Purpose and Use of This Guideline

This guideline was developed by the New York State Department of Health (NYSDOH) AIDS Institute (AI) for healthcare practitioners in any medical setting (e.g., emergency department, sexual health clinic, urgent care clinic, inpatient unit primary care practice) who manage the care of individuals who request post-exposure prophylaxis (PEP) after a possible exposure to HIV. Despite the availability of prevention measures, exposures occur that pose the risk of transmission. Fortunately, with rapid initiation of PEP, infection can be blocked. Preventing new HIV infections is crucial to the success of New York State’s Ending the Epidemic Initiative.

HIV transmission can be prevented through use of barrier protection during sex (e.g., latex condoms), safer drug injection techniques, and adherence to universal precautions in the healthcare setting. HIV infection can also be prevented with use of antiretroviral (ARV) medications taken as pre-exposure prophylaxis (PrEP). After an exposure has occurred, HIV infection can be prevented with rapid administration of ARV medications as PEP. The first dose of PEP should be administered within 2 hours of an exposure (ideal) and no later than 72 hours after an exposure.

In addition to clinical recommendations, this guideline details selected good practices and highlights laws and legal considerations that are pertinent in delivering PEP care.

Goals: This guideline aims to achieve the following goals:

• Prevent HIV infection in individuals who experience a high-risk exposure.
• Reinforce that HIV exposure is an emergency that requires rapid response, with immediate administration of the first dose of PEP medications.
• Reduce under- and over-prescribing of PEP by describing the benefits of PEP and providing guidance for identifying high-risk HIV exposures for which PEP is indicated.
• Ensure prescription of PEP regimens that are effective and well tolerated.
• Assist clinicians in recognizing and addressing challenges to successful completion of a PEP regimen.
• Detail the baseline testing, monitoring, and follow-up that should accompany prescription of a 28-day course of PEP.
• Assist clinicians in managing potential concurrent exposures to hepatitis B virus (HBV) and hepatitis C virus (HCV).

How to use this guideline: This guideline is organized to support rapid location of key topics, such as when to initiate PEP, how to evaluate whether continuation of PEP is necessary based on specific risk factors, source testing, how to choose and prescribe a PEP regimen, and recommendations for follow-up care for exposed individuals.

The NYSDOH AI Medical Care Criteria Committee recommendations for prescribing PEP are based on a comprehensive review of available published evidence. In formulating recommendations for NYS, this Committee balanced the strength of published evidence regarding efficacy and timing of initiation of the PEP regimen. See the Guideline Development and Recommendation Ratings for a description of the development and ratings processes.

Risk of Infection Following an Exposure to HIV

Factors that increase the risk of transmission: Many factors that contribute to HIV infection are shared by the 4 PEP scenarios outlined below. HIV transmission risk depends on the viral load of the source with HIV and the type of exposure [Sultan, et al. 2014]. Factors that increase the risk of HIV transmission include early- and late-stage untreated HIV infection and a high level of HIV RNA in the blood [Cardo, et al. 1997], the presence of genital or anorectal ulcers from sexually transmitted infections (STIs), and direct blood-to-blood exchange, such as syringe sharing during injection drug use [Wall, et al. 2017; Mayer and Venkatesh 2011; Johnson and Lewis 2008; Blank 2005; Kaplan and Heimer 1992].

Factors that decrease the risk of HIV transmission: Similarly, across the 4 PEP scenarios, there are shared factors that decrease the risk of HIV infection. HIV transmission risk is low and often negligible when the source of the exposure has a low or undetectable viral load [Rodger, et al. 2019; Rodger, et al. 2016] and is lower if the source is circumcised (if a cis-gender male and the circumcision is healed) [Bailey, et al. 2007; Gray, et al. 2007; Auvert, et al. 2005] or is taking antiretroviral medications as pre-exposure prophylaxis (PrEP) [Baeten, et al. 2012; Grant, et al. 2010]. In the context of sexual exposure, there is a robust body of evidence that individuals do not sexually transmit HIV if they are taking antiretroviral therapy (ART) and have an undetectable viral load (HIV RNA <200 copies/mL); see NYSDOH AI U=U Guidance for Implementation in Clinical Settings. Data are insufficient to make recommendations regarding HIV transmission via breastfeeding.

Rationale for PEP and Evidence of PEP Effectiveness

Authors

Post-exposure prophylaxis (PEP) has been established to effectively prevent HIV infection in an exposed individual when initiated within 2 hours (ideal) and no later than 72 hours after an exposure. Rapid and effective response to a reported HIV exposure are key to the successful prevention of HIV infection.

PEP blocks viral replication: After percutaneous or mucosal exposure to HIV, local replication of virus occurs in tissue macrophages or dendritic cells (see Figure 1, below). However, if infection cannot be contained at this stage, it is followed within 48 to 72 hours by replication of HIV in regional lymph nodes. Viremia then follows within 72 to 120 hours (3 to 5 days) of virus inoculation.

This sequence of events carries significant implications. Given the rapid appearance of productively-infected cells following the introduction of virus, PEP regimens with the most rapid onset of activity, multiple sites of antiviral action, and greatest potency are likely most effective.

Evidence of PEP effectiveness: Evidence of PEP effectiveness has been derived primarily from animal model studies and extrapolated from clinical trials of ARV prophylaxis to prevent perinatal transmission of HIV.

Evidence from animal models: Animal studies demonstrate time-dependent efficacy of PEP within 72 hours of exposure, with excellent efficacy reported if initiated within 36 hours [Otten, et al. 2000; Tsai, et al. 1998].

• In a recent study, infected mice injected intraperitoneally with fluorescently labeled HIV-1 had no detectable plasma p24 or HIV-1 RNA when treated with raltegravir 1 day post infection. Ten mice that were not treated and became positive for plasma p24 and HIV-1 RNA and developed swollen lymph nodes in the peritoneal cavity [Ogata-Aoki, et al. 2018].
• A systematic review and meta-analysis identified 16 studies that specifically assessed the efficacy of PEP (N = 180) compared with controls (N = 103). A pooled analysis of all animal studies reported the risk of seroconversion was 89% lower among primates exposed to PEP than among controls [Irvine, et al. 2015].
• In macaques exposed to HIV intravaginally, PEP initiated at 12 and 36 hours post exposure prevented infection; however, breakthrough plasma viremia was observed in some animals when PEP was initiated 72 hours post exposure [Otten, et al. 2000].
• SIV infection was prevented in macaques treated 24 hours post exposure with ARV medications as PEP (short-term 9-[2-(R)-(phosphonomethoxy)propyl]adenine); half of the subjects that received PEP at 48 and 72 hours post exposure developed infection [Tsai, et al. 1998].

Figure 1

Sequence of Events Following HIV Exposure, With and Without Administration of Post-Exposure Prophylaxis (PEP).

Evidence from human studies: A limited number of case-control studies and clinical trials have established PEP effectiveness in humans.

