Re: Pre-Exposure Prophylaxis for Mitigating Risk of HIV Transmission During HIV Cure–Related Clinical Trials With a Treatment Interruption

2019 ◽  
Vol 220 (7) ◽  
pp. 1231-1233
Author(s):  
Morenike Oluwatoyin Folayan ◽  
Bridget Haire ◽  
Veronica Noseda
Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 334
Author(s):  
Christel Protiere ◽  
Lisa Fressard ◽  
Marion Mora ◽  
Laurence Meyer ◽  
Marie Préau ◽  
...  

HIV cure-related clinical trials (HCRCT) with analytical antiretroviral treatment interruptions (ATIs) have become unavoidable. However, the limited benefits for participants and the risk of HIV transmission during ATI might negatively impact physicians’ motivations to propose HCRCT to patients. Between October 2016 and March 2017, 164 French HIV physicians were asked about their level of agreement with four viewpoints regarding HCRCT. A reluctance score was derived from their answers and factors associated with reluctance identified. Results showed the highest reluctance to propose HCRCT was among physicians with a less research-orientated professional activity, those not informing themselves about cure trials through scientific literature, and those who participated in trials because their department head asked them. Physicians’ perceptions of the impact of HIV on their patients’ lives were also associated with their motivation to propose HCRCT: those who considered that living with HIV means living with a secret were more motivated, while those worrying about the negative impact on person living with HIV’s professional lives were more reluctant. Our study highlighted the need to design a HCRCT that minimizes constraints for participants and for continuous training programs to help physicians keep up-to-date with recent advances in HIV cure research.


2019 ◽  
Vol 220 (Supplement_1) ◽  
pp. S16-S18 ◽  
Author(s):  
Jean-Daniel Lelièvre

AbstractAnalytical treatment interruption performed during human immunodeficiency virus (HIV) cure–related clinical trials exposes sex partners of participants in these trials to a risk of HIV transmission. Preexposure prophylaxis (PrEP), which emerged in recent years as a key strategy for preventing HIV transmission, is often considered a useful tool to prevent this risk. This article supports offering PrEP to the stable sex partners of participants in these trials but also notes limitations that must be addressed. It concludes that PrEP cannot on its own eliminate the risk of secondary transmission in this context.


2020 ◽  
Vol 222 (10) ◽  
pp. 1655-1659 ◽  
Author(s):  
Michael C Sneller ◽  
Erin D Huiting ◽  
Katherine E Clarridge ◽  
Catherine Seamon ◽  
Jana Blazkova ◽  
...  

Abstract Historical data regarding time to viral rebound following analytical treatment interruption (ATI) have been used to determine therapeutic efficacy in HIV cure trials; however, such data were collected from studies conducted a decade or more ago and included participants receiving older antiretroviral therapy (ART) regimens with infrequent virologic monitoring. We conducted a study of 22 HIV-infected participants receiving modern ART to determine the kinetics of plasma viral rebound following ATI. Our data suggest that modern ART does not alter kinetics of viral rebound when compared to previous regimens and that immunologic interventions may be necessary to achieve ART-free virologic remission. Clinical Trials Registration ClinicaTrials.gov identifier: NCT03225118.


AIDS ◽  
2020 ◽  
Vol 34 (7) ◽  
pp. 1095-1099 ◽  
Author(s):  
Christel Protiere ◽  
Marion Fiorentino ◽  
Abdourahmane Sow ◽  
Marie Préau ◽  
Marion Mora ◽  
...  

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S521-S522
Author(s):  
Jennifer R Silva-Nash ◽  
Stacie Bordelon ◽  
Ryan K Dare ◽  
Sherrie Searcy

Abstract Background Nonoccupational post exposure prophylaxis (nPEP) following sexual assault can prevent HIV transmission. A standardized Emergency Department (ED) protocol for evaluation, treatment, and follow up for post assault victims was implemented to improve compliance with CDC nPEP guidelines. Methods A single-center observational study of post sexual assault patients before/after implementation of an ED nPEP protocol was conducted by comparing the appropriateness of prescriptions, labs, and necessary follow up. A standardized order-set based on CDC nPEP guidelines, with involvement of an HIV pharmacist and ID clinic, was implemented during the 2018-2019 academic year. Clinical data from pre-intervention period (07/2016-06/2017) was compared to post-intervention period (07/2018-08/2019) following a 1-year washout period. Results During the study, 147 post-sexual assault patients (59 Pre, 88 Post) were included. One hundred thirty-three (90.4%) were female, 68 (46.6%) were African American and 133 (90.4%) were candidates for nPEP. Median time to presentation following assault was 12.6 hours. nPEP was offered to 40 (67.8%) and 84 (95.5%) patients (P< 0.001) and ultimately prescribed to 29 (49.2%) and 71 (80.7%) patients (P< 0.001) in pre and post periods respectively. Renal function (37.3% vs 88.6%; P< 0.001), pregnancy (39.0% vs 79.6%; P< 0.001), syphilis (3.4% vs 89.8%; P< 0.001), hepatitis B (15.3% vs 95.5%; P< 0.001) and hepatitis C (27.1% vs 94.3%) screening occurred more frequently during the post period. Labratory, nPEP Prescription and Follow up Details for Patients Prescribed nPEP Conclusion The standardization of an nPEP ED protocol for sexual assault victims resulted in increased nPEP administration, appropriateness of prescription, screening for other sexually transmitted infectious and scheduling follow up care. While guideline compliance dramatically improved, further interventions are likely warranted in this vulnerable population. Disclosures Ryan K. Dare, MD, MS, Accelerate Diagnostics, Inc (Research Grant or Support)


