Download Arizona Statewide Pre-Exposure Prophylaxis Provider Survey

HIV PRE-EXPOSURE PROPHYLAXIS (PREP)
YUMA HEALTH DISTRICT 5/23/16
ALYSSA GUIDO, MPH
PROGRAM DIRECTOR, ARIZONA AETC
ARIZONA AIDS EDUCATION AND TRAINING CENTER
This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant # U1OHA29292-0101, Regional AIDS Education and Training Centers, PAETC award: $3,018,761. This information or content and conclusions are those of the author and should not be construed as the
official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.”
HIV/AIDS IN THE US AND WORLDWIDE
 Approximately 1.2 million people are living with HIV/AIDS in the United States
 An estimated ~13 % of those people are undiagnosed
 Since the start of the epidemic, 636,000 people have died of AIDS
 An estimated 50,000 new HIV infections occur in the US every year
 More than 35 million people are living with HIV/AIDS worldwide
 In 2012, an estimated 2.3 million people were newly infected with HIV
CDC-Division of HIV/AIDS Prevention
Estimating Lifetime Risk of HIV Diagnosis
 Estimated lifetime risk of an HIV diagnosis among MSM
 Black/African American 1:2
 Hispanic/ Latino 1:6
 White 1:11
 Lifetime risk of an HIV diagnosis among people with injection drug use
 Male 1:36; Female 1:23
 African American male 1:9; African American female 1:6
 MSM 79 times the risk of heterosexuals
 PWID 13 times the risk of heterosexuals
CROI 2016 OA 52; Estimating the Lifetime Risk of a Diagnosis of HIV Infection in the United States Kristen Hess; Xiaohong Hu; Amy Lansky; Jonathan Mermin;
H. Irene Hall; CDC, Atlanta, GA, USA
CONTINUED NEED FOR HIV RISK AND PREVENTION/DISPARITIES
AMONG POPULATIONS
 Gay, bisexual, and other men who have sex with men (MSM) make up 64% of all HIV-
infected people in the United States
 The rate of new diagnoses for MSM is more than 44 times that of other men and
more than 40 times that of women
 African Americans are 8 times more likely to be living with HIV than whites
 Hispanic /Latinos are 3 times more likely to be living with HIV than whites
HIV PREVENTION
 Safer-sex counseling: understanding risk
 Condoms and lubricant
 Sterile syringes and avoiding sharing “works”
 HIV testing
 STI testing and treatment
 PEP (post-exposure prophylaxis)
 PrEP (pre-exposure prophylaxis)
What is PrEP?
Pre-Exposure Prophylaxis is a treatment regimen which protects
the body and helps prevent HIV infection
What is PrEP?
PrEP is not PEP
PrEP is not vaccine
PrEP is not a substitute for condoms
Pre-Exposure Prophylaxis (PrEP)
HIV-
HIV+
HIV Infection
Pre-Exposure Prophylaxis (PrEP)
“Prophylaxis” – action taken to prevent disease, especially by specified means or against a
specified disease.
HIV-
HIV-
Effectiveness
“Will PrEP make me immune to HIV?”
“Is PrEP better than condoms?”
 PrEP Reduces risk of HIV infection by up to 92%
 PrEP Does not reduce the risk of other STIs
 Condoms are still the most effective method of prevention.
1 Effectiveness
among individuals with detectable drug levels from the iPrEx study.
How do I take PrEP?
“How often do I take PrEP?”
“Can I skip doses?”
“Is it like a vaccine?”
 PrEP must be taken daily
 PrEP only reaches effectiveness after 20 days
Why do I need lab work before starting PrEP?
“What will I be tested for?”
 Labs will include: HIV testing (preferably 4th generation), STI testing,
Hepatitis panel, kidney function and pregnancy for women
 It is possible to develop drug resistance if an HIV-infected person starts
using PrEP.
Is PrEP safe?
“What are the side effects?”
 Clinical trials have shown side effects to mild, like headache and nausea
 Can cause mild loss of bone mineral density (does not appear to
increase risk of fractures). Bone density returns to normal levels when
PrEP is stopped.
 Some persons with kidney disease may not be able to take PrEP
I FEEL COMFORTABLE TALKING TO MY PATIENTS/CLIENTS ABOUT
PREP…
17%1. Yes, I can talk in detail
70%2. A little bit, jus a few basic facts
13%3. No, not at all
I KNOW WHERE TO REFER PATIENTS TO PREP…
41%1.