• Occupational exposure: In a Centers for Disease Control and Prevention (CDC) retrospective case-control study of zidovudine (ZDV) use after occupational HIV exposure in healthcare workers, the risk of HIV infection was reduced by 81% in those who received ZDV [Cardo, et al. 1997]. In a 4-country study, 33 cases of occupationally acquired HIV were compared with 665 control subjects. Case patients were significantly less likely than control subjects to have taken ZDV prophylaxis after exposure, with an odds ratio of 0.19 [Cardo, et al. 1997].
• Since 1999, only 1 confirmed case of occupationally acquired HIV has been reported to the CDC [Joyce, et al. 2015]. In this case, a laboratory technician sustained a needle puncture while working with concentrated HIV cultures, which is a very high-risk scenario.
• PEP following needle sharing and transfusion: No specific studies currently address PEP use and its efficacy among individuals who inject drugs and share needles, and no data are currently available regarding HIV transmission via needle sharing when the source has an undetectable viral load.

  –

  Retrospective analyses of PEP do include small numbers of participants with injection drug use as a risk factor and did not report PEP failures among this group [McDougal, et al. 2014; Kahn, et al. 2001].

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  One case report demonstrated PEP effectiveness for a 12-year-old girl with sickle cell disease who received 4-drug PEP with tenofovir, emtricitabine, ritonavir-boosted darunavir, and raltegravir after a blood transfusion and exposure to the blood of a donor who had an HIV viral load of 9,740 copies/mL [Al-Hajjar, et al. 2014].

Evidence from studies of seroconversion with PEP use after sexual exposure: Observational cohorts have provided some data about seroconversion rates among PEP users and possible risk factors among seroconverters.

• A retrospective study analyzed all non-occupational PEP courses prompted by sexual exposure at a California health center to determine factors associated with seroconversion within 24 weeks of initiating PEP. The incidence rate of HIV infection was 2.3/100 person-years. Of note, 17 seroconversions occurred among 1,744 individuals who followed up within the 24-week period; of these 17 seroconversions, 7 had re-exposure risks, 8 had condom-protected sex only, and 2 reported abstinence from sex following the exposure for which they received PEP. In a multivariate analysis, significant predictors of seroconversion included methamphetamine use, incomplete PEP medication adherence, and time from initial exposure to PEP dose >48 hours but <72 hours [Beymer, et al. 2017].
• One systematic review analyzed completion rates among 15 studies (1,830 initiations) of 2-drug PEP regimens and 10 studies (1,755 initiations) of 3-drug PEP regimens. Although the failure rate as determined by HIV seroconversion could not be compared because events overall were rare and protocols for follow-up were not uniform, the data underscore the value and effectiveness of PEP initiation [Ford, et al. 2015].

PEP following sexual assault of children and adolescents: One study reported that in an inner-city pediatric emergency department in an area with high HIV prevalence, PEP was offered to 87 survivors of sexual assault who qualified for the intervention. Of those 87 children, only 5.7% were provided with PEP, but 69% were given antibiotic prophylaxis to prevent sexually transmitted infections other than HIV [Fajman and Wright 2006]. The reasons for such a low number (5 children) of PEP initiations were not provided. Among those who did receive PEP, there was no record of seroconversions, but 2 of those patients were lost to follow-up. The study had many limitations.

First Dose of PEP and Management of the Exposure Site

Exposure Risk Evaluation

Occupational Exposure Risk Evaluation

PEP is indicated whenever an occupational exposure to blood, visibly bloody fluids, or other potentially infectious material occurs through percutaneous or mucocutaneous routes or through non-intact skin. Figure 2, below, illustrates the steps in determining whether ongoing PEP is indicated after the first emergency dose.

Occupational exposures for which PEP is indicated include the following:

• Break in the skin by a sharp object (including hollow-bore, solid-bore, and cutting needles or broken glassware) that has been in the source’s blood vessel or is contaminated with blood, visibly bloody fluid, or other potentially infectious material.
• Bite from a patient with visible bleeding in the mouth that causes bleeding in the exposed individual.

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  PEP is not indicated for an exposure to saliva, including from being spat on, in the absence of visible blood.

• Splash of blood, visibly bloody fluid, or other potentially infectious material to the mouth, nose, or eyes.
• A non-intact skin (e.g., dermatitis, chapped skin, abrasion, or open wound) exposure to blood, visibly bloody fluid, or other potentially infectious material.

Evaluation for other bloodborne pathogens: See the following sections of this guideline: Management of Potential Exposure to Hepatitis B Virus and Management of Potential Exposure to Hepatitis C Virus.

Figure 2

Occupational HIV Exposure: Post-Exposure Prophylaxis (PEP) and Exposure Management When Reported Within 72 Hours. Abbreviation key: Ag/Ab, antigen/antibody; CrCl, creatinine clearance; HBV, hepatitis B virus; HBsAg, hepatitis B surface antigen; HCV, hepatitis (more...)

Non-Occupational Exposure Risk Evaluation

In many cases of non-occupational exposure, the source is not available for testing. The HIV status of the source should not be the focus of the initial evaluation; determination of whether the exposure warrants PEP and, when indicated, prompt initiation of PEP, should be the focus. Figure 3, below, illustrates the steps in determining whether ongoing PEP is indicated after the first emergency dose.

KEY POINTS

• The decision to recommend PEP is based on the nature of the exposure and not on the geographic location at which an assault occurred or the location of the source’s or the exposed individual’s residence.
• When an individual presents for PEP, evaluation and PEP services should be delivered in combination with patient education, with a strong emphasis on prevention of future exposures [Golub, et al. 2008].

  • For more information on pre-exposure prophylaxis (PrEP), see the NYSDOH AI guideline PrEP to Prevent HIV and Promote Sexual Health.

Risk of transmission: Box 1: Risk per 10,000 Exposures of Acquiring HIV From an Infected Source and Factors That Increase Risk, above, provides the risk of HIV infection following various types of non-occupational exposure to an individual known to have HIV and factors that may increase risk. HIV transmission occurs most frequently during sexual or drug use exposures; however, many factors can influence risk.

Exposure to a source with acute HIV: Due to the presence of high HIV viral load levels, the probability of transmission when the source is in the acute and early stage of HIV infection (first 6 months) is 8- to almost 12-fold higher than it is once a source’s viral set point has been established, typically about 6 months after infection [Wawer, et al. 2005; Pilcher, et al. 2004]. The presence of STIs in either the source or the exposed individual also increases risk of HIV transmission [CDC 2017; Johnson and Lewis 2008; Advisory Committee for HIV and STD Prevention 1998]. Conversely, transmission risk with sexual exposure is significantly decreased when a source is taking effective antiretroviral therapy (ART) and has an undetectable viral load [Cohen, et al. 2011] (see NYSDOH AI U=U Guidance for Implementation in Clinical Settings).

Box 4, below, lists non-occupational exposures that should prompt consideration of PEP and those that do not warrant PEP.

Box 4Non-Occupational Exposure Risks and Indications for Post-Exposure Prophylaxis (PEP)

Higher-Risk: PEP is Recommended:

• Receptive and insertive vaginal or anal intercourse [^a].
• Needle sharing [^a].
• Penetrating injury, such as a needlestick with a hollow-bore needle, with exposure to blood or other potentially infected fluids [^a].
• Bite with visible bleeding in the mouth that causes bleeding in the exposed individual.

