scholarly journals Plasma and intracellular pharmacokinetics of tenofovir disoproxil fumarate and emtricitabine in transgender women receiving feminizing hormone therapy

2020 ◽  
Vol 75 (5) ◽  
pp. 1242-1249 ◽  
Author(s):  
Lauren R Cirrincione ◽  
Anthony T Podany ◽  
Joshua P Havens ◽  
Sara H Bares ◽  
Shetty Ravi Dyavar ◽  
...  
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Geometric Mean ◽  
Increased Risk ◽  
And Gender ◽  
Hiv Acquisition ◽  
Risk Of Hiv Acquisition ◽  
Exposure Prophylaxis ◽  
Tissue Compartments ◽  
Tenofovir Diphosphate ◽  
Hiv Negative

Abstract Background Transwomen have an increased risk of HIV acquisition compared with other adults. Drug–drug interactions between pre-exposure prophylaxis (PrEP) and gender-affirming therapy are cited as a reason for poor PrEP uptake among transwomen. We evaluated plasma tenofovir and emtricitabine pharmacokinetics and their active intracellular anabolites, tenofovir-diphosphate and emtricitabine-triphosphate, in transwomen receiving feminizing hormones. Methods We enrolled HIV-negative transwomen (≥19 years) not receiving PrEP. Participants took oral tenofovir disoproxil fumarate/emtricitabine 300/200 mg daily for 14 days. Plasma was collected at 0 h (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 h on day 14 post-tenofovir disoproxil fumarate/emtricitabine dose. The plasma AUC0–24 was calculated using the trapezoidal rule and compared with historical HIV-negative cisgender adults as geometric mean ratios (GMRs, 90% CI). Secondarily, tenofovir-diphosphate and emtricitabine-triphosphate from PBMCs collected at 0 h and 12 h were reported descriptively as geometric means (90% CI). Clinical trials registration: NCT03270969. Results Among 15 transwomen (mean age 32 years), geometric mean tenofovir and emtricitabine plasma AUC0–24 were lower compared with controls: tenofovir, 2.10 versus 2.76 mg·h/L, GMR 0.76 (0.65–0.90), P = 0.01; emtricitabine, 9.15 versus 10.64 mg·h/L, GMR 0.86 (0.75–0.98), P = 0.07. Tenofovir-diphosphate and emtricitabine-triphosphate concentrations were higher than previously reported in the literature: 167.1 (146.6–190.5) fmol/106 cells and 15.4 (13.8–17.3) pmol/106 cells, respectively. Conclusions We observed lower plasma tenofovir and emtricitabine concentrations in transwomen compared with historical cisgender adults, yet intracellular tenofovir-diphosphate and emtricitabine-triphosphate concentrations were higher than previously reported in PBMCs. Understanding the differences of PrEP pharmacokinetics in plasma and tissue compartments and the resultant impact on efficacy remains important for transwomen.

High uptake of pre-exposure prophylaxis (PrEP) during early roll-out in Belgium: results from surveillance reports

Sexual Health ◽  
2019 ◽  
Vol 16 (1) ◽  
pp. 80 ◽  
Author(s):  
Bea Vuylsteke ◽  
Thijs Reyniers ◽  
Catherine Lucet ◽  
Christiana Nöstlinger ◽  
Jessika Deblonde ◽  
...  
Keyword(s):  
Disability Insurance ◽  
Aggregated Data ◽  
Increased Risk ◽  
Event Driven ◽  
Sub Saharan ◽  
Sex With Men ◽  
Hiv Acquisition ◽  
Risk Of Hiv Acquisition ◽  
Exposure Prophylaxis ◽  
Roll Out

