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PrEP Should Be Offered to All Sexually Active Adolescents for Prevention debate PowerPoint Presentation

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Description : PrEP Should Be Offered to All Sexually Active Adolescents for Prevention debate

Tags : Pediatrics, Child Health, pediatric practice, pediatrician, health providers, HIV-infected infants, Adolescent Transition, HIV-infected adolescents, epidemiology, south Africa, nutrition, PrEP

Published on : Jul 18, 2020 | Views : 1665 | Downloads : 1

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Slide 1-

PrEP Should Be Offered to All Sexually Active Adolescents for Prevention Lynne Mofenson MD Elizabeth Glaser Pediatric AIDS Foundation VOTE NO!!
Slide 2-

You May Notice I Am Not Audrey Pettifor = Audrey sends her regrets but she unfortunately is unable to attend I will give it my best but apologize ahead of time to Audrey – any errors are mine!
Slide 3-

All Adolescents are Not the Same Sexually active adolescents are at risk of HIV. However, this risk is not uniform. Adolescent in countries where HIV is widespread are at higher risk sexual HIV transmission than those in low-prevalence countries. Adolescents who have unprotected intercourse with members of very high-risk groups for HIV (eg., MSM, IDU) are also at high risk. These patterns have important implications for prevention; suggests programs that focus on those at highest risk of infection would be most effective (as well as cost-effective).
Slide 4-

Adolescent HIV is Not Uniformly Distributed Globally – So Recommendations for Prevention May Not Be Uniform 82% of adolescents living with HIV come from Africa UNICEF 2016 Key findings adolescents and young people Eastern and Southern Africa 1,200,000 61% West and Central Africa 420,000 21% 7% East Asia and the Pacific 87,000 4% South Asia 130,000 America and the Caribbean 83,000 4% Latin Rest of the 2% 18,000 1% world 35,000 CEE/CIS Middle East and North Africa 11,000 1% Total: Estimated Percentage of Adolescents Aged 10-19 Years Living with HIV by UNICEF Region, 2014
Slide 5-

Adolescent HIV is Not Uniformly Distributed Globally – So Recommendations for Prevention May Not Be Uniform h Estimated % of Adolescents Aged 10-19 Years Living with HIV in Selected Countries, 2014 77% of adolescents living wit HIV come from only 13 countries UNICEF 2016 Key findings adolescents and young people About half of adolescents living with HIV are in just 6 countries: South Africa, Nigeria, Kenya, India, Mozambique and Tanzania.
Slide 6-

Adolescent HIV is Not Uniformly Distributed Globally – So Recommendations for Prevention May Not Be Uniform h HIV come from only 13 countries Living with HIV in Selected Countries, 2014 UNICEF 2016 Key findings adolescents and young people living with HIV are South Africa, Nigeria, Kenya, India, Mozambique and Tanzania. Estimated % oAf Adroleescenyts Aogedu10-1r9 Yeearas lly going to recommend that ALL sexually-active youth world-wide should receive PrEP whenAhboiugt hhalfHofIaVdolescents 77% ofiandocleisdceentns licvieng wisit resitnrjuisct t6ecodunttroies: only a few cou ntries?
Slide 7-

2.3% 4.1% 3.6% 4.0% 2.1% 6.0% 2.0% 9.4% 2.6% 13.8% 4.1% 14.4% 5.8% 31.2% 7.9% 25.0% 12.2% 28.9% 11.0% 26.3% 0% 5% 10% 15% 25% 20% 30% 35% 40% 45% 55% 50% Males Females 95% Confidence Interval Age 15 Age Age 16 17 Age Age Age 18 19 20 Age Age 21 22 Age 23 Age 24 Pettifor A, et al. AIDS 2005, 19: 1525-1534. HIV Prevalence by Age and Gender Among South African Youth Age 15-24 Years
Slide 8-

Pettifor A, et al. 2015 unpublished HIV Incidence by Age in Young Women in HPTN 068 1.3% 1.9% 1.8% 3.6% 4.8% 4.9% 0.03% <=15 16 0.0% 1.0% 2.0% 3.0% 4.0% 5.0% 6.0% 17 18 Age in Years 19 20 >=21 HIV Incidence Incidence only >3% in young women at age 19 years or older. Incidence in adolescent men is even lower until reach mid-20’s.
Slide 9-

Epidemiology of Adolescent HIV in the United States Is Very Different Diagnoses of HIV in Adolescents and Young Adults Age 13-24 Years by Transmission Category 2010-2014, United States Diagnoses of HIV Infection in Adolescents 13-19 years, 2014
Slide 10-

There is no question that PrEP Works TDF TDF/FTC IF you adhere to it….
Slide 11-

Relationship Between Adherence to PrEP and PrEP’s Effectiveness in Reducing Transmission Fonner VA et al. JAIDS 2016 (Epub ahead of print) PrEP highly effective PrEP not effective PrEP Effectiveness and PrEP Use by Study
Slide 12-

What Do We Know About PrEP Adherence in Adolescents? Not much – because most studies enrolled only individuals >18 years, and only small percentage were 18-24 years. Total sample 18-24 years <18 years US enrollment Pace J et al. Clin Infect Dis 2014;56:1149-55 Recent dapivirine microbicide ring studies provide some data on differences in adherence between young women 18-24 vs older women.
Slide 13-

