scholarly journals 999. Using the F/TDF Adherence-Efficacy Relationship to Calculate Background HIV incidence: Results from the DISCOVER trial

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S528-S529
Author(s):  
David V Glidden ◽  
David T Dunn ◽  
Moupali Das ◽  
Ramin Ebrahimi ◽  
Lijie Zhong ◽  
...  
Keyword(s):  
Prior Distribution ◽  
Controlled Trial ◽  
Seroconversion Rate ◽  
Hiv Infections ◽  
Credible Interval ◽  
Hiv Incidence ◽  
Material Support ◽  
Bayesian Inferences ◽  
Informative Prior Distribution ◽  
Sex With Men

Abstract Background RRandomized trials of new PrEP agents compare to oral emtricitabine+tenofovir disoproxil fumarate (F/TDF) and do not have a placebo arm. We used the well-characterized adherence-efficacy relationship for F/TDF from iPrEX OLE, to back-calculate the (non-PrEP) background HIV incidence (bHIV) in the F/TDF arm of DISCOVER and estimate comparative efficacy (to bHIV). Methods TDISCOVER is an ongoing randomized active-controlled trial in 5,387 men who have sex with men and transgender women that demonstrated non-inferiority of F+tenofovir alafenamide (F/TAF) to F/TDF (IRR 0.47 (95% CI 0.19, 1.15). TFV-DP levels in DBS were assessed for all diagnosed with HIV and in a randomized subset of 10%. We used a Bayesian model with a prior distribution, derived from iPrEx OLE, relating TFV-DP levels to HIV prevention efficacy: eg TFV-DP levels of < 350 (low), 350 to < 700 (medium) and ≥700 (high) fmol/punch were assumed to provide 0%, 86% and 98% HIV protection, respectively. This prior, combined with F/TDF seroconversion rate and TFV-DP levels, yields Bayesian inferences on the bHIV. In R, STAN was used to sample 10,000 realizations from the posterior distribution. Results There were 6 vs. 11 post-baseline HIV infections (0.14 v. 0.25 per 100 person-years [PY]) on F/TAF and F/TDF. Of the 11 on F/TDF, 10 had low, 0 had medium, and 1 had high TFV-DP levels; among HIV-negative controls, 5% of the person-time had low, 9% had medium, and 86% had high TFV-DP levels. A non-informative prior distribution for bHIV, combined with the prior for TFV-DP level-efficacy relationship, yielded a posterior bHIV incidence [0.80 Bayesian credible interval (CrI)] of 3.4/100 [1.9, 6.0/100] PY; which suggests a median F/TAF efficacy [0.95 CrI] of 96% [88%,99%] and 93% [87%,96%] for F/TDF compared to bHIV. If we chose a conservative prior distribution for bHIV of 1.0/100 PY, the model yields a median posterior bHIV [0.80 CrI] of 2.8/100 [1.7, 4.7/100] PY; which suggests a median efficacy [0.95 Cr] of 95% [86%, 99%] for F/TAF and 92% [86%, 67%] for F/TDF compared to bHIV with corresponding number of HIV infections averted of 117 and 114, respectively (Figure). Figure. Conclusion The F/TDF adherence-efficacy relationship can be used to back-calculate bHIV incidence in MSM/TW PrEP trials and assess the efficacy of new PrEP agents compared to bHIV. Disclosures David V. Glidden, MD, Gilead Sciences Inc. (Other Financial or Material Support, Personal fees) David T. Dunn, MD, Gilead Sciences Inc. (Other Financial or Material Support, Personal fees)Viiv Healthcare (Other Financial or Material Support, Personal fees) Moupali Das, MD, Gilead Sciences Inc. (Employee, Shareholder) Ramin Ebrahimi, MSc, Gilead Sciences Inc. (Employee, Shareholder) Lijie Zhong, PhD, Gilead Sciences Inc. (Employee, Shareholder) Oliver T. Stirrup, MD, Gilead Sciences Inc. (Other Financial or Material Support, Personal fees) Peter L. Anderson, PharmD, Gilead Sciences Inc. (Other Financial or Material Support, Personal fees)

scholarly journals Estimation of HIV incidence in two Brazilian municipalities, 2013

