PrEP, or Pre-Exposure Prophylaxis, is a once a day pill that can be taken by an HIV negative individual to prevent HIV infection. This presentation reviews current statistics, research and policy regarding PrEP.
3. National HIV/AIDS Strategy Vision
Statement
“The United States will become a place where new
infections are rare and when they do occur, every
person, regardless of age, gender, race/ethnicity,
sexual orientation, gender identity or socio-
economic circumstance, will have unfettered
access to high quality, life extending care, free from
stigma and discrimination” (Forsyth, 2011).
4. Objectives
Review current national, state and city data.
Review current WHO recommendations for PrEP
use.
Review current CDC guidelines for PrEP use.
Identify indications for PrEP and area resources for
evaluation and PrEP treatment.
5. HIV in the US today:
According to the Centers for
Disease Control (CDC),
“approximately 50,000
Americans become infected
with HIV annually, and
16,000 people with AIDS died
in 2008.” (CDC, 2013).
6. HIV in the US today:
Reference for the New HIV Infections line: CDC. HIV prevalence estimates- United States, 2006. MMWR 2008;57: 1073-
1076 Reference for the People Living With HIV/AIDS line: Hall HI, Song R, Rhodes P, et al. Estimation of HIV incidence in
the United States. JAMA 2008; 300:520-529
14. PrEP Research For:
MSM & Transwomen:
The iPrEx study: compared Truvada with a placebo.
2,499 participants in 6 countries.
All of the participants also got safer sex counseling and condoms,
regular sexually transmitted infection (STI) check-ups and treatment,
and HIV testing.
Truvada group participants with detectable levels of the drugs in their
blood (to evaluate for compliance): transmissions dropped by as
much as 92%.
Drug levels corresponding to daily use: associated with 99%
protection against HIV.
15. PrEP Research for: Serodischordant
Couples
The Partners PrEP study: compared Truvada or
Viread alone compared to placebo.
Population: 4,500+ heterosexual men and women in
Kenya and Uganda who were “serodiscordant”
couples.
In Truvada group: reduction in new infections of up to
75%.
Truvada group participants with detectable levels of
the drugs in their blood (to evaluate for compliance):
transmissions dropped by as much as 90%.
16. PrEP Research for:
IV Drug Users
The Bangkok Tenofovir Study: compared Truvada with a
placebo.
2,400 participants who reported injecting drugs during the
previous year in Bangkok, Thailand.
In intervention group: Truvada was associated with a
nearly 49% overall reduction in risk of HIV infection in IDU
participants.
Risk reduction of up to 74% noted among those who were
directly observed taking drug.
17. Current WHO
Recommendation:
MSM: “PrEP is recommended as an additional HIV
prevention choice within a comprehensive HIV
prevention package.
Serodiscordant Couples: “ Where additional HIV
prevention choices for them are needed, daily oral
PrEP may be considered as a possible additional
intervention for the uninfected
partner” .
(WHO, 2014)
19. more about changes in guidelines for
care
This new set of recommendations focused on
“prevention with positives”:
Incorporating HIV prevention into the care of
individuals living with HIV.
In this set of guidelines, the CDC recommends
that HIV prophylaxis should be available for
“uninfected partners when clinically indicated to
reduce risk of HIV acquisition” (CDC, 2014).
21. A final word about PrEP…
Debate over the use of PrEP increasing risky
behavior.
iPrEx Study: no evidence of "risk compensation"
among PrEP users.
Sexual practices among in both groups: safer by
self-report.
Syphilis incidence: comparable between groups.
24. Great Links and Resources
http://prepfacts.org/
http://www.ispreprightforme.com/
http://www.thestigmaproject.org/
http://myprepexperience.blogspot.com/p/truvada-
track.html
26. References
Baeten, J. M., Donnell, D., Ndase, P., Mugo, N. R., Campbell, J. D., Wangisi, J., et al. (2012). Antiretroviral prophylaxis for HIV prevention in heterosexual men and
women. N Engl J Med, 367(5), 399-410. doi:10.1056/NEJMoa1108524
Baltimore City HIV/AIDS Epidemiological Profile. (2012, December 31). Retrieved April 11, 2015.
Centers for Disease Control. High-Impact HIV Prevention: CDC's Approach to Reducing HIV Infections in the United States. (2013, April 17). Retrieved April 11, 2015,
from
http://www.cdc.gov/hiv/policies/hip.html
Centers for Disease Control. Recommendations for HIV prevention with adults and adolescents with HIV in the United States, 2014 : Summary for clinical providers.