Author(s):  
Violeta J. Rodriguez ◽  
Andrew Spence ◽  
Mallory Monda ◽  
JoNell Potter ◽  
Deborah Jones

Background: Desires to have children are not lessened by a woman’s HIV status. Couples may lack information to conceive safely, and men may be especially uninformed. This study examined reproductive intentions, practices, and attitudes among men in HIV-infected couples, including attitudes regarding the perceived risk of vertical and horizontal transmission, safer conception, and preconception planning. Methods: Men ( n = 12) in HIV-infected couples were interviewed regarding reproductive intentions, attitudes, and knowledge and qualitative assessments were coded for dominant themes. Results: Themes primarily addressed concerns about the health of the baby, men’s involvement in pregnancy, safer conception, concerns about HIV transmission and antiretroviral therapy, and HIV infection. Men lacked information on safer conception and newer HIV prevention strategies, such as pre-exposure prophylaxis (PrEP). Discussion: Gaps in knowledge regarding preconception practices among men in HIV-infected couples were identified. Results highlight men’s desire for involvement in preconception planning, and opportunities for providers to facilitate this practice and to increase patient education and the use of PrEP are discussed.


2018 ◽  
Vol 30 (5) ◽  
pp. 393-405 ◽  
Author(s):  
Matthew A. Hevey ◽  
Jennifer L. Walsh ◽  
Andrew E. Petroll

HIV pre-exposure prophylaxis (PrEP) has been demonstrated to be a safe and effective method of reducing HIV incidence. Questions remain regarding PrEP's efficacy and outcomes in real-world clinical settings. We conducted a retrospective review to assess PrEP outcomes in an academic clinic setting and focused on retention in care, reasons for discontinuation, and receipt of appropriate preventive care (immunizations, HIV testing, and STI testing). One hundred thirty-four patients were seen between 2010 and 2016 over 309 visits. One hundred sixteen patients (87%) started daily PrEP and of those, 88 (76%) attended at least one 6-month follow-up visit. Over 60% of PrEP patients completed all recommended STI screening after starting PrEP. Only 40% of patients had all appropriate immunizations at baseline; 78% had all appropriate immunizations at study completion. This study demonstrated high rates of both retention and of attaining recommended preventive care in a clinical setting outside of the rigors of clinical trials.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S833-S833
Author(s):  
Alyson L Singleton ◽  
Brandon D Marshall ◽  
Xiao Zang ◽  
Amy S Nunn ◽  
William C Goedel

Abstract Background Although there is ongoing debate over the need for substantial increases in PrEP use when antiretroviral treatment confers the dual benefits of reducing HIV-related morbidity and mortality and the risk of HIV transmission, no studies to date have quantified the potential added benefits of PrEP use in settings with high treatment engagement across variable sub-epidemics in the United States. Methods We used a previously published agent-based network model to simulate HIV transmission in a dynamic network of 17,440 Black/African American and White MSM in Atlanta, Georgia from 2015 to 2024 to understand how the magnitude of reductions in HIV incidence attributable to varying levels of PrEP use (0–90%) changes in potential futures where high levels of treatment engagement (i.e. the UNAIDS ‘90-90-90’ goals and eventual ‘95-95-95’ goals) are achieved and maintained, as compared to current levels of treatment engagement in Atlanta (Figure 1). Model inputs related to HIV treatment engagement among Black/African American and White men who have sex with men in Atlanta. A comparison of current levels of treatment engagement (Panel A) to treatment engagement at ‘90-90-90’ (Panel B) and ‘95-95-95’ goals (Panel C). Results Even at achievement and maintenance of ‘90-90-90’ goals, 75% PrEP coverage reduced incidence rates by an additional 67.9% and 74.2% to 1.53 (SI: 1.39, 1.70) and 0.355 (SI: 0.316, 0.391) per 100 person-years for Black/African American and White MSM, respectively (Figure 2), compared to the same scenario with no PrEP use. Additionally, an increase from 15% PrEP coverage to 75% under ‘90-90-90’ goals only increased person-years of PrEP use per HIV infection averted, a measure of efficiency of PrEP, by 8.1% and 10.5% to 26.7 (SI: 25.6, 28.0) and 73.3 (SI: 70.6, 75.7) among Black/African American MSM and White MSM, respectively (Figure 3). Overall (Panel A) and race-stratified (Panel B and Panel C) marginal changes in HIV incidence over ten years among Black/African American and White men who have sex with men in Atlanta across scenarios of varied levels of treatment engagement among agents living with HIV infection and levels of pre-exposure prophylaxis use among HIV-uninfected agents. Note: All changes are calculated within each set of treatment scenarios relative to a scenario where no agents use pre-exposure prophylaxis. Person-years of pre-exposure prophylaxis use per HIV infection averted among Black/African American (Panel A) and White (Panel B) men who have sex with men in Atlanta across scenarios of varied levels of treatment engagement among agents living with HIV infection and levels of pre-exposure prophylaxis use among HIV-uninfected agents. Note: The number of HIV infections averted is calculated within each set of treatment scenarios relative to a scenario where no agents use pre-exposure prophylaxis. Conclusion Even in the context of high treatment engagement, substantial expansion of PrEP use still contributes to meaningful decreases in HIV incidence among MSM with minimal changes in person-years of PrEP use per HIV infection averted, particularly for Black/African American MSM. Disclosures All Authors: No reported disclosures


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