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SAFE-TA Webinar Series This project was supported by Grant No. 2005 -WI-AX- K 004 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. www. safeta. org
Speakers for Today’s Discussion Edith Swann, RN, Ph. D, Vaccine Clinical Research Branch/DAIDS, NIH, Bethesda, MD Ecoee Rooney, MSN, RN, SANE-A, Interim LSU Public Hospital, New Orleans, LA Terri Hamrick, BA, MNM, WVLSW, Executive Director, Survivors, Inc. Kim Day, RN, SANE-A, moderator www. safeta. org
HIV Infection following Sexual Assault Edith M. Swann RN, Ph. D. Vaccine Clinical Research Branch/DAIDS NIH, Bethesda, MD www. safeta. org
PEP Defined The use of therapeutic agents to prevent infection following exposure to a pathogen The immediate use of antiretroviral (ARV) drugs to prevent HIV sero conversion after exposure to potentially HIV-infected blood or body fluids. (UNAIDS) Occupational Exposure (Health care workerspercutaneous (needlestick), splash, bite, etc. ) Non-occupational Exposure (sexual assault, IVDU exposure, etc) www. safeta. org
CDC Guidelines for Nonoccupational exposures Are not applicable for occupational exposures Based on data from: Animal transmission models (suggest less effectiveness beyond 24 -36 hours) Perinatal clinical trials (Prevention of Mother to Child Transmission) Occupational exposures (health care workers- usually receive PEP within a few hours of exposure < 4 hrs) Observational studies • Evidence of cost-effectiveness: when the partner (assailant) source is known to be • • HIV-infected or after unprotected receptive anal intercourse with homosexual or bisexual man of unknown status. • Recommendations may be established by State/local jurisdictions MMWR, 2005, 54, RR-2 www. safeta. org
State and International Guidelines (Fisher et al. , 2006; Miles et al. , 2001; NY State Dept of Health, 2008; www. unaids. org/en/policyandpractice/prevention/HIVPEP) State Initiation Considerations Preferred Regimen Follow-up NY (2008) Within 2 hrs, no later than 36 hrs. Risk behavior, degree of transmission, exposure source. Not to be used as pre-exposure prophylactics. 3 drug regimen: AZT +3 TC(Combivir), and TDF, or AZT + FTC +TDF for 28 days Continued testing at 1, 3 and 6 months CA (2001) Initiated as soon as possible, not offered > 72 hrs >12 yrs of age, degree of risk (measurable, possible, no risk), assailants status, treatments of STD’s PEP not offered in every county. AZT + 3 TC (Combivir) or 3 TC + d 4 T for 28 days Follow-up testing at 8 wks and 14 wks WHO (2005) Initiated as soon as possible, but < 72 hrs Source exposure, significant exposure. Special considerations for children and pregnant women. AZT + 3 TC, or RDF + 3 TC or d 4 T + 3 TC for 28 days. 3 drug: source is HIV+, ARV resistance, status unknown. Follow-up testing 3 -6 months. UK (2006) Initiated in < 72 hrs Risk vs benefit of PEP, risk of transmission, risk of source, willingness to start ARV’s AZT + 3 TC, d 4 T + 3 TC, or TDF + FTC for 28 days Testing at 3 months and 6 months www. safeta. org
HIV Exposure Risk/Incidence following Sexual Assault Exposure risk is extremely low (rough estimates only) Less than those projected for consensual sex Increased risk with repeated sexual exposures Specific Circumstances/Considerations Trauma/tearing of mucosal tissue Bleeding/presence of blood Penetration (vaginal/anal) Site of exposure to ejaculate Viral load measures Presence of STD’s/genital lesions Risk behaviors of assailant (MSM, IDU) Multiple assailants (CDC STD Treatment Guidelines, 2006; Garcia et al. , 2005, Roland, et al. 2005 ) www. safeta. org
Estimated Per-Act Risk for Acquisition of HIV by Exposure Route Blood transfusion (1 unit) Needle-sharing injection drug use Risk % 90 -100% 0. 67% Receptive anal intercourse 0. 1 -3. 0% Percutaneous needle stick 0. 3% Receptive vaginal intercourse Insertive anal intercourse Insertive vaginal intercourse Receptive oral intercourse Mucosal Membrane Exposure 0. 1 -0. 2% 0. 06% 0. 03 -0. 09% 0 -0. 04% 0. 09% (AETC National Resource Center 2008, www. aidsetc. org, Fisher et al. , 2006)
Nonoccupational PEP: Evaluation & Treatment Algorithm MMWR January 21, 2005, Vol 54, No. RR-2
Situations for which expert consultation for HIV post-exposure prophylaxis (PEP) is advised Resistance of the source virus to antiretroviral agents • Influence of drug resistance on transmission risk unknown If source person’s virus is known or suspected to be resistant to one or more of the drugs considered for PEP, selection of drugs to which the source person’s virus is unlikely to be resistant recommended Resistance testing of the source person’s virus at the time of the exposure not recommended Initiation of PEP not to be delayed while awaiting results of resistance testing Toxicity of the initial PEP regimen • • • Adverse symptoms (nausea, diarrhea) Management of symptoms (antimotility or antiemetic agents) Modifying dose intervals may assist in the management of adverse symptoms • Delayed exposure report • Interval after which lack of benefit from PEP undefined (MMWR 2005; 54(No. RR-9) www. safeta. org
