Marys Medicine


Microsoft powerpoint - hiv npep for iafn final 12-5-13 [compatibility mode]

Welcome to the IAFN, SAFE-TA, and MATEC Webinar: PEP for Prevention
of HIV: When, Why & How
IAFN requests that you e-mail the names of any non-registered
attendees who may be sharing this webinar experience with you
so we can track attendance. Please send additional attendee
names to [email protected] today.
Thank you in advance for your help and cooperation!
This webinar was supported by Grant No. 2011-TA-AX-
K021 awarded by the Office on Violence Against
Women, U.S. Department of Justice. The opinions,
findings, conclusions, and recommendations expressed
in this presentation are those of the authors and do not
necessarily reflect the views of the Department of
Justice, Office on Violence Against Women.
This webinar is supported with funding from the U.S.
Public Health Service, Health Resources and Services
Administration (HRSA), HIV/AIDS Bureau under Grant
Joint Position on Universal
Access to Anti-HIV Medication
The Association of Nurses in AIDS Care (ANAC), International Association of Forensic Nurses (IAFN), National Alliance to End Sexual Violence (NAESV), and National Sexual Violence Resource Center (NSVRC) recommend that systems be established to ensure that survivors of sexual assault have universal access to medications to prevent HIV following rape. In too many communities, access to these medications is lacking or Joint Position (Continued)
In summary the above mentioned organizations recommend that:Health care providers treating sexual assault patients include HIV risk assessment and potential prophylaxis as a standard component of the medical-forensic examination.
Anti-HIV medications be available where and when patients present after sexual assault.
People who have been sexually assaulted not be expected to carry the financial burden for HIV nPEP.
People who have been sexually assaulted have access to advocacy and supportive services before, during and after HIV testing and nPEP provision.
At the conclusion of this program, participants will be able Identify patients of sexual assault patients who are appropriate patients to receive antivirals post-assault.
Select appropriate antivirals for patients who have been Identify resources in their respective practice settings to assist post sexual assault patients with acquiring antivirals.
Should be OBJECTIVES Not Agenda Implement HIV nPEP Resources for care Kim Day, 9/5/2013 Postexposure Prophylaxis
(nPEP) for HIV
Diane M. Janowicz, MD
Assistant Professor of Medicine Indiana University School of Medicine MATEC Indiana - Clinical Faculty Global Summary of the AIDS
WHO-HIV Department, November 12, 2013. WHO/UNAIDS/UNICEF
US HIV Epidemiology
 1.2 million persons living with HIV  21% of infected persons unaware of status!  50,000 new infections/year  stable for two decades  $19 billion/year for prevention, care, &

What is nPEP?
 antiretroviral (HIV) medications prescribed within 72 hrs to patients with a known or suspected exposure to prevent active HIV  nPEP regimen similar to those used to treat HIV infection, but for 28 days Estimated Per-Act Risk
for Acquisition of HIV by
Blood transfusion (1 unit) Needle-sharing injection drug use Receptive anal intercourse Percutaneous needle stick Receptive vaginal intercourse Insertive anal intercourse Insertive vaginal intercourse Receptive oral intercourse Mucosal Membrane Exposure (AETC National Resource Center 2008,, Fisher et al., 2006)
Evidence for nPEP
 Animal models demonstrate variable results  Macaque Model (SIV) – 4 animals, start 12 hrs after exp – x 28 d (0/4 SIV)– 4 animals, start 36 hrs after exp – x 28 d (0/4 SIV)– 4 animals, start 72 hrs after exp – x 28 d (1/4 SIV)  Small window period during which ART may interrupt the initial infection of cervicovaginal mucosa or the dissemination of local infection Evidence for nPEP
 Post-natal prophylaxis reduces HIV transmission at 14-16 w1 – Mother receives nevirapine during labor, baby within 72 h (25% transmission rate to 13.1%)  Occupational PEP2 – 33 cases, 655 controls– AZT PEP reduced acquisition (OR: 0.19 CI: 1LA Guay et al. Lancet, 1999 and 2DM Cardo et al New Engl J Med. 1997.
