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Postexposure HIV Prophylaxis in Physicians and Medical Personnel 

  • Author: Charles S Gilman, MD, FACEP; Chief Editor: John Bartlett, MD  more...
 
Updated: Dec 17, 2015
 

Practice Essentials

The risk of occupational exposure to HIV has resulted in the creation of strategies to reduce the risk in physicians and medical personnel. Such strategies focus on consideration of modes and risk of transmission, baseline and follow-up testing, and prophylaxis.

Updated guidelines from the United States Public Health Service (USPHS) and New York State Department of Health AIDS Institute recommend that, after any occupational exposure to HIV, healthcare personnel should immediately receive a postexposure prophylaxis (PEP) three-drug regimen.[1, 2] Specific recommendations also include the following:

  • Primary prevention strategies are emphasized, along with prompt reporting and management of occupational exposures.
  • The HIV status of the source of the exposure should be determined to guide the need for HIV PEP; if the HIV status of the source is unknown, it should be determined, usually with a rapid and reliable test such as the fourth-generation HIV test. If there is a concern about a false-negative result (eg, result is negative but there has been a risk for HIV transmission to the source prior to test detection, about 4-10 days for tests that detect Ag and/or Ab, including the fourth-generation test), plasma HIV RNA (HIV viral load) testing of the source is recommended.
  • PEP should be initiated as soon as possible, ideally within 2 hours of exposure; a first dose of PEP should be offered to the exposed worker while the evaluation is underway if HIV transmission is considered credible.
  • A PEP supply for 3-5 days is available for urgent use, and the exposed worker obtains a continuous supply to complete the 28-day course.
  • Follow-up appointments should begin within 72 hours of HIV exposure and should include follow-up HIV testing, monitoring for drug toxicity, and counseling.
  • Repeat HIV testing should be obtained at 6 weeks and 4 months postexposure. Testing should also be performed using the fourth-generation assay or HIV viral load if the injured healthcare worker has symptoms of the acute retroviral syndrome.

Updated guidelines should be distributed to emergency physicians and other providers as needed; many healthcare personnel exposures occur outside of normal office hours. Clinicians who do not have access to experienced HIV clinicians should call the National Clinicians' Consultation Center PEP Line at 1-888-448-4911. 

Risk factors

The risk of HIV transmission after exposure to body fluids from an HIV-infected patient is generally low. Risks associated with the 3 main routes of exposure are as follows:[3, 4]

  • Percutaneous exposure - Risk with an HIV-positive source, approximately 0.3%; risk is increased by hollow-bore needles, visibly bloody devices, deep injuries, and source person with terminal illness reflecting higher titer of HIV
  • Cutaneous exposure (ie, via nonintact skin) - Risk with an HIV-positive source, less than 0.09%
  • Mucous membrane exposure - Risk with an HIV-positive source, approximately 0.09%; risk is increased with a high viral load in the source and large-volume exposure

Management of exposure

Initial management steps for healthcare personnel exposed to HIV include the following:

  • Immediate decontamination (if not already performed by the healthcare worker) - For percutaneous or cutaneous exposure, washing of the area with soap and water; for mucous membrane exposure, copious irrigation of the area with water or sterile saline; for puncture wounds, cleanse with alcohol-based hand wipes; for eye exposures, irrigation with copious amounts of sterile water or saline
  • Initiation of institutional PEP plan - Reporting of exposure; confirmation of medication availability; provision of the initial supply; authorizing release of the drugs; determination of how the healthcare worker will obtain the medications to complete the 28-day regimen
  • Ordering of blood tests, immediate treatment, and follow-up within 72 hours, at which time further review and evaluation can be carried out
  • Source of exposure - Voluntary testing for HIV, hepatitis C virus antibody, and hepatitis B surface antigen (HBsAg); if HIV test is positive, confirmatory Western blot; if HIV infection is known to be present, elicitation of relevant information about disease stage
  • Healthcare worker - Testing for HIV, HCV antibody, HBsAg, and hepatitis B surface antibody (HBsAb); in females of child-bearing age, pregnancy testing; if HIV PEP is initiated, baseline complete blood (CBC) count, blood urea nitrogen (BUN), creatinine, and alanine aminotransferase (ALT)

When indicated, PEP should be initiated as soon as possible (ideally ≤2 hours and generally ≤72 hours) after exposure. The approach to PEP depends on the type of exposure, the source, and the HIV status of the source.

Follow-up measures should include the following:

  • Refraining from donation of blood, tissue, semen, or organs
  • Avoiding sexual intercourse or using barrier precautions; , avoiding breastfeeding; informing the provider if the at-risk healthcare worker is pregnant
  • Follow-up HIV antibody testing at 6 weeks and 4 months
  • Rechecking of CBC, renal function, and hepatic function at 2 and 4 weeks
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Epidemiology

Investigators from the Centers for Disease Control and Prevention (CDC) estimate that more than 380,000 total percutaneous exposures occur each year.[5] Underreporting of exposures has long been recognized as a significant problem due to the perception of technical incompetence, nature of the intervention, lack of understanding of the risks, and concern about excessive paperwork.[6]

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Modes of Transmission

HIV may theoretically be transmitted occupationally to medical personnel engaged in many routine medical procedures and activities. After initial exposure, HIV replicates within dendritic cells of the skin and mucosa before spreading through lymphatic vessels and developing into a systemic infection. This delay in systemic spread leads to a window of opportunity for postexposure prophylaxis (PEP) using antiretroviral drugs to block replication of HIV and prevent establishment of chronic HIV infection.