Background Since 1 June 2017, oral pre-exposure prophylaxis (PrEP) could be prescribed and reimbursed in Belgium as prophylactic medication for people who are at increased risk of HIV acquisition. The aim of this study was to determine the uptake of daily and event-driven PrEP in Belgium during the first 9 months of roll-out. Methods: Routine aggregated data on the number of reimbursement requests and the number of boxes of Truvada (Gilead Sciences, Cambridge, UK) delivered for PrEP through the Belgian pharmacies were obtained from the National Institute for Health and Disability Insurance. We also collected aggregated data from seven Aids Reference Centres (ARCs) currently providing most of the PrEP care in Belgium. Results: From 1 June 2017 to 28 February 2018, 1352 requests for reimbursement were approved by the National Institute for Health and Disability Insurance. Almost 98% of those who bought at least one box of 30 tablets of emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (FTC/TDF) in a Belgian pharmacy were male, and most (67%) were between 30 and 50 years of age. According to data obtained from ARCs, the proportion of those choosing event-driven PrEP initially ranged between 29% and 73%. Conclusions: The uptake of PrEP in Belgium since the start of the roll-out in June 2017 has been high, and almost entirely limited to men who have sex with men, of whom 43% initially prefer a non-daily regimen. A better understanding is needed as to why other populations, such as sub-Saharan African migrants, are not accessing PrEP, as well as the development of a more sustainable PrEP delivery model.

scholarly journals Factors associated with knowledge of pre-exposure prophylaxis in pregnant women in Cape Town, South Africa

2019 ◽  
Vol 30 (11) ◽  
pp. 1063-1070
Author(s):  
David J DiTullio ◽  
Elise Farley ◽  
Yolanda Gomba ◽  
Thomas J. Coates ◽  
Linda-Gail Bekker ◽  
...  
Keyword(s):  
Cape Town ◽  
Health Clinic ◽  
Postpartum Women ◽  
Factors Associated ◽  
Increased Risk ◽  
Pregnancy And Postpartum ◽  
Hiv Acquisition ◽  
Risk Of Hiv Acquisition ◽  
Exposure Prophylaxis ◽  
In Pregnancy

Pregnant and postpartum women in Southern Africa are at increased risk of HIV infection. Pre-exposure prophylaxis in pregnancy and postpartum periods could significantly reduce the risk of HIV acquisition and transmission in pregnancy. Participants at a community health clinic in Cape Town completed a survey about demographic and sexual risk behaviors, and prior knowledge of pre-exposure prophylaxis. We evaluated factors associated with knowledge of pre-exposure prophylaxis using multivariable logistic regression. We enrolled 50 pregnant and 37 postpartum women, of whom 51% were HIV-uninfected. Twenty-nine (33%) knew about pre-exposure prophylaxis, most from their healthcare provider (69%). Older age (adjusted odds ratio [aOR]/year = 1.09, 95% CI = 1.00–1.19), unintended pregnancy (aOR = 3.36, 95% CI = 1.06–12.12), and more than one sex partner in the last year (aOR = 5.31, 95% CI = 1.12–30.07) were associated with pre-exposure prophylaxis knowledge. Our study identified low levels of pre-exposure prophylaxis knowledge in pregnant and breastfeeding women, but increased knowledge in higher risk women. These results provide guidance to develop interventions to increase pre-exposure prophylaxis knowledge and uptake.

Defining the PrEP care continuum among recently incarcerated men at high risk for HIV infection (Preprint)

2021 ◽  
Author(s):  
Matthew Murphy ◽  
Colette Sosnowy ◽  
Brooke Rogers ◽  
Siena Napoleon ◽  
Drew Galipeau ◽  
...  
Keyword(s):  
Public Health ◽  
High Risk ◽  
Hiv Infection ◽  
Care Continuum ◽  
Increased Risk ◽  
Biomedical Intervention ◽  
Prep Implementation ◽  
Hiv Acquisition ◽  
Risk Of Hiv Acquisition ◽  
Prospective Longitudinal