Situations for which expert consultation for HIV post-exposure prophylaxis (PEP) is advised (cont. ) Unknown source Use of PEP to be decided on a case-by-case basis Consider severity of exposure and likelihood of exposure Known or suspected pregnancy in the exposed person Use of optimal PEP regimens not precluded PEP not denied solely on basis of pregnancy Breastfeeding in the exposed person Use of optimal PEP regimens not precluded PEP not denied solely on basis of breast feeding (MMWR 2005; 54(No. RR-9) www. safeta. org
Challenges of implementing PEP following Sexual Assault Differing guidelines (country, state) Type and number of ARV’s to use (availability, toxicity, effectiveness) Lab monitoring Access and cost of ARV’s Follow-up Confidentiality and Reporting requirements Determining status of the assailant Cost Effectiveness American Academy of Pediatrics has issued n. PEP for pediatric patients (MMWR , 54 (RR-2), 2005, Roland, 2007) www. safeta. org
When should PEP be started? benefits of PEP risks of PEP time exposure www. safeta. org
HIV-1 Transmission Event Established Infection Virus Concentration in Extracellular Fluid or Plasma (Copies/ml) 108 Symptoms 107 106 Set Point 105 104 eclipse 103 102 101 Reservoir Virus dissemination 0 10 -1 10 -2 Limit of detection of assay for plasma virus Transit 10 -3 10 -4 10 -5 0 Transmission 5 10 15 20 25 30 35 40 45 50 55 60 65 70 Time Post Exposure (days) Adapted from Johnston & Fauci, NEJM 2007
PEP Regimens: Basic regimens Two NRTIs Simple dosing, fewer side effects Preferred basic regimens: zidovudine (AZT) OR tenofovir (TDF) plus lamivudine (3 TC) OR emtricitabine (FTC) Alternative basic regimens: stavudine (d 4 T) OR didanosine (dd. I) plus lamivudine (3 TC) OR emtricitabine (FTC) (Cochrane Collaboration, 2009, MMWR 2005; 54(No. RR-9).
Expanded PEP Regimens Basic regimen plus a third agent Rationale: 3 drugs may be more effective than 2 drugs, though direct evidence is lacking Consider for more serious exposures or if resistance in the source patient is suspected Adherence more difficult More potential for toxicity Preferred Expanded Regimen: Basic regimen plus lopinavir/ritonavir (Kaletra) Alternate Expanded Regimens: Basic regimen plus one of the following: Atazanavir* +/- ritonavir Fosamprenavir +/- ritonavir Indinavir +/- ritonavir Saquinavir (hgc; Invirase) + ritonavir Nelfinavir Efavirenz (MMWR 2005; 54(RR-9) www. safeta. org
Considerations for PEP in Pregnancy • Most ARV’s are pregnancy class B or C • Antiretroviral Pregnancy Registry Avoid Efavirenz due to potential teratogenicity in pregnant or women of childbearing age at risk for becoming pregnant (anacephaly in monkeys) Avoid prolonged use of Stavudine (d 4 T)-potential for mortality attributed to lactic acidosis Avoid Amprenavir (ossification defects in rabbits), and Indinavir in late term (hyperbilirubinemia) (Garcia et al. ICAAC, December 2001, MMWR, 54 (RR-2), 2005)
Duration of PEP In animal model, 28 days more effective than 10 days or 3 days of PEP 4 weeks (28 days) used in casecontrol study and recommended by CDC guidelines Treatment of STD’s must be considered separate from PEP www. safeta. org
www. safeta. org
Ongoing and Planned Pr. EP Trials Study Location Sponsor i. Pr. EX (Brazil, Intervention Arms Pr. EP strategies Status NIH, Gates 3, 000 Gay men, Foundation MSM 1 TDF + FTC Enrolling (2010) Partners Pr. EP Study Gates 3, 900 Foundation serodiscordant couples 2 TDF; TDF + FTC Enrolling (2012) VOICE Study (South MTN, NIH 4, 200 sexually active women 3 TDF; TDF +FTC; TDF gel Planning Phase (anticipate 2 Q/2009) FEMPr. EP FHI, USAID 3, 900 high-risk women 1 TDF + FTC Planning Phase Equador, SA, Thailand, US) (Kenya, Uganda) Population Africa) (Kenya, Malawi, SA, Tanzania) (anticipate 2 Q/2009)
Microbicide Trial (HPTN 035: 4 arm study) Pro 2000 Gel (0. 5%) Synthetic polymer- acts by blocking attachment of HIV to host cell. Pre-clinical-In Vitro: prevents HIV, active against HSV-2, N. gonorrhea Showed protection in macaque SIV challenge model. Phase I study showed no safety concerns, good acceptability. No serious adverse events/toxicity. Buffer Gel (Carbopol 974 P) • Gelling agent that: • • www. safeta. org • Enhances body’s natural defenses • Maintains low vaginal p. H In Vitro: inactivated STD pathogens and sperm, semen inflammatory cells Well documented safety profile in animals Phase I safety and acceptability Phase III trial showed good safety and contraceptive efficacy when used w/diaphragm.