A portal of entry (percutaneous, cutaneous, or mucous membrane) is necessary along with exposure to infectious body fluid. Potentially infectious body fluids include blood, semen, vaginal fluids, amniotic fluids, breast milk, cerebrospinal fluid, pericardial fluid, peritoneal fluid, pleural fluid, and synovial fluid. Exposure to saliva, vomitus, urine, feces, sweat, tears, and respiratory secretions does not pose a risk for HIV transmission unless the fluid is visibly bloody. A bite from an HIV-infected patient with visible bleeding in the mouth that causes bleeding in the healthcare worker is considered an exposure. Splash of blood, visibly bloody fluid, or other potentially infectious material to a mucosal surface (mouth, nose, eyes) is also considered an exposure. 

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Risk of Transmission

The risk of transmission of HIV after exposure to body fluids from an HIV-infected patient is generally low.[7] Typical exposures result from percutaneous exposure to contaminated sharps such as needles, scalpels, and broken glass. Needlesticks such as from a large-bore hollow needle are thought to carry a higher risk of transmission. Other factors for higher risk are detailed in Table 1. Nonintact skin exposures occur when the medical worker has evidence of compromised skin integrity such as an abrasion, dermatitis, or open wound. Intact skin is considered an effective barrier against HIV infection, and contamination by blood or other fluids is not considered an exposure. From a review[3] in the era prior to highly active antiretroviral therapy (HAART), the following risks of HIV transmission were found: 

Table 1. Risk of Transmission of HIV (Open Table in a new window)

Route of Exposure Risk with HIV-Positive Source Factors Increasing Risk
Percutaneous ≈ 1 in 300 (0.3%) Hollow bore needles, visibly bloody devices, deep injury, source with terminal illness
Cutaneous < 1 in 1000 (0.09%) Must involve nonintact skin integrity
Mucous membrane ≈ 1 in 1000 (0.09%) High viral load in source
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Postexposure Management

If not already performed by the healthcare worker, immediate decontamination should be done. In the case of a needlestick injury, the area should be washed with soap and water. The wound should not be squeezed or milked or exposed to caustic agents such as bleach. For a cutaneous exposure, the area should be treated similarly with soap and water. In the mucous membrane exposure to blood or body fluids, the area should be copiously irrigated with water or sterile saline.

All healthcare institutions should have an easily accessible system in place available 24 hours a day that allows for reporting and managing the healthcare worker who experiences an occupational exposure to HIV. The plan for providing PEP should encompass how the medication will be made available, provision of the initial 24- to 48-hour supply, authority for releasing the drugs, and how the healthcare worker will obtain the PEP medications to complete the 4-week regimen in light of the circumstances that some individuals may be reluctant to go to their local pharmacy. In the United States, a policy for managing exposures is required and must comply with the regulations of the Occupational Safety and Health Administration (OSHA standard 1910.1030 Blood borne Pathogens).

Clinicians charged with managing these exposures should have the capability to initiate blood tests, start immediate treatment, and arrange for follow-up within 72 hours. At that time, the opportunity for further clarification of the nature of the exposure, review of source test results, and evaluation of the PEP regimen exists.

The source person may know his or her HIV status, and the person’s health records may be readily available. If the source person’s HIV status is unknown, voluntary testing for HIV (preferably the fourth-generation test), HCV Ab, and HBsAg should be performed. If these tests have previously been performed, clinical judgment should be used to determine whether the studies need repeating. Rapid EIA HIV Ab testing is extremely sensitive and specific and, if positive, should be considered a true positive for the purposes of PEP decision-making. A positive rapid test result requires a Western blot confirmatory test. If the rapid HIV test is not available on a timely basis, PEP treatment should be started knowing that it can be stopped if the test yields a negative result.

If the source patient has known HIV infection, relevant information about regarding most recent viral load, antiretroviral therapy (ART) history, and the most recent resistance test results should be elicited. If the HIV status of the source in unknown, HIV testing, preferably with the fourth-generation HIV test, as advocated by the CDC, should be performed. This test may return false-negative results during the first 2 weeks of virus transmission. Note that there have been no reported cases of transmission involving an exposure, during this period, although this is a time in which the viral load is especially high, suggesting very high vulnerability.[7] If the source person has been at risk for HIV exposure during the preceding 2 weeks, HIV viral load testing should be considered. Permission for testing should be obtained from the source person. Refusal by the source person for blood draw should be discussed with the local health department for assistance in the matter. Laws and regulations regarding this scenario vary from state to state.

For the healthcare worker, baseline laboratory studies include HIV, HCV Ab, HBV surface Ag, and HBV surface Ab. Hepatitis B testing depends on immunization status. Most healthcare personnel have been immunized against hepatitis B. If they know they responded to the vaccination series, they have lifelong immunity and require no further testing. If they are unaware of their response status, HBV surface Ab should be drawn to determine if they have a positive titer. If PEP is being considered and the healthcare worker is a female of childbearing age, an immediate pregnancy test should be performed. If HIV PEP is initiated, a baseline CBC count, BUN, creatinine, and ALT should also be drawn.