BACKGROUND HIV disproportionately impacts criminal justice (CJ)-involved individuals, including men who experience incarceration. Men make up the vast majority of those experiencing incarceration as well as those newly diagnosed with HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention that significantly reduces the risk of HIV acquisition. However, implementation in CJ-systems is limited. Little is known about effective PrEP implementation and use in this unique public health context. OBJECTIVE This article describes a PrEP care continuum for men experiencing incarceration who are at increased risk of HIV acquisition, which can help conceptualize approaches to evaluating PrEP implementation. METHODS Men incarcerated in the Rhode Island Department of Corrections, a correctional system composed of all of the state's sentenced and awaiting trial population, are screened for HIV acquisition risk during the course of routine clinical care. Those identified at high risk for HIV acquisition are referred for evaluation for PrEP initiation and enrollment in this study. Individuals who express interest in initiating PrEP and consent to the study are then followed in a prospective longitudinal cohort. RESULTS The outlined study will enroll 100 men experiencing incarceration at high risk for HIV acquisition prior to release into the community. The goal is to initiate PrEP prior to incarceration and link individuals to PrEP providers in the community, capturing barriers and facilitators to PrEP use during this uniquely vulnerable time period for HIV acquisition. CONCLUSIONS Based on the proposed care continuum and what is known about HIV risk and prevention efforts in the CJ-context, we outline key future research efforts to better understand effective approaches to preventing HIV infection among this vulnerable population. The described approach presents a powerful public health opportunity to help end the HIV epidemic.

scholarly journals Increased tenofovir monoester concentrations in patients receiving tenofovir disoproxil fumarate with ledipasvir/sofosbuvir

2019 ◽  
Vol 74 (8) ◽  
pp. 2360-2364 ◽  
Author(s):  
Kristina M Brooks ◽  
Jose R Castillo-Mancilla ◽  
Joshua Blum ◽  
Ryan Huntley ◽  
Samantha MaWhinney ◽  
...  
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Clinical Relevance ◽  
Geometric Mean ◽  
Plasma Concentrations ◽  
Dried Blood Spots ◽  
Pharmacokinetic Parameters ◽  
Post Dose ◽  
P Values ◽  
Hydrolysis Of ◽  
Tenofovir Diphosphate

AbstractBackgroundIntracellular tenofovir diphosphate concentrations are markedly increased in HIV/HCV coinfected individuals receiving tenofovir disoproxil fumarate (TDF) with sofosbuvir-containing treatment. Sofosbuvir may inhibit the hydrolysis of TDF to tenofovir, resulting in increased concentrations of the disoproxil or monoester forms, which may augment cell loading. We sought to quantify tenofovir disoproxil and monoester concentrations in individuals receiving TDF with and without ledipasvir/sofosbuvir.MethodsHIV/HCV coinfected participants receiving TDF-based therapy were sampled pre-dose and 1 and 4 h post-dose prior to and 4 weeks after initiating ledipasvir/sofosbuvir. Tenofovir disoproxil was not detectable. Tenofovir monoester in plasma and tenofovir diphosphate in PBMC and dried blood spots (DBS) were quantified using LC-MS/MS. Geometric mean ratios (week 4 versus baseline) and 95% CIs were generated for the pharmacokinetic parameters. P values reflect paired t-tests.ResultsTen participants had complete data. At baseline, geometric mean (95% CI) tenofovir monoester plasma concentrations at 1 and 4 h post-dose were 97.4 ng/mL (33.0–287.5) and 0.74 ng/mL (0.27–2.06), respectively. With ledipasvir/sofosbuvir, tenofovir monoester concentrations at 4 h post-dose were 5.02-fold higher (95% CI 1.40–18.05; P = 0.019), but did not significantly differ at 1 h post-dose (1.72-fold higher, 95% CI 0.25–11.78; P = 0.54), possibly due to absorption variability. Tenofovir diphosphate in PBMC and DBS were increased 2.80-fold (95% CI 1.71–4.57; P = 0.001) and 7.31-fold (95% CI 4.47–11.95; P < 0.0001), respectively, after 4 weeks of ledipasvir/sofosbuvir.ConclusionsTenofovir monoester concentrations were increased in individuals receiving TDF with ledipasvir/sofosbuvir, consistent with inhibition of TDF hydrolysis. Additional studies are needed to determine the clinical relevance of this interaction.

