Pep trial 2000


















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. 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.

Other studies have investigated 2-drug PEP regimens and found excellent tolerability [ Kumar, et al. The recommendations for drug choices and dosages presented here follow current U. 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.

The medications listed in Table 5 , below, should be avoided. 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.

ARV prophylaxis can prevent HIV transmission during acute infection in pregnancy, when viral loads are extremely high, which is associated with a high risk of infection to the infant [ Patterson KB, et al.

However, no clinical trial data regarding PEP use in pregnant individuals are currently available [ CDC ], and data are limited on the use of integrase inhibitors during pregnancy [ DHHS ]. Current U. Although birth defects and adverse effects on human fetuses have generally not been associated with the ARV agents that are currently available, exposure of a fetus to ARV agents during pregnancy carries a theoretical risk of embryotoxicity.

Based on animal data, there has been a theoretical concern for teratogenicity of EFV in the first trimester; however, current federal perinatal guidelines do not preclude its use [ DHHS ; Martinez de Tejada, et al. Both HIV and ARV medications may be found in breast milk; therefore, breastfeeding should be avoided for 3 months after the exposure to prevent HIV transmission and potential drug toxicities [ American Academy of Pediatrics ].

Clinicians should discuss the risks and benefits with the patient. Single-tablet regimens: With the availability of several single-tablet regimens, many clinicians prefer them for PEP to optimize adherence or to use commercial medication assistance programs that may be available to uninsured or under-insured individuals. Both cohorts reported gastrointestinal adverse effects as the most common adverse events.

Neither study documented HIV seroconversions. Together, these study results demonstrate that once-daily PEP regimens with multiple pills can be well tolerated and have high completion rates. Many agency guidelines switched first-line recommendations to include RAL as a third agent because it had a more favorable adverse effect profile and fewer drug-drug interactions [ McAllister, et al.

It is rare that PEP is extended beyond the standard day regimen. The only circumstances under which PEP would be extended include the following: The exposed individual has an indeterminate HIV test result at 4 weeks post exposure or is experiencing acute retroviral syndrome at 4 weeks post exposure. The exposed individual is pregnant and there is a high probability of HIV exposure, given the risk of viral rebound in pregnancy.

In these cases, the care provider should consult with an experienced HIV care provider. Otherwise, no data are available to support extending PEP beyond 28 days to prevent HIV infection following an exposure within the previous 28 days. 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.

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. 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. 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.

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.

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. This risk data may provide some reassuring perspective to the parent s or guardian s. Clinicians should include antiemetics in the starter packs for children. Good Practice.

Starter packs may reduce the time to PEP initiation and have been used in several PEP protocols, including emergency department visits following sexual assault [ Kumar, et al. If a day supply of medications cannot be provided, then in most cases, a 7-day supply will allow an individual sufficient time to access the additional medications needed to complete the full course of treatment.

Patients who receive a 7-day starter pack should be informed that it does not contain the full day course of PEP medication and assisted in creating a plan to obtain the rest of the required medications. Federal law requires covered employers to ensure that all medical evaluations and procedures, vaccines, and post-exposure prophylaxis are made available to the employee within a reasonable time, at a reasonable location, and at no cost to the employee OSHA, Federal law: Federal law mandates that employers must ensure that all medical evaluations and procedures, vaccines, and PEP medications 7-day starter pack and access to the full day course of medications are made available to the employee within a reasonable time, at a reasonable location, and at no cost to the employee OSHA, Employers should not expect exposed workers to pay out of pocket for PEP, including copays, even if they are reimbursed at a later date.

Care providers should ensure that a patient can acquire the medications needed to continue PEP through 28 days regardless of insurance coverage status.

Options for patients who are uninsured or under-insured include medication assistance programs MAPs and health centers specifically funded to provide PEP at no or low cost. If a medication-dispensing facility does not receive reimbursement for these services, such expenses may be included in their annual Institutional Cost Report as part of indigent care costs.

For patients who are paying out of pocket, cost is a factor in selecting a regimen. Dolutegravir DTG; Tivicay. Raltegravir RAL; Isentress. Clinicians should work with social workers and support staff to enroll patients in these programs, if indicated, to provide PEP to patients without alternative means of coverage or payment.

These programs often provide 1 course of PEP. Obtaining future courses may be challenging, so clinicians should consider whether pre-exposure prophylaxis is appropriate for patients who receive PEP from a MAP. In New York State, all children qualify for health insurance regardless of their immigration status. Payment difficulties may arise for patients who have private insurance with high medication copays.