2016 ◽  
Vol 50 (0) ◽  
Author(s):  
Célia Landmann Szwarcwald ◽  
Orlando da Costa Ferreira Júnior ◽  
Ana Maria de Brito ◽  
Karin Regina Luhm ◽  
Clea Elisa Lopes Ribeiro ◽  
...  
Keyword(s):  
Total Population ◽  
Hiv Infections ◽  
Incidence Rates ◽  
Hiv Incidence ◽  
Female Ratio ◽  
Exposure Category ◽  
Two Cities ◽  
Population Subgroup ◽  
Sex With Men ◽  
Male To Female

ABSTRACT OBJECTIVE To estimate HIV incidence in two Brazilian municipalities, Recife and Curitiba, in the year of 2013. METHODS The method for estimating incidence was based on primary information, resulting from the Lag-Avidity laboratory test for detection of recent HIV infections, applied in a sample of the cases diagnosed in the two cities in 2013. For the estimation of the HIV incidence for the total population of the cities, the recent infections detected in the research were annualized and weighted by the inverse of the probability of HIV testing in 2013 among the infected and not diagnosed cases. After estimating HIV incidence for the total population, the incidence rates were estimated by sex, age group, and exposure category. RESULTS In Recife, 902 individuals aged 13 years and older were diagnosed with HIV infection. From these, 528 were included in the study, and the estimated proportion of recent infections was 13.1%. In Curitiba, 1,013 people aged 13 years and older were diagnosed, 497 participated in the study, and the proportion of recent infections was 10.5%. In Recife, the estimated incidence rate was 53.1/100,000 inhabitants of 13 years and older, while in Curitiba, it was 41.1/100,000, with male-to-female ratio of 3.5 and 2.4, respectively. We observed high rates of HIV incidence among men who have sex with men, of 1.47% in Recife and 0.92% in Curitiba. CONCLUSIONS The results obtained in the two cities showed that the group of men who have sex with men are disproportionately subject to a greater risk of new infections, and indicate that strategies to control the spread of the epidemic in this population subgroup are essential and urgent.

“Proud I Am Negative”

2017 ◽  
Vol 21 (2) ◽  
pp. 276-290 ◽  
Author(s):  
Jagadisa-devasri Dacus ◽  
Dexter R. Voisin ◽  
Judith Barker
Keyword(s):  
New York ◽  
New York City ◽  
Social Supports ◽  
Hiv Infections ◽  
Hiv Stigma ◽  
Hiv Incidence ◽  
Personal Agency ◽  
Safe Spaces ◽  
Sex With Men ◽  
Hiv Negative

HIV incidence among black men who have sex with men (BMSM) is at epidemic proportions. However, the vast majority of studies have focused on risk factors related to HIV infections with a dearth of research on resiliency and how BMSM maintain seronegativity. Using three focus groups ( N = 29) comprised of BMSM in New York City, this study explored psychosocial factors and practices related to maintaining seronegativity. Major themes included having spirituality and/or religious beliefs, access to social supports that held positive expectations, and having personal agency by engaging in seroadaptive harm reduction practices. Overall, findings highlight the importance of addressing HIV stigma, supporting the need for BMSM to be validated, and creating safe spaces that allow them to discuss the challenges related to remaining HIV-negative.

scholarly journals Antiretroviral therapy for prevention of HIV transmission: implications for Europe

2013 ◽  
Vol 18 (48) ◽  
Author(s):  
V Cambiano ◽  
J O’Connor ◽  
A N Phillips ◽  
A Rodger ◽  
R Lodwick ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
People Who Inject Drugs ◽  
Hiv Transmission ◽  
Controlled Trial ◽  
Population Level ◽  
Hiv Infections ◽  
Cd4 Count ◽  
Art Initiation ◽  
Sex With Men ◽  
Randomised Controlled

