Postexposure HIV Prophylaxis in Physicians and Medical Personnel 

Updated: Sep 22, 2021
  • Author: Ana Elizabeth Markelz, MD, FACP, FIDSA; Chief Editor: John Bartlett, MD  more...
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Practice Essentials

The risk for 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 for transmission, baseline and follow-up testing, and prophylaxis.

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) 3-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 recent risk for HIV transmission to the source), plasma HIV RNA (HIV viral load) testing of the source is recommended.
  • PEP should be initiated as soon as possible, ideally within hours of exposure; a first dose of PEP should be offered to the exposed worker while the evaluation is underway. Evaluation and laboratory testing can proceed after the first dose of PEP is administered.
  • 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 be performed using the fourth-generation assay; if a fourth-generation assay is unavailable, repeat HIV testing should be obtained at 6 weeks, 12 weeks, and 6 months postexposure. An HIV viral load should be obtained if the exposed healthcare worker has symptoms of 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 for 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 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 HIV 1/2 Ab differentiation immunoassay; if HIV infection is known to be present, obtain relevant information about disease stage
  • Healthcare worker - Testing for HIV, HCV antibody, HBsAg, and hepatitis B surface antibody (HBsAb); in women and people of childbearing age, pregnancy testing; if HIV PEP is initiated, baseline complete blood count (CBC), basic metabolic panel (BMP) and liver associated enzymes

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 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 without using barrier precautions; avoiding breastfeeding if possible; informing the provider if the at-risk healthcare worker is pregnant
  • Follow-up HIV antibody testing at 6 weeks and 4 months if using fourth-generation HIV test; if fourth-generation HIV test is unavailable, testing should be conducted at 6 weeks, 12 weeks, and 6 months
  • Rechecking of CBC, BMP, and liver associated enzymes at 2 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]  A report from the CDC's National Surveillance System for Healthcare Workers (NaSH), a legacy system to the National Healthcare Safety Network (NHSN), collected data on blood and body fluid (BBF) exposures from healthcare workers (HCW) working in US facilties participaitng in NaSH between 1995 and 2007. Of the 30,945 BBF exposures reported to the NaSH during this period, 82% were percutaneous injuries and 79% involved blood or blood products. The inpatient units and operating room accounted for 65% of exposures, and 72% involved direct care employees (nurses 42% and physicians 30%). Hollow-bore needles accounted for 55% of the reported percutaneous injuries. The source patient was identified in 92% of reported BBF exposures and 12% of the source patients tested positive for one or more bloodborne viruses. HIV was detected in 4.5% of source patients, and 38% of source patients infected with HIV were co-infected with HCV. Of the 1,465 HCW exposed to an HIV-positive source, only 63% took PEP. PEP was initiated within 3 hours among 80% of HCW prescribed PEP, and the average duration of adherence was 25 days. Nealry 50% of HCW who took PEP reported an adverse effect. Nausea and malaise/fatigue were the most commonly reported adverse effects at a frequency of 28.6% and 24.1% respectively. [7]     

Despite a large number of reported exposures, the number of occupationally acquired HIV infections among HCW reported to the CDC has been much lower. Between 1985 and 2013, 58 confirmed and 150 possible cases of occupationally acquired HIV infections were reported to the CDC. Only one confirmed case has been reported since 1999. This case involved a laboratory technician working with a live HIV culture in 2008. Nurses accounted for the highest number of confirmed and possible occupationally acquired HIV cases, representing 41.4% and 24.7% of cases, respectively. [8]  More recently, a single center surveillance study of 266 healthcare injures were evaluated to assess HIV seroconversion. Among this cohort, 21.1% of HCP received PEP and none of the HCP exposed to HIV infected fluids seroconverted. [9]

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Modes of Transmission

HIV theoretically may 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 for Transmission

The risk for transmission of HIV after exposure to body fluids from an HIV-infected patient is generally low. [10] 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 for 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 combination antiretroviral therapy (cART), the following risks for HIV transmission were found:

Table 1. Risk for 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 the exposure 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 supply, authority for releasing the drugs, and how the healthcare worker will obtain the PEP medications to complete the 4-week regimen. 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 Bloodborne 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 confirmatory HIV 1/2 Ab differentiation immunoassay. 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 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 is 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 4 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 and has been associated with increased transmissibility in non-occupational exposures. [10] If the source person has been at risk for HIV exposure during the preceding 4 weeks, HIV viral load testing should be performed. 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 woman or person of childbearing age, an immediate pregnancy test should be performed. If HIV PEP is initiated, a baseline CBC, BMP and liver associated enzymes should be obtained.

