20th International AIDS Conference - Melbourne, Australia

TUAC01 Oral Pre-exposure Prophylaxis: New Evidence for Targeted Implementation
  Oral Abstract Session : Track C
Venue: Melbourne Room 2
Time: 22.07.2014, 16:30 - 18:00
Co-Chairs: Carlos F. Caceres, Peru
Joseph Fai Tak Lau, China

The potential role of HIV self-testing within pre-exposure prophylaxis implementation
K. Curran1, C. Johnson1, K. Ngure2,3, N. Mugo4,5, J. Baeten3, R. Heffron3, F. Koechlin1, K. O'Reilly6, R. Baggaley1
1World Health Organization, HIV/AIDS, Geneva, Switzerland, 2Jomo Kenyatta University of Agriculture and Technology, College of Health Sciences, Nairobi, Kenya, 3University of Washington, Global Health, Seattle, United States, 4Kenya Medical Research Institute, Center for Clinical Research, Nairobi, Kenya, 5Partners in Reproductive Health and Development, Thika, Kenya, 6Medical University of South Carolina, Charleston, United States

Sex on PrEP: qualitative findings from the iPrEx open label extension (OLE) in the US
K. Koester1, R. Amico2, A. Liu3, V. McMahan4, S. Hosek5, K. Mayer6, R. Grant4
1Gladstone Institute of Gladstone & Immunology, San Francisco, United States, 2Gladstone's iPrEx Team, Storrs, United States, 3San Francisco Department of Public Health, San Francisco, United States, 4Gladstone Institute of Virology and Immunology, San Francisco, United States, 5Stroger Hospital of Cook County, Psychiatry, Chicago, United States, 6Fenway Institute, Boston, United States

High adherence rate to intermittent oral PrEP with TDF/FTC among high risk MSM (ANRS Ipergay)
J. Fonsart1, C. Capitant2, B. Spire3,4, L. Cotte5,6, G. Pialoux7, N. Lorente3,4, G. Peytavin8,9, I. Charreau2, J.-P. Aboulker2, J.-M. Molina10, ANRS Ipergay Study Group
1Saint-Louis Hospital, Biochimie, Paris, France, 2INSERM, SC10-US019, Villejuif, France, 3INSERM, UMR912 (SE4S), Marseille, France, 4Aix Marseille University, IRD, UMR-S912, Marseille, France, 5Hospices Civils de Lyon, Infectious Diseases, Lyon, France, 6INSERM, U1052, Lyon, France, 7Tenon Hospital, Infectious Diseases, Paris, France, 8Bichat Hospital, Laboratoire de Pharmaco-Toxicologie, Paris, France, 9INSERM, UMR 1137, Paris, France, 10Saint-Louis Hospital, Infectious Diseases, Paris, France

Enrollment into open-label phase of TDF2 PrEP Study, Botswana, 2013
L. Chirwa1, A. Taylor2, T. Williams3, F. Henderson3, M. Kasonde4, R. Mutanhaurwa4, O. Matlhaba4, K. Hageman2, P. Casillas4, T. Samandari2
1Centers for Disease Control and Prevention, HIV Prevention Research, Francistown, Botswana, 2Centers for Disease Control and Prevention, DHAP, Atlanta, United States, 3Centers for Disease Control and Prevention, Atlanta, United States, 4Centers for Disease Control and Prevention, HIV Prevention Research, Gaborone, Botswana

Results of the iPrEx open-label extension (iPrEx OLE) in men and transgender women who have sex with men: PrEP uptake, sexual practices, and HIV incidence
R.M. Grant1,2,3, P.L. Anderson4, V. McMahan1, A. Liu2,5, K.R. Amico6, M. Mehrotra1, C. Mosquera7, M. Casapia8, O. Montoya9, S. Buchbinder2,5, V.G. Veloso10, K. Mayer11, S. Chariyalertsak12, L.G. Bekker13, S. Hosek14, E.G. Kallas15, M. Schechter16, D. Glidden2, for the iPrEx study team
1Gladstone Institutes, San Francisco, United States, 2University of California, San Francisco, United States, 3San Francisco AIDS Foundation, San Francisco, United States, 4University of Colorado, Denver, United States, 5San Francisco Department of Public Health, San Francisco, United States, 6University of Connecticut, Storr, United States, 7INMENSA, Lima, Peru, 8ACSA, Iquitos, Peru, 9Equidad, Guayaquil, Ecuador, 10FIOCRUZ, Rio de Janeiro, Brazil, 11Fenway Health, Boston, United States, 12Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand, 13Desmond Tutu Health Foundation, Cape Town, South Africa, 14Stroger Hospital of Cook County/The CORE Center, Chicago, United States, 15University of Sao Paulo, Sao Paulo, Brazil, 16Praca Onze, Rio de Janeiro, Brazil

Moderated discussion

Powerpoints presentations
The potential role of HIV self-testing within pre-exposure prophylaxis implementation - Cheryl Johnson