The aim of this review is to summarise the evidence on the population-level effect of antiretroviral therapy (ART) in preventing HIV infections, and to discuss potential implications in the European context of recommending starting ART when the CD4 count is above 350 cells/mm3. The ability of ART to reduce the risk of HIV transmission has been reported in observational studies and in a randomised controlled trial (HPTN 052), in which ART initiation reduced HIV transmission by 96% within serodiscordant couples. As yet, there is no direct evidence for such an effect among men having sex with men or people who inject drugs. HPTN 052 led international organisations to develop recommendations with a higher CD4 threshold for ART initiation. However, there remains a lack of strong evidence of clinical benefit for HIV-positive individuals starting ART with CD4 count above 350 cells/mm3. The main goal of ART provision should be to increase ART coverage for all those in need, based on the current guidelines, and the offer of ART to those who wish to reduce infectivity; increased HIV testing is therefore a key requirement. Other proven prevention means such as condom use and harm reduction for people who inject drugs remain critical.

scholarly journals HIV incidence among gay men and other men who have sex with men in 2020: where is the epidemic heading?

Sexual Health ◽  
2017 ◽  
Vol 14 (1) ◽  
pp. 5 ◽  
Author(s):  
Shauna Stahlman ◽  
Carrie Lyons ◽  
Patrick S. Sullivan ◽  
Kenneth H. Mayer ◽  
Sean Hosein ◽  
...  
Keyword(s):  
Hiv Transmission ◽  
Hiv Infections ◽  
Retention In Care ◽  
Hiv Treatment ◽  
Treatment As Prevention ◽  
Structural Level ◽  
Hiv Incidence ◽  
Hiv Risks ◽  
Sex With Men ◽  
Hiv Acquisition

The goal to effectively prevent new HIV infections among gay, bisexual, and other men who have sex with men (MSM) is more challenging now than ever before. Despite declines in the late 1990s and early 2000s, HIV incidence among MSM is now increasing in many low- and high-income settings including the US, with young, adolescent, and racial/ethnic minority MSM being among those at highest risk. Potentiating HIV risks across all settings are individual-, network-, and structural-level factors such as stigma and lack of access to pre-exposure prophylaxis (PrEP) and antiretroviral treatment as prevention. To make a sustained impact on the epidemic, a concerted effort must integrate all evidence-based interventions that will most proximally decrease HIV acquisition and transmission risks, together with structural interventions that will support improved coverage and retention in care. Universal HIV treatment, increased access to HIV testing, and daily oral PrEP have emerged as integral to the prevention of HIV transmission, and such efforts should be immediately expanded for MSM and other populations disproportionately affected by HIV. Respect for human rights and efforts to combat stigma and improve access to prevention services are needed to change the trajectory of the HIV pandemic among MSM.

HIV incidence trends vary between jurisdictions in Australia: an extended back-projection analysis of men who have sex with men

Sexual Health ◽  
2012 ◽  
Vol 9 (2) ◽  
pp. 138 ◽  
Author(s):  
Kylie-Ann Mallitt ◽  
David P. Wilson ◽  
Ann McDonald ◽  
Handan Wand
Keyword(s):  
South Australia ◽  
Hiv Infections ◽  
Surveillance Data ◽  
Hiv Incidence ◽  
Back Projection ◽  
Hiv Diagnosis ◽  
Incidence Trends ◽  
The Past ◽  
Sex With Men ◽  
Incident Cases

