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New PEP Guidelines Recommend 3-Drug ART After Occupational HIV Exposure

The U.S. Public Health Service this month released updated guidelines for post-exposure prophylaxis (PEP) after occupational exposure in healthcare settings to blood or other body fluids that may contain HIV. The new recommendations call for immediately starting a 4-week regimen containing at least 3 antiretroviral drugs.

To ensure timely post-exposure management and administration of 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 guidelines state.

Although the principles of exposure management remain unchanged from the previous guidelines issued in 2005, recommended antiretroviral regimens for PEP and the duration of follow-up testing have been updated, David Kuhar from the Centers for Disease Control and Prevention (CDC) and fellow members of the U.S. Public Health Service Working Groupwrite in the August 6, 2013, advance online edition of Infection Control and Hospital Epidemiology.

The guidelines are intended for healthcare personnel who have the potential for exposure to infectious material, including (but not limited to) emergency medical service personnel, nurses, physicians, pharmacists, therapists, technicians and laboratory workers, dental personnel, health facility housekeeping staff, and people who perform autopsies.

The report emphasizes the importance of preventing HIV exposure before it occurs by employing standard precautions including consistent use of appropriate work practices and personal protective equipment. Exposures that might place healthcare personnel at risk include percutaneous injury (for example, a needle-stick or cut with a sharp object) or contact with mucous membranes, broken skin, blood, tissue, or other body fluids that are potentially infectious (cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids, as well as semen and vaginal secretions); feces, nasal secretions, saliva, sputum, sweat, tears, urine, and vomit are not considered potentially infectious unless they are visibly bloody.

The HIV status of the source patient should be determined, if possible, to help guide whether PEP is needed.However, the authors note the difficulty of determining when PEP is needed and what is the best regimen. A literature search did not find studies demonstrating whether 2- or 3-drug regimens are better, and occupational exposure is low risk enough -- approximately 0.3% per exposure -- that randomized controlled trials assessing overall or comparative efficacy are not practical. Given this lack of data, the guidelines were developed by experts in the treatment of HIV, use of antiretroviral drugs, and PEP.

The new recommendations state that antiretroviral regimens for PEP should be started as soon as possible after exposure and should be continued for 4 weeks. Expert consultation should be sought, but not at the cost of delaying treatment.

PEP regimens should contain at least 3 antiretrovirals for all occupational exposures, emphasizing selection of drugs that have the fewest side effects and are best tolerated. Given that modern antiretrovirals are highly effective and generally well-tolerated, the guidelines no longer recommend assessing the level of risk associated with individual exposures to help determine the appropriate number of drugs (previously 2-drug regimens were commonly used).

The preferred HIV PEP regimen consists of 400 mg raltegravir (Isentress) taken twice-daily plus the Truvada (tenofovir/emtricitabine) combination pill taken once-daily. (This is also ranked as one of the preferred regimens for first-line treatment for people known to be HIV-infected.)

Alternative regimens may include the boosted protease inhibitors atazanavir (Reyataz), darunavir (Prezista), or lopinavir/ritonavir (Kaletra), or the NNRTIs etravirine (Intelence) or rilpivirine (Edurant), and may include zidovudine (AZT, Retrovir) or lamivudine (3TC, Epivir) as alternative NRTIs. The 4-in-1 single-tablet regimen Stribild (elvitegravir/cobicistat/tenofovir/emtricitabine) is also listed as an alternative. Other agents either should be used only with expert consultation or are not recommended for PEP; nevirapine (Viramune) is listed as "contraindicated."

Expert consultation should be sought in special cases, for example if an exposed  healthcare worker is pregnant or has co-existing conditions such as impaired kidney function, or if the source patient is known to have highly resistant virus.

Once PEP is underway, recipients should undergo close follow-up including monitoring for adherence and drug side effects and toxicities. Follow-up HIV testing should typically last for 6 months after exposure, but if a newer fourth-generation combination HIV p24 antigen/HIV antibody test is used, follow-up can be shortened to 4 months.

"Preventing exposures should be the leading strategy to prevent occupational HIV infections," Kuhar said in a press release issued by the Society for Healthcare Epidemiology of America. "However, when an exposure occurs, it should be considered an urgent medical concern and a PEP regimen should be started right away, ideally within hours of the potential exposure."

8/14/13

Reference

DT Kuhar, DK Henderson, KA Struble, et al. Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis. Infection Control and Hospital Epidemiology34(9):875-892. September 2013 (Epub August 6, 2013).

Other Source

Society for Healthcare Epidemiology of America. New Federal Guidelines for Managing Occupational Exposures to HIV. Press release. August 6, 2013.