Trial Conclusion PRO 2000 was 30% effective in preventing HIV (effect was not statistically significant). Buffer Gel did not alter the risk of HIV infection. Placebo Gel had no impact on risk of HIV acquisition (similar in the No Gel arm). Both Buffer Gel and PRO 2000 were: Safe for intravaginal use for extended period of time Not contraceptive Not effective against STI’s: BV, Chlamydia, HSV-2 , gonorrhea, genital ulcer disease, trichomoniasis. www. safeta. org
Current Observational Cohort Studies Study/ Location Sponsor Population HVTN 906 (NY, HVTN, NIH High Risk Women + Partners Observational Open HVTN 907 HVTN, NIH High Risk Women-CSW Observational Open HPTN 064 HPTN High Risk Women Observational Open Philly, Chicago) (Haiti, PR, DR) (ISIS) www. safeta. org Intervention Status
Additional Studies Study/ Location Sponsor Population Intervention Status JHU- Baltimore Network intervention for reducing sexual risk. CDC African American MSM Cognitive. Behavioral, counseling Open (7/089/09) Behavioral Counseling — UCSF NIMH HIV – Men Specialized Sept. 2005 Cognitive-Behavioral Dec 2010 Counseling- to reduce transmission in MSM RV 217 USMHRP, NIH High Risk (males + females) Acute Infection www. safeta. org Anticipate 6/09
Resources National PEP Registry 1 -877 -HIV-1 PEP www. hivpepregistry. org National Clinicians’ Post-Exposure Prophylaxis Hotline (PEPline) (888) HIV-4911 www. safeta. org
References MMWR-CDC (2005), Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug Use, or Other Nonoccupational Exposure to HIV in the United States. January, 21, 2005, Vol. 54, No. RR-2 New York State Department of Health (2008). HIV prophylaxis following non-occupational exposure including sexual assault. New York (NY) State Department of Health. San Francisco Department of Public Health (2001). Offering HIV Prophylaxis Following Sexual Assault: Recommendations for the State of California. The California HIV PEP after Sexual assault Task Force in conjunction with The California State Office of AIDS. Fisher, M. , Benn, P. , Evans, B. et al. (2006). UK Guidelines for the use of post-exposure prophylaxis for HIV following sexual exposure. International Journal of STD & AIDS, 17; 81 -92. www. safeta. org
References UNAIDS (2006). HIV Post-Exposure prophylaxis. Obtained 4/7/09 from: www. unaids. org/en/Policy. And. Practice/Prevention/HIVPEP/ Centers for Disease Control (CDC) (2008). CDC’s Clinical Studies of Pre. Exposure Prophylaxis for HIV Prevention. Obtained 4/10/09 from : www. cdc. gov/hiv Pinkerton, S. , Martin, J. , Roland, M. et al. , (2004). Cost-effectiveness of HIV postexposure prophylaxis following sexual or injection drug exposure in 96 metropolitan areas in the United States. AIDS, 18; 2065 -2073. The Cochrane Collaboration (2009). Antiretroviral post-exposure prophylaxis (PEP) for occupational HIV exposure (Review). Wiley & Sons Ltd, issue 2. www. safeta. org
References Garcia, M. , Figueiredo, R. , Moretti, M. et al. , (2005). Postexposure Prophylaxis After Sexual Assaults: A Prospective Cohort Study. Sexually Transmitted Diseases, April, 32 (4), 214 -219. Roland, M. (2007). Postexposure prophylaxis after sexual exposure to HIV. Current Opinion in Infectious Diseases, 20, 39 -46. Roland. M. , Neilands, T. , Krone, M. et al. , (2005). Seroconversion Following Nonoccupational Postexposure Prophylaxis against HIV. Clinical Infectious Diseases, 41, 1507 -13. Cohen, M. , Kaleebu, P. , Coates, T. (2008). Prevention of the sexual transmission of HIV-1: preparing for success. Journal of the International AIDS Society 11: 4. www. safeta. org
Non-occupational Post Exposure Delivery Systems: Sexual Assault Patients Ecoee Rooney, MSN, RN, SANE-A Interim LSU Public Hospital New Orleans, LA
• The Interim LSU Public Hospital has offered HIV prophylaxis to patients reporting sexual assault since the program’s inception in the Spring of 2000. • The initial protocol model used was from the British Columbia guidelines, until new guidelines were adopted by the Centers for Disease Control in 2004. www. safeta. org
Components of an effective n. PEP delivery system • Include: – a patient-centered approach – sexual assault forensic examiners that are aware of n. PEP options – careful evaluation of risks versus benefits to identify appropriate candidates – thorough discussion and education with the patient regarding options and medications – availability of n. PEP drugs thorough, clear and concise oral and written discharge instructions – a clear transition to an HIV or infectious disease (ID) clinic for follow-up at 5 days and throughout the treatment period. www. safeta. org