scholarly journals Actual sexual risk and perceived risk of HIV acquisition among HIV-negative men who have sex with men in Toronto, Canada

2016 ◽  
Vol 16 (1) ◽  
Author(s):  
Maya A. Kesler ◽  
Rupert Kaul ◽  
Juan Liu ◽  
Mona Loutfy ◽  
Dionne Gesink ◽  
...  
Keyword(s):  
Sexual Risk ◽  
Perceived Risk ◽  
Sex With Men ◽  
Hiv Acquisition ◽  
Risk Of Hiv Acquisition ◽  
Hiv Negative

scholarly journals A Web-Based Study of HIV Prevention in the Era of Pre-Exposure Prophylaxis Among Vulnerable HIV-Negative Gay and Bisexual Men, Transmen, and Transwomen Who Have Sex With Men: Protocol for an Observational Cohort Study (Preprint)

2019 ◽  
Author(s):  
Denis Nash ◽  
Matthew Stief ◽  
Caitlin MacCrate ◽  
Chloe Mirzayi ◽  
Viraj V Patel ◽  
...  
Keyword(s):  
High Risk ◽  
Hiv Prevention ◽  
Hiv Testing ◽  
The United States ◽  
Racially Diverse ◽  
Web Based ◽  
Sex With Men ◽  
Hiv Acquisition ◽  
Exposure Prophylaxis ◽  
Hiv Negative

BACKGROUND Gay, bisexual, and other men who have sex with men continue to bear a large burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years. OBJECTIVE The Together 5000 (T5K) Study aimed to enroll a US-based, racially diverse sample of HIV-negative men, transmen, and transwomen who are not on pre-exposure prophylaxis (PrEP) into an observational cohort to inform the design, implementation, scale-up, and evaluation of HIV prevention programs. METHODS We used internet-based strategies to enroll a large, racially diverse national sample of HIV-negative men, transmen, and transwomen aged 16 to 49 years at high risk of HIV acquisition via sexual networking apps. Study participants are contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (ie, attempts to access, PrEP initiation, and PrEP discontinuation). Participants complete annual self-administered at-home HIV testing and Web-based surveys. Using baseline serologic data and self-reported HIV testing history, we reconstructed a cohort of persons who were HIV negative at 12 months before baseline to estimate HIV incidence leading up to cohort enrollment. RESULTS The study sample included 8777 participants from all 50 US states, Puerto Rico, and Guam; 50.91% (4468/8777) were persons of color and 25.30% (2221/8777) were young individuals aged 16 to 24 years. Per eligibility criteria, all T5K participants reported having sex with >2 male partners in the 90 days before enrollment, self-reported not having been diagnosed with HIV, and were not actively taking PrEP. In addition, 79.39% (6968/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days. Furthermore, most (7525/8777, 85.74%) reported never having taken PrEP. In total, 70.25% (6166/8777) were sent a self-administered at-home HIV test kit and 82.29% (5074/6166) of those sent a kit returned a sample for testing. The HIV incidence rate during the 12-month period leading up to enrollment was estimated to be 2.41 (95% CI 2.02-2.90) per 100 person-years. CONCLUSIONS A large, national, and racially diverse fully Web-based cohort of HIV-negative men, transmen, and transwomen at high risk for HIV seroconversion has successfully been recruited into longitudinal follow-up. This cohort is at high risk for HIV acquisition and can provide important insights related to the real-world uptake, impact, and equity of HIV prevention interventions in the United States. Participants can be invited to participate in trials aimed at testing strategies to improve the uptake of and engagement in these interventions. INTERNATIONAL REGISTERED REPORT RR1-10.2196/13715

scholarly journals Knowledge of HIV pre-exposure prophylaxis among immigrant Asian gay men living in New Zealand