Timely administration of PEP should not be delayed by drawing blood for laboratory studies. PEP should be initiated as soon as possible, ideally within 2 hours and generally no later than 36 hours after the possible exposure. Decisions regarding initiation of PEP beyond 36 hours postexposure should be made on a case-by-case basis with the realization of diminished efficacy when timing of initiation is prolonged. The sooner the medications are started, the more effective they may be.[8]

PEP is recommended when an exposure to an HIV-positive patient has occurred. PEP is generally not warranted in cases of unknown status, but this can be considered from a source with HIV risk factors. If the source person is unknown (sharps box injury), PEP is generally not warranted but can be considered when exposure to HIV-infected persons is likely. 

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PEP Regimen

Three-drug PEP regimens are now the recommended regimens for all exposures owing to the safety and tolerability of new HIV drugs. The guidelines no longer require assessing the severity of exposure. There are some special circumstances, however, in which a 2-drug regimen can be used, especially when recommended antiretroviral medications are unavailable or there is concern about potential adherence problems or toxicity. An expert should be consulted if a 2-drug PEP regimen is being considered.

The preferred HIV 3-drug PEP regimen is raltegravir (Isentress) 400 mg PO twice daily plus Truvada (tenofovir DF 300 mg/emtricitabine 200 mg) 1 PO once daily

Note that many PEP services are recommending dolutegravir (DTG; 50 mg/d) plus tenofovir (TDF)/lamivudine (3TC) (300/200 qd) based on potency, tolerance, convenience of once-daily pill, and resistance to resistance. (This ART regimen is not in the guidelines since it was FDA-approved after the PEP guidance was written but is favored by most authorities.)

Table 2. Information on HIV PEP Medications[2] (Open Table in a new window)

Drug name Drug class Dosing (dosage form) Advantages Disadvantages
Abacavir (Ziagen; ABC) NRTI ABC: 300 mg daily; available as 300-mg tablet



Also available as component of fixed-dose combination Epzicom, dosed daily (300 mg of 3TC + 600 mg of ABC)



Trizivir, dosed twice daily (150 mg of 3TC + 300 mg of ABC + 300 mg of AZT)



Take without regard for food Potential for life-threatening ABC hypersensitivity reaction (rash, fever, nausea, vomiting, diarrhea, abdominal pain, malaise, respiratory symptoms) in patients with HLA-B*5701; requires patient testing prior to use, which may not be available or practical prior to initiating PEP
Atazanavir (Reyataz; ATV) PI ATV: 300 mg + RTV: 100 mg once daily (preferred dosing for PEPa)



ATV: 400 mg once daily without RTV (alternative dosing—may not be used in combination with TDF)



Available as 100-, 150-, 200-, and 300-mg capsules



Well tolerated Indirect hyperbilirubinemia and jaundice common



Rash



Nephrolithiasis



Potential for serious or life-threatening drug interactions that may affect dosing



Absorption depends on low pH; caution when coadministered with H2 antagonists, antacids, and proton pump inhibitors



PR interval prolongation



Caution in patients with underlying conduction defects or on concomitant medications that can cause PR prolongation



Must be given with food



Darunavir (Prezista; DRV) PI DRV: 800 mg once daily + RTV: 100 mg once daily (preferred dosing for PEPa )



DRV: 600 mg twice daily + RTV: 100 mg twice daily (alternative dosing)



Available as 75-, 150-, 400-, and 600-mg tablets



Well tolerated Rash (DRV has sulfonamide moiety)



Diarrhea, nausea, headache



Hepatotoxicity



Potential for serious or life-threatening drug interactions that may affect dosing



Must be given with food and with RTV



Efavirenz (Sustiva; EFV) NNRTI EFV: 600 mg daily; available as 50- and 200-mg capsules and 600-mg tablets



Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC + 300 mg of TDF + 600 mg of EFV)



Available as a complete regimen dosed once per day Rash



Neuropsychiatric side effects (eg, dizziness, somnolence, insomnia, abnormal dreaming) common; severe psychiatric symptoms possible (dosing before bedtime might minimize these side effects); use with caution in shift workers



Do not use during pregnancy; teratogen in nonhuman primates



Potential for serious or life-threatening drug interactions that may affect dosing



May cause false-positive results with some cannabinoid and benzodiazepine screening assays Take on an empty stomach



Elvitegravir (EVG) INSTI Available as a component of fixed-dose combination Stribild, dosed daily (150 mg of EVG + 150 mg of cobicistat + 300 mg of TDF + 200 mg of FTC) Well tolerated



Available as a complete regimen dosed once per day



Diarrhea, nausea, headache



Nephrotoxicity; should not be administered to individuals with acute or chronic kidney injury or those with eGFR <70



Cobicistat is a pharmacokinetic enhancer to increase EVG exposures and has no antiviral activity but is a potent CYP3A inhibitor



Potential for serious or life-threatening drug interactions



Must be given with food



Emtricitabine (Emtriva; FTC) NRTI 200 mg once daily; available as 200-mg capsule



Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC + 300 mg of TDF + 600 mg of EFV)



Complera, dosed daily (25 mg of RPV + 300 mg of TDF + 200 mg of FTC)



Stribild, dosed daily (150 mg of EVG + 150 mg of cobicistat + 300 mg of TDF + 200 mg of FTC)



Truvada, dosed daily (200 mg of FTC + 300 mg of TDF)



Well tolerated



Minimal toxicity



Minimal drug interactions



Take without regard for food



Rash perhaps more frequent than with 3TC



Hyperpigmentation/skin discoloration



If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation



Enfuvirtide (Fuzeon; T20) FI T20: 90 mg (1 mL) twice daily by subcutaneous injection; available as single-dose vial, reconstituted to 90 mg/mL --- Local injection-site reactions occur in almost 100% of patients