Timely administration of PEP should not be delayed by drawing blood for laboratory studies. PEP should be initiated as soon as possible, ideally within a few hours and no later than 72 hours after the possible exposure. The sooner the medications are started, the more effective they may be. Decisions regarding initiation of PEP beyond 72 hours postexposure should be made on a case-by-case basis since there is no evidence of PEP efficacy beyond 72 hours. [11]  The New York State Department PEP guidelines do not recommend initiating PEP after 72 hours in any situation since HIV infection may have been established and the risk for viral rebound with inadvertent interruption of cART after 28 days is significant and associated with risk of developing resistance to cART. [1]

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

The Public Health Service (PHS) Guidelines published in 2013 recommend a 3-drug PEP for all exposures owing to the safety and tolerability of current 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 PHS 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. 

Alternative regimens recommended by the PHS: Combine 1 drug or drug pair from the left column with 1 pair of nucleoside/nucleotide reverse-transcriptase inhibitors from the right column; prescribers unfamiliar with these agents/regimens should consult providers familiar with these drugs and their toxicities. 

Table 2. Alternative PEP Regimens (Open Table in a new window)

Anchor Drug Nucleoside/Nucleoside reverse-transcriptase inhibitors 
Raltegravir (Isentress; RAL) Tenofovir DF (Viread;TDF) + emtricitabine (Emtriva; FTC) available as Truvada
Dolutegravir (Tivicay; DTG)*  
Darunavir(Prezista; DRV/ritonavir (Norvir;RTV) Tenofovir DF (Viread; TDF) + lamivudine (Epivir; 3TC)
Etravirine (Intelence, ETR)  
Rilpivirine (Edurant; RPV) Zidovudine (Retrovir; ZDV; AZT) + lamivudine (Epivir; 3TC) available as Combivir
Atazanavir (Reyataz/ATV)/ritonavir (Norvir; RTV)  
Lopinavir/ritonavir (Kaletra; LPR/RTV) Zidovudine (Retrovir; ZDV: AZT) + emtricitabine (Emtriva; FTC)
Elvitegravir/cobicistat/tenofovir DF/emtricitabine (EVG/COBI/TDF/FTC; Stribild); fixed dose regimen  

* Dolutegravir not in the 2013 guidelines, but recommended in 2016 non-occupational exposure guidelines and New York State HIV Guidelines

The 2016 guidelines for antiretroviral postexposure prophylaxis for non-occupational exposure to HIV recommend either raltegravir (RAL) 400 mg twice daily or dolutegravir (DTG) 50 mg daily in combination with tenofovir disoproxil fumarate (TDF) 300 mg and emtricitabine (FTC) 200 mg daily as the preferred regimen in healthy adults and adolescents. [12] Dolutegravir provides a reasonable once-daily alternative to raltegravir. This ART regimen is not in the 2013 postoccupational exposure to HIV guidelines since it was FDA-approved after the PEP guidelines were written but is favored by most authorities.

In May 2018, the CDC and FDA issued guidance to avoid dolutegravir (DTG) based on data from surveillance studies suggesting an increased risk for neural tube defects associated with exposure to dolutegravir (DTG) at conception. [13] Since then, additional data have demonstrated less risk than previously thought. The Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission removed restrictions on the use of DTG in women who are trying to conceive and during the first trimester of pregnancy based on data as of August 2019. [14] In addition, DTG was selected as a preferred antiretroviral medication during pregnancy and as an alternative antiretroviral medication for persons who are trying to conceive. [14] The surveillance data from Botswana revealed a higher prevalence of neural tube defects in infants born to women taking dolutegravir (0.3%; 95% confidence interval [CI], 0.12 - 0.69) compared with other antiretroviral regimens (0.1%; 95% CI, 0.06  - 0.17). [15] In contrast, the same group did not identify any birth defects among 280 infants born to women who initiated DTG after 4 weeks of conception or among 729 infants born to women who initiated DTG in the second or third trimester. [16]

The CDC has not updated their guidance. The CDC still recommends that healthcare providers avoid DTG for PEP in the following patients [13] :

  • Nonpregnant women or people of childbearing potential who are not on an effective birth control method and who are sexually active or who have been sexually assaulted
  • Pregnant women or people who are early in their pregnancy (within the first 28 days)

In these situations, according to CDC guidance, the preferred PEP regimen is raltegravir, tenofovir, and emtricitabine. For situations of intolerability or unavailability of the medications, the National Clinicians’ Postexposure Prophylaxis Hotline (PEPline) should be contacted at 888-448-4911 daily from 9 am to 2 am EST (6 am to 11 pm PST) for alternative PEP options. The Antiretroviral Pregnancy Registry can be contacted at 800-258-4263. [13]

All women or people of childbearing potential should undergo pregnancy testing before initiation of PEP.  A nonpregnant person of childbearing potential who is prescribed dolutegravir should be counseled to use an effective birth control method until they complete the PEP regimen. Pregnant peoples who are exposed to DTG should be monitored for neural tube defects, especially if the exposure occurred during the first trimester. [13]

A 2016 randomized prospective noninferiority study of ritonavir-boosted darunavir (DRV/r) versus the standard of care (SOC) for HIV PEP concluded that DRV/r should be included as a standard component of recommended regimens in PEP guidelines. The recommendation was based on the tolerability and safety profile of DRV/r. [17]

Two recently published studies provide evidence to support tolerabilty and adherence to the fixed-dose regimen of TDF/FTC/elvitegravir/cobicistat (Stribild). Adherence was 92% in the French cohort and 71% in the Boston cohort. [18, 19]  Neither study documented HIV seroconversions, and gastrointestingal side effects were the most common adverese effect reported in both cohorts. This regimen is listed as an alternative regimen for PEP on the The New York State HIV Guidelines. 