Patient-Centered Approach • In addressing the possible n. PEP needs of patients who have been sexually assaulted, there are psychological issues that factor into the discussion of n. PEP, patient understanding and adherence to an n. PEP regimen. • Patients may have an emotional reaction (whether made apparent to the provider or not) to the discussion of HIV prophylaxis after having been sexually assaulted –anger, fear, frustration or sadness – because it evokes the thought of a possible HIV infection. • A compassionate response, preparation for a possibly emotional reaction to the discussion, and patience are all required competencies in addressing n. PEP in this context. www. safeta. org
Sexual assault forensic examiners that are aware of n. PEP options • SANEs must be able to discuss n. PEP options, in tandem with other involved care providers (physicians, pharmacists) • Use of HIV Hotline when needed www. safeta. org
Careful evaluation of risks vs benefits to identify appropriate n. PEP candidates • SANEs must be able to discuss n. PEP options, in tandem with other involved care providers (physicians, pharmacists), to carefully evaluate the risks versus benefits to identify appropriate candidates. www. safeta. org
Thorough discussion and education with the patient regarding options/medications • Consideration of the fact that often patients who have been sexually assaulted have been traumatized and are in need of tools – clear, concise written information in large print or diagrams – concise and thorough discharge information • including provider and medical records department contact numbers www. safeta. org
Availability of n. PEP drugs is tantamount to providing prophylaxis • access to the initial dose • a plan for providing the interim 5 day dose – the dose the patient will take until they see follow up care providers in the ID or HIV clinic • a plan for providing the final 23 day course that will carry them through the full 28 day regimen. • There a variety of models to provide this medication – through contracts with the health department, sponsorships, or grants. www. safeta. org
Clear transition to an HIV or infectious disease (ID) clinic for follow-up • Critical piece to ensuring patients have the follow up they will need. • Simple, streamlined process to get them from the acute provider to the follow up appointment. – The SAFE can meet them at the appointment to introduce them to their HIV/ID care provider. • The HIV/ID care provider should have already obtained their medical record to minimize the need to repeat what has already been done for the patient. • The HIV/ID provider should also know to minimize retraumatizing the patient with seeking to obtain any unnecessary information. www. safeta. org
Patient-Centered n. PEP Delivery System Model for Patients Reporting Sexual Assault n. PEP drugs (5 day supply onsite and method for patient to procure rest of 23 day supply) Thorough, clear and concise oral and written discharge instructions discussion/ education and transition to with patient regarding options and meds Patient HIV or ID clinic follow up at Careful evaluation of risks vs benefits SAFE Provider Aware of n. PEP options 5 days and throughout treatment period © Rooney, Dumestre, Travis
Sample Non-Occupational Post HIV Exposure Follow up Protocol Patient treated in ED with post-exposure HIV prophylaxis Baseline serum HIV test, RPR, Hepatitis ABC, UPT, CMP, CBC, GC C/S, Chlamydia in ED 1 st dose Combivir 1 tablet & Kaletra (200/50) 2 tablets PO in ED & 5 days of meds from outpt pharmacy Follow Up appointment faxed to outpatient ID/HIV Clinic. Appointment card given to patient. SANE Patient: Met by SANE at Outpatient HIV/ID Clinic for initial visit • Even if PEP declined, HIV testing schedule is the same, except without monitoring CBC and LFTs. • Use of trade names and commercial sources is for identification only and does not imply endorsement by the author. Weekly followup at Outpatient HIV/ID Clinic for medication adherence and side effects Week 2 Monitoring CBC, LFTs Week 4 Monitoring CBC, LFTs, HIV Serology Month 3 Monitoring: HIV, RPR, Hepatitis panel test (if previously nonreactive) Month 6 Monitoring: HIV test, if previously nonreactive