Never studied among antiretroviral-naive or HIV-negative patients



False-positive EIA HIV antibody tests might result from formation of anti-T20 antibodies that crossreact with anti-gp41 antibodies



Twice-daily injection



Etravirine (Intelence; ETR) NNRTI 200 mg twice daily; available as 100- and 200-mg tablets Well tolerated and has not had the same frequency of CNS side effects reported as EFV Rash (including SJS) and hypersensitivity (sometimes with organ dysfunction, including hepatic failure)



Nausea



Potential for serious or life-threatening drug interactions that may affect dosing



Must be given with food



Fosamprenavir (Lexiva; FOSAPV) PI FOSAPV: 1,400 mg daily + RTV: 100 mg once daily (preferred dosing for PEP)



FOSAPV: 1,400 mg twice daily without RTV (alternative dosing)



Available as 700-mg tablet



Well tolerated Diarrhea, nausea, vomiting, headache, rash (FOSAPV has sulfonamide moiety)



Potential for serious or life-threatening drug interactions that may affect dosing



Oral contraceptives decrease FOSAPV concentrations



Take with food if given with RTV



Lamivudine (Epivir; 3TC) NRTI 3TC: 300 mg once daily (preferred dosing for PEP)



3TC: 150 mg twice daily (alternative dosing)



Available as 150- and 300-mg tablets



Also available as component of fixed-dose combination generic lamivudine/zidovudine, dosed twice daily (150 mg of 3TC + 300 mg of AZT)



Combivir, dosed twice daily (150 mg of 3TC + 300 mg of AZT)



Epzicom, dosed daily (300 mg of 3TC + 600 mg of ABC)



Trizivir, dosed twice daily (150 mg of 3TC + 300 mg of ABC + 300 mg of AZT)



Well tolerated



Minimal toxicity



Minimal drug interactions



Take without regard for food



If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation
Lopinavir/ritonavir (Kaletra; LPV/RTV) PI Kaletra: 400/100 mg = 2 tablets twice daily (preferred dosing for PEP)



Kaletra: 800/200 mg = 4 tablets once daily (alternative dosing)



Available as 200/50-mg tablets



Take without regard for food GI intolerance, nausea, vomiting, diarrhea are common



PR and QT interval prolongation have been reported; use with caution in patients at risk of cardiac conduction abnormalities or receiving other drugs with similar effect



Potential for serious or life-threatening drug interactions that may affect dosing



Maraviroc (Selzentry; MVC) CCR5 coreceptor antagonist MVC: 300 mg twice daily (if on concomitant CYP3A inducers, dose may need adjustment by expert consultant); available as 150- and 300-mg tablets Well tolerated Abdominal pain, cough, dizziness, musculoskeletal symptoms, pyrexia, rash, orthostatic hypotension



Hepatotoxicity that may present with an allergic reaction, including rash



Requires HIV tropism testing of source virus before treatment to ensure CCR5-tropic virus and efficacy, which may not be available or practical prior to initiating PEP



Potential for serious or life-threatening drug interactions that may affect dosing



Dose adjustments for MVC required when given with potent CYP3A inhibitors or inducers



Raltegravir (Isentress; RAL) INSTI 400 mg twice daily; available as 400-mg tablet Well tolerated



Minimal drug interactions



Take without regard for food



Insomnia, nausea, fatigue, headache, and severe skin and hypersensitivity reactions have been reported
Rilpivirine (Edurant; RPV) NNRTI 25 mg once daily; available as 25- mg tablet



Also available as component of fixed-dose combination Complera, dosed daily (25 mg of RPV + 300 mg of TDF + 300 mg of FTC)



Well tolerated and fewer rashes and discontinuations for CNS adverse effects compared with EFV



Available as a complete regimen dosed once per day



Depression, insomnia, rash, hypersensitivity, headache



Potential for serious or life-threatening drug interactions that may affect dosing



Caution when coadministered with H2 antagonists and antacids



Coadministration with proton pump inhibitors is contraindicated



Use RPV with caution when coadministered with a drug having a known risk of torsades de pointes



Must be given with food



Saquinavir (Invirase; SQV) PI SQV: 1,000 mg + RTV: 100 mg twice daily (preferred dosing for PEP); available as 500 mg tablet Well tolerated, although GI events common GI intolerance, nausea, diarrhea, headache



Pretreatment ECG recommended



SQV/r is not recommended for patients with any of the following: (1) congenital or acquired QT prolongation, (2) pretreatment ECG 1450 msec, (3) receiving concomitant therapy with other drugs that prolong QT interval, (4) complete AV block without implanted pacemakers, and (5) risk of complete AV block



PR and QT interval prolongations, torsades de pointes has been reported



Potential for serious or life-threatening drug interactions that may affect dosing



Must be given with food



Stavudine (Zerit; d4T) NRTI d4T: 40 mg twice daily if body weight is >60 kg



d4T: 30 mg twice daily if body weight is <60 kg



Available as 15-, 20-, 30-, and 40-mg tablets



Take without regard for food GI side effects include diarrhea and nausea



Hepatotoxicity, neurologic symptoms (eg, peripheral neuropathy), pancreatitis



Tenofovir DF (Viread; TDF) NRTI 300 mg once daily; available as 300-mg tablet



Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC + 300 mg of TDF + 600 mg of EFV)



