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New US Fed HIV Post Exposure Prophylaxis Guidelines (PEP)
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The following is a summary of recommendations:
(1) PEP is recommended when occupational exposures to HIV occur;
(2) the HIV status of the exposure source patient should be determined, if possible, to guide need for HIV PEP;
(3) PEP medication regimens should be started as soon as possible after occupational exposure to HIV, and they should be continued for a 4-week duration; (4) new recommendation-PEP medication regimens should contain 3 (or more) antiretroviral drugs (listed in Appendix A) for all occupational exposures to HIV;
(5) expert consultation is recommended for any occupational exposures to HIV and at a minimum for situations described in Box 1;
(6) close follow-up for exposed personnel (Box 2) should be provided that includes counseling, baseline and follow-up HIV testing, and monitoring for drug toxicity; follow-up appointments should begin within 72 hours of an HIV exposure; and
(7) new recommendation-if a newer fourth-generation combination HIV p24 antigen-HIV antibody test is utilized for follow-up HIV testing of exposed HCP, HIV testing may be concluded 4 months after exposure (Box 2); if a newer testing platform is not available, follow-up HIV testing is typically concluded 6 months after an HIV exposure.
Recommended Regimens Table 1a below
and new New York state Guidelines for PEP were just announced & distributed to NATAP email listserve & are now posted on the NATAP website in HIV section.
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New Guidelines: HIV Exposure at Work, Treat ASAP
Published: Aug 9, 2013 | Updated: Aug 9, 2013
Michael Smith, North American Correspondent, MedPage Today
Action Points
· Health care workers exposed to HIV at work should immediately begin four weeks of post-exposure prophylaxis with three anti-retroviral drugs.
· Point out that the previous recommendations suggested that follow-up testing should continue for 6 months, but the new guidelines say that can be shortened to 4 months if a fourth-generation test is used.
Healthcare workers exposed to HIV at work should immediately begin four weeks of post-exposure prophylaxis with three antiretroviral drugs, according to new recommendations.
The three-drug guideline is a change from the 2005 recommendations of the U.S. Public Health Service, which suggested prescribing the number of drugs based on an assessment of the risk of infection, according to David Kuhar, MD, of the CDC, and colleagues.
The new guidelines also suggest that the period of follow-up HIV testing can be shortened if newer fourth-generation assays are used, Kuhar and colleagues reported online and in the September issue of Infection Control and Hospital Epidemiology.
The revised recommendations take into account improvements in antiretroviral drugs, including better tolerability and convenience since the 2005 guidelines were established, Kuhar and colleagues noted.
The earlier recommendations were challenging to apply, the authors noted, in part because it is hard to determine the level of risk of infection in any given incident.
That, in turn, made it hard to determine whether two or three drugs should be used.
And the "high frequency of side effects and toxicities" associated with drug combinations available at the time made adherence difficult.
Occupational exposure to HIV leads to infection only about 0.3% of the time, so that a randomized trial to establish how many drugs should be used would be impractical, the authors noted.
Instead, the guideline working group and an expert panel of consultants chewed over the evidence and their experience to come up with the new recommendations.
Several remain unchanged:
· Post-exposure prophylaxis is recommended whenever there's occupational HIV exposure -- ranging from needlesticks to contact between a cut and potentially infectious fluids.
· If possible, the HIV status of the exposure source should be determined to help guide the need for prophylaxis.
· Medication should start as soon as possible and should be continued for 4 weeks.
· HIV experts should be consulted, and especially in complicated cases -- cases where the exposed person is pregnant, there is a suspicion of HIV drug resistance in the source, the initial regimen is toxic, or the exposed worker has serious underlying illness, such as renal disease.
· Exposed personnel should have close follow-up -- including counseling, baseline and follow-up HIV testing, and monitoring for drug toxicity -- that begins within 72 hours of exposure.
The new recommendations also shortened the interval for follow-up testing from 6 months to 4 if a fourth-generation test is used because the newer tests detect both the HIV p24 antigen and antibodies to the virus and are considered more reliable than earlier tests.
The new recommendations also suggest a preferred initial regimen -- the combination of tenofovir and emtricitabine (Truvada) with raltegravir (Isentress).
That regimen has the desired qualities of "a favorable side effect profile as well as a convenient dosing schedule," Kuhar and colleagues wrote.
But it's not one-size-fits-all, they noted, and expert consultation is needed to tailor the regimen to the exposed healthcare worker. For instance, they wrote, tenofovir has been associated with renal toxicity and should be avoided in people with kidney disease.