Lower-Risk: Assess Factors that Increase Need for PEP:

• Exposure: Oral-vaginal and oral-anal contact, receptive and insertive; receptive and insertive penile-oral contact, with or without ejaculation.
• Factors that increase risk: 1) Source is known to have HIV with high viral load. 2) Non-intact oral mucosa, e.g., oral lesions, gingivitis, wounds. 3) Blood exposure—may be minimal and not recognized by the exposed individual; if frank blood exposure is reported, then PEP is indicated. 4) Presence of genital ulcer disease or other sexually transmitted infections.

PEP is Not Indicated [^b]:

• Kissing: Remote risk associated with open-mouthed kissing if blood is exchanged due to sores or bleeding gums [Kaplan and Heimer 1992].
• Oral-to-oral contact in the absence of mucosal damage, e.g., mouth-to-mouth resuscitation.
• Human bites not involving blood.
• Exposure to solid-bore needles or sharps not in recent contact with blood: Examples of solid-bore needles include tattoo needles and lancets used to measure blood-sugar levels.
• Mutual masturbation without skin breakdown or blood exposure.
• Exposure to saliva, including if spat on, in the absence of visible blood.

a

Source is known to have HIV or source’s HIV status is not known.

b

See also NYSDOH AI U=U Guidance for Implementation in Clinical Settings.

A frank discussion between the clinician and an exposed individual regarding sexual activities, needle sharing, and other drug-using activities that have the potential for exposure to blood and other body fluids can help determine a patient’s need for PEP (see Boxes 1 and 4). The behaviors that confer the highest risk are needle sharing and receptive unprotected anal intercourse with an individual who has HIV [Varghese, et al. 2002; CDC 1997; DeGruttola, et al. 1989].

Clinicians should also assess factors that have been associated with increased risk of HIV infection, including:

• Trauma at the site of exposure, especially if there was contact with blood, semen, or vaginal fluids.
• Presence of genital ulcer disease or other STIs [CDC 2017; LeGoff, et al. 2007].
• High plasma viral load in a source with HIV [Patterson BK, et al. 2002; Tovanabutra, et al. 2002].
• Exposure in an uncircumcised male [Bailey, et al. 2007; Gray, et al. 2007; Patterson BK, et al. 2002].

Factors that may significantly decrease transmission of HIV include exposure to a source who is taking effective ART (see NYSDOH AI U=U Guidance for Implementation in Clinical Settings) or use of daily PrEP and use of condoms during sexual exposures [Weller and Davis 2002]. After consensual sexual exposures that meet NYSDOH U=U Guidance criteria in the source, there is no evidence to support the use of PEP by the exposed individual. Furthermore, there is no evidence that a 3-drug PEP regimen provides any additional benefit to an exposed individual who adheres to a daily PrEP regimen; consistent use of PrEP has been shown to be 99% effective when taken appropriately (see the NYSDOH AI guideline PrEP to Prevent HIV and Promote Sexual Health > PrEP Efficacy). Correct condom use is highly effective in preventing transmission of HIV; however, during the post-exposure evaluation, it often is not possible to reliably ascertain whether condoms were used correctly or whether breakage, slippage, or spillage occurred.

Evaluation for exposure to STIs other than HIV: Risk behaviors leading to HIV infection also confer risk or exposure to other STIs. Patients who present for PEP after a consensual sexual exposure should be evaluated for other STIs.

Baseline testing generally cannot detect STIs that were acquired as a result of the exposure, but it may detect infections present prior to the exposure that prompted the evaluation for PEP. Presentation for PEP provides an opportunity to screen individuals at risk of STIs and treat infections as indicated. High rates of concomitant STIs at the time of presentation for PEP have been found in men who have sex with men [Jamani, et al. 2013; Hamlyn, et al. 2006].

Routine empiric treatment for STIs is not recommended for consensual sexual exposures. Education about STI symptoms should be provided, and patients should be instructed to call their healthcare provider if symptoms occur. Follow-up STI screening should be considered at 2 weeks post exposure to definitively exclude STIs [Mayer, et al. 2017; McAllister, et al. 2017; Oldenburg, et al. 2015; Annandale, et al. 2012; Mayer, et al. 2012; Tosini, et al. 2010; Mayer, et al. 2008].

Evaluation for other bloodborne pathogens: See the following sections of this guideline: Management of Potential Exposure to Hepatitis B Virus and Management of Potential Exposure to Hepatitis C Virus.

Emergency contraception: For individuals who can but who do not desire to become pregnant, and who consent, emergency contraception should be initiated immediately. There are a range of methods (copper intrauterine device, levonorgestrel, and ulipristal acetate) that can be taken within 5 days of a sexual exposure. Of note, emergency contraception is not an abortifacient and will generally not disrupt an ongoing healthy pregnancy. For more information, see Bedsider: Emergency Contraception.

Figure 3

Non-Occupational HIV Exposure: Post-Exposure Prophylaxis and Management When Reported Within 72 Hours. Abbrevlatlons: Ag/Ab, antigen/antibody; CrCl, creatinine clearance; CT/GC NAAT, chlamydia/gonorrhea nucleic acid amplification testing; HBV, hepatitis (more...)

Sexual Assault Exposure Risk Evaluation

The decision to recommend PEP to an individual who may have been exposed to HIV through sexual assault should not be based on the geographic location of the assault but rather on the nature of the exposure during the assault and the HIV status of the defendant, if known. Although the seroprevalence of HIV in different New York State communities may vary, the HIV status of an individual accused of sexual assault remains unknown until that individual has been tested.

KEY POINTS

• The decision to offer PEP should be based on evaluation of the exposure, not on the perceived or assumed risk behavior of a defendant or the geographical location.
• If a significant exposure has occurred during an assault, then PEP should be recommended.

Risk of HIV transmission: The risk of HIV transmission in sexual assault is greater due to the presence of genitorectal trauma, which may be present in as many as 50% to 85% of sexual assault patients [Sommers, et al. 2012; Jones, et al. 2009; Sachs and Chu 2002]. Studies on sexual assault document high rates of unprotected receptive anal intercourse (10% to 15%) and unprotected vaginal penetration (55% to 80%) [Draughon Moret, et al. 2016]. Studies also demonstrate a wide range (20% to 85%) of incidence of anogenital trauma [Larsen, et al. 2015; Laitinen, et al. 2013; Sugar, et al. 2004; Grossin, et al. 2003; Jones, et al. 2003; Riggs, et al. 2000]. In one study, 1% of men convicted of sexual assault in Rhode Island had HIV when entering prison [Di Giovanni, et al. 1991], higher than the general male population (0.3%).

The absence of visible trauma does not rule out sexual assault; microabrasions and bruising are common, and the appearance of these manifestations following sexual assault may be delayed. Oral trauma may also occur during sexual assault, with potential exposure to blood, semen, or vaginal fluids from the defendant, which may carry a potential risk for HIV exposure. Bites or trauma may be inflicted during an assault and are indications for prophylaxis if there is the possibility of contact with blood, semen, or vaginal fluids from the defendant. A bite from a source with visible bleeding in the mouth that causes bleeding in the exposed individual is an indication for PEP.