Complera, dosed daily (25 mg of RPV + 300 mg of TDF + 200 mg of FTC)



Stribild, dosed daily (150 mg of EVG + 150 mg of cobicistat + 300 mg of TDF + 200 mg of FTC)



Truvada, dosed daily (200 mg of FTC + 300 mg of TDF)



Well tolerated



Take without regard for food



Asthenia, headache, diarrhea, nausea, vomiting



Nephrotoxicity; should not be administered to individuals with acute or chronic kidney injury or those with eGFR <60



If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation



Drug interactions



Zidovudine (Retrovir; ZDV; AZT) NRTI AZT: 300 mg twice daily; available as 100-mg capsule or 300- mg tablet



Also available as component of fixed-dose combination generic lamivudine/zidovudine, dosed twice daily (150 mg of 3TC + 300 mg of AZT)



Combivir, dosed twice daily (150 mg of 3TC + 300 mg of AZT)



Trizivir, dosed twice daily (150 mg of 3TC + 300 mg of ABC + 300 mg of AZT) Ta



Take without regard for food Side effects (especially nausea, vomiting, headache, insomnia, and fatigue) common and might result in low adherence



Anemia and neutropenia



NOTE. This table does not provide comprehensive information on each individual drug. For detailed information, please refer to individual drug package inserts. AV, atrioventricular; CNS, central nervous system; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; EIA, enzyme immunoassay; GI, gastrointestinal; SJS, Stevens-Johnson syndrome.



a Certain antiretroviral agents, such as PIs, have the option of once- or twice-daily dosing depending on treatment history and use with ritonavir. For PEP, the selection of dosing and schedule is to optimize adherence while minimizing side effects where possible. This table includes the preferred dosing schedule for each agent, and in all cases with the exception of Kaletra the once-daily regimen option is preferred for PEP. Twice-daily administration of Kaletra is better tolerated with respect to GI toxicities compared with the once-daily regimen. Alternative dosing and schedules may be appropriate for PEP in certain circumstances and should preferably be prescribed by individuals experienced in the use of antiretroviral medications.



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Follow-up of Exposed Healthcare Worker

PEP is given for 28 days. If source person testing is negative for HIV, PEP can be stopped before 28 days. During the follow-up period, especially the first 6-12 weeks, exposed healthcare workers should undertake precautions to prevent further transmission of HIV. They should not donate blood, tissue, semen, or organs. They should not engage in sexual intercourse, become pregnant, or breastfeed. Follow-up HIV Ab testing should be performed at 6 weeks and 4 months. A negative result at 12 weeks reasonably excludes HIV infection related to the occupational exposure. Routine testing at 6 months postexposure is no longer recommended.

Symptoms of acute HIV (fever, sore throat, lymphadenopathy, rash, flu-like symptoms, and weight loss) should prompt immediate evaluation. For patients who receive PEP, CBC, renal, and hepatic function should be rechecked at 2 and 4 weeks. 

Table 3. Monitoring Recommendations After Initiation of PEP Regimens Following Occupational Exposurea[9] (Open Table in a new window)

  Baseline Week 1 Week 2 Week 3 Week 4 Week 12
Clinic visit



Or by telephone







Or by telephone







Or by telephone



 
Pregnancy test          
Serum liver enzymes, BUN, creatinine, CBC countb      
HIV testc      
a See also Hepatitis C and Hepatitis B Immune Globulin (HBIG).



b CBC count should be obtained in all exposed workers at baseline; a follow-up CBC count is indicated only in those receiving a zidovudine-containing regimen.



c Recommended even if PEP is declined.



Adverse effects are generally self-limited but sometimes can last the duration of the 28-day PEP course. Gastrointestinal symptoms (nausea, vomiting, diarrhea) are most common. Headache, fatigue, and insomnia are other adverse effects. Antiemetic and antidiarrheal medications can be prescribed to help with PEP adherence. If adverse effects are severe, consider changing to a different regimen. Toxicities are rare with the current preferred PEP regimens, generally not life-threatening, and reversible.

Because of the complexity and potential adverse drug effects, follow-up visits should be with an experienced occupational health clinician or HIV specialist. There is no need to modify the patient care responsibilities of the exposed healthcare worker. 

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PEP for the Pregnant or Breastfeeding Medical Worker

As with all medications, the risks and benefits of PEP should be discussed with the pregnant medical worker who has sustained an exposure. All pregnant women starting antiretroviral therapy (ART) should be entered into the Antiretroviral Pregnancy Registry, a database designed to collect information on the outcomes of antiretroviral-exposed pregnancies regardless of HIV status. Most antiretroviral drugs are category B or C. Based on limited data, the benefit of antiretroviral drugs in pregnancy, including during the first trimester, outweigh the risks and do not appear to increase the risk of birth defects.

Drugs to avoid during pregnancy are well covered in Antiretroviral Therapy for Pregnant HIV-Infected Patients. Contraindicated medications include efavirenz (which is contraindicated in the first trimester), indinavir, and the combination of didanosine and stavudine. Based on increasing clinical experience with HAART, PEP is indicated at any time during pregnancy when a significant exposure has occurred.[10]

Women who may have been exposed to HIV should avoid breastfeeding for 3 months after the exposure. Both HIV and antiretroviral drugs may be found in breast milk. 

