|To:||Massachusetts Medical Providers|
|From:||Howard K. Koh, MD, MPH, Commissioner|
Al DeMaria, MD, Director, Communicable Disease Control
Jean Flatley McGuire, Ph.D., Director, HIV/AIDS Bureau
|Date:||October 20, 2000|
|Re:||HIV Prophylaxis for Non-Occupational Exposures|
For almost ten years, antiretroviral prophylaxis has been a standard of care for health care workers experiencing occupational HIV exposures. National and state guidelines have been issued and updated during that period 1,2. More recently, the appropriateness of prophylactic treatment for individuals with non-health care related exposures has come under increased discussion 3,4,5. The Centers for Disease Control and Prevention (CDC) animal studies and clinical data suggest potential benefit in preventing transmission after sexual and parenteral exposures outside of health care settings. Particular concerns have focused on HIV transmission risk faced by discordant couples and victims of sexual assault 6. Although the efficacy of HIV post-exposure prophylaxis (PEP) for sexual or other non-health care related exposures has yet to be established, CDC has issued guidance summarizing current understanding of the issue and providing recommendations for treatment approaches 7. Assessment and PEP for non-health care related exposures is an evolving practice 8.
During the last two years, the MDPH implemented two non-occupational PEP feasibility pilot studies; completed a statewide survey of emergency department PEP practices; collaborated in the initiation of a CDC observational study; and convened two clinical and community advisory meetings regarding PEP. These efforts brought attention to the following concerns: non-occupational HIV PEP assessment and prescribing is occurring on an increasing but sporadic basis across the state; PEP access varies by geography and by clinical setting; clinician information and support regarding PEP is limited; and reimbursement for medications and follow-up costs may be uncertain.
The MDPH has determined that:
- HIV risk assessment and PEP should be considered for individuals who present within 72 hours of a high-risk sexual or other non-health care related exposure.
- Patient access to well-informed care, including that provided by infectious disease clinicians or other expert consultation, should not be limited by geography or income.
- Assessment and prescription of treatment should take place in clinical settings with access to expert consultation.
- Written protocols should be in place and should address risk assessment, informed consent, follow-up care, and ongoing risk reduction.
- Data collection regarding outcome is important in an arena where efficacy is still unproven.
In order to promote broad access to appropriate prophylactic HIV treatment, the MDPH has:
- Initiated 24-hour on-call support for PEP treatment decision-making through the University of Massachusetts ACTNow HIV Primary Care Program Call (888) 855-9324;
- Identified PEP treatment information access and training options for interested clinicians through the New England AIDS Education and Training Center Call (617) 566-2283;
- Assured access to clinical follow-up through the HIV/AIDS Bureau's regional ACTNow Primary Care Centers. Contact information is attached;
- Arranged follow-up care and reimbursement for 28-day drug regimens for uninsured individuals through the Bureau's regional ACTNow Programs and through the HIV Drug Assistance Program (HDAP), depending on ongoing availability of funds. Contact information is attached. The Community Research Initiative of New England (CRI) can be contacted at (800) 228-2573 for PEP reimbursement issues.
- Collaborated with CDC in supporting data reporting to their voluntary registry for non-occupational PEP. All clinicians are urged to report cases of non-occupational PEP treatment to (877) 448-1737 or via the Internet (www.hivpepregistry.org). Reporting is without personal identifiers.
HIV PEP offers the possibility of preventing HIV transmission in the context of high-risk exposures. Individuals experiencing such exposures should be given full information and support to make difficult treatment decisions. Follow-up care to assist with adherence during treatment and to determine the outcome of treatment is necessary. Special consideration must be given to the challenges faced by victims of sexual assault; to the extent possible, sexual assault nurse examiner assessment and support are strongly recommended.
Attached are recommended management protocol components and information regarding clinician support, follow-up care sites, and registry reporting.
1 Center for Disease Control and Prevention (CDC). Report of the NIH panel to define principles of therapy of HIV infection and Guidelines for the use of anti-retroviral agents in HIV-infected adults and adolescents. MMWR 1998;47(No.RR-5):1-82
2 Massachusetts Department of Public Health. Clinical Advisory. 1992
3 Katz MH., Gerberding., JL. Post-Exposure treatment of People Exposed to the Human Immunodeficiency Virus through Sexual Contact or Injection Drug Use. N Engl. J Med. 1997; 336:1097-1100
4 Lurie P., Milles S., Hecht F., et al. Post Exposure Prophylaxis after Non-Occupational HIV Exposures. JAMA 1998;280:1769-73
5 Janssen R.,CDC. Division of HIV/AIDS Prevention-Surveillance and Epidemiology. National Center for HIV, STD, and TB Prevention. Atlanta, Georgia 30333
6 Bamberger JD., Waldo CR., Gerberding JL., Katz MH. Post-Exposure Prophylaxis for Human Immunodeficiency Virus (HIV) Infection following Sexual Assault. Am J Med. 1999 Mar; 106(3):323-
7 Centers for Disease Control and Prevention. Management of Possible Sexual, Injecting-Drug-Use, or other Non-Occupational Exposures to HIV, including considerations related to Anti-Retroviral Therapy. MMWR 1998;47:RR-17
8 New York Department of Public Health. AIDS Institute. HIV Prophylaxis following Sexual Assault. Guidelines for Adults and Adolescents. June, 1998