Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) has great potential to reduce HIV incidence among young black men who have sex with men (YBMSM); however, initiation and persistence ...for this group remain low. We sought to understand the patterns and predictors of PrEP uptake and discontinuation among YBMSM in Atlanta, Georgia.
PrEP was offered to all participants in a prospective cohort of YBMSM aged 18-29 years not living with HIV. Time to PrEP uptake, first discontinuation, and final discontinuation were assessed using the Kaplan-Meier method. Cox proportional hazard models were used to identify predictors of uptake and discontinuation.
After 440 person-years of follow-up, 44% of YBMSM initiated PrEP through the study after a median of 122 days. Of PrEP initiators, 69% had a first discontinuation and 40% had a final discontinuation during the study period. The median time to first PrEP discontinuation was 159 days. Factors associated with PrEP uptake included higher self-efficacy, sexually transmitted infection (STI), and condomless anal intercourse. Factors associated with discontinuation included younger age, cannabis use, STI, and fewer sex partners. HIV incidence was 5.23/100 person-years (95% confidence interval CI, 3.40-7.23), with a lower rate among those who started PrEP (incidence rate ratio, 0.39; 95% CI, .16-.92).
Persistent PrEP coverage in this cohort of YBMSM was suboptimal, and discontinuations were common despite additional support services available through the study. Interventions to support PrEP uptake and persistence, especially for younger and substance-using YBMSM, are necessary to achieve full PrEP effectiveness.
NCT02503618.
Approximately 50% of people living with HIV (PLWH) in the United States are ≥50 years old. Clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) demonstrated potent efficacy ...and favorable safety in older PLWH; however, real-world data would be useful to validate these results.Retrospective cohort study.We evaluated records from PLWH aged ≥50 years at the Orlando Immunology Center who were switched to B/F/TAF between February 2018 and August 2019. Eligible patients had baseline HIV-1 RNA <50 copies/mL and 48 weeks of follow-up data. The primary endpoint was maintenance of HIV-1 RNA <50 copies/mL at Week 48. The impact of switching to B/F/TAF on drug-drug interactions (DDIs) and safety parameters were also assessed.Three-hundred and fifty patients met inclusion criteria, median age was 57 years, 20% were women, and 43% were non-White. Fifty-five percent of patients switched from integrase inhibitor-based regimens; the most common reason for switch was simplification. At Week 48, 330 (94%) patients maintained an HIV-1 RNA <50 copies/mL and 20 (6%) had an HIV-1 RNA between 50 and 400 copies/mL. One-hundred and forty potential DDIs were identified in 121 (35%) patients taking a boosting agent or rilpivirine at baseline that were resolved after switching to B/F/TAF. Treatment-related adverse events occurred in 51 (15%) patients (all Grade 1-2) and led to 8 discontinuations.In this real-world cohort, switching to B/F/TAF was associated with maintenance of virologic control, and avoidance of DDIs in a large proportion of patients. These data support use of B/F/TAF as a treatment option in older PLWH.
For marginalized populations, county health departments may be important PrEP access points; however, there are little data on successful PrEP programs at these venues outside of incentivized ...demonstration projects. Therefore, we implemented an open-access, free PrEP clinic at a county health department in Atlanta, GA to promote PrEP uptake among high-risk clients. The Fulton County Board of Health PrEP clinic launched in October 2015, and eligible clients who expressed interest initiated PrEP and attended follow-up visits per CDC guidelines. Clients engaged in quarterly follow-up and seen within the last 6 months were defined as “persistent”, whereas clients with a lapse in follow-up of > 6 months were defined as “not persistent.” Factors associated with PrEP persistence were assessed with unadjusted odds ratios. Between October 2015 and June 2017, 399 clients were screened for PrEP, almost all were eligible 392/399 (98%); however, 158/392 (40%) did not return to start PrEP after screening. Of 234 patients, 216 (92%) received a prescription for PrEP. As of June 2017, only 69/216 (32%) clients remained persistent in PrEP care, and the only evaluated factor significantly associated with PrEP persistence was age ≥ 30 years (OR 1.86, 95% CI 1.02, 3.42). Implementation of PrEP in the county health department setting is feasible; however, we have identified significant challenges with PrEP uptake and persistence in our setting. Further research is needed to fully understand mediators of PrEP persistence and inform interventions to optimize health department-based PrEP services.
In a cohort of young black men who have sex with men, we observed high human immunodeficiency virus incidence despite education and access to preexposure prophylaxis (PrEP). Although PrEP has ...efficacy in clinical trials, we identify barriers to real-world effectiveness.
