Biomedical HIV Prevention & PrEP Pre exposure Prophylaxis 2013 Community Education Team The AIDS Institute/AIDS Alliance Be the Generation to End the AIDS Epidemic bethegeneration.nih.gov www.aids-alliance.org/education/vaccine This work is supported by the BTG Bridge Project, a collaboration between FHI 360/HIV Prevention Trials Network (HPTN) and the Legacy Project at the Office of HIV/AIDS Network Coordination (HANC).
Today s Agenda & Ground-rules Agenda 1.Project Overview 2.Introduction to biomedical HIV prevention & research 3.Highlight on HIV PrEP 4.Discussion & Questions Ground rules 1.Sign in sheet 2.Time for Discussion 3.Parking lot 4.More information
Be The Generation The Be The Generation project was created to promote awareness and understanding of biomedical prevention in communities most impacted by the HIV/AIDS epidemic Biomedical HIV Prevention involves approaches to HIV prevention that include medicines or are medically based Some are still in development & require more research, such as HIV vaccines, microbicides Some are already available and recently proven by research, such as Pre-exposure prophylaxis (PrEP), Treatment as Prevention (TaP) The best prevention strategies will be a combination of biomedical and behavioral approaches such as condom use and limiting substance abuse.
PMTCT- Prevention of Mother to Child Transmission First Biomedical HIV Prevention Success Now regular care in U.S. and much of the world. Before 1994, HIV positive women had at least a 25% chance of passing HIV onto their babies. (1 in 4) Now, in the U.S with PMTCT treatment there is approx. 1% chance of HIV infection in babies where mom and baby treated with HIV meds (1 in 100) Result of a prevention research study known as PACTG 076
Why is it important to have community involvement and understanding of biomedical HIV prevention and research?
Value of Community Support & Involvement in Research Every year about 50,000 people become infected with HIV in the United States. Even with tremendous advances in treatment prevention is still the best strategy. The relatives, friends and neighbors of people living with HIV may benefit most from prevention advances. Opportunity to better understand the priorities, concerns, beliefs and knowledge of community members
Work in progress!
Ice Breaker Exercise QUESTION 1 What have I heard about PrEP? QUESTION 2 What would I like to know about PrEP? Question 3 What would I like to know about other biomedical prevention efforts?
PrEP- Pre Exposure Prophylaxis Daily use of anti-hiv medication (Truvada) by HIV negative people to prevent HIV infection Recommended by the CDC January 2011 Men who have sex with men August 2012 Heterosexual men & women Approved by the FDA June 2012 Approval based on Recent Biomedical HIV Prevention Research Different than post-exposure prophylaxis
PrEP Studies Development
How the PrEP Studies worked HIV (-) Participants, Randomly Assigned to Drug or Placebo Drug (Truvada) Counseling & Condoms, STD Care Placebo drug, Counseling & Condoms, STD Care Regular Visits for 2-3 Years Regular Visits for 2-3 Years Check HIV status, side effects, all info into computer database Check HIV status, side effects, all info into computer database All information on participants is monitored throughout the study by an external group of experts, known as the DSMB- looking for unexpected side effects or unexpected overwhelming evidence of effect
PrEP- Pre Exposure Prophylaxis iprex Study: Enrolled 2,500 HIV (-) MSM and transgender women in 6 countries 2007-2010 One half received Truvada daily One half received Placebo daily All received monthly visits, safe sex counseling, condoms and STI treatment Results showed an average 44% reduction in getting HIV in Treatment group overall compared to Placebo Group In those with 90% adherence = 73% reduction in getting HIV
PrEP- Pre Exposure Prophylaxis Partners Prep Study: Enrolled almost 5,000 discordant heterosexual couples in Kenya and Uganda. Study of treating the uninfected partner Approximately equal enrollment by sex (positive partner at enrollment equal btwn men & women) HIV positive person was not on treatment as did not meet country standards for treatment. HIV negative person received study drug: 1/3 received Viread daily 1/3 received Truvada daily 1/3 received placebo daily All negative partners received monthly visits, counseling, condoms, treatment for STI
PrEP- Pre Exposure Prophylaxis PartnersPrep: Results in August 2012 67% reduction in HIV transmission in Viread group 75% reduction in HIV transmission in Truvada group In treated group- 92% reported adherence rate overall (and in 83% there were adequate drug levels to back-up self-reports of adherence) Gender of negative partner made no difference in effectiveness, equal results in men & women
PrEP- Pre Exposure Prophylaxis FemPrEP Study: Enrolled more than 2,000 HIV (-) women at increased risk for HIV in 3 African countries ½ received Truvada daily ½ received Placebo daily All received monthly visits, counseling, condoms and STI treatment No difference in rate of HIV infection btwn placebo treated and Truvada treated groups Despite monthly visits and reports of adherence, less than 40% of Truvada group had adequate drug levels in blood
PrEP- CDC Recommendations as a result of these studies Only to be used by confirmed HIV-negative people Effective for men and women when used properly. It s not 100%-it was only shown to be partially effective when used in combo with regular HIV testing, condoms, and other proven prevention methods. It does not protect against other sexually transmitted infections. People should still use condoms consistently and correctly Get HIV tested regularly on PrEP to know your status Get tested and treated if needed for other STDs Get information and support to reduce drug use and sexual risk behavior Taking PrEP daily is critical with close monitoring by health care providers.
New PrEP Studies IPREX Ole: Looking at people who participated in original IPREX, no placebo and all get study drug but more like real-life without the same level of counseling. Results in late 2013 NEXT-PrEP: HPTN 069 : Testing another approved anti-hiv drug Maraviroc for safety & effectiveness in protecting HIV(-) people. Designed due to concerns about Truvada resistance ADAPT: HPTN 067 (Alternate dosing) Looking at intermittent Truvada in 540 men & women in US, SA & Thailand
PrEP- Pre Exposure Prophylaxis Questions & Issues Who prescribes it? Who pays for it? Who provides the follow-up? What happens when follow-up is less intensive? What is the risk of resistance in people who become infected while on PrEP? Why are the studies of women showing less adherence? Are there any long term side effects? How is it marketed or publicized? Who decides who is at increased risk?
Discussion & Information www.cdc.gov/hiv/prep www.hptn.org www.avac.org www.aidsalliance.org