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Further Resources

The National Clinicians’ Postexposure Prophylaxis Hotline (PEPline) can be contacted at 888-448-4911 daily from 9 am to 2 am EST (6 am to 11 pm PST) for assistance in assessing risk and advice on managing occupational exposures to HIV and other blood borne pathogens. The Antiretroviral Pregnancy Registry can be contacted at 800-258-4263.

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Contributor Information and Disclosures
Author

Charles S Gilman, MD, FACEP Assistant Professor of Medicine, Division of Emergency Medicine, Medical University of South Carolina College of Medicine; Attending Physician, Division of Emergency Medicine, MUSC Health

Charles S Gilman, MD, FACEP is a member of the following medical societies: American College of Emergency Physicians

Disclosure: Nothing to disclose.

Specialty Editor Board

Francisco Talavera, PharmD, PhD Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Received salary from Medscape for employment. for: Medscape.

Chief Editor

John Bartlett, MD Professor Emeritus, Johns Hopkins University School of Medicine

John Bartlett, MD is a member of the following medical societies: Alpha Omega Alpha, American College of Clinical Pharmacology, American College of Physicians, American Society for Microbiology, American Society of Tropical Medicine and Hygiene, American Thoracic Society, American Venereal Disease Association, Association of American Physicians, Infectious Diseases Society of America, Society of Critical Care Medicine

Disclosure: Nothing to disclose.

References
  1. [Guideline] HIV Prophylaxis Following Occupational Exposure. New York Department of Health AIDS Institute. Available at http://www.hivguidelines.org. Accessed: October 25, 2014.

  2. Kuhar DT, Henderson DK, Struble KA, Heneine W, Thomas V, Cheever LW, et al. Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis. Infect Control Hosp Epidemiol. 2013 Sep. 34(9):875-92. [Medline].

  3. Henderson DK, Fahey BJ, Willy M, Schmitt JM, Carey K, Koziol DE, et al. Risk for occupational transmission of human immunodeficiency virus type 1 (HIV-1) associated with clinical exposures. A prospective evaluation. Ann Intern Med. 1990 Nov 15. 113(10):740-6. [Medline].

  4. Henderson DK. Management of needlestick injuries: a house officer who has a needlestick. JAMA. 2012 Jan 4. 307 (1):75-84. [Medline].

  5. Panlilio AL, Orelien JG, Srivastava PU, Jagger J, Cohn RD, Cardo DM. Estimate of the annual number of percutaneous injuries among hospital-based healthcare workers in the United States, 1997-1998. Infect Control Hosp Epidemiol. 2004 Jul. 25(7):556-62. [Medline].

  6. Hamory BH. Underreporting of needlestick injuries in a university hospital. Am J Infect Control. 1983. 11(5):174-177.

  7. [Guideline] Panlilio AL, Cardo DM, Grohskopf LA, Heneine W, Ross CS,. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2005 Sep 30. 54(RR-9):1-17. [Medline].

  8. Young T, Arens FJ, Kennedy GE, Laurie JW, Rutherford GW. Antiretroviral postexposure prophylaxis (PEP) for occupational HIV exposure. Cochrane Collaboration. 2010. Issue 3:

  9. New York State Department of Health AIDS Institute, Clinical Guidelines Development Program. Available at http://www.hivguidelines.org/clinical-guidelines/post-exposure-prophylaxis/hiv-prophylaxis-following-occupational-exposure/.

  10. Jamieson DJ, Clark J, Kourtis AP, Taylor AW, Lampe MA, Fowler MG. Recommendations for human immunodeficiency virus screening, prophylaxis, and treatment for pregnant women in the United States. Am J Obstet Gynecol. 2007 Sep. 197(3 Suppl):S26-32. [Medline].

 
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Table 1. Risk of Transmission of HIV
Route of Exposure Risk with HIV-Positive Source Factors Increasing Risk
Percutaneous ≈ 1 in 300 (0.3%) Hollow bore needles, visibly bloody devices, deep injury, source with terminal illness
Cutaneous < 1 in 1000 (0.09%) Must involve nonintact skin integrity
Mucous membrane ≈ 1 in 1000 (0.09%) High viral load in source
Table 2. Information on HIV PEP Medications [2]
Drug name Drug class Dosing (dosage form) Advantages Disadvantages
Abacavir (Ziagen; ABC) NRTI ABC: 300 mg daily; available as 300-mg tablet



Also available as component of fixed-dose combination Epzicom, dosed daily (300 mg of 3TC + 600 mg of ABC)



Trizivir, dosed twice daily (150 mg of 3TC + 300 mg of ABC + 300 mg of AZT)



Take without regard for food Potential for life-threatening ABC hypersensitivity reaction (rash, fever, nausea, vomiting, diarrhea, abdominal pain, malaise, respiratory symptoms) in patients with HLA-B*5701; requires patient testing prior to use, which may not be available or practical prior to initiating PEP
Atazanavir (Reyataz; ATV) PI ATV: 300 mg + RTV: 100 mg once daily (preferred dosing for PEPa)



ATV: 400 mg once daily without RTV (alternative dosing—may not be used in combination with TDF)



Available as 100-, 150-, 200-, and 300-mg capsules



Well tolerated Indirect hyperbilirubinemia and jaundice common



Rash



Nephrolithiasis



Potential for serious or life-threatening drug interactions that may affect dosing



Absorption depends on low pH; caution when coadministered with H2 antagonists, antacids, and proton pump inhibitors



PR interval prolongation



Caution in patients with underlying conduction defects or on concomitant medications that can cause PR prolongation