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US Public Health Service Guideline
Received June 27, 2013; accepted June 27, 2013; electronically published August 6, 2013
http://www.jstor.org/stable/10.1086/672271
Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis
David T. Kuhar, MD,1 David K. Henderson, MD,2 Kimberly A. Struble, PharmD,3 Walid Heneine, PhD,4 Vasavi Thomas, RPh, MPH,4 Laura W. Cheever, MD, ScM,5 Ahmed Gomaa, MD, ScD, MSPH,6 Adelisa L. Panlilio, MD,1 and US Public Health Service Working Group
"The PHS now recommends emtricitabine (FTC) plus TDF (these 2 agents may be dispensed as Truvada, a fixed-dose combination tablet) plus raltegravir (RAL) as HIV PEP for occupational exposures to HIV. This regimen is tolerable, potent, and conveniently administered, and it has been associated with minimal drug interactions. Additionally, although we have only limited data on the safety of RAL during pregnancy, this regimen could be administered to pregnant HCP as PEP (see the discussion above). Preparation of this PEP regimen in single-dose "starter packets," which are kept on hand at sites expected to manage
occupational exposures to HIV, may facilitate timely initiation of PEP......
.....Several drugs may be used as alternatives to FTC plus TDF plus RAL. TDF has been associated with renal toxicity,69and an alternative should be sought for HCP who have underlying renal disease. Zidovudine could be used as an alternative to TDF and could be conveniently prescribed in combination with lamivudine, to replace both TDF and FTC, as Combivir. Alternatives to RAL include darunavir plus ritonavir (RTV), etravirine, rilpivirine, atazanavir plus RTV, and lopinivir plus RTV. When a more cost-efficient alternative to RAL is required, saquinivir plus RTV could be considered. A list of preferred alternative PEP regimens is provided in Appendix A." see Table 1a below
1. Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
2. Office of the Deputy Director for Clinical Care, Clinical Center, National Institutes of Health, Bethesda, Maryland
3. Division of Antiviral Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland
4. Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
5. HIV/AIDS Bureau, Health Resources and Services Administration, Rockville, Maryland
6. Division of Surveillance, Hazard Evaluation, and Health Studies, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Cincinnati, Ohio
Address correspondence to David T. Kuhar, MD, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS A-31, Atlanta, GA 30333 (jto7@cdc.gov).
This report updates US Public Health Service recommendations for the management of healthcare personnel (HCP) who experience occupational exposure to blood and/or other body fluids that might contain human immunodeficiency virus (HIV).
Although the principles of exposure management remain unchanged, recommended HIV postexposure prophylaxis (PEP) regimens and the duration of HIV follow-up testing for exposed personnel have been updated. This report emphasizes the importance of primary prevention strategies, the prompt reporting and management of occupational exposures, adherence to recommended HIV PEP regimens when indicated for an exposure, expert consultation in management of exposures, follow-up of exposed HCP to improve adherence to PEP, and careful monitoring for adverse events related to treatment, as well as for virologic, immunologic, and serologic signs of infection. To ensure timely postexposure management and administration of HIV PEP, clinicians should consider occupational exposures as urgent medical concerns, and institutions should take steps to ensure that staff are aware of both the importance of and the institutional mechanisms available for reporting and seeking care for such exposures. The following is a summary of recommendations: (1) PEP is recommended when occupational exposures to HIV occur; (2) the HIV status of the exposure source patient should be determined, if possible, to guide need for HIV PEP; (3) PEP medication regimens should be started as soon as possible after occupational exposure to HIV, and they should be continued for a 4-week duration; (4) new recommendation-PEP medication regimens should contain 3 (or more) antiretroviral drugs (listed in Appendix A) for all occupational exposures to HIV; (5) expert consultation is recommended for any occupational exposures to HIV and at a minimum for situations described in Box 1; (6) close follow-up for exposed personnel (Box 2) should be provided that includes counseling, baseline and follow-up HIV testing, and monitoring for drug toxicity; follow-up appointments should begin within 72 hours of an HIV exposure; and (7) new recommendation-if a newer fourth-generation combination HIV p24 antigen-HIV antibody test is utilized for follow-up HIV testing of exposed HCP, HIV testing may be concluded 4 months after exposure (Box 2); if a newer testing platform is not available, follow-up HIV testing is typically concluded 6 months after an HIV exposure.
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