Sex on PrEP: qualitative findings from the iPrEx open label extension (OLE) in the US - Kimberly Koester

Enrollment into open-label phase of TDF2 PrEP Study, Botswana, 2013 - Allan Taylor

Results of the iPrEx open-label extension (iPrEx OLE) in men and transgender women who have sex with men: PrEP uptake, sexual practices, and HIV incidence - Robert M Grant

Rapporteur reports

Track C report by Maria Veras

C Johnson examined the potential role for HIV self-testing among PrEP users. The study was done in Kenya, compared  annual cost per person in 3 different models. The 1st: conventional (standard facility-based testing using, no self-testing); 2nd option: facility-based supervised HIV self-testing, and the 3rd: home-based self-testing. The study compared the 3 options and found the facility-based HIV Self-testing cheaper than the other two options. They also performed sensitivity analysis that confirmed self-testing less cost per client. Several limitations were pointed out, including public health benefits, opportunity benefits. Recommendations were made in terms of exploring other scenarios. The discussion included questions on window period and the choice between oral fluid and finger punch self-test. Also it was mentioned the cascade and linkage to care as one potential benefit of keeping patients coming to the clinic every 3 months. 

K Koester explored how PrEP influenced sexual practices among its users. Preliminary qualitative analysis of in-depth interviews with 60 participants from IPrEX study,  were from Boston, Chicago and San Francisco. The presentation highlighted some of the testimonies related to condom use and meaning experiences. Prior to PrEP condom use varied from routine to never. Majority of the participants did not report significant changes in condom use, except younger participantes from Chicago, who actually increased its use. In summary the analyses presented that in most cases Prep did not lead to condom less sex, and decreased stress, fear and guilt. Participants referred less anxiety about HIV infection. The theoretical desire of abandon condom was not verified. Questions were raised if it would be different if people have to pay for the drugs, if there was better measurement than condom use? One questioned why use PrEP and keep condom, the role of condom in preventing other STIs.

J-M Molina examined if there is higher adherence rates to PrEP when it is used in an intermittent way. The study is a RCT, TDF/FTC versus placebo – HIV infection is the outcome. Participants are high risk behavior MSM from France and Canada. The results presented here are from an ongoing study, and includes 129 participants. The regimen is two tablets before having sex, one 24 for hours after and another one 48 hours after. CASI and face-to-face interviews, as well as the measurement of the drug concentration in the blood were performed.  Adherence results were higher than IPrEX: 53% reported perfect adherence, 28% sub-optimal and 19% did not use. Average pills/month used was 15 pills/month. TFV was detected in plasma on average 86% of the intervention versus 4% of the control group. FTC: overall 82% versus 3% in placebo. Placebo group reported being in PEP. Discussion raised questions regarding tolerability, side effects, that were not reported. Also questioned the specific definition of sexual intercourse, if there was more than one per time. The recommendation was made for take the pills if any sexual intercourse. Some of the audience observed that it is a very sexually active cohort.

A Taylor presented data on baseline characteristics, visit adherence and preliminary safety of an open label PrEP experience among former participants of TDF2 study among heterosexual couples in Botswana (2007-2009). Exclusion included HIV infection and pregnancy. Monthly follow up visits and quarterly, when specimens were taken; from the remaining study only 48% were found, 20% of whom not eligible. They were offered PrEP. From 256 eligible, 38 did not start. They did not differ in the socio demographic profile. Motivation for starting was feeling at risk or partner at risk, and this differed between who took and who not the medication. Retention was 54% after one year of follow-up. The self-risk perception of HIV infection was 30,8% among those who accepted PrEP versus 69% among those who did not. 10 severe adverse effects among 8 participants were reported. Those with higher risk-perception at baseline were more likely to adhere. Logistical considerations such as the delay in starting the study and lack of reimbursement contributed to low adherence over time. They did not provide information on gender differences and circumcision status.  

R. Grant provided a late breaker presentation of the iPrEx Open Label Extension (OLE) among MSM and Trans women. PrEP uptake varied according to unprotected anal intercourse and HSV seropositivity, no difference by age, education, transgender, prior randomized group or use of alcohol, methamphetamine, or cocaine. Main reason of declining PrEP was fear of the side effects. Findings from this study suggest that adherence does not have to be perfect. A risk reduction in HIV transmission of 84% was observed among those who took 2-3 tablets/week, and risk reduction of 100% with at >=4 tablets/week. TFV was measured in dried blood spots and its concentration was highly correlated with HIV incidence. Compared with iPpEx trial, they observed that among young men in Peru there was an increased in adherence to PrEP. 


Track C report by Mark Stoove

Session Overview:

Moving beyond recent PrEP randomised controlled trial, this session reported important data on the extension of these trials to open-label phases. Ongoing interest in continuing PrEP among participants across these studies and the effectiveness of less than daily PrEP dosing regimens in preventing HIV acquisition were key findings emerging from the session.

