Pre-exposure Prophylaxis. Robert M Grant October 2014

Transcription

1 Pre-exposure Prophylaxis Robert M Grant October 2014

2 The HIV Pandemic 2.3 Million New HIV Infections in % in Young People (ages 15-24)

3 The HIV Pandemic 1.6 Million Started Therapy in New Infections For Everyone Starting Therapy 3

4 Men who have sex with men (MSM) have 19.3 Higher Odds of HIV infection Baral S, Plos Med 2007

5 HIV Incidence in the United States: No change over the past 20 years. Estimated Number of New HIV Infections, , , ,000 80,000 60,000 40,000 20,000 0 Note: Estimates are for 2-year intervals during , 3-year intervals during and and 4-year intervals for CDC. Estimates of new HIV infections in the United States. HIV/AIDS Fact Sheet, August CDC. HIV Surveillance Report 2010;Vol 22. Published March 2012

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8 Only 1 in 6 MSM uses consistently Must be used every time More intense promotion does not increase use Nothing passes through condoms: Use with confidence

9 PrEP with oral FTC/TDF is indicated for the prevention of HIV acquisition in gay and bisexual men and heterosexual men and women.

10 I am encouraged by this announcement of groundbreaking research on HIV prevention. While more work is needed, these kinds of studies could mark the beginning of a new era in HIV prevention. Barack Obama, November 23, 2010

11 PrEP News in Andrew Cuomo, July 7 th NY funds PREP

12 Pre-Exposure Prophylaxis (PrEP) Initiative: Open Label Extension Robert M Grant, Peter L. Anderson, Vanessa McMahan, Albert Liu, K. Rivet Amico, Megha Mehrotra, Carlos Mosquera, Martin Casapia, Orlando Montoya, Susan Buchbinder, Valdilea G. Veloso, Kenneth Mayer, Suwat Chariyalertsak, Linda-Gail Bekker, Sybil Hosek, Esper G. Kallas, Mauro Schechter, David V. Glidden for the iprex study team. Sponsored by NIH/NIAID/DAIDS and drug donated by Gilead Sciences Grant et al, WAC Melbourne, July 22, 2014; Grant et al, Lancet Infectious Diseases, published online July 22, 2014

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14 Visits from Jun 2011 to Dec 2013 Sites 11 Total enrolled in OLE 1770 PrEP Eligible 1603 Average age 28 San Francisco Chicago Boston Chiang Mai Guayaquil Lima Iquitos Sao Paulo Rio de Janeiro Cape Town Grant WAC Melbourne

15 PrEP Uptake % Of Cohort % PREP Uptake Uptake P Value Non-condom Receptive Anal Intercourse No 68% 75% Yes 32% 81% HSV Seropositive 0.03 No 87% 75% Yes 13% 77% No difference in PrEP uptake by age, education, transgender, prior randomized group or use of alcohol, methamphetamine, or cocaine. Grant WAC Melbourne 2014; Grant et al, Lancet Infectious Diseases, published online July 22,

16 Reasons Given For Not Wanting PrEP: CASI at OLE enrollment, check all that apply, N=373 Reason Given for Declining PrEP % I am concerned about side effects from the pills 50% I don t want to take a pill every day 16% I don t like taking pills 13% I can avoid HIV in other ways 14% I am concerned that people will think that I am HIV positive because I am taking Truvada 7% I am concerned that people will know that I have sex with men and/or trans people because I am taking Truvada 3% Reasons did not differ by prior randomized assignment to active vs. placebo. Grant WAC Melbourne 2014; Grant et al, Lancet Infectious Diseases, published online July 22,

17 Oral FTC/TDF PREP Safety No effect on liver, glucose, amylase, blood counts. No alteration in lipids or body fat distribution. No hepatitis B flares after stopping. Nausea or abdominal cramping in <10%, Resolved after the first weeks of use. Creatinine elevations in 1:200 users, Reversible after stopping PrEP, Do not recur when PREP is resumed. Bone Density 1% decrease in 24 months, No progression over 3 years, partially reverses when stopping, no excess in fractures. Grant NEJM, 2010; Mulligan CROI 2011, Mulligan CROI

18 HIV Incidence and Drug Concentrations Follow-up % 26% 12% 21% 12% Risk Reduction 44% 84% 100% 100% 95% CI -31 to 77% 21 to 99% 86 to 100% (combined) Grant WAC Melbourne 2014; Grant et al, Lancet Infectious Diseases, published online July 22,

19 Patients Reporting URAI (%) HIV-Negative Participants With Any Unprotected Sex (%) No Evidence of Risk Compensation in PrEP Clinical Trials iprex [1] Partners PrEP [2] Placebo FTC/TDF Placebo FTC/TDF TDF Wks Since Randomization Follow-up Time (Mos) 1. Grant R, et al. CROI Abstract Baeten JM, et al. N Engl J Med. 2012;[Epub ahead of print].

20 Why Behavior Becomes Safer During PREP Use? Less denial of HIV Paralyzing fear replaced by action Pills can serve as a daily reminder of imminent risk Risk mitigation strategies thought through in calm moments over many days. Acceptable options inspire action Social support Regular consistent contact with testing, counseling, and peers focused on HIV Acceptance of social and sexual goals

21 Conclusions PrEP is safe and effective for HIV prevention in sexually active adults PrEP is approved by the US FDA, and recommended by the CDC and WHO. PrEP may be well suited for people in transition: immigrants, new to the city, coming out of the closet, dating after a long term relationship. Offering PrEP has many indirect benefits We value you message Inspires planning for sex in calm moments Motivates HIV testing Engagement in sexual health care including contraception and testing for sexually transmitted infections.

22 This work was made possible by the participants and their communities who believed that research could improve their lives