2019 ◽  
Vol 11 (4) ◽  
pp. 351 ◽  
Author(s):  
Jeffery Adams ◽  
Rommel Coquilla ◽  
Jed Montayre ◽  
Stephen Neville
Keyword(s):  
Health Promotion ◽  
New Zealand ◽  
Gay Men ◽  
Individual Level ◽  
Care Services ◽  
Primary Care Services ◽  
The Individual ◽  
Hiv Acquisition ◽  
Risk Of Hiv Acquisition ◽  
Exposure Prophylaxis

ABSTRACT INTRODUCTIONHIV pre-exposure prophylaxis (PrEP) is a new bio-medical means of reducing the risk of HIV infection. It’s use by individuals at high risk of HIV acquisition is recommended. AimsThis study identifies the ways immigrant Asian gay men living in New Zealand talk about and understand issues related to PrEP. METHODSA qualitative descriptive methodology was used. Individual interviews were conducted with 18 immigrant Asian gay men who were not users of PrEP. Participants were aged 21 – 36 years and one-third had arrived in New Zealand within 3 years of completing the interview. Data were analysed using thematic analysis. RESULTSThree themes evident across the men’s talk in relation to pre-exposure prophylaxis were identified: ‘I’m not sure what PrEP is’; ‘PrEP is not proven’; and ‘PrEP is for others, not me’. DISCUSSIONPrEP is necessary for working towards the elimination of HIV. To improve uptake among Asian gay men, improved literacy around HIV and pre-exposure prophylaxis is required. This knowledge needs to be improved at both the individual level in primary care services and collectively through health promotion initiatives. These services and health promotion initiatives need to be provided in ways that encourage engagement by Asian gay men.

scholarly journals Depot Medroxyprogesterone Acetate and the Vaginal Microbiome as Modifiers of Tenofovir Diphosphate and Lamivudine Triphosphate Concentrations in the Female Genital Tract of Ugandan Women: Implications for Tenofovir Disoproxil Fumarate/Lamivudine in Preexposure Prophylaxis

2019 ◽  
Vol 70 (8) ◽  
pp. 1717-1724 ◽  
Author(s):  
Melanie R Nicol ◽  
Prosperity Eneh ◽  
Rita Nakalega ◽  
Thomas Kaiser ◽  
Samuel Kabwigu ◽  
...  
Keyword(s):  
Medroxyprogesterone Acetate ◽  
Tenofovir Disoproxil Fumarate ◽  
Genital Tract ◽  
Female Genital Tract ◽  
Depot Medroxyprogesterone Acetate ◽  
Preexposure Prophylaxis ◽  
Increased Risk ◽  
Vaginal Swabs ◽  
Tenofovir Diphosphate ◽  
Female Genital

Abstract Background Effective concentrations of antiretrovirals in the female genital tract (FGT) are critical for suppression of viral shedding or effective preexposure prophylaxis. The disposition of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in the FGT have been previously described. Despite widespread use, however, lamivudine triphosphate (3TC-TP) exposure in the FGT is unknown. Depot medroxyprogesterone acetate (DMPA) and vaginal dysbiosis have been implicated in increased risk of human immunodeficiency virus (HIV) acquisition, but whether they alter TFV-DP or 3TC-TP exposure, and therefore compromise prevention efficacy, is unknown. Methods Fifty premenopausal women living with HIV in Kampala, Uganda, and receiving daily tenofovir disoproxil fumarate/lamivudine were recruited. Ectocervical biopsies were obtained for quantification of TFV-DP and 3TC-TP using liquid chromatography–mass spectrometry. 16S ribosomal RNA gene sequencing was performed on DNA extracted from vaginal swabs. Wilcoxon rank-sum was used to test for differences between contraceptive groups. Results 3TC-TP concentrations were on average 17-fold greater than TFV-DP concentrations in cervical tissues. TFV-DP concentrations in cervical biopsies were 76% greater in DMPA users compared with women using nonhormonal contraception (n = 23 per group). Abundance of Lactobacillus in vaginal swabs was correlated with 3TC-TP concentrations in cervical tissues. Conclusions We found that TFV-DP concentrations were significantly greater in DMPA users compared with women using nonhormonal contraception, suggesting that prevention efficacy is unlikely to be compromised by DMPA use. Similar to reports of FTC-TP, 3TC-TP exposure was significantly greater than TFV-DP in cervical tissue and was correlated with abundance of Lactobacillus. These data support lamivudine as an option for preexposure prophylaxis. Clinical Trials Registration NCT03377608.