 South Africa study of rape survivors – -480 women followed for 6 weeks – -zidovudine + lamivudine (AZT + 3TC)  1 acquired HIV (started 96 hrs after assault) 1 woman who sought treatment 12 days after the assault acquired HIV (seroconverted at 6 wks)  Brazilian study of sexually assaulted women – -(AZT + 3TC)+/- indinavir if < 72 hrs  0 of 180 PEP acquired HIV – no treatment if > 72hrs, HIV- assailant, or condom used and no mucosal trauma  4 of 145 untreated women acquired HIV Evaluating a Patient
Step 1: Order an HIV Test
Detect Antibodies Detect Antibodies Hours or Days for
20 minutes for
Oral or finger stick
Results must be Step 2: Review Results
Reactive HIV Screening Test:
– Do NOT offer nPEP.
– This patient MAY have HIV infection.
– Confirm HIV infection with a Western Blot.
– Refer patient to an HIV Expert.
Non-reactive HIV Screening Test:
– Your patient was not previously infected.  Window period of up to 3 months before Ab to HIV are produced after an exposure; during this period, HIV screening tests may be non-reactive! Discuss with your – Your patient may be a candidate for nPEP.
Step 3: Assess Risk
Substantial Exposure Risk
Negligible Exposure Risk
vagina, rectum, eye, mouth, or other vagina, rectum, eye, mouth, or other mucous membrane, non-intact skin, mucous membrane, non-intact skin, or percutaneous contact or percutaneous contact blood, semen, vaginal secretions, Urine, nasal secretions, saliva, sweat, rectal secretions, breast milk, or or tears if not visibly contaminated any body fluid that is visibly contaminated with blood Of the known or suspected HIV status the source is known to be HIV Step 4: Follow the nPEP
< 72 hours since >72 hours since Source patient of unknown HIV status Step 5: Make an nPEP
 The situation you described puts you at low risk for
exposure to HIV. In this situation, we do not routinely recommend the HIV exposure medications. If you feel strongly that you want to be given these medications we will provide them for you.
 The situation you have described to me is a high
risk situation because _. We recommend the
following medications because they have been shown to minimize the possibility of a patient becoming HIV positive. Your HIV screening was negative today, so we can start you on the Step 6: Prescribe nPEP
Initiate within 2 hrs, up to 72 hrs Discuss and document: Potential benefit, unproven efficacy & potential toxicity of PEP Importance of adherence Risk reduction & prevention behaviors Signs & symptoms of primary HIV infection Necessary clinical & lab monitoring follow-up Every patient prescribed nPEP should leave with a Starter Pack (enough meds for 3-7 days) Labs Needed for nPEP
Weeks Post
Months Post
Months Post
HIV antibody
Serum Liver
STD Screen
Common nPEP Regimens
II (Integrase Inhibitors)
Raltegravir (Isentress) 400 mg twice Dolutegravir (Tivicay) 50 mg daily  PI (Protease Inhibitors)
Lopinavir 200 mg/Ritonavir 50 mg– (Kaletra) 2 tablets twice dailyAtazanavir (Reyataz) 300 mg & Ritonavir (Norvir) 100 mg daily (Nucleoside Reverse Transcriptase Inhibitors) •*Emtricitabine + tenofovir (Truvada®)
Lamivudine + zidovudine (Combivir®)
Common Side Effects
Drug Class
Ergot Derivatives Dihydroergotamine, ergonovine, GI Motility Agents HMG-CoA Reductase Lovastatin, simvastatin Midazolam, triazolam nPEP + Contraception
 Kaletra decreases the efficacy of OCPs. -additional forms of protection [should be using condoms anyway] to prevent pregnancy for up to 2 months after completing nPEP.
 Kaletra interacts with Plan B.
– In situations where the patient has a high- risk exposure (assailant known HIV+), raltegravir could be considered over other Hepatitis B
If victim has evidence of full HBV vaccine series, no screening or prophylaxis is necessary.
If victim is non-immune, risk for acquiring Hepatitis B if assailant was HBsAg+ (chronic hepatitis B or carrier state).
-incidence of HBsAg+ in USA: 0.2%.