HIV testing of the sexual assault patient should be performed in the emergency department setting. HIV testing may be performed on excess blood specimens obtained in the emergency department for other reasons, but only if informed consent has been obtained. In the absence of a baseline HIV test result, it may not be possible to establish that the assault resulted in HIV infection if the patient is later confirmed to have HIV.

If PEP is initiated, then responsibility for monitoring and follow-up should be coordinated by the treating clinician. If the baseline screening HIV test is reactive, then the assault patient should continue the PEP regimen until the result is confirmed with a differentiation immunoassay or HIV RNA and linkage to care with an experienced HIV care provider has been made. If the patient is not under the care of a primary care clinician, the emergency department clinician who has obtained the HIV test is responsible for ensuring that the patient is informed of the result promptly. If HIV infection has been diagnosed, the PEP regimen may be altered by the HIV care provider or continued in this case as ART.

Every hospital that provides emergency treatment to a sexual assault patient must adhere to and fully document services provided, consistent with the following standards of professional practice and Public Health Law 2805-P:

• Counsel sexual assault patients about options for emergency contraception to prevent pregnancy. Prompt access improves efficacy.
• Provide sexual assault patients with written information about emergency contraception that has been prepared or approved by the NYSDOH.
• Consider a urine pregnancy test to diagnose unplanned pregnancy, similar to STI screening in individuals who may be at risk. Inform the individual that a pregnancy test is being performed.

The following websites offer more information about the use of emergency contraception:

• Bedsider: Emergency Contraception
• Emergency Contraception: What You Need to Know

NEW YORK STATE LAW

• If a sexual assault exposure is assessed as high-risk:

  • Provide a 7-day starter pack of medications if the patient is ≥18 years old.
  • Provide the full 28-day course of PEP medications if the patient is <18 years old.
  • Arrange a follow-up appointment with an experienced HIV care provider.
  • If the sexual assault patient is not able to make a timely decision about PEP, provide a starter pack and arrange for a follow-up appointment within 24 hours to review indications for PEP.
• Notify the sexual assault patient, verbally and in writing, of their right to decline to provide private health insurance information for billing for a forensic rape examination.

STI prophylaxis: Clinicians should offer all sexual assault patients prophylactic medication to prevent gonorrheal and chlamydial infections and trichomoniasis. Rates of STIs have increased in all populations in the United States through a combination of increased incidence of infection and changes in diagnostic, screening, and reporting practices. Surveillance data for the United States indicate that between 2014 and 2018, rates increased for chlamydia (by 19%), gonorrhea (by 64%), primary and secondary syphilis (by 71%) and congenital syphilis(by 185%) [CDC 2019a, 2018]. Trichomoniasis can be diagnosed or excluded in the emergency department if microscopy is available; otherwise, empiric treatment should be administered.

In cases of sexual assault, routine testing for gonorrhea, chlamydia, and syphilis is not recommended because test results would only determine whether the patient had an STI prior to the assault, and this information can be used to bias a jury against a survivor of sexual assault in court [NYSDOH 2020].

Evaluation for exposure to HBV: See guideline section Management of Potential Exposure to Hepatitis B Virus.

Evaluation for exposure to HCV: See guideline section Management of Potential Exposure to Hepatitis C Virus.

RESOURCES

• NYSDOH Sexual Violence Prevention Program
• NYSDOH Rape Crisis Programs by County
• Domestic and Other Violence Emergencies (DOVE) at New York-Presbyterian/Columbia University Medical Center
• NYC Anti-Violence Project
• New York State Coalition Against Sexual Assault and New York City Alliance Against Sexual Assault
• Sexual Assault Victim Bill of Rights

Figure 4, below, illustrates the steps in determining whether ongoing PEP is indicated after the first emergency dose.

Figure 4

Sexual Assault HIV Exposure: Post-Exposure Prophylaxis and Exposure Management When Reported Within 72 Hours. Abbreviations: Ag/Ab, antigen/antibody; ART, antiretroviral therapy; HBV, hepatitis B virus; HCV, hepatitis C virus; STI, sexually transmitted (more...)

Source HIV Status and Management

In many cases of non-occupational exposure, the source is not available for testing. The HIV status of the source should not be the focus of the initial evaluation; determination of whether the exposure warrants PEP and, when indicated, prompt initiation of PEP, should be the focus.

If the source is NOT available: When the source of any potential exposure to HIV is not known, not available, or cannot be HIV tested for any reason, the care provider should assess the exposed individual’s level of risk, assume the source has HIV until proven otherwise, and respond accordingly.

Determining whether the exposure warrants PEP and promptly initiating PEP when indicated should be the focus at initial presentation, rather than the HIV status of the source.

If the source IS available-test for HIV: When the source is available and consents to HIV testing, use of a 4th-generation HIV-1/2 antigen/antibody (Ag/Ab) combination immunoassay is recommended, preferably with a fast turn-around time. Results from point-of-care (POC) assays are available in less than 1 hour, and results from laboratory-based screening tests are often available within 1 to 2 hours. Rapid oral testing is not recommended due to lack of sensitivity to identify recent infection and requirements regarding food, drink, and tobacco use.

When obtaining HIV testing in the source of a potential HIV exposure, consideration must be given to the source’s risk of HIV acquisition in the 4 weeks prior. During this period, often referred to as the “window period” of the 4th-generation HIV Ag/Ab assay, an initial HIV screening test may be nonreactive. If the source has engaged in condomless sexual intercourse (insertive or receptive anal, penile-vaginal) with or without pre-exposure prophylaxis (PrEP), or has shared intravenous needles or syringes with or without PrEP, then the source should also be tested for acute HIV infection with an HIV-1 RNA assay (qualitative or quantitative). Please note, only the qualitative HIV-1 RNA assay is U.S. Food and Drug Administration (FDA)-approved for aid in diagnosis of HIV.

PEP initiation should not be delayed; the first dose of PEP medications should be administered to the exposed individual before HIV testing and exposure evaluation. Only after the first dose of PEP has been administered should the source’s HIV serostatus, HIV exposure history, and other HIV-related information be evaluated to determine whether to continue PEP.

The most sensitive screening tests available should be used to allow for detection of early or acute HIV infection. The Centers for Disease Control and Prevention (CDC) and this Committee recommend screening with an FDA-approved 4th-generation Ag/Ab combination immunoassay, followed by confirmation with an FDA-approved HIV-1/HIV-2 Ag/Ab-differentiation assay (see the NYSDOH AI guideline HIV Testing and the CDC’s Recommended Laboratory HIV Testing Algorithm for Serum or Plasma Specimens).

Source with confirmed HIV: If the source is known to have HIV, information about their viral load, ART medication history, and history of ART drug resistance should be obtained, when possible, to assist in the selection of a regimen if PEP is indicated [Beltrami, et al. 2003]. Administration of the exposed individual’s first emergency dose of PEP should not be delayed while awaiting this information.