Age-Related HIV Protection Effectiveness of Ring Likely Related to Adherence to Product Use -27% (-133, 31) PL incidence 5.4%/yr Baeten J et al. CROI 2016 Boston Abs 109LB/NEJM 2016 Feb 22 epub Age 18-21 Yr ─ 18-21 yr ─ 22-26 yr ─ 27-45 yr % Visits with Good Adherence Plasma DPV >95 pg/mL & Residual Ring DPV <23.5 mg Adherence measures were significantly lower among women aged 18-21 yrs: adherence levels were higher by a factor of 1.6 (p=0.07) in women 22-26 yrs and a factor of 4.1 (p<0.001) in women aged 27-45 yrs compared to women 18-21 yrs.
Slide 14-

Age-Related HIV Protection Effectiveness of Ring and Adherence to Product Use Nel A et al. CROI 2016 Boston Abs 110LB Significant effect of age (< 21 yr vs >21 yr) on ring efficacy: Treatment effect p=0.10 Age effect p=0.07 Treatment*age p=0.43
Slide 15-

TDF is Not Risk-Free
Slide 16-

TDF is Not Risk Free Bone loss is a primary toxicity of TDF when used for either HIV treatment or PrEP. Peak bone mass is typically achieved in early adulthood and is an important predictor of osteoporosis and fracture risk later in life. Thus, there is heightened concern about the use of TDF for HIV prevention in adolescents prior to attainment of peak bone mass.
Slide 17-

Lumbar Spine Bone Mineral Density Changes Infancy Through Adulthood Peak Bone Mass (PBM) attained in 20s 20 Puthanakit and Siberry JIAS 2013
Slide 18-

Etiology of Osteoporosis: The Importance of Peak Bone Mass Relative Bone Mass (% ideal peak bone mass) 100 80 60 40 20 20 30 40 50 Age (years) 60 70 80 Low Peak Normal
Slide 19-

Adolescent Trials Network (ATN) 110 Open label demonstration study of PrEP in adolescent and young MSM to examine patterns of use and expand safety data. Enrolled 200 at-risk HIV-uninfected MSM, age 18-22 years at 12 urban sites in US (median 20 yrs, black 47%, Latino 27%); 48 weeks study. All participants offered TDF/FTC PrEP (98% acceptance) plus behavioral risk reduction, sexual health and adherence counseling, STI testing/treatment and condoms. DXA hip, spine, body at baseline, weeks 24 and 48.
Slide 20-

Change from Baseline in Bone Mineral Density (ITT, medians) Mulligan K et al. 2015 International Workshop on Comorbidities and Adverse Drug Reactions
Slide 21-

Median Percent Change by TFV-DP Levels Youth with TFV-DP >700 fmol (protective levels) had decrease in BMD, while those without drug had no change or increased Mulligan K et al. 2015 International Workshop on Comorbidities and Adverse Drug Reactions
Slide 22-

Bone Mineral Density Changes (Forearm, Spine, Hip) in HIV-Uninfected Young Adults in TDF-2 Study in Botswana Kasonde M et al. PLosOne 2014;9:e90111 DXA substudy of TDF-2 study (men and women) – 57.8% 18-24 years; 42.2% 24-29 years 220 had baseline: 6.8% of participants had BMD z-score <-2 at baseline (2.6% women,11.3% men) Longitudinal data on 147 BMD losses of >3% at any anatomic site significantly greater for TDF/FTC than placebo (50% vs 32.9%, p=0.04). Significant difference mean % change in TDF-FTC group (forearm -0.84%, spine -1.62%, hip -1.51%).
Slide 23-

Mean % BMD Change from Baseline Significantly Lower in the TDF-FTC Group Compared to Placebo
Slide 24-

Bone Mineral Density Changes Among Young Healthy African Women Receiving TDF for PrEP Mirembe BG et al. JAIDS 2016;71:287-94. HIV-uninfected women Uganda/ Zimbabwe in VOICE trial had DXA lumbar spine/ hip at baseline and q 6 months. In the subset with TFV detection 75-100% of plasma samples, LS was 1.4% lower with TDF or TDF/FTC than placebo and hip was 0.9% lower than placebo.
Slide 25-

Cost-Effectiveness Universal ART, General PrEP or Focused (High-Risk) PrEP Alone or in Combination, South Africa PrEP focused on high-risk individuals (alone or in combination with universal ART) is as effective in reducing HIV and significantly more cost-effective than providing PrEP to the general population. General PrEP is costly and provides limited benefits beyond ART scale-up. Alistar SS et al. BMC Med 2014;12:46 General PrEP becomes even less cost-effective when ART is universal. ($12,600/QALY gained) Focused PrEP is cost-saving or highly C-E vs status quo and when added to ART strategies
Slide 26-

WHO Guidelines 2016
Slide 27-

Recommendation from My Esteemed Opponent South African Medical Journal November 2015
Slide 28-

Summary Adolescents are not a uniform group; they they differ in HIV risk, based on the type of HIV epidemic where they reside and their behaviors. PrEP works - IF you adhere to it. Adolescents are significantly less likely to adhere to PrEP than adults. There are potential risks to providing PrEP to low-risk healthy adolescents re: risk of BMD toxicities Not cost effective to provide PrEP to everyone. PrEP SHOULD be given to adolescents, but targeted to those at high risk for best risk/benefit ratio and to be cost-effective.
Slide 29-

It is hard to vote against the awesome Linda-Gail Bekker But in this case, you should! Vote THUMBS DOWN for ALL sexually active youth to receive PrEP

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