Abstract
Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) has high biomedical efficacy; however, awareness, access, uptake, and persistence on therapy remain low among black men who have sex with men (BMSM), who are at highest risk of HIV in the United States. To date, discussions of "PrEP failure" have focused on one typology: rare, documented HIV acquisitions among PrEP users with adequate serum drug levels (ie, biomedical failure). In our cohort of HIV-negative young BMSM in Atlanta, Georgia, we continue to observe a high HIV incidence (6.2% annually at interim analysis) despite access to free PrEP services. Among 14 seroconversions, all were offered PrEP before acquiring HIV. Among these participants, we identified 4 additional typologies of PrEP failure that expand beyond biomedical failure: low PrEP adherence, PrEP discontinuation, PrEP contemplation without initiation, and PrEP refusal. We describe the 5 typologies and suggest interventions to improve PrEP effectiveness among those at highest risk.
Orlando has the second highest HIV incidence in the USA. Tenofovir disoproxil fumarate/emtricitabine is approved as pre-exposure prophylaxis (PrEP) to minimize HIV transmission. Our study describes ...the PrEP care continuum and factors impacting PrEP persistence during the first year of PrEP care at a sexual health clinic in Orlando. Patients initiating PrEP between 2014 and 2017 with at least 1 year of follow-up were eligible for inclusion. Demographic and clinical factors were extracted from medical records. At the end of the first year of PrEP care, patients seen within the last 6 months were defined as 'persistent' whereas patients lost to follow-up for ≥6 months were defined as 'not persistent'. We evaluated factors associated with PrEP persistence with Firth's multivariable logistic regression. Of 300 patients meeting inclusion criteria, 96% were male, 59% were ≥30 years old, 59% identified as men who have sex with men and 57% endorsed recent condomless anal intercourse. Of PrEP initiators, 133 (44.3%) were persistent in the first year, whereas 167 (55.7%) were not persistent. PrEP persistence was positively associated with age ≥30 years (OR 1.04, 95% CI 1.0 to 1.08) and negatively associated with non-white race (OR 0.33, 95% CI 0.12 to 0.83). There were no HIV seroconversions among persistent patients. In our study, younger and minority patients were less likely to persist in PrEP care and persistence was poor despite many being insured and 'high-risk'. Further research is needed to identify and address barriers that hinder PrEP persistence, specifically among younger, minority patients.
Human immunodeficiency virus (HIV)-1-specific broadly neutralizing monoclonal antibodies are currently under development to treat and prevent HIV-1 infection. We performed a single-center, ...randomized, double-blind, dose-escalation, placebo-controlled trial of a single administration of the HIV-1 V3-glycan-specific antibody PGT121 at 3, 10 and 30 mg kg
in HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART), as well as a multicenter, open-label trial of one infusion of PGT121 at 30 mg kg
in viremic HIV-infected adults not on ART (no. NCT02960581). The primary endpoints were safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART. The secondary endpoints were changes in anti-PGT121 antibody titers and CD4
T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance. Among 48 participants enrolled, no treatment-related serious adverse events, potential immune-mediated diseases or Grade 3 or higher adverse events were reported. The most common reactions among PGT121 recipients were intravenous/injection site tenderness, pain and headache. Absolute and relative CD4
T-cell counts did not change following PGT121 infusion in HIV-infected participants. Neutralizing anti-drug antibodies were not elicited. PGT121 reduced plasma HIV RNA levels by a median of 1.77 log in viremic participants, with a viral load nadir at a median of 8.5 days. Two individuals with low baseline viral loads experienced ART-free viral suppression for ≥168 days following antibody infusion, and rebound viruses in these individuals demonstrated full or partial PGT121 sensitivity. The trial met the prespecified endpoints. These data suggest that further investigation of the potential of antibody-based therapeutic strategies for long-term suppression of HIV is warranted, including in individuals off ART and with low viral load.
Background
Cohort studies suggest higher discontinuation rates with integrase strand transfer inhibitors (INSTIs) than are seen in clinical trials. We assessed discontinuations and adverse events ...(AEs) that were considered related to the initial INSTI in the first year following initiation among treatment-naïve people living with HIV (PLWH).
Methods
Newly diagnosed PLWH initiating raltegravir, elvitegravir/cobicistat, dolutegravir or bictegravir in combination with emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil fumarate between 10/2007 and 1/2020 at the Orlando Immunology Center were included. Unadjusted incidence rates (IRs) and incidence rate ratios (IRRs) were calculated for treatment-related discontinuations and AEs associated with the initial INSTI in the first year following initiation.
Results
Of 331 enrolled, 26 (8%) initiated raltegravir, 151 (46%) initiated elvitegravir/cobicistat, 74 (22%) initiated dolutegravir and 80 (24%) initiated bictegravir. Within the first year, treatment-related discontinuations occurred in 3 on elvitegravir/cobicistat (IR 0.02 per person-years (PPY)) and 5 on dolutegravir (IR 0.08 PPY); no treatment-related discontinuations occurred among those initiating raltegravir or bictegravir. Eleven treatment-related AEs occurred in 7 on raltegravir (IR 0.46 PPY), 100 treatment-related AEs occurred in 63 on elvitegravir/cobicistat (IR 0.72 PPY), 66 treatment-related AEs occurred in 37 on dolutegravir (IR 0.97 PPY) and 65 treatment-related AEs occurred in 34 on bictegravir (IR 0.88 PPY). Unadjusted IRRs did not reveal any significant difference between INSTIs in terms of early treatment-related discontinuations or AEs.