Truvada has activity against Hep B and may be helpful in preventing acquisition Guidelines exist for giving HBIG for known positive Hep B assailants Information All Patients
 Written instructions on: – Importance of taking HIV medications as prescribed and until gone – How to protect themselves and others from – Must use condoms for 3 months – Who to call if they have questions or concerns National Post-Exposure Prophylaxis
(24 hours per day and 7 days per week) Implementation of HIV
Lee Wilbur, MD, FAAEM
Professor of Clinical Emergency Medicine
Vice Chairman; Department of Emergency Medicine
Director of Interprofessional Education
University of Arkansas for Medical Sciences
 2004 – 2013  Medical Director Wishard Hospital Center  Medical Director Wishard Emergency Department HIV Team  What is the Center of Hope?  What is the Emergency Department HIV Topics to Discuss
 Rationale for nPEP  Overcoming barriers from the Medical Director perspective  The nPEP protocol at Wishard  Liability concerns…how we feel protected.
 IAFN: Joint Position on Universal Access to Anti-HIV Medication  HIGHLY vulnerable population  LOW rate of follow up historically  Cost: Who pays for the HIV test? Who
pays for the Starter Packs? Who pays of the remainder of the nPEP  Follow-up: Does everyone on nPEP need
Infectious Disease Follow-up? What if the patient has side effects?  Staff: Who are they? Their nPEP training?
Program Oversight: Who? How?
Overcoming Barriers:
 Putting together a strong team  Collaborative relationships: – Medicine, Nursing, Pharmacy, Administration, Law Enforcement, and the Community  Removed barriers FROM THE PATIENT'S! – Eliminated need to f/u with Inf. Dz.
– 5 day starter packs provided free– Remaining 23 days provided free **– No longer require blood draw prior to nPEP Your Team
 Administrative Champion  Pharmacy Advocate  SANEs Trained on HIV nPEP  Physicians (including Residents!)  Community Pharmacy Wishard Protocol: Sep 2013
When the HIV status of the assailant is UNKNOWN, then
the preferred regimen is: Truvada (tenofovir/emtricitabine) – 1 tablet once a
If Truvada is contraindicated, then
Combivir (zidovudine/lamivudine) – 1 tablet twice a
Wishard Protocol: Amended
 To be completed when protocol UPDATED and APPROVED. Moving to a 3 drug Has few side effects and does not require monitoring; thus the entire 28 days can be dispensed – eliminating the need for routine I.D. Clinic follow-up and the reduction in follow- through that this may induce. For patients who are assaulted by someone KNOWN to be
HIV-infected with unavailable or unknown medication and resistance history, the patient will be given the 5-day "starter pack" of medications: Truvada (emtricitabine/tenofovir) – 1 tablet daily
Reyataz (atazanavir) 300 mg – 1 tablet daily
Norvir (ritonavir) 100 mg – 1 tablet daily

This is a once-daily regimen which may be taken at any time of day. This can ONLY be used if patient is not taking and agrees not to take antacids of any kind, including proton pump inhibitors, H2 blockers, or TUMS. If the patient must be on acid suppression is:
Truvada (emtricitabine/tenofovir) – 1 tablet daily
Kaletra (lopinavir/ritonavir) – 2 tablets twice a day

Contraindications to the regimens above include an allergy to any of its components or a concurrent medication which significantly interacts with RITONAVIR. The list of interactions is long, and all medications must be cross-checked with the package insert or the Pharmacy. Some merely require close monitoring, others require dose modification, while others are contraindicated. Truvada should be adjusted for renal insufficiency which would necessitate a call to Infectious Follow-up at Wishard (1)
One of the following two options below for follow-up will
be offered based on the case complexity: A visit scheduled at the Special Medicine Clinic within 5 days The
Special Medicine Clinic will provide a prescription for the remaining medications to complete a 28-day course of treatment, and consultation as needed for the patient. This would be the preferred
method of follow-up for complicated cases and those on 3
drug PEP regimens exposed to known HIV positive assailants.
Follow-up at Wishard (2)
A visit will be scheduled with the Center of Hope within 5 days to
check on adherence and tolerance of medications. Center of Hope will email Infectious Disease, who will attempt to be available at the time of this appointment as needed, to either consult over the phone with the practitioner or to see the patient briefly in the Center of Hope setting if needed. In particular for those individuals receiving
Truvada alone, this second option may be better to avoid the
trauma of being seen in the I.D. Clinic.