Yes, I know exactly who to refer patients to
45%2.
I’m not sure, I’d have to do more research
14%3.
I have no idea where to refer patients who want PrEP
I THINK PREP SHOULD BE…
4% 1. Not available at all
29% 2. Provided to patients only in select cases
58% 3. Widely available
8% 4. Undecided
I FEEL THAT PATIENTS ON PREP WILL…
58% 1. Increase their risk behavior
13% 2. Decrease their risk behavior
21% 3. No change in behavior
8%
4. I don’t know
I THINK PREP WILL…
96%
1. Have a significant impact on reducing new HIV infections
4%
2. Small impact on reducing new HIV infections
0%
3. No impact on the epidemic
0%
4. Unsure
MY TOP TWO CONCERNS ABOUT PREP ARE…
29%
1. Not enough research on long term effects of PrEP
71%
2. Financial concerns – who is paying for it?
13%
3. STDs will increase due to increase in risk behavior
8%
4. Patients will not be adherent
50%
5. Not enough education for providers
4%
6. Other
Understanding PrEP
Example: Birth Control
Oral Contraceptive
(“The Pill”)
Pre-Exposure Prophylaxis
(PrEP)
Prevents pregnancy if taken before sex. Does not work as
morning-after pill.
Prevents HIV infection pre-exposure. Will not work if
already exposed.
Does not always start working immediately.
Does not start working immediately.
Must take daily – cannot skip doses.
Must take daily – cannot skip doses.
Only helps prevent pregnancy, will not prevent STIs (should
still use condoms).
Only helps prevent HIV – will not prevent other STIs (should
still use condoms).
Very effective at preventing pregnancy, but not 100%
effective.
Very effective at preventing HIV infection, but not 100%
effective.
Should be taken by anyone who is sexually active (at risk for
becoming pregnant)
Should be taken by anyone who could be exposed to the
HIV virus (at risk for HIV)
PREP AWARENESS AMONG PATIENTS IN ARIZONA
1
YES
8
8
5
NO
0
N = 45
1
11
5
Coconino
Pima
1
3
4
10
Maricopa
1
15
Pinal
Yavapai
Yuma
2
20
Many
51%
49%
25
No Zip Code
NUMBER OF RESPONDENTS THAT HAVE HAD PATIENTS ASK ABOUT PREP. Provider responses to the question, “Has a patient ever asked
you about PrEP?” Respondents are disaggregated by county.
PREP AWARENESS AMONG PROVIDERS IN ARIZONA
YES
1
NO
9
8
4
0
N = 45
1
11
5
Coconino
4
10
Maricopa
Pima
15
Pinal
Yavapai
Yuma
3
1
2
1
20
Many
51%
49%
25
No Zip Code
NUMBER OF RESPONDENTS THAT INITIATED DISCUSSIONS ABOUT PREP. Provider responses to the question, “Have you ever initiated
a discussion about PrEP with a patient?” Provider responses disaggregated by county.
PROVIDER EXPERIENCE WITH PREP
I have prescribed and/or currently prescribe ARVs for HIV prevention (PrEP).
1
I refer patients to other providers who prescribe PrEP.
2
With more education and training, I would refer patients to other…
Pinal
1
33%
9%
1
6
3
0
Pima
1
3
2
29%
0
Other
Maricopa
2
1
16%
2
2
I will not prescribe PrEP to my patients.
Coconino
6
3
1
With more education and training, I would prescribe PrEP.
N=45
5
2
2
Yavapai
4
Yuma
13%
1
6
Many
8
10
12
14
16
No Zip Code
FIGURE 5. PROVIDER EXPERIENCE WITH PREP DISAGGREGATED BY COUNTY. Respondents were asked to select which statement best applies to them. The
bar graph indicates the number of respondents that selected each statement. Responses are disaggregated by county.
PREP CLINICAL TRIALS
• iPrEx Study – MSM and transgender women in 6 countries, 44% reduction
• TDF2 Study - Men and Women in Botswana. 62.2 % reduction in HIV incidence
• Partners PrEP Study – Randomized control trial of serodiscordant couples in
Kenya and Uganda, 67% reduction in HIV incidence
• Bangkok Tenofovir Study – IDU in Thailand, Tenofovir only, 48.9% reduction in
HIV incidence
• Risk reduction 44% - 92%
WHO SHOULD TAKE PREP?