When a sexual exposure to a source with HIV occurs, the exposed individual may discontinue PEP if the source is taking ART and has an undetectable viral load at the time of exposure. In that scenario, providing information about U=U to the exposed individual and may be reassuring. However, if an exposed individual requests PEP, it should not be denied (see NYSDOH AI U=U Guidance for Implementation in Clinical Settings).

Informed consent: If the source is available and has an unconfirmed HIV status, then consent for voluntary HIV testing should be sought as soon as possible after the exposure. Clinicians should follow individual institutional policies for obtaining consent for HIV testing of the source. In New York State, when the source has the capacity to consent to HIV testing, that individual should be informed that HIV testing will be performed unless the source objects.

If the source objects, the care provider should inform the source that an HIV exposure may require the exposed individual to take medications to prevent infection, and the results of the source’s HIV test could help determine the duration of the exposed individual’s treatment. This information may encourage the source to agree to testing. However, if the source continues to refuse, then HIV testing cannot be performed.

HIV testing in the source of an occupational exposure: If a source does not have the capacity to consent, consent may be obtained from a surrogate, or anonymous testing may be performed if a surrogate is not immediately available (see Box 7, below). Clinicians should follow individual institutional policies for obtaining consent.

HIV testing in the source of a non-occupational exposure when the source is taking PrEP: If the source is taking PrEP, then plasma HIV RNA testing should be performed if the 4th-generation HIV Ag/Ab test is negative, as is recommended for other groups at high risk (such as a source who reports possible exposure to HIV within the previous 4 weeks through sex or needle sharing). A negative viral load test will provide reassurance that the source is adherent to PrEP and allow the clinician and the exposed individual to rely on more than just the verbal report of the source.

HIV testing in the source of a sexual assault exposure: In most instances, the HIV status of the assailant will not be known and cannot be available in sufficient time to influence the decision to initiate PEP. If the HIV status of the defendant is established and confirmed, that knowledge should guide the decision to initiate or continue PEP; if the drug resistance data are available for a defendant with HIV, then that information can be used to tailor the PEP regimen. A negative HIV status of a defendant can determine whether the sexual assault patient should complete the 28-day PEP regimen; discontinuing unnecessary PEP has medical and psychological benefits. See NYSDOH Guidance for HIV Testing of Sexual Assault Defendants for more information.

As of November 1, 2007, New York State Criminal Procedure Law § 210.16 requires testing of criminal defendants indicted for certain felony sex offenses for HIV, upon the request of the victim. For guidance on defendant testing, please visit NYS Court-Ordered HIV Testing of Defendants. Information regarding interpretation of HIV tests can be found in the CDC’s Recommended Laboratory HIV Testing Algorithm for Serum or Plasma Specimens.

The increased risk of HIV transmission can be attributed to risk behavior profiles of the defendant, who engage in high-risk behaviors [Klot, et al. 2013].

Confirmed defendant HIV status: If the defendant is confirmed to have HIV, then information about the defendant’s viral load, ART medication history, and history of ART drug resistance should be obtained, if possible, to assist in selection of a PEP regimen [Beltrami, et al. 2003]. Administration of the first emergency dose of PEP should not be delayed while awaiting this information.

HIV status of defendant is unknown or unconfirmed: Even if the individual reporting sexual assault knows the defendant, assumptions about HIV status or risk should have limited influence on the decision to initiate PEP. Familiarity with the defendant may influence the patient’s perception of risk and their decision to accept PEP. Because HIV risk behaviors and status may be hidden from close friends and family, decisions based on familiarity with the defendant should be made cautiously. It is not possible to know whether a defendant has HIV infection solely by risk behaviors. Categorical judgments should not be made on perceived risk. The decision to offer PEP should be based on whether significant exposure has occurred during the assault rather than on the risk behavior of the defendant.

Baseline Testing of the Exposed Individual

Authors

Baseline HIV testing of the exposed individual identifies individuals who were already infected with HIV at the time of presentation (see Table 1, below). Results may inform decision-making regarding initiation of ART as treatment for established infection or initiation of 28 days of PEP to prevent HIV infection (see the NYSDOH AI guideline When to Initiate ART, With Protocol for Rapid Initiation).

An initial reactive screening result must be confirmed with an HIV differentiation immunoassay, and the PEP regimen should be continued until that result is obtained. Furthermore, the PEP regimen should be continued as rapid ART initiation if the reactive result is confirmed with a differentiation immunoassay or HIV-1 RNA, and the exposed individual should be referred to an experienced HIV care provider.

Baseline Testing of Exposed Individuals

Table 1

Baseline Testing Based on Age of Exposed Individual and Type of Exposure.

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SELECTED GOOD PRACTICE REMINDERS

ALL EXPOSURES Test results: Perform baseline HIV testing of the exposed individual. When results are available, explain them to the patient and ensure understanding. If HIV infection is confirmed in the exposed individual: Explain the benefits of rapid initiation of ART and provide a referral for HIV care. ART initiation: Rapid initiation of ART is recommended for all patients diagnosed with HIV. See the NYSDOH AI guideline When to Initiate ART, With Protocol for Rapid Initiation. Arrange for HIV care: If HIV infection is confirmed, or if seroconversion is suspected, or if HIV infection cannot be ruled out, then refer the exposed individual for HIV care and rapid initiation of ART. Pregnancy testing: Perform pregnancy testing in all individuals of childbearing capacity. Sexually transmitted infections (STIs) other than HIV: Provide counseling about the risk of acquiring other STIs through sexual exposure and information on signs and symptoms of STIs, and stress the need to seek medical attention if symptoms occur. – Sexual assault exposures: See U.S. Department of Justice. A National Protocol for Sexual Assault Medical Forensic Examinations Adults/Adolescents Second Edition. 2013. NCJ 228119. – See NYSDOH Sexual Assault Victim Bill of Rights. Emergency contraception: Offer emergency contraception to individuals of childbearing potential who report sexual exposure. SEXUAL ASSAULT EXPOSURES Undetectable equals untransmittable (U=U): Research has established that a source with HIV who is taking ART and has an undetectable viral load (HIV RNA <200 copies/mL) at the time of a consensual sexual (only) exposure will not transmit the virus through sex [Rodger, et al. 2019; Cohen, et al. 2016; Rodger, et al. 2016]. If the source’s viral load at the time of a sexual exposure is available: Offer information about U=U as reassurance for the exposed individual. U=U pertains only to consensual sexual exposure: It does not apply to exposure through needle sharing, breastfeeding, or needlestick injury.