Must be given with food



Darunavir (Prezista; DRV) PI DRV: 800 mg once daily + RTV: 100 mg once daily (preferred dosing for PEPa )



DRV: 600 mg twice daily + RTV: 100 mg twice daily (alternative dosing)



Available as 75-, 150-, 400-, and 600-mg tablets



Well tolerated Rash (DRV has sulfonamide moiety)



Diarrhea, nausea, headache



Hepatotoxicity



Potential for serious or life-threatening drug interactions that may affect dosing



Must be given with food and with RTV



Efavirenz (Sustiva; EFV) NNRTI EFV: 600 mg daily; available as 50- and 200-mg capsules and 600-mg tablets



Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC + 300 mg of TDF + 600 mg of EFV)



Available as a complete regimen dosed once per day Rash



Neuropsychiatric side effects (eg, dizziness, somnolence, insomnia, abnormal dreaming) common; severe psychiatric symptoms possible (dosing before bedtime might minimize these side effects); use with caution in shift workers



Do not use during pregnancy; teratogen in nonhuman primates



Potential for serious or life-threatening drug interactions that may affect dosing



May cause false-positive results with some cannabinoid and benzodiazepine screening assays Take on an empty stomach



Elvitegravir (EVG) INSTI Available as a component of fixed-dose combination Stribild, dosed daily (150 mg of EVG + 150 mg of cobicistat + 300 mg of TDF + 200 mg of FTC) Well tolerated



Available as a complete regimen dosed once per day



Diarrhea, nausea, headache



Nephrotoxicity; should not be administered to individuals with acute or chronic kidney injury or those with eGFR <70



Cobicistat is a pharmacokinetic enhancer to increase EVG exposures and has no antiviral activity but is a potent CYP3A inhibitor



Potential for serious or life-threatening drug interactions



Must be given with food



Emtricitabine (Emtriva; FTC) NRTI 200 mg once daily; available as 200-mg capsule



Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC + 300 mg of TDF + 600 mg of EFV)



Complera, dosed daily (25 mg of RPV + 300 mg of TDF + 200 mg of FTC)



Stribild, dosed daily (150 mg of EVG + 150 mg of cobicistat + 300 mg of TDF + 200 mg of FTC)



Truvada, dosed daily (200 mg of FTC + 300 mg of TDF)



Well tolerated



Minimal toxicity



Minimal drug interactions



Take without regard for food



Rash perhaps more frequent than with 3TC



Hyperpigmentation/skin discoloration



If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation



Enfuvirtide (Fuzeon; T20) FI T20: 90 mg (1 mL) twice daily by subcutaneous injection; available as single-dose vial, reconstituted to 90 mg/mL --- Local injection-site reactions occur in almost 100% of patients



Never studied among antiretroviral-naive or HIV-negative patients



False-positive EIA HIV antibody tests might result from formation of anti-T20 antibodies that crossreact with anti-gp41 antibodies



Twice-daily injection



Etravirine (Intelence; ETR) NNRTI 200 mg twice daily; available as 100- and 200-mg tablets Well tolerated and has not had the same frequency of CNS side effects reported as EFV Rash (including SJS) and hypersensitivity (sometimes with organ dysfunction, including hepatic failure)



Nausea



Potential for serious or life-threatening drug interactions that may affect dosing



Must be given with food



Fosamprenavir (Lexiva; FOSAPV) PI FOSAPV: 1,400 mg daily + RTV: 100 mg once daily (preferred dosing for PEP)



FOSAPV: 1,400 mg twice daily without RTV (alternative dosing)



Available as 700-mg tablet



Well tolerated Diarrhea, nausea, vomiting, headache, rash (FOSAPV has sulfonamide moiety)



Potential for serious or life-threatening drug interactions that may affect dosing



Oral contraceptives decrease FOSAPV concentrations



Take with food if given with RTV



Lamivudine (Epivir; 3TC) NRTI 3TC: 300 mg once daily (preferred dosing for PEP)



3TC: 150 mg twice daily (alternative dosing)



Available as 150- and 300-mg tablets



Also available as component of fixed-dose combination generic lamivudine/zidovudine, dosed twice daily (150 mg of 3TC + 300 mg of AZT)



Combivir, dosed twice daily (150 mg of 3TC + 300 mg of AZT)



Epzicom, dosed daily (300 mg of 3TC + 600 mg of ABC)



Trizivir, dosed twice daily (150 mg of 3TC + 300 mg of ABC + 300 mg of AZT)



Well tolerated



Minimal toxicity



Minimal drug interactions



Take without regard for food



If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation
Lopinavir/ritonavir (Kaletra; LPV/RTV) PI Kaletra: 400/100 mg = 2 tablets twice daily (preferred dosing for PEP)



Kaletra: 800/200 mg = 4 tablets once daily (alternative dosing)



Available as 200/50-mg tablets



Take without regard for food GI intolerance, nausea, vomiting, diarrhea are common



PR and QT interval prolongation have been reported; use with caution in patients at risk of cardiac conduction abnormalities or receiving other drugs with similar effect



Potential for serious or life-threatening drug interactions that may affect dosing



Maraviroc (Selzentry; MVC) CCR5 coreceptor antagonist MVC: 300 mg twice daily (if on concomitant CYP3A inducers, dose may need adjustment by expert consultant); available as 150- and 300-mg tablets Well tolerated Abdominal pain, cough, dizziness, musculoskeletal symptoms, pyrexia, rash, orthostatic hypotension