 June 16, 2012 FDA approved Truvada for prevention for HIV
 May 14, 2014, the US Public Health Service and the CDC released the first
comprehensive guidelines for PrEP.
 PrEP is indicated in patients who are HIV-negative and have one of the following risk
factors:
1. HIV-positive partners
2. MSM with recent unprotected sex or STD
3. Intravenous drug users (IDU) who reported sharing needles or equipment, or have
recently starting substance use treatment program (high-risk for relapse).
4. Heterosexual men or women who infrequently use condoms and have sex with high-
risk partners
NATIONAL ESTIMATE (CDC)
MSM
Indicated for PrEP
IDU
Not Indicated for PrEP
Indicated for PrEP
Not Indicated for PrEP
115,000,
19%
492,000,
25%
1,499,903,
75%
HETEROSEXUAL
Indicated for PrEP
Not Indicated for PrEP
624,000,
0.40%
506,600,
81%
156,000,000,
99.60%
1 in 4
1 in 5
1 in 200
Centers for Disease Control and Prevention (2015) Vital Signs: Estimated Percentages and Numbers of Adults with Indications for Preexposure Prophylaxis to Prevent
HIV Acquisition — United States, 2015. Morbidity and Mortality Weekly Report, 64(46);1291-1295. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6446a4.htm
Centers for Disease Control and Prevention (2015) Vital Signs: Estimated Percentages and Numbers of Adults with Indications for Preexposure Prophylaxis to Prevent
HIV Acquisition — United States, 2015. Morbidity and Mortality Weekly Report, 64(46);1291-1295. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6446a4.htm
A CRITICAL GAP….
 Restrictions in the uses of CDC and HRSA/HAB
funding to pay for the medication
 19 states (many in the South) have not yet adopted
Medicaid expansion
1.2 million individuals
indicated for PrEP
 Affordability of insurance remains a barrier,
particularly co-payments/co-insurance for HIV
medications
3-4% access it
Sources:
D. Smith et al. Vital Signs Nov. 27, 2015
J. Krellenstein and J. Johnson. TAGline, Spring 2016
31
PREP CYCLE
PREP COST
ESTIMATING YEARLY OUT OF POCKET COSTS
lab copay (4)
+ medical visit copay (4) + medication copay (12)
Other factors:
Maximum out of Pocket
Once this is met, no more cost for
services for the rest of the year
=
Total Yearly Cost
Truvada Patient Assistance Programs
Patients who qualify, might not pay anything out of
pocket for medication
Accessing PrEP – Insured Individuals
• Covered by all commercial insurance companies and most Medicaid plans. Some insurance plans
require Prior Authorization
• GILEAD’s Co-Pay Card Program
• Covers up to $3,600 per year, out-of-pocket costs
• Insured individuals only
• Not used with Medicaid, Medicare of VA
• Patient Advocate Foundation
• Below 400% FPL
• $7,500 max per year, co-pay / deductible costs – may reapply
• Patient Access Network Foundation – Funds currently depleted
• Below 500% FPL
• $7,500 max per year, may reapply
• Co-pays, deductibles, co-insurance
Accessing PrEP – Uninsured Individuals
Gilead Medication Assistance Program
• Below 500% FPL
• Re-apply as needed
• Only covers medication costs – does not medical appointments and lab costs
Community health centers have a sliding scale fee and can provide medical care and labs
CONCLUSIONS
 PrEP is recommended as one prevention option for sexually active MSM, heterosexual men and women, IDU at substantial
risk of HIV acquisition
 Adherence is a key factor in PrEP efficacy
 Before prescribing PrEP, HIV infection must be excluded, and the patient should be assessed for comorbidities that may
present health risks
 The recommended PrEP regimen is fixed-dose TDF/FTC (Truvada)
 Patients prescribed PrEP need to return for follow-up visits at least every 3 months and be retested for HIV
 Affordability of PrEP can pose a barrier but there are patient assistance programs that can help with co-pays.
CONNECT TO A PREP PROVIDER
 Does patient have PCP willing to prescribe PrEP?
 Is the patient willing to switch PCPs if necessary?