Selecting and Initiating a 28-Day Course of PEP

Preferred PEP Regimens for Patients Who Weigh ≥40 kg

The medications that comprise the recommended PEP regimens (and substitutions) listed in Table 2: Preferred Post-Exposure Prophylaxis Regimen for Patients Who Weigh ≥40 kg, below, have favorable adverse effect profiles, fewer potential drug-drug interactions, and expected efficacy similar to older PEP regimens that contained ZDV or PIs. Researchers have reported increased rates of adherence and regimen completion when TDF/FTC or TDF/3TC have been used as components of the PEP regimen [Tosini, et al. 2010; Mayer, et al. 2008]. Observational cohorts and 1 small randomized study reported improved tolerability with TDF/FTC plus RAL [McAllister, et al. 2017; Annandale, et al. 2012; Mayer, et al. 2012]. Additionally, TDF/FTC has been highly successful in recent studies of pre-exposure prophylaxis [Baeten, et al. 2012; Thigpen, et al. 2012; Grant, et al. 2010]. One observational cohort demonstrated high completion rates with TDF/FTC plus DTG [McAllister, et al. 2017].

Unlike PIs, which block HIV replication after integration with cellular DNA, all currently recommended medications (TDF/FTC plus DTG or RAL) act before viral integration with cellular DNA, providing a theoretical advantage in preventing establishment of HIV infection.

KEY POINT

• ZDV is not recommended for PEP in adults: This committee no longer recommends the use of ZDV in PEP regimens for adults. ZDV confers no advantage in expected efficacy over TDF, and it has significantly higher rates of treatment-limiting adverse effects. Tolerability is one of the most important factors in completion of the 28-day PEP regimen. ZDV is still recommended for prevention of perinatal HIV transmission.

Table 2

Preferred Post-Exposure Prophylaxis Regimens for Patients Who Weigh ≥40 kg [,].

Alternative PEP Regimens for Patients Who Weigh ≥40 kg

Table 3, below, lists 2 alternative PEP regimens that are acceptable options when a preferred regimen is not available. They are possibly less well tolerated than the preferred regimen of TDF/FTC plus RAL or DTG, but they are significantly better tolerated than regimens containing ZDV or lopinavir/ritonavir (LPV/RTV). Observational studies have demonstrated excellent tolerability and completion rates [Mayer, et al. 2017; Fätkenheuer, et al. 2016; Valin, et al. 2016].

A single-tablet regimen for a patient with adequate kidney function (CrCl >70 mL/min) and no expected drug-drug interactions may be a good option for those who prefer a once-daily, single-tablet PEP regimen. It also allows use of medication assistance programs if a patient has limited medication coverage options.

Drug-drug interactions: The potential for drug-drug interactions in patients receiving PIs or cobicistat (COBI) is increased due to the extensive cytochrome P450 interactions. Clinicians should assess for potential interactions before prescribing a PEP regimen.

Table 3

Alternative Post-Exposure Prophylaxis Regimens for Patients Who Weigh ≥40 kg [,].

KEY POINT

• Call the Clinical Education Initiative (CEI Line) to speak with an experienced HIV care provider regarding PEP: 1-866-637-2342 (press “1” for HIV PEP). The CEI Line is available 24/7.

Other alternative PEP regimens: Other alternative PEP regimens may be acceptable in certain situations. Some clinicians continue to favor the use of ZDV in PEP regimens based on the results of a retrospective study supporting the efficacy of the agent [Cardo, et al. 1997] and from long-term experience in occupational PEP. Clinicians who continue to prescribe ZDV should recognize and inform patients that the drug is associated with significant adverse effects and that better tolerated agents are available.

Use of LPV/RTV has greater potential for drug-drug interactions and adverse effects than RAL, DTG, or DRV/r (the preferred alternative boosted PI), with little added efficacy benefit expected. Studies have demonstrated decreasing PI resistance among HIV strains [Paquet, et al. 2011], suggesting there may be a diminishing benefit to choosing LPV/RTV for its activity against resistant HIV strains. DRV/r has excellent activity against many PI-resistant strains and is better tolerated than LPV/RTV.

This Committee recommends a 3-drug regimen because of the greater likelihood of enhanced effectiveness; however, if tolerability is a concern, use of a 2-drug regimen would be preferred to discontinuing the regimen completely. An early case-control study of occupational exposure demonstrated an 81% reduction in seroconversion with the use of ZDV monotherapy alone [Cardo, et al. 1997], suggesting that treatment with any active ARV agent is beneficial in reducing risk. Other studies have investigated 2-drug PEP regimens and found excellent tolerability [Kumar, et al. 2017; Mayer, et al. 2008].

PEP Regimens for Patients Who Weigh <40 kg

Authors

Pediatric PEP lead author: Aracelis Fernandez, MD, Lisa-Gaye Robinson, MD, and Ruby Fayorsey, MD.

No clinical studies are available to determine the best regimens for HIV PEP in children. The recommendations for drug choices and dosages presented here follow current U.S. Department of Health and Human Services recommendations in Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, which are based on expert opinion. The recommended regimens reflect experience with ARV combinations that effectively suppress viral replication in children with HIV and with combinations that are well tolerated and increase adherence to PEP. The chosen preferred regimens have demonstrated good potency and tolerability.

The alternative PEP regimens for children are also based on expert opinion. They all have demonstrated potent antiviral activity. However, the PI-containing regimens are often more difficult to tolerate, secondary to gastrointestinal adverse effects. To improve adherence, clinicians can and should prescribe preemptive antiemetics for anticipated gastrointestinal adverse effects.

When choosing a PEP regimen, care providers should consider factors that may affect adherence, such as ARV drug intolerance, regimen complexity, expense, and drug availability.

Table 4

Post-Exposure Prophylaxis Regimens for Patients 2 to 12 Years Old Who Weigh <40 kg [a].

KEY POINTS

• A systematic review of several studies that included ARV medications used as PEP in children exposed to HIV and of antiretroviral therapy (ART) for children with HIV reported a 4.5% rate of discontinuation due to adverse events [Penazzato, et al. 2015].
• Limited data exist on dosing or safety for some ARV agents, including INSTIs, used in children.
• Poor palatability of liquid medication preparations and high pill burden of some pediatric dose formulations can also affect adherence to the PEP regimen.

ARV Medications to Avoid for PEP

Newer ARV medications have demonstrated significantly fewer adverse effects than older ARVs. The medications listed in Table 5, below, should be avoided.

Table 5

Antiretroviral (ARV) Medications to Avoid for Post-Exposure Prophylaxis.

Consultation with an experienced HIV care provider is recommended before using any of the medications listed above for PEP, or before using etravirine or doravirine, for which limited data exist.

Counseling and Patient Education

The checklist in Box 8, below, includes topics for patient education for an individual exposed to HIV who has presented for post-exposure prophylaxis (PEP) or for the parent(s) or guardian(s) accompanying a child who is being evaluated for or initiated on PEP.

Information about serial HIV testing: Clinicians should educate the exposed individual about the “window period” of HIV infection and the importance of serial HIV testing to avoid a false-negative result during the early stages of infection. A negative baseline HIV test does not confirm negative status, so further testing at 4 and 12 weeks post exposure can determine seroconversion in any exposed individual, whether PEP is taken or not.

Clinicians should arrange appropriate medical follow-up for the exposed individual, particularly if an emergency department performed the initial evaluation and treatment. Appropriate medical follow-up includes access to a care provider in the event of possible PEP-related adverse effects or symptoms suggestive of acute retroviral syndrome (ARS). Toward that end, the exposed individual should be provided with a telephone number to reach an outpatient medical facility that can provide treatment within 24 hours to address adverse effects or to evaluate for ARS.