Follow-up at Wishard (3)
A visit will be scheduled with the Center of hope at 2 weeks for
fol ow-up CBC and LFTs for those patients on the Truvada-Reyataz- Norvir, Truvada-Kaletra, Truvada-Lexiva, and Combivir regimens (i.e.,
not needed for the Truvada alone regimen). If they are abnormal,
the nurse will communicate these results with the Special Medicine Clinic at 630-6643. Follow-up at Wishard (4)
 A visit will be scheduled with the Center of hope at 2 weeks for
fol ow-up CBC and LFTs for those patients on the Truvada-Reyataz- Norvir, Truvada-Kaletra, Truvada-Lexiva, and Combivir regimens (i.e., not needed for the Truvada alone regimen). If they are
abnormal, the COH will communicate these results with Infectious  A visit will be scheduled at the Center of Hope or elsewhere at 6
weeks, 3 months and 6 months for follow-up HIV testing
Nuts and Bolts
 Who writes the scripts?  Who pays for the scripts? A Note on Liability
 Collaborative Practice Agreements: – Medical Director signs for all SANE's– Provide scope of practice for Center of Hope  Hospital approved protocols: – HIV Screening during SANE exam– SANEs operate within hospital protocol– Infectious Disease consultation– Pharmacy agreement  Rationale: to serve a vulnerable
Barriers: Overcome through
collaboration and communication  Protocol: In consultation with Infectious
Disease. Make an institutional policy.
Liability: Minimal
Resources for Providing
HIV nPEP to Uninsured &
Lynn Young, LSW
Forensic Specialist,
Indiana University Health Methodist Hospital Indianapolis, Indiana Paying for the Medications
 All patients who are prescribed nPEP should leave with a starter pack of medications. This helps to fill the gaps if a patient has trouble getting the  Insured Patients Should use their insurance (private or Medicaid). If they do not pay – then move to patient assistance. Co Pay Assistance programs are available also through Drug Companies.
 Non-Insured Patients The makers of Exposure Medications have great Patient Assistance Programs and will provide FREE Importance of Starter Packs
 All patients (insured or not insured) who are prescribed nPEP should leave with a starter pack of medications.
 This helps to fill the gaps if a patient has trouble getting the prescription filled.
 Most Emergency Departments provide 4-7 days of treatment in their starter packs Truvada Patient Assistance
Advancing Access™ Program
Provides immediate access to Truvada® (emtricitabine and tenofovir disoproxil fumarate) for U.S. patients who cannot obtain reimbursement or afford to pay for all or part of the cost of Truvada. The program enables patients who meet program criteria to access Truvada on the same day they receive a prescription from their healthcare provider. Advancing Access also helps patients find insurance coverage and provides Truvada until other support covering the cost becomes available, if ongoing medication is needed beyond the emergent 28 days. Accessing the Truvada
Advancing Access™ Program
For more information about Advancing Access, physicians and patients may call: 1-800-226-2056 between 9:00 a.m. and 8:00
p.m. Eastern Time.
Immediate vouchers for medication assistance can be obtained with a statement of emergent need from an NP or MD faxed to 800-216-6857. Kaletra and Norvir
The AbbVie Patient Assistance Foundation
Provides AbbVie medicines at no cost to qualified patients who are experiencing financial difficulties and who generally do not have coverage available for these products through private insurance or government funded programs.
To enhance patient lives by providing AbbVie products to financially disadvantaged individuals who cannot access needed treatment through Accessing AbbVie Patient
AbbVie Patient Assistance Foundation
For more information, physicians and patients may 8:00 a.m. – 5:00 p.m. Central Time.
Company will provide priority fax line for urgent exposure referrals. Medications are shipped within VIIV Patient Assistance Program Emergency Medication Voucher can be obtained same day by calling 877-784-4842. Statement of emergent need by NP/MD can be faxed 877-784-4004. Merck Patient Assistance For information and application for assistance call Applications marked "Urgent Exposure" can be faxed to 866-410-1913. Shipping of medication will occur in 24-48 hours. Bristol-Myer Squibb
Patient Assistance Program
For information and application call 888-281-8981. Applications for assistance marked "Post Exposure" Can be faxed to 888-281-8985.
Medication will be shipped within 24-48 hours. Barriers to Patient
Patient assistance programs are not available on Patients with health savings accounts/plans, or high deductibles may need to complete an appeal process for assistance if their need exceeds companies co pay assistance programs. Medicare D, Medicaid spendowns, and veterans may be excluded from co pay assistance A resource that is available to explore medication patient assistance and discounted programs for other medication needs your patient may express.


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