POST EXPOSURE PROPHYLAXIS (PEP)
THANK YOU
Alyssa Guido, MPH
Program Director
Arizona AIDS Education & Training Center
520-626-0723
[email protected]
Physician Resource Line for Clinical Consultations
Local: (520) 694-5868
Long Distance: (800) 328-5868
Mexico: 001-800-328-5868
* Ask for the Infectious Disease Specialist on call
EXTRA SLIDES
MICHAEL
 You are evaluating a 23 year-old male at your office.
 He has no active complaints. He is sexually active with men and had six partners over the
past year.
 He has a history of syphilis diagnosed two-years ago and was treated with IM penicillin.
 Six months ago, you counseled him on the importance of consistent condom use.
 He reports that he currently uses condoms ~80% of the time.
 No recent STD since last visit. He drinks alcohol occasionally and no illicit drug use.
WHAT WOULD YOU RECOMMEND FOR MICHAEL?
1. HIV screening
2. HIV and STD screening
3. HIV, STD screening and discuss importance of persistent condom use
4. Offer daily Truvada (TDF/FTC) + HIV, STD screening and discuss importance
of persistent condom use
PRE-EXPOSURE CHEMOPROPHYLAXIS FOR HIV PREVENTION IN MEN WHO
HAVE SEX WITH MEN - THE IPREX TRIAL
 Randomized clinical trial- 4905
subjects
 Truvada (TDF/FTC) was shown to
decrease the risk of HIV transmission
by 42% in MSM who also received
comprehensive preventive services
 The risk was decreased by 92% in
patients with detectable drug levels
Grant RM, et al. N Engl J Med 2010;363:2587-99
PRE-EXPOSURE CHEMOPROPHYLAXIS FOR HIV PREVENTION IN MEN WHO HAVE
SEX WITH MEN- THE IPREX TRIAL
GRANT RM ET AL. N ENGL J MED 2010;363:2587-2599.
ANTIRETROVIRAL PROPHYLAXIS FOR HIV PREVENTION IN
HETEROSEXUAL MEN AND WOMEN- THE PARTNERS-PREP TRIAL
 Truvada (TDF/FTC) was shown to decrease the risk of HIV
transmission by 75% in uninfected individuals in stable
heterosexual serodiscordant relationship who also received
comprehensive preventive services
 Tenofovir alone decreased the risk by 67%.
 The risk was decreased by 90% in patients with detectable
TDF and FTC levels
 8 patients were infected with HIV before randomization.
Resistant HIV to the study medications developed in 2 cases
 No participants who acquired HIV after randomization
developed resistance
BAETEN JM ET AL. N ENGL J MED 2012;367:399-410.
PrEP Clinical Trials
Iniciativa Profilaxis Pre-Exposición (iPrEx) Study1
• Randomized clinical trial of gay and bisexual men
• 2499 Participants in 6 countries
• PrEP group overall 44% less likely to get HIV than those who were given a
placebo.
• Risk of infection reduced by 92% in men with detectable levels of drug in
bloodstream.
1Grant
2599
RM et al. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men N Engl J Med 2010;363:2587-
PrEP Clinical Trials
TDF2 Study Among Men and Women in Botswana2
• Heterosexually active men and women in Botswana
• Randomized clinical trial of 1219 participants
• PrEP reduced the risk of getting HIV by 62%
• Participants who became infected had less drug in their blood compared to those
who remained uninfected.
2 Thigpen, MC
367:423-434
et al. Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana N Engl J Med 2012;
PrEP Clinical Trials
The Partners PrEP Study3
• HIV discordant couples in Kenya and Uganda
• Randomized clinical trial of 4,747 participants
• PrEP group 75% less likely to become infected than those on placebo.
• Among those with detectable levels of medicine in their blood, PrEP reduced the
risk of HIV infection by 90%.
3 Baeten
JM, Donnell D, Ndase P, et al. Antiretroviral Prophylaxis for HIV-1 Prevention among Heterosexual Men and Women. The New England journal of
medicine 2012;367(5):399-410. doi:10.1056/NEJMoa1108524.
PrEP Clinical Trials
Bangkok Tenofovir Study4
• Placebo-controlled clinical trial (tenofovir vs placebo)
• 2413 Injection drug users in Thailand
• Tenofovir group had reduced risk of HIV by 49%
• Participants with detectable tenofovir in their blood, risk of infection reduced by
74%
4 Choopanya, Kachit
et al. 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, The Lancet,Volume 381, Issue 9883, 15–21