Early experience of implementing a national HIV pre-exposure prophylaxis service in Wales, United Kingdom 2017

Sexual Health ◽  
2019 ◽  
Vol 16 (1) ◽  
pp. 56 ◽  
Author(s):  
Laia Fina ◽  
Amy L. Phillips ◽  
Adam T. Jones ◽  
Zoë M. Couzens ◽  
Rachel Drayton ◽  
...  
Keyword(s):  
Sexual Health ◽  
Early Experience ◽  
Hiv Positive ◽  
Transgender People ◽  
Positive Individual ◽  
Sexually Transmissible Infections ◽  
Sex With Men ◽  
Hiv Acquisition ◽  
Risk Of Hiv Acquisition ◽  
Exposure Prophylaxis

Background Pre-exposure prophylaxis (PrEP) was introduced in Sexual Health Services of the Welsh National Health Service (NHS Wales) in July 2017 as a 3-year pilot service. Methods: Data were collected through the pre-existing Sexual Health in Wales Surveillance System, to which codes were added to capture PrEP eligibility, outcome of offer of PrEP, reasons for declining and adherence. Eligibility categories were defined based on nationally agreed criteria: men who have sex with men (MSM) and transgender people at high risk of HIV acquisition; partners of HIV-positive individuals not known to be virally suppressed; and heterosexuals reporting condomless intercourse with a HIV-positive individual not known to be virally suppressed. Results: During the first 6 months, 516 people were eligible, 96% of which were MSM. Overall, 57% of those eligible (296/516) started PrEP. Reasons for declining PrEP were given by 88 (56%) of 157 people; 50 (57%) of whom did not believe themselves to be at risk. Of the available adherence assessments, 89% considered that all risk episodes had been covered. Persistence at 3 months was assessed for 141 people, of which 93 (66%) were still using PrEP. There were no HIV diagnoses in people taking PrEP during the first 6 months. Twenty-nine people were diagnosed with 37 episodes of sexually transmissible infections (STIs) while on PrEP. STI incidence was 105.7 per 100 person-years. Conclusions: The early trend indicates that implementation of PrEP is progressing as planned, and the service has been utilised by clients. This analysis can help refine implementation, inform planning and research around uptake, use and effect in Wales and internationally.

Missed opportunities for HIV pre-exposure prophylaxis during a rapid scale-up program at Sydney Sexual Health Centre

Sexual Health ◽  
2019 ◽  
Vol 16 (6) ◽  
pp. 591
Author(s):  
David Atefi ◽  
Ruthy McIver ◽  
Christopher Bourne
Keyword(s):  
Sexual Health ◽  
Medical Records ◽  
Health Centre ◽  
Scale Up ◽  
Missed Opportunities ◽  
Standard Component ◽  
Hiv Acquisition ◽  
Risk Of Hiv Acquisition ◽  
Exposure Prophylaxis ◽  
Missed Opportunity

We aimed to estimate HIV pre-exposure prophylaxis (PrEP) uptake and missed opportunities for PrEP through a retrospective review of medical records of clients at high risk of HIV attending the Sydney Sexual Health Centre. Most clients (69%) were taking PrEP, and 7% of those eligible for PrEP were classified as a missed opportunity for PrEP. Although missed opportunities were uncommon, PrEP discussions should be a standard component of care for all clients at risk of HIV acquisition.

Sign in / Sign up

Export Citation Format

Share Document