort of YBMSM was suboptimal and discontinuations, including multiple discontinuations, were common despite additional support services available through the study. Interventions to support PrEP persistence, especially for younger and substance using YBMSM, will be necessary to achieve full effectiveness of PrEP. For the future, regimens that do not require adherence to a daily medication could help facilitate PrEP persistence in this key population.

Poster Abstracts

CROI 2019 377