(2014, December 14). Retrieved April 6, 2015, from http://stacks.cdc.gov/view/cdc/26063
Fleming P, Ward JW, Janssen RS, De Cock JM. Guidelines for National Human Immunodeficiency Virus Case Surveillance, Including Monitoring for Human
Immunodeficiency Virus Infection and Acquired Immunodeficiency Syndrome: National Health Interview Survey, 1999. National Center for Health Statistics.
MMWR 48(RR13). 1999.
Forsyth, A. (Director) (2011, November 10). Achieving the HIV Testing Goals of the National HIV/AIDS Strategy: An Update from DHHS. DHHS Office of HIV/AIDS
Policy. Lecture conducted from U.S. Department of Health and Human Services. Retrieved April 2, 2015, from: http://www.theaidsinstitute.org
Grant, R. M., Lama, J. R., Anderson, P. L., McMahan, V., Liu, A. Y., Vargas, L., et al. (2010). Preexposure chemoprophylaxis for HIV prevention in men who have sex
with men. N Engl J Med, 363(27), 2587-2599. doi:10.1056/NEJMoa1011205
Kachit Choopanya, Martin, M. V. (2013). Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a
randomised, double-blind, placebo-controlled phase 3 trial. Lancet, 381(9883), 2083-2090.
U.S. Census Bureau. (2014). State and County Quick Facts: Baltimore, Maryland. Retrieved from http://quickfacts.census.gov/qfd/states/24/24510.html
According to the US Department of Health and Humans Services, the National HIV/AIDS Strategy Vision Statement is: “The United States will become a place where new infections are rare and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity or socio-economic circumstance, will have unfettered access to high quality, life extending care, free from stigma and discrimination”.
This is an excellent goal to strive for for in the longterm, but for the purposes of this activity, the streamlined goal is simply: To reduce rates of HIV transmission in Baltimore City.
Current advances in treatment and prevention efforts have stabilized the number of new infections per year for the last ten years (Fleming, 1999), and prolonged the lives of those with HIV.
Because of this steady flow of new cases and fewer deaths from AIDS, the number of individuals living with HIV in the United States is now approximately 1.2 million, and growing by tens of thousands each year. While increasing the survival rate for individuals with HIV is desirable, this also translates to increased opportunities for HIV transmission and a new facet to the issue of HIV in the United States.
So lets take a look at how Maryland ranks in HIV: In 2011, Maryland had an estimated 1,783 these new HIV diagnoses, ranking seventh in the US for the number of new cases, and 3rd highest per capita.
Maryland had an estimated 30,558 adults living with HIV at the end of 2010, ranking 9th highest in number of cases for any state or territory, 4th per capita (CDC, 2011)
The DC Metro Area ranks fifth in new HIV diagnoses in 2011, with Baltimore ranking 6th.
And again Baltimore City ranks third in the estimated number of persons living with HIV.
So why is the HIV rate so high in our area? While it is true that anyone can contract HIV, the HIV epidemic affects some specific populations disproportionately and these are the populations we must focus prevention efforts on: According to the CDC the populations at highest risk for HIV include: MSM: gay and bisexual men of all races and ethnicities, african-americans & latinos (both male and female), intravenous drug abusers and transgender individuals (CDC, 2014).
In 2014 Baltimore’s estimated population was 622,793, 63% of which are African American, and 4.6% are Hispanic of Latino (U.S. Census, 2014). Well over half of the city is at an increased risk for HIV infection (and it shows in our ranking by rate) and therefore a higher need for targeted prevention strategies.
One intervention that is getting a lot of attention for its effectiveness is the use of PrEP: Pre-exposure prophylaxis.
What is PREP? Prep is pre-exposure prophylaxis. Its a way for people who do not have HIV to help prevent HIV infection by taking a pill, truvada, every day. Truvada, is a combination pill that you are familiar with as part of treatment since it’s approval for use in 2004. While PrEP is not a cure for HIV, and is not a failure free method of prevention, it is part of a larger plan of prevention. For example, individuals who use PrEP should use it along with other effective HIV prevention strategies including: Using condoms consistently and correctly,Getting HIV testing with your partners, Getting STD testing with your partners, Choosing less risky sexual behaviors, such as oral sex. If you inject drugs, participating in a drug treatment program or using clean needles.
People who use PrEP must be able to take the drug every day and to return to their health care provider every 3 months for a repeat HIV test, prescription refills, and follow-up.
PrEP is a powerful HIV prevention tool. According to CDC guidelines: When used consistently and as directed PrEP can lower one’s risk of HIV up to 92% lower than those who do not take prep.