Background Trends in HIV diagnoses differ across Australia and are primarily driven by men who have sex with men (MSM). We use national population surveillance data to estimate the incidence of HIV infections among MSM by jurisdiction and infer the proportion of undiagnosed infections. Methods: Annual surveillance data for AIDS diagnoses, HIV diagnoses and recently acquired HIV infections were obtained from 1980 to 2009. A modified statistical back-projection method was used to reconstruct HIV incidence by jurisdiction. Results: HIV incidence among MSM peaked for all jurisdictions in the early 1980s and then declined into the early 1990s, after which incidence increased. Trends then differ between jurisdictions. In New South Wales (NSW) and South Australia, estimated HIV incidence peaked at 371 and 50 cases respectively in 2003, and has since decreased to 258 and 24 cases respectively in 2009. HIV infections in Queensland (Qld) have more than doubled over the past decade, from 84 cases in 2000 to 192 cases in 2009. Victoria and Western Australia have seen a rise in HIV incidence from 2000 to 2006 (to a peak of 250 and 38 incident cases respectively), followed by a plateau to 2009. HIV incidence in the Northern Territory, Tasmania and Australian Capital Territory have increased since 2000; however, case numbers remain small (<20 per year). The estimated proportion of HIV infections not yet diagnosed to 2009 ranges from 10% (NSW) to 18% (Qld), with an average of 12% across Australia. Conclusions: HIV diagnosis trends among MSM in Australia reflect changes in estimated incidence to 2009, and reveal the largest increase in the past 10 years in Qld.

scholarly journals HIV incidence among men who have sex with men in mainland China: a systematic review protocol

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Wenting Huang ◽  
Liming Wang ◽  
Mi Guodong ◽  
Ryan J. Zahn ◽  
Jennifer Taussig ◽  
...  
Keyword(s):  
Systematic Review ◽  
Assessment Tool ◽  
Meta Analysis ◽  
Temporal Trends ◽  
Mainland China ◽  
Hiv Infections ◽  
Future Research ◽  
Hiv Incidence ◽  
Geographic Variations ◽  
Sex With Men

Abstract Background Men who have sex with men (MSM) are disproportionately affected by HIV in China. Globally, younger MSM are at higher risk for incident HIV infections, but there has been substantial variation in the estimates of age-stratified HIV incidence among MSM in mainland China, potentially due to regional differences in the nature of the epidemic. Given the need for quality epidemiological data to meet the global goal of ending new HIV infections by 2030, this systematic review and meta-analysis aims to determine age-stratified HIV incidence in mainland China, including consideration by geographic region and time. Methods This review will include longitudinal studies, cross-sectional surveys, and surveillance reports among MSM in mainland China that have reported HIV incidence. We will search studies and reports published from January 1, 2003, to April 30, 2020, in both English and Chinese language literature databases. For each study considered, two reviewers will independently screen, determine eligibility, and extract relevant data, with discrepancies resolved by consensus of a third reviewer. The methodological quality of included studies will be assessed by the Quality Assessment Tool for Systematic Reviews of Observational Studies Score (QATSO). We will develop age-stratified estimates of HIV incidence with geographic variations and temporal trends. Heterogeneity will be examined using statistical techniques appropriate to the dataset. For subgroup analyses, we will conduct mixed-effects meta-analysis models. Discussion This review will contribute to a better understanding of the HIV epidemic among MSM in mainland China by providing age-stratified estimates of HIV incidence with a portrayal of geographic and temporal variations. Findings will reflect epidemic dynamics, informing local and national intervention programs and policies for HIV prevention, and providing estimation data to inform future research among MSM in China. Systematic review registration PROSPERO ID 154834

Increases in newly acquired HIV infections in Victoria, Australia: epidemiological evidence of successful prevention?

Sexual Health ◽  
2013 ◽  
Vol 10 (2) ◽  
pp. 166 ◽  
Author(s):  
Anita Feigin ◽  
Carol El-Hayek ◽  
Margaret Hellard ◽  
Alisa Pedrana ◽  
Ellen Donnan ◽  
...  
Keyword(s):  
Health Promotion ◽  
Linear Trend ◽  
Hiv Infections ◽  
Hiv Incidence ◽  
Risk Behaviours ◽  
Epidemiological Evidence ◽  
Hiv Surveillance ◽  
Recent Trends ◽  
Sex With Men ◽  
Successful Prevention