Symptoms of acute HIV infection: Inform exposed individuals about the possible symptoms of acute HIV:

• Influenza- or mononucleosis-like illness
• Fever and night sweats
• Lymphadenopathy
• Myalgias
• Arthralgias
• Sore throat Fatigue or malaise
• Headache
• Generalized rash
• Mucocutaneous ulcers
• Meningismus
• Oropharyngeal candidiasis

For additional information, see the NYSDOH AI guideline Diagnosis and Management of Acute HIV > Acute Retroviral Syndrome.

Because of the similarity of acute HIV infection to influenza- or mononucleosis-like illnesses, the exposed individual should be encouraged to seek medical attention if these symptoms develop, regardless of PEP use. The exposed individual should also be educated about the high risk of HIV transmission during acute HIV infection.

Adherence to the PEP regimen: Education about adherence should stress the need to take all doses of PEP medications as directed and to complete the 28 days of PEP unless otherwise directed. Make sure the patient understands that of a dose of PEP medications is missed, a “double-up” dose is not necessary. Instead, if dose is missed at a specific time, it can be taken as soon as it is remembered within 24 hours of the scheduled time.

Risk reduction: Individuals who present with potential HIV exposures as a result of ongoing engagement in risk behavior should be referred for pre-exposure prophylaxis (PrEP). See the NYSDOH AI guideline PrEP to Prevent HIV and Promote Sexual Health.

An individual’s intent to change behavior should be assessed, and an individualized risk-reduction plan should be developed. After completion of the 28-day PEP regimen, initiation of PrEP should be considered.

Occupational risk reduction: To decrease the risk of future exposures, employers are required to provide education regarding the prevention of needlestick injury at the time of hire and annually thereafter. Each institution should have internal protocols consistent with current state and federal laws.

Information for an exposed child and family: A potential HIV exposure in a child is likely to be an emotionally challenging situation for the family. Care providers should assess the health literacy of the parent(s) or guardian(s) and provide information at the appropriate level of understanding. Information should include risk of HIV acquisition based on type of exposure (see guideline section Risk of Infection Following an Exposure to HIV). This risk data may provide some reassuring perspective to the parent(s) or guardian(s). Emphasize that when PEP is initiated within the 72 hours following HIV exposure, failure is rare.

Providing PEP Medications and Other Services

XI. Follow-Up of the Exposed Individual

Sequential HIV Testing and Laboratory Monitoring

Authors

During the 28-day PEP treatment period, laboratory tests may be indicated to monitor for adverse effects of treatment. The timing and specific testing indicated varies based on the PEP regimen used (see Table 6: Recommended Monitoring After Post-Exposure Prophylaxis Initiation, below).

Renal and liver function tests may be repeated during the 28-day follow-up period in the event of abnormal baseline renal or liver function tests (grade 1 abnormalities or higher). In one New York City PEP cohort, only 32 individuals (2.9%) and 95 individuals (8.5%) had abnormal renal function or liver function tests at baseline [Mikati, et al. 2019]. Follow-up testing found mostly grade 1 abnormalities, and no PEP regimens were changed because of renal function or liver function abnormalities. Repeat renal and liver function testing is advised for patients with decreased urine output, abdominal pain, nausea, vomiting, jaundice, or diarrhea.

Repeat sexually transmitted infection (STI) screening for non-occupational PEP following sexual exposure should also be considered at week 2 to assess for possible bacterial STI infection at the time of the potential HIV exposure, which would not have been detected with baseline testing. Screening should include chlamydia, gonorrhea, syphilis, and trichomoniasis if symptoms are present.

Sequential HIV testing (beyond the baseline): If HIV is transmitted during an exposure, seroconversion will generally occur within 2 to 4 weeks [Joyce, et al. 2015; Cardo, et al. 1997; Ciesielski and Metler 1997]. HIV testing at baseline, 4 weeks, and 12 weeks is recommended for all individuals who experience a high-risk exposure, even if PEP is declined.

Recommended HIV test: Point-of-care HIV tests in general are slightly less sensitive than laboratory-based HIV tests; therefore, exposed individuals should be tested with laboratory-based HIV tests whenever possible. A 4th-generation HIV Ag/Ab combination test is the recommended serologic screening test. Point-of-care HIV tests that are antigen/antibody tests are acceptable for follow-up testing.

HIV testing at 6 months after exposure is no longer recommended: Late seroconversion (i.e., after 3 months) is rare [Ciesielski and Metler 1997; Ridzon, et al. 1997] but has occurred after completion of PEP [Terzi, et al. 2007]. It is unclear whether these rare events were related to the original or subsequent exposures. This Committee believes that because of the infrequency of late seroconversion and the increased sensitivity of standard HIV tests to detect early infection and seroconversion, the benefit of routinely testing all exposed individuals for HIV at 6 months after exposure is outweighed by the added anxiety and significant consequences of an additional 3 months of precautions and testing for exposed individuals.

Laboratory monitoring: Table 6 includes recommended laboratory monitoring for patients who initiate a 28-day course of PEP. Serial HIV testing is recommended even if a patient declines PEP.

Table 6

Recommended Monitoring After Post-Exposure Prophylaxis Initiation.

Management of Potential Exposure to Hepatitis B Virus

Authors

Risk of HBV transmission: The risk of HBV transmission from an occupational exposure is significantly greater than the risk of HIV transmission and ranges from 1% to 31% depending on the presence of hepatitis B e antigen (HBeAg), which is a marker of active replication [Schillie, et al. 2013].

Average risk of HBV transmission after needlestick (compared with HIV) [Schillie, et al. 2013; CDC 2001a]:

• HBV: 1.0% to 31.0%.

  –

  HBeAg+: 22% to 31%.

  –

  HBeAg-: 1.0% to 6.0%.

• HIV: 0.3%.

Factors that may increase the risk of sexual transmission include degree of viremia in the source, sex with multiple partners, history of sexually transmitted infections (including HIV), or any disruption of mucous membranes.

Any area exposed to blood or bodily fluid, including via needlestick, should be washed with soap and water as soon as possible after exposure. No data are available to suggest that the use of bleach or other antiseptic agents reduces transmission [Schillie, et al. 2013].

HBV vaccine: When considering PEP for HBV exposure, evaluation of both the source’s HBsAg status and the exposed individual’s vaccination status is necessary (see below). Even if the risk of exposure to HBV is not deemed significant, HBV vaccination is advised for all non-HBV-immune individuals. Household, sex, and needle sharing contacts of HBsAg-positive individuals should be identified and vaccinated according to the guidelines for patients exposed to known HBsAg-positive individuals, and the source should be referred for evaluation and treatment of HBV infection.

Both the first dose of the HBV vaccine and, if indicated, HBIG should be administered as soon as possible after HBV exposure. The HBV vaccine should be administered within 24 hours post exposure, and HBIG should be administered within 7 days (ideally) and not later than 14 days post exposure.