References • Centers for Disease Control and Prevention. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or nonoccupational exposure to HIV in the United States: recommendations from the U. S. Department of Health and Human Services. MMWR 2005; 54 (No. RR-2): [11 -12] • Rooney, E. , Dumestre, J. , Travis, D. (2008) SANE Dialogues: Focus group on use of n. PEP in SANE programs. www. safeta. org
Role of Advocacy HIV Risk Assessment, Sexual Assault, and the Critical Role of the Advocate Terri Hamrick, BA, MNM, WVLSW Executive Director, Survivors, Inc. www. safeta. org
Overview of this section ¢ Role of the Advocate ¢ Discussion of HIV Risk for the Victim ¢ Case Management, Access to Services and Follow-up www. safeta. org
Role of the Sexual Assault Advocate ¢ Providing information, education and support if the face of HIV infection concerns l HIV Transmission and Testing Options l Window Period/HIV Antibodies l Baseline at point of SART kit l Impact on Victim and Prosecution l Anonymous versus Confidential Testing l To advocate on behalf of the Victim
Reality of HIV Risk for the Rape Survivor ¢ Understanding HIV Transmission l l ¢ Assessing risk l l l ¢ 3 fluids transmit- blood, vaginal secretions, semen and breast milk Vaginal, Anal, Oral and other contact risk Knowledge of assailant(s) and assailant’s risk factors Type of assault- penetration and receptive partner? In case of Incest, Marital Rape, or other repeated Sexual Assault over time- often risk is under assessed and may be under reported Creating a plan l Does the Victim have support on two levels • Sexual Assault • Support for the HIV PEP Process • • ¢ Partnering with HIV Programs in advance is crucial- proactive rather than reactive Agency policy for HIV/AIDS should include PEP and relevant partnerships The Victim is the expert, and makes the ultimate decision to access PEP! www. safeta. org
Case Management, Access, Linka and Follow Up ¢ Development and maintenance of a relationship with the AIDS Service Organization and/or Ryan White Funded HIV Specialist serving the community l Anonymous Testing Sites l HIV Prevention Case Management l Part B and C (formerly known as Title II and III Ryan White Funded Service Providers) www. safeta. org
Stay tuned for Q&A www. safeta. org
What are the risks to the patient of changing to a different medication regimen midstream during the 28 -day cycle? www. safeta. org
Circumcision was listed on the behavior prevention strategies, what is the data on percentage of decrease in the risk of transmission or reception of HIV? www. safeta. org
Are there samples of written information or does anyone have any suggestions about the dialogue to have with patients about risk and the discharge instructions that are on n. PEP? www. safeta. org
www. safeta. org
With Ryan White funded HIV specialty services, can victims remain anonymous? www. safeta. org
If someone lives in an area where there is very low incidence of HIV, should they still offer n. PEP? www. safeta. org
Should every patient receive, regardless of the risk apparent in their assault, have a discussion regarding HIV prophylaxis, their risk, and advisability of receiving postexposure prophylaxis? www. safeta. org
Ecoee, would you be willing to share any of the information that you have that you share with your patients? www. safeta. org
Should all the patients leaving the sexual assault exam with post-exposure prophylaxis also receive Hepatitis B vaccine, when there is no clear history of Hepatitis B series in their lives? www. safeta. org
Polling questions – N/A to online viewers – please wait www. safeta. org
Do you refer patients primarily to local health departments/AIDS programs for follow-up even if they have insurance so that there’s good continuity about education and medication profiles? www. safeta. org
Polling questions – N/A to online viewers – please wait www. safeta. org
There are some legislative reps that want to test perpetrators – comments www. safeta. org
Pediatric patients – discussion www. safeta. org
Victims that report post 72 -hours, what do we do with them? www. safeta. org
What would be the reason for opposition to perpetrator testing? www. safeta. org
Thank You! For more information, visit: www. safeta. org and www. iafn. org
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