Conclusions
In our cohort, treatment-related AEs occurred in 43% initiating INSTIs but were responsible for early discontinuation in only 2% with no treatment-related discontinuations observed among those initiating RAL or BIC.
BACKGROUND:HIV incidence among US young, black men who have sex with men (YBMSM) is high, and structural barriers (eg lack of health insurance) may limit access to Pre-exposure prophylaxis (PrEP). ...Research studies conducted with YBMSM must ensure access to the best available HIV prevention methods, including PrEP.
METHODS:We implemented an optional, nonincentivized PrEP program in addition to the standard HIV prevention services in a prospective, observational cohort of HIV-negative YBMSM in Atlanta, GA. Provider visits and laboratory costs were covered; participant insurance plans and/or the manufacturer assistance program were used to obtain drugs. Factors associated with PrEP initiation were assessed with prevalence ratios and time to PrEP initiation with Kaplan–Meier methods.
RESULTS:Of 192 enrolled YBMSM, 4% were taking PrEP at study entry. Of 184 eligible men, 63% indicated interest in initiating PrEP, 10% reported no PrEP interest, and 27% wanted to discuss PrEP again at a future study visit. Of 116 interested men, 46% have not attended a PrEP initiation appointment. Sixty-three men (63/184; 34%) initiated PrEP; 11/63 (17%) subsequently discontinued PrEP. The only factor associated with PrEP initiation was reported sexually transmitted infection in the previous year (prevalence ratio 1.50, 95% confidence interval1.002 to 2.25). Among interested men, median time to PrEP initiation was 16 weeks (95% confidence interval7 to 36).
CONCLUSIONS:Despite high levels of interest, PrEP uptake may be suboptimal among YBMSM in our cohort even with amelioration of structural barriers that can limit use. PrEP implementation as the standard of HIV prevention care in observational studies is feasible; however, further research is needed to optimize uptake for YBMSM.
Young Black men who have sex with men (YBMSM) bear a disproportionate burden of HIV, and HIV pre-exposure prophylaxis (PrEP) uptake has been slow. Decisions regarding PrEP initiation change in ...different life contexts over time. Our YBMSM cohort study found about 1/3 of those who initially declined PrEP subsequently changed and initiated PrEP care. This study explores the process of their PrEP decision changes. The study interviewed participants who initially voiced strong and clear reservations about PrEP, but subsequently started PrEP 1-14 months later. In "review/renew" follow-up interviews, participants reviewed their past statements from a time they declined PrEP, and renew their understanding regarding perspective and behavioral change. Analyzing the data with a positive deviance framework, we found that shifting the decisional balance in favor of PrEP initiation only required change in some areas. There were not consistent factors that prevented or facilitated PrEP uptake. Instead, YBMSM initiated PrEP while maintaining an array of substantial reservations. PrEP initiation discussions should be viewed by health practitioners as a longitudinal process, and routine PrEP offers should be made over time. To optimally facilitate PrEP use among YBMSM, the diverse benefits of PrEP should be emphasized rather than focusing on allaying all concerns.
Dolutegravir/lamivudine (DTG/3TC) is indicated for treatment-naive and experienced people with HIV; however, questions remain about its utility in a test-and-treat setting because of potential ...transmitted resistance and baseline hepatitis B virus (HBV) co-infection. We present feasibility and efficacy of DTG/3TC in newly diagnosed individuals in a test-and-treat setting.
The single-arm STAT study evaluated DTG/3TC in a US test-and-treat setting.
Eligible adults initiated DTG/3TC 14 days or less after HIV-1 diagnosis without availability of baseline laboratory results. If baseline testing indicated DTG or 3TC resistance, HBV co-infection, or creatinine clearance less than 30 ml/min per 1.73 m2, participants remained on study with treatment modification. Efficacy endpoints included proportions of participants with HIV-1 RNA less than 50 copies/ml at Week 24, regardless of antiretroviral regimen, among all participants (intention-to-treat exposed) and those with available HIV-1 RNA data (observed).
Of 131 participants enrolled, 8% were female and 50% were non-white. Through Week 24, treatment was modified in eight participants five with HBV co-infection, one with baseline M184V, one for adverse event (rash), one participant decision. At Week 24, 78% (102/131) of all participants and 92% (102/111) of those with available data achieved HIV-1 RNA less than 50 copies/ml. Incidence of drug-related adverse events was low (7%); no drug-related serious adverse events occurred.
These data demonstrate the feasibility, efficacy, and safety of using DTG/3TC as a first-line regimen in a test-and-treat setting, with therapy adjustments for baseline resistance or HBV co-infection occurring safely via routine clinical care as needed ClinicalTrials.gov, NCT03945981; see Supplemental Digital Content 1, video abstract (Video abstract summarizing the STAT study design and results), http://links.lww.com/QAD/C189.
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