Hepatotoxicity that may present with an allergic reaction, including rash



Requires HIV tropism testing of source virus before treatment to ensure CCR5-tropic virus and efficacy, which may not be available or practical prior to initiating PEP



Potential for serious or life-threatening drug interactions that may affect dosing



Dose adjustments for MVC required when given with potent CYP3A inhibitors or inducers



Raltegravir (Isentress; RAL) INSTI 400 mg twice daily; available as 400-mg tablet Well tolerated



Minimal drug interactions



Take without regard for food



Insomnia, nausea, fatigue, headache, and severe skin and hypersensitivity reactions have been reported
Rilpivirine (Edurant; RPV) NNRTI 25 mg once daily; available as 25- mg tablet



Also available as component of fixed-dose combination Complera, dosed daily (25 mg of RPV + 300 mg of TDF + 300 mg of FTC)



Well tolerated and fewer rashes and discontinuations for CNS adverse effects compared with EFV



Available as a complete regimen dosed once per day



Depression, insomnia, rash, hypersensitivity, headache



Potential for serious or life-threatening drug interactions that may affect dosing



Caution when coadministered with H2 antagonists and antacids



Coadministration with proton pump inhibitors is contraindicated



Use RPV with caution when coadministered with a drug having a known risk of torsades de pointes



Must be given with food



Saquinavir (Invirase; SQV) PI SQV: 1,000 mg + RTV: 100 mg twice daily (preferred dosing for PEP); available as 500 mg tablet Well tolerated, although GI events common GI intolerance, nausea, diarrhea, headache



Pretreatment ECG recommended



SQV/r is not recommended for patients with any of the following: (1) congenital or acquired QT prolongation, (2) pretreatment ECG 1450 msec, (3) receiving concomitant therapy with other drugs that prolong QT interval, (4) complete AV block without implanted pacemakers, and (5) risk of complete AV block



PR and QT interval prolongations, torsades de pointes has been reported



Potential for serious or life-threatening drug interactions that may affect dosing



Must be given with food



Stavudine (Zerit; d4T) NRTI d4T: 40 mg twice daily if body weight is >60 kg



d4T: 30 mg twice daily if body weight is <60 kg



Available as 15-, 20-, 30-, and 40-mg tablets



Take without regard for food GI side effects include diarrhea and nausea



Hepatotoxicity, neurologic symptoms (eg, peripheral neuropathy), pancreatitis



Tenofovir DF (Viread; TDF) NRTI 300 mg once daily; available as 300-mg tablet



Also available as component of fixed-dose combination Atripla, dosed daily (200 mg of FTC + 300 mg of TDF + 600 mg of EFV)



Complera, dosed daily (25 mg of RPV + 300 mg of TDF + 200 mg of FTC)



Stribild, dosed daily (150 mg of EVG + 150 mg of cobicistat + 300 mg of TDF + 200 mg of FTC)



Truvada, dosed daily (200 mg of FTC + 300 mg of TDF)



Well tolerated



Take without regard for food



Asthenia, headache, diarrhea, nausea, vomiting



Nephrotoxicity; should not be administered to individuals with acute or chronic kidney injury or those with eGFR <60



If the PEP recipient has chronic hepatitis B, withdrawal of this drug may cause an acute hepatitis exacerbation



Drug interactions



Zidovudine (Retrovir; ZDV; AZT) NRTI AZT: 300 mg twice daily; available as 100-mg capsule or 300- mg tablet



Also available as component of fixed-dose combination generic lamivudine/zidovudine, dosed twice daily (150 mg of 3TC + 300 mg of AZT)



Combivir, dosed twice daily (150 mg of 3TC + 300 mg of AZT)



Trizivir, dosed twice daily (150 mg of 3TC + 300 mg of ABC + 300 mg of AZT) Ta



Take without regard for food Side effects (especially nausea, vomiting, headache, insomnia, and fatigue) common and might result in low adherence



Anemia and neutropenia



NOTE. This table does not provide comprehensive information on each individual drug. For detailed information, please refer to individual drug package inserts. AV, atrioventricular; CNS, central nervous system; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; EIA, enzyme immunoassay; GI, gastrointestinal; SJS, Stevens-Johnson syndrome.



a Certain antiretroviral agents, such as PIs, have the option of once- or twice-daily dosing depending on treatment history and use with ritonavir. For PEP, the selection of dosing and schedule is to optimize adherence while minimizing side effects where possible. This table includes the preferred dosing schedule for each agent, and in all cases with the exception of Kaletra the once-daily regimen option is preferred for PEP. Twice-daily administration of Kaletra is better tolerated with respect to GI toxicities compared with the once-daily regimen. Alternative dosing and schedules may be appropriate for PEP in certain circumstances and should preferably be prescribed by individuals experienced in the use of antiretroviral medications.



Table 3. Monitoring Recommendations After Initiation of PEP Regimens Following Occupational Exposure a [9]
  Baseline Week 1 Week 2 Week 3 Week 4 Week 12
Clinic visit



Or by telephone







Or by telephone







Or by telephone



 
Pregnancy test          
Serum liver enzymes, BUN, creatinine, CBC countb      
HIV testc      
a See also Hepatitis C and Hepatitis B Immune Globulin (HBIG).



b CBC count should be obtained in all exposed workers at baseline; a follow-up CBC count is indicated only in those receiving a zidovudine-containing regimen.



c Recommended even if PEP is declined.



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