Table 2. Information on recommended and alternative HIV medications for PEP [2] (Open Table in a new window)

Drug name

Drug class

Dosing (dosage form)

Advantages

Disadvantages

Atazanavir (Reyataz;ATZ) PI  ATV: 300 mg  RTV: 100 mg once daily (preferred dosing for PEP) 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 capsule Well tolerated

Indirect hyperbilirubinemia and jaundice

Rash

Nephrolithiasis

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

Absorption depends on low pH

PR interval 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 or Cobicistat (COBI)

Dolutegravir

(Tivicay; DTG)

INSTI 50 mg daily; available as a 50-mg tablet

Once daily

Well tolerated

Take without regard for food

Do not use during pregnancy, especially during first trimester; associated with neural tube defects.

Dose adjustment to 50 mg twice daily required if coadministered with rifampin, fosamprenavir/ritonavir, tipranavir/ritonavir or efavirenz. Do not administer with polyvalent cations.

Insomnia, nausea, fatigue, headache, and severe skin and hypersensitivity reactions have been reported.

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

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

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

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

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

 ZDV  has higher rates of treatment-limiting adverse effects. Tolerability is one of the most important factors in completion of the 28-day PEP regimen. 

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 unprotected (condomless/barrier-free, partner not on PEP) sexual intercourse (with an HIV-positive partner), 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, BMP, and liver associated enzymes should be rechecked at 2 and 4 weeks.

Table 3. Monitoring Recommendations After Initiation of PEP Regimens Following Occupational Exposurea [20] (Open Table in a new window)

 

Baseline

Week 1

Week 2

Week 6

Week 16

Clinic visit

√  72 hours

 

 

 

Pregnancy test

 

 

 

 

Serum liver-associated enzymes, BMP, CBC countb

 

 

 

HIV testc

 

 

a See also Hepatitis C and Hepatitis B Immune Globulin (HBIG).

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

c Recommended even if PEP is declined. If a fourth-generation HIV test is not used, the testing schedule should be 6 weeks, 12 weeks, and 6 months.

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 people 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 per the FDA include efavirenz (which is contraindicated in the first trimester), indinavir, and the combination of didanosine and stavudine. According to CDC and FDA guidance, dolutegravir should also be avoided in the first trimester because of concerns regarding an increased risk for neural tube defects. [13] However, it is important to point out that the Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission does not place restrictions on either dolutegravir or efavirenz during pregnancy. [14] Based on increasing clinical experience with ART, PEP is indicated at any time during pregnancy when a significant exposure has occurred. [21]

Individuals 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 human 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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Questions & Answers

Overview

How can the risk of occupational exposure to HIV be mitigated?

What is the postexposure prophylaxis (PEP) regimen for healthcare personnel exposed to HIV?

What is the risk of exposure to body fluids from an HIV-infected patient?

What are the initial management steps for healthcare personnel exposed to HIV?

When should postexposure prophylaxis (PEP) be initiated after occupational exposure to HIV?

What follow-up measures are indicated after postexposure prophylaxis for HIV?

How many total percutaneous HIV exposures occur each year in healthcare workers according to the CDC?

How are healthcare workers exposed to HIV?

How is decontamination performed after occupational exposure to HIV?

How should a healthcare worker who experiences an occupational exposure to HIV report the exposure?

What testing is indicated in the potential source of an occupational HIV exposure?

What testing is indicated in a healthcare worker who has been exposed to HIV?

When should postexposure prophylaxis (PEP) be initiated in occupational exposures to HIV?

When is postexposure prophylaxis (PEP) indicated in occupational exposures to HIV?

What is the recommended postexposure prophylaxis (PEP) regimen for occupational exposure to HIV?

What is the recommended postexposure prophylaxis (PEP) regimen for nonoccupational exposure to HIV?

What follow-up is indicated in a healthcare worker who has been exposed to HIV?

What acute symptoms indicate immediate evaluation in cases of occupational exposure to HIV?

Should postexposure prophylaxis (PEP) be given to pregnant or breastfeeding medical workers who have been exposed to HIV?

What resources are available for healthcare workers who have been exposed to HIV?

What is the risk of transmission of HIV after exposure to body fluids from an HIV-infected patient?

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