Title: The potential role of HIV self-testing within pre-exposure prophylaxis implementation

Author: Cheryl Johnson


C Johnson reported data from the Partner’s PreP Demonstration Project in Thika, Kenya, examining the economic burden of recommended three-monthly HIV re-testing for people receiving PreP. The study focussed on the cost savings associated with three-monthly HIV self-re-testing using estimates based on 100 clients in the first year of the PrEP programme. Comparisons were made across 1) standard facility-based re-testing only, with 2) supervised facility-based self-re-testing and 3) alternating unsupervised home-based self-re-testing with facility-based testing. The authors found that self-re-testing costs less than facility-based re-testing when test kit costs are ≤5USD for supervised self-re-testing and ≤3USD for alternating unsupervised self-re-testing. While test kit costs were important, health worker time involved in re-testing consumed the largest resources.


Title: Sex on PrEP: qualitative findings from the iPrEx open label extension (OLE) in the US

Author: Kimberly Koester


K Koester presented qualitative data from 60 in-depth interviews with MSM in the United States participating in the open-label extension of the iPrEx PreP trial, focussing on how PrEP use affected sexual risk practices among PrEP users. The majority of participants reported that PreP did not lead to increases in condomless sex despite a theoretical desire reported by participants for more disinhibited and risky sexual practices. PrEP use did, however, lead to decreased stress, fear and guilt in relation to sexual practices, whether men were practicing ongoing condomless sex or not. In this study, PreP appeared to be used to supplement, rather than replace, existing HIV prevention strategies.

In questioning, the relevance of condom use as a risk compensation outcome related to PreP was questioned.

Title: High adherence rate to intermittent oral PrEP with TDF/FTC among high risk MSM (ANRS Ipergay)

Author: Jean-Michel Molina


In the context of low adherence affecting effectiveness in daily dose PreP trials, J-M Molina reported adherence data from intermittent, event-based (prior to and post sexual encounters) oral PrEP with TDF/FTC among High Risk MSM in the Ipergay randomised controlled trial. Self-report and TDF and TFC plasma markers demonstrated high adherence among 129 participants across 543 sexual intercourse events. Overall, an average of 86% had TDF and 82% had FTC detected in blood across 10 months of follow-up. The authors will continue to monitor adherence across the trial to assess if this high adherence level is sustained over a longer period.

Upon questioning, toxicity of a four-pill/48 hour regimen was reported as low, with no participants missing doses because of issues with tolerance.


Title: Enrollment into open-label phase of TDF2 PrEP Study, Botswana, 2013

Author: Allan Taylor


A Taylor reported preliminary data from the 12-month open-label extension phase of the TDF-2 trial in Botswana with heterosexual young people to examine adherence and factors associated with commencing and being retained on the open-label trial. 229 participants started the open-label trial (86% of those eligible and contactable), with commencing and non-commencing participants not significantly different on baseline risk socio-demographic characteristics. Commencement was associated with self-reporting being at risk of HIV at the beginning of the open-label trial or that their partner was at risk. 54% of those who commenced on the open-label trial completed 12-months of follow-up. Completion of the 12 month trial was associated with self-perceived being at high or medium risk (compared with low risk) in the six months prior to final screening. 10 adverse toxicity-related events were detected. Despite loss to follow-up during the trial, the authors reported that interest in ongoing use of PrEP for HIV prevention was high, with 79% of TDF-2 trial participants contacted being interested enough to attend initial screening and 86% of those eligible starting the open-label trial.


Title: Results of the iPrEx open-label extension (iPrEx OLE) in men and transgender women who have sex with men: PrEP uptake, sexual practices, and HIV incidence

Author: Robert M Grant


In this late-breaker presentation, R Grant reported data from the open-label extension of iPrEx (June 2011-December 2013), identifying individual characteristics associated with post-iPrEx open-label uptake/adherence, describing ongoing effectiveness of PrEP in a clinical practice setting, describing sexual practices of people who know they are receiving effective PrEP and validating convenient markers of long-term PrEP use. 1225 MSM (77% of HIV negative iPrEx trial participants) continued open-label PreP with condomless receptive anal sex and HSV seropositivity associated with ongoing PrEP. Half of the iPrEx participants who did not continue to open-label use did so because they were concerned about side effects. In adjusted analysis, greater plasma TFV-DP concentration detected through DBS testing was associated with declining HIV incidence, with 44% risk reduction with ≤2 tablets/week, 84% risk reduction conferred by 2-3 tablets/week and 100% risk reduction conferred by ≥4 tablets/week. Greater drug concentration was associated with reporting non-condom receptive anal sex at baseline, reporting ≥5 sex partners in the past three months, having a HIV positive partner, older age (especially being aged ≥40 years) and higher education level. Being a transgender female status was associated with lower drug concentrations. No risk compensation was reported among participants. Average DBS drug concentration was considered a valid marker of ongoing PreP protection.


    The organizers reserve the right to amend the programme.