• The 3-dose vaccine (e.g., Recombivax-HB, Engerix-B) is administered at 0, 1 to 2, and 6 months.
• The 2-dose vaccine (e.g., Heplisav-B) is administered at day 0 and 1 month later.
• Hepatitis A vaccination can be combined with hepatitis B (e.g., Twinrix) in a 3-dose series.

Anti-HBs should be obtained within 1 to 2 months after completion of the last dose of the vaccine.

• See the Centers for Disease Control and Prevention (CDC) Vaccine Recommendations on Hepatitis B and American Academy of Pediatrics Care of the Adolescent After an Acute Sexual Assault [Crawford-Jakubiak, et al. 2017].

Initiation of the HBV vaccine series within 12 to 24 hours post exposure has been demonstrated to be 70% to 90% effective in preventing HBV infection [Schillie, et al. 2013]. The combination of vaccine and HBIG achieves a similar level of efficacy [Perrillo, et al. 1984; Redeker, et al. 1975]. Among known nonresponders to vaccination, one dose of HBIG is 70% to 90% effective in preventing HBV when administered within 7 days of percutaneous HBV exposure [Weinbaum, et al. 2003; Beasley, et al. 1983]. The maximum effective interval for prophylaxis is likely within 14 days for sexual exposure [Papaevangelou, et al. 1988; Roumeliotou-Karayannis, et al. 1986; Perrillo, et al. 1984; Szmuness, et al. 1980; Redeker, et al. 1975]. It should be noted that a brief period of HBsAg positivity, reflecting a false-positive value, can be seen after vaccination [Rysgaard, et al. 2012].

Pregnant women can safely receive both the HBV 3-dose vaccine series and HBIG. However, to date, there are no data available on the use of the newer 2-dose vaccine in pregnant patients, children, or patients on hemodialysis. Both the standard 3-dose vaccine and immunoglobulin are thought to be safe for both adult and pediatric patients; the 2-dose vaccine is not approved for patients younger than 18 years [FDA 2017; CDC 2001a]. Adverse effects of the vaccines, also present at the same rate in placebo, include pain at the injection site and fever [CDC 2001a]. HBIG is also safe for administration; there is no history of transmission of viral hepatitis or HIV through HBIG because the viruses are screened, inactivated, and eliminated during production of HBIG. Although anaphylactic reactions to HBIG or other immunoglobulin preparations are rare, if a patient does have a history of anaphylaxis after receipt of immunoglobulin, HBIG should not be given.

Table 7: Recommended Post-Exposure Prophylaxis for Hepatitis B Virus Exposure, below, shows indicated treatment for individuals exposed to HBV, based on the status of the source. For the most current information regarding HBV post-exposure management, please refer to the CDC Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices.

Table 7

Recommended Post-Exposure Prophylaxis for Hepatitis B Virus [].

Management of Potential Exposure to Hepatitis C Virus

Authors

Risk of HCV transmission: The risk of transmission of HCV is significantly greater than the risk of HIV transmission after bloodborne exposure. In cases of occupational exposure, the risk of HCV infection following a needlestick is 1.8%, whereas the risk of HIV infection is 0.3% [Beltrami, et al. 2000]. The risk of HCV transmission from a single mucous membrane exposure is negligible, except when the potential exposure is through receptive anal intercourse.

Factors that may increase the risk of sexual transmission include sex with multiple partners, history of sexually transmitted infections (including HIV), or any other practice that might disrupt mucous membranes (e.g., fisting or use of sex toys).

The following activities carry risk of HCV transmission:

• Blood-to-blood contact, including through sharing of personal care items, such as razors or toothbrushes, that may have been exposed to another individual’s blood; occupational needlestick injuries; and sharing needles, syringes, intranasal straws, or other equipment to inject or inhale drugs.
• Sexual activity, particularly anal receptive intercourse.
• Receipt of blood, plasma, organs, tissue, or semen.
• Perinatal transmission.

HCV is not spread via food or water and is not transmitted by:

• Sharing of eating utensils.
• Hugging, kissing, or holding hands.
• Coughing or sneezing.
• Breastfeeding: HCV is not transmitted by breastfeeding; however, HCV is spread by infected blood. Therefore, if the HCV-positive mother’s nipples and/or surrounding areola are cracked and bleeding, she should stop nursing temporarily.

  –

  Clinicians should advise women who may have been exposed to HIV to avoid breastfeeding for 3 months after the exposure (see guideline section Selecting and Initiating a 28-Day PEP Regimen > PEP During Pregnancy or Breastfeeding).

HCV testing of source: If the source is tested for HCV antibody and found to be positive, follow-up testing is necessary to confirm the source’s status. HCV RNA may be used as the confirmatory test. If the source tests positive with an HCV RNA test, the exposed individual should be managed as if the source has chronic HCV. If the source patient has recent risks for new HCV acquisition or the risk is unknown, consider nucleic acid amplification testing (NAAT) for HCV RNA as an initial test.

Figure 5

Evaluation of Hepatitis C Virus Exposure Risk and Recommended Follow-Up.

PEP for HCV: Currently, research has identified no effective prophylaxis for HCV infection. Immunoglobulin and antiviral agents are not recommended for HCV PEP. However, if an individual becomes acutely infected with HCV and is diagnosed at that time, immediate referral to a clinician experienced in the treatment of HCV is strongly recommended. Currently, the best regimen or duration of therapy for acute HCV is unknown, even with the availability of direct-acting HCV antiviral therapy. Patients should be managed according to genotype, liver disease progression, and history of previous HCV treatment, if any (see the NYSDOH AI guideline Treatment of Chronic HCV with Direct-Acting Antivirals).

Observation for a period of 8 to 12 weeks post infection is reasonable to assess for possible spontaneous resolution of acute HCV [Ghany, et al. 2009], and clinical trials are underway to assess the value of treatment with direct-acting antivirals for acute HCV infection. Whether treatment with direct-acting antiviral agents is appropriate will depend upon the individual scenario [Boerekamps, et al. 2019; Chromy, et al. 2019; Naggie, et al. 2019].

Follow-up: For individuals who are exposed to a source with HCV, regular follow-up with HCV RNA testing is recommended in addition to HCV antibody testing. HCV RNA testing can identify acute infection within 2 weeks of exposure, whereas the antibody test may not provide an accurate result for up to several months after acute infection (i.e., during the “window period”). Seroconversion with the enzyme-linked immunosorbent assay (ELISA) antibody test occurs in 50% of patients who are infected within 9 weeks of exposure, in 80% of patients within 15 weeks of exposure, and in at least 97% of patients within 6 months of exposure [CDC 2001a]. The ELISA test is highly sensitive but relatively nonspecific, resulting in a low positive predictive value in low-prevalence populations. Positive HCV ELISA antibody test results require confirmation by a quantitative viral load assay, such as an HCV polymerase chain reaction assay. This Committee recommends linking exposed patients to HCV care for monitoring and assessment for treatment (see the NYSDOH AI guideline Treatment of Chronic HCV with Direct-Acting Antivirals).

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Supplementary Materials

Employer Responsibilities in PEP Management to Prevent HIV Infection Following an Occupational Exposure

Services for Sexual Assault Patient