Background Rates of newly acquired HIV notifications provide useful data for monitoring transmission trends. Methods: We describe 10-year (2001–10) trends in newly acquired HIV notifications in Victoria, Australia. We also examine recent trends in HIV testing and incidence and risk behaviours among gay and other men who have sex with men (MSM) attending four high MSM caseload clinics. Results: Between 2001 and 2010 there was a significant increasing linear trend in newly acquired HIV that was driven primarily by increases between 2009–2010. MSM accounted for 85% of newly acquired HIV notifications. Between 2007–10, the total number of HIV tests per year at the high caseload clinics increased 41% among MSM and HIV incidence declined by 52%; reported risk behaviours remained relatively stable among these MSM. Conclusion: More newly acquired HIV notifications may reflect recent increased testing among MSM; continued scrutiny of surveillance data will assess the sustained effectiveness of testing as prevention, health promotion and the contribution of risk and testing behaviours to HIV surveillance outcomes.

scholarly journals Why we need pre-exposure prophylaxis: incident HIV and syphilis among men, and transgender women, who have sex with men, Bangkok, Thailand, 2005–2015

2019 ◽  
Vol 30 (5) ◽  
pp. 430-439 ◽  
Author(s):  
TH Holtz ◽  
W Wimonsate ◽  
PA Mock ◽  
S Pattanasin ◽  
W Chonwattana ◽  
...  
Keyword(s):  
Temporal Trends ◽  
Treponema Pallidum ◽  
Hiv Infections ◽  
Transgender Women ◽  
Hiv Incidence ◽  
Syphilis Infection ◽  
Transmitted Infection ◽  
Sti Prevention ◽  
Voluntary Counseling And Testing ◽  
Sex With Men

We describe incident human immunodeficiency virus (HIV) and syphilis trends in men who have sex with men (MSM) and transgender women (TGW) presenting for HIV voluntary counseling and testing (VCT) services and sexually transmitted infection (STI) management at the Silom Community Clinic, Bangkok, Thailand. Clients underwent rapid HIV testing and syphilis rapid plasma reagin (RPR) testing. For incidence analysis, we included clients with >1 follow-up visit. Initial negative HIV with subsequent positive HIV defined incident HIV infection; incident syphilis infection was defined as negative RPR followed by positive RPR (titer ≥1:8) and confirmatory anti- Treponema pallidum antibodies. Calculation of incidence using Poisson regression assumed a uniform probability distribution throughout the seroconversion interval. From 15 September 2005 to 31 December 2015, we tested 10,158 clients for HIV and 10,324 for syphilis. Overall, 7109 clients tested HIV-seronegative and contributed 7157 person-years (PY). Three-hundred forty-seven incident HIV infections resulted in an incidence rate of 4.8 per 100 PY (95% confidence interval [CI] 4.4–5.4). We found an inverted U-shape trend of HIV incidence over time with a peak of 6.4 per 100 PY in quarter 2/2011 ( p < 0.01) (Poisson with RCS function, p = 0.001). Overall, 8713 clients tested seronegative for syphilis and contributed 8623 PY. The incidence of syphilis infection was 4.4 per 100 PY (95% CI 3.9–4.8). Despite an apparent decline in HIV incidence among MSM and TGW attending VCT services, syphilis incidence rose and remained high. Evaluating temporal trends of HIV and syphilis incidence provides an opportunity to evaluate epidemic trajectories and target limited program funding. We recommend focused HIV and STI prevention interventions for MSM in Bangkok.

scholarly journals A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Katie B Biello ◽  
Christina Psaros ◽  
Douglas S Krakower ◽  
Elliot Marrow ◽  
Steven A Safren ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Young Men ◽  
The United States ◽  
Hiv Incidence ◽  
Randomized Controlled ◽  
Adherence Intervention ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
Pilot Randomized Controlled Trial

BACKGROUND New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed. OBJECTIVE This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY). METHODS This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States. RESULTS Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019. CONCLUSIONS Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population’s high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM’s PrEP uptake and adherence to decrease the HIV incidence. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10661

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