Also, PrEP is only for people who are at ongoing substantial risk of HIV infection. For people who need to prevent HIV after a single high-risk event of potential HIV exposure—such as sex without a condom, needle-sharing injection drug use, or sexual assault—there is another option called postexposure prophylaxis, or PEP. PEP must begin within 72 hours of exposure.
So lets take a look at some research on the effectiveness of PrEP for different high risk populations:
The analysis showed that the group assigned to receive Truvada had a 42% reduction in HIV risk compared with those who received placebo. However, the Truvada group included people who were offered Truvada but did not take the pills. When the researchers looked at data only from people with detectable levels of the drugs in their blood (a sign than the medication was being taken regularly), they found that transmissions dropped by as much as 92%. Further analyses indicate that drug levels corresponding to daily use are associated with 99% protection against HIV.
For heterosexual women and men who participated in PrEP clinical trials:
AGAIN: COMPLIANCE MATTERS!
Because participants in the study may have been both injecting drugs and having sex without condoms, it still unclear whether Truvada specifically prevents “parenteral” HIV acquisition—that is, acquisition through injection rather than sex.
THE MESSAGE IS CLEAR: If you don’t take PrEP consistently it can’t protect you from HIV, but if you do take it regularly it can offer strong protection.
In light of the research we just discussed, treatment guidelines and recommendations are changing.
In June of 2014 the WHO released updated recommendations for the prevention of HIV. These updated recommendations include the inclusion of PrEP as a part of a larger treatment package (as we just discussed: HIV treatment, condoms, clean needles etc.).
Specifically, the guidelines recommend that health care providers inform all persons with HIV and any of their HIV-uninfected partners about the availability of preexposure prophylaxis (PrEP) when clinically indicated to reduce their risk of HIV acquisition. All persons should be informed of the efficacy and limitations of PrEP, and the names and locations of health care facilities where HIV-uninfected partners can be evaluated for treatment, and assisting with accessing these services (monetary for assistance, etc).
There is this transition to focusing on preventing with positives, and using various types or prevention strategies in concert…especially for those who are in a high risk group.
In December of 2014, the CDC released “Recommendations for HIV Prevention with Adults and Adolescents with HIV in the United States, 2014”.
Historically, HIV prevention initiatives in this country have largely focused on those who are not HIV infected, and educating them on prevention of sexually transmitted infections. For example, ad campaigns on bus stops and in beauty shops offering free HIV testing and condoms have been used throughout Baltimore City for decades to increase awareness.
In this set of guidelines, much like the WHO recommendations we just covered, the CDC recommends prevention with positives. The CDC also recommends that Prep for HIV prophylaxis should be available for “uninfected partners when clinically indicated to reduce risk of HIV acquisition” (CDC, 2014).
So…for whom is PrEP clinically indicated? PrEP is not for everyone. CDC recommends PrEP be considered for people who are HIV-negative and at substantial risk for HIV infection. This includes anyone who:
Is in an ongoing relationship with an HIV-infected partner (aka a serodischordant couple);
Is not in a mutually monogamous relationship with a partner who recently tested HIV-negative; and is a gay or bisexual man who has had sex without a condom or been diagnosed with a sexually transmitted infection within the past six months; heterosexual man or woman who does not regularly use condoms when having sex with partners known to be at risk for HIV (e.g., injecting drug users or bisexual male partners of unknown HIV status); or Has, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.
For heterosexual couples where one partner has HIV and the other does not, PrEP is one of several options to protect the uninfected partner during conception and pregnancy.
Despite considerable speculation that access to PrEP could cause individuals to increase their sexual risk-taking behavior, iPrEx OLE found no evidence of "risk compensation" among PrEP users.
Sexual practices among both PrEP receivers and those not receiving PrEP became safer by self-report. Syphilis incidence, another important marker of sexual risk behavior, was comparable between the two groups.
We must increase awareness of PrEP among all who could benefit from it, and overcome critical barriers to PrEP access including: misinformation, lack of provider training and insufficient coverage via health insurance and other payor programs.
Originally I had planned to make business cards with sort of a PrEP 101/FAQ but as I began working on that I found some great brochure resources at the CDC website. Instead of re-inventing the wheel and possibly providing you all with a resource that would take time/trouble to implement I am instead bringing these in today. I can also email the link to the CDC page should you want more.
I also printed out this information about a presentation on May 4 about PrEP at the JHU School of nursing. While we are passing this information around, Can anyone tell me what EJC procedure is for PrEP?
Here are some great links and resources both for clients and healthcare workers.