Management of Occupational Exposure: Recommendations

Management of Occupational Exposure

Recommendations

The following recommendations are provisional because they are based on limited data regarding efficacy and toxicity of PEP and risk for HIV infection after different types of exposure. Because most occupational exposures to HIV do not result in infection transmission, potential toxicity must be carefully considered when prescribing PEP. When possible, these recommendations should be implemented in consultation with persons having expertise in antiretroviral therapy and HIV transmission. Changes in drug regimens may be appropriate, based on factors such as the probable antiretroviral drug resistance profile of HIV from the source patient; local availability of drugs; and medical conditions, concurrent drug therapy, and drug toxicity in the exposed worker. These recommendations were not developed to address nonoccupational (e.g., sexual) exposures.

1. Chemoprophylaxis should be recommended to exposed workers after occupational exposures associated with the highest risk for HIV transmission. For exposures with a lower, but nonnegligible risk, PEP should be offered, balancing the lower risk against the use of drugs having uncertain efficacy and toxicity. For exposures with negligible risk, PEP is not justified (Table 1). Exposed workers should be informed that a) knowledge about the efficacy and toxicity of PEP is limited; b) for agents other than ZDV, data are limited regarding toxicity in persons without HIV infection or who are pregnant; and c) any or all drugs for PEP may be declined by the exposed worker.

2. At present, ZDV should be considered for all PEP regimens because ZDV is the only agent for which data support the efficacy of PEP in the clinical setting. 3TC should usually be added to ZDV for increased antiretroviral activity and activity against many ZDV-resistant strains. A protease inhibitor (preferably IDV because of the characteristics summarized in this report) should be added for exposures with the highest risk for HIV transmission (Table 1). Adding a protease inhibitor also may be considered for lower risk exposures if ZDV-resistant strains are likely, although it is uncertain whether the potential additional toxicity of a third drug is justified for lower risk exposures. For HIV strains resistant to both ZDV and 3TC or resistant to a protease inhibitor, or if these drugs are contraindicated or poorly tolerated, the optimal PEP regimen is uncertain; expert consultation is advised ****.

3. PEP should be initiated promptly, preferably within 1-2 hours postexposure. Although animal studies suggest that PEP probably is not effective when started later than 24-36 hours postexposure (6,7), the interval after which there is no benefit from PEP for humans is undefined. Initiating therapy after a longer interval (e.g., 1-2 weeks) may be considered for the highest risk exposures; even if infection is not prevented, early treatment of acute HIV infection may be beneficial (10). The optimal duration of PEP is unknown; because 4 weeks of ZDV appeared protective (2), PEP should probably be administered for 4 weeks, if tolerated.

4. If the source patient or the patient's HIV status is unknown, initiating PEP should be decided on a case-by-case basis, based on the exposure risk and likelihood of HIV infection in known or possible source patients. If additional information becomes available, decisions about PEP can be modified.

5. Workers with occupational exposures to HIV should receive follow-up counseling and medical evaluation, including HIV-antibody tests at baseline and periodically for at least 6 months postexposure (e.g., 6 weeks, 12 weeks, and 6 months), and should observe precautions to prevent possible secondary transmission (1). If PEP is used, drug-toxicity monitoring should include a complete blood count and renal and hepatic chemical function tests at baseline and 2 weeks after starting PEP. If subjective or objective toxicity is noted, dose reduction or drug substitution should be considered with expert consultation, and further diagnostic studies may be indicated. Health-care workers who become infected with HIV should receive appropriate medical care.

6. Beginning July 15, 1996, health-care providers in the United States are encouraged to enroll all workers who receive PEP in an anonymous registry being developed by CDC, Glaxo Wellcome Inc., and Merck & Co., Inc., to assess toxicity (telephone {888} 737-4448 {(888) PEP-4HIV}). Unusual or severe toxicity from antiretroviral drugs should be reported to the manufacturer and/or the Food and Drug Administration (telephone {800} 332-1088). Updated information about HIV PEP will be available beginning in early 1997 from the CDC's fax information service, telephone (404) 332-4565 (Hospital Infections Program directory); the National AIDS Clearinghouse, telephone (800) 458-5231; and the HIV/AIDS Treatment Information Service, telephone (800) 448-0440.

Reported by: Center for Drug Evaluation and Research, Food and Drug Administration. AIDS Program Office, Health Resources and Svcs Administration. National Institute of Allergy and Infectious Diseases, Warren H. Magnuson Clinical Center, National Institutes of Health. National Center for HIV, STD, and TB Prevention (proposed); National Institute for Occupational Safety and Health; and National Center for Infectious Diseases, CDC.

Table 1

Type of Exposure	Source Material^*	Antiretroviral Prophylaxis⁺	Antiretroviral Regimen^&

Percutaneous	Blood^£
	Highest risk Increased risk No increased risk	Recommended Recommended Offer	ZDV plus 3TC plus IDV ZDV plus 3TC, ± IDV** ZDV plus 3TC
	Fluid containing visible blood, other potentially infectious fluid++, or tissue	Offer	ZDV plus 3TC
	Other body fluid (e.g., urine)	Not Offer

Mucous Membrane	Blood	Offer	ZDV plus 3TC, ± IDV**
	Fluid containing visible blood, other potentially infectious fluid++, or tissue	Offer	ZDV, ± 3TC
	Other body fluid (e.g., urine)	Not Offer

Skin	Increased risk Blood	Offer	ZDV plus 3TC, ± IDV**
	Fluid containing visible blood, other potentially infectious fluid++, or tissue	Offer	ZDV, ± 3TC
	Other body fluid (e.g., urine)	Not Offer

* Any exposure to concentrated HIV (e.g., in a research laboratory or production facility) is treated as percutaneous exposure to blood with highest risk.
+ Recommend -- Postexposure prophylaxis (PEP) should be recommended to the exposed worker with counseling (see text).
Offer -- PEP should be offered to the exposed worker with counseling (see text).
Not offer -- PEP should not be offered because these are not occupational exposures to HIV (1).
& Regimens: zidovudine (ZDV), 200 mg three times a day; lamivudine (3TC), 150 mg two times a day; indinavir (IDV), 800 mg three times a day (if IDV is not available, saquinavir may be used, 600 mg three times a day). Prophylaxis is given for 4 weeks. For full prescribing information, see package inserts.
£ Highest risk -- BOTH larger volume of blood (e.g., deep injury with large diameter hollow needle previously in source patient's vein or artery, especially involving an injection of source-patient's blood) AND blood containing a high titer of HIV (e.g., source with acute retroviral illness or end-stage AIDS; viral load measurement may be considered, but its use in relation to PEP has not been evaluated).
Increased risk -- EITHER exposure to larger volume of blood OR blood with a high titer of HIV.
No increased risk -- NEITHER exposure to larger volume of blood NOR blood with a high titer of HIV (e.g., solid suture needle injury from source patient with asymptomatic HIV infection).
** Possible toxicity of additional drug may not be warranted (see text).
++ Includes semen; vaginal secretions; cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids.
&& For skin, risk is increased for exposures involving a high titer of HIV; prolonged contact, an extensive area, or an area in which skin integrity is visibly compromised. For skin exposures without increased risk, the risk of drug toxicity outweighs the benefit of PEP.

Source: The Centers for Disease Control and Prevention

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