Right to decline provision of private health insurance: Under New York State law, hospitals must notify sexual assault patients, orally and in writing, of their right to decline to provide private health insurance information for billing for a forensic rape examination FRE. If a sexual assault patient declines to provide such information, the hospital is prohibited from billing the patient or their insurance company for the FRE. A minor patient may sign the FRE claim form so the facility can seek reimbursement for the sexual assault examination through the FRE program; however, it must be reasonable to conclude that the minor understands what they are signing and why.

Hospitals are required to advise sexual assault patients orally and in writing that they may decline to provide information about private health insurance benefits if they believe that provision of such information will substantially interfere with their privacy or safety. If a sexual assault patient is not insured or is a minor, a full OVS claim application should be filed.

Minors are permitted to sign only the FRE claim form. Reported an exposure for which post-exposure prophylaxis PEP was not indicated following assessment of risk. Engages in risk-taking behaviors, such as unprotected sexual intercourse or intravenous drug use.

Will continue to engage in risk-taking behaviors after completing the day PEP regimen. Initial follow-up within 48 hours: Clinicians should follow up with the exposed individual within 48 hours, either by telephone call or in person, to assess PEP tolerability and adherence and to confirm access to the medications required to complete the full day PEP regimen.

If the patient has difficulty accessing the prescribed PEP medications, a social worker or patient navigator should be engaged to explore options and assist with medication access. Follow-up care is necessary for patients taking PEP medications, to monitor for adverse effects and maximize adherence.

Patients who report adverse effects by telephone should be evaluated in person if they require a physical examination e. If the patient does not tolerate the recommended regimen well, an early switch to an alternative regimen is encouraged to improve adherence. Discuss the best method of contact for any adolescent or young adult who does not wish to disclose HIV exposure to parent s or guardian s and make sure to note the confidential phone number or method of contact.

Adherence support: Follow-up should also include discussions of daily adherence and reminders to complete the full 28 days of PEP.

Ongoing follow-up: After the initial follow-up within 48 hours, a care provider or member of the PEP care team such as a registered nurse, social worker, or patient navigator should follow up with the patient by telephone or in-person visit by week 2 to further assess for adverse effects and confirm access to the medications required to complete the full day course of PEP. Patients who experience intolerable adverse effects may require in-person evaluation by a healthcare provider.

Care providers should pay particular attention to any symptoms suggestive of acute retroviral syndrome. These seroconversions are likely due to ongoing risk behaviors that may have been prevented by repeated courses of PEP or, more suitably, use of PrEP. If a sexual assault patient is too distraught to engage in discussion and decision-making about PEP, then the care provider should encourage the individual to take a single dose of PEP and revisit the discussion the following day.

The risk of taking one dose is minimal, and the efficacy that would be lost if delayed a whole day may be salvaged.

If the individual decides to defer the decision to initiate PEP, then a follow-up visit within 24 hours should be scheduled to ensure that PEP is started as soon as possible and no later than 72 hours post exposure. Resources and support for sexual assault patients: Sexual assault patients may require additional resources and support to ensure adherence to the daily PEP regimen and completion of the day course.

Specific factors in this population may influence the acceptance of PEP. For instance, an analysis of forensic nurse examinations in the Mid-Atlantic region of the United States found that patients with injuries to the anus or genitalia were more likely to initiate PEP than patients with injuries to the face or head [ Draughon Moret, et al.

These data suggest that sexual assault patients may need additional in-person visits or follow-up telephone calls from patient navigators, and social workers, and medical monitoring for adverse effects.

The treating clinician, preferably a sexual assault forensic examiner SAFE , must coordinate care to encourage medical follow-up and adherence to PEP. The rape crisis advocate may become the crucial link between the sexual assault patient and the care provider, clarifying communication and facilitating follow-up care for the patient. When the patient does not have a primary care provider or has difficulty arranging access to a clinician experienced in HIV PEP, this link is especially important.

Support from the advocate increases the likelihood that the sexual assault patient will adhere to the PEP regimen and that the primary care provider, PEP prescriber, or SAFE will be notified of medical problems. The advocate can also ensure that problems are addressed expeditiously as they arise. Review and confirm the decision to complete the full day course of PEP and confirm that the patient has access to required PEP medications.

Assess for and advise on the management of adverse effects associated with PEP medications as needed. Sequential testing at 4 and 12 weeks is recommended even if an exposed individual refuses PEP. During the day PEP treatment period, laboratory tests may be indicated to monitor for adverse effects of treatment. Renal and liver function tests may be repeated during the day follow-up period in the event of abnormal baseline renal or liver function tests grade 1 abnormalities or higher.

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.

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. HIV testing at 6 months after exposure is no longer recommended: Late seroconversion i. 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 day course of PEP. Authors Christine A. Kerr , MD, Lead author. If the HBV vaccine series has been initiated in an exposed individual, the clinician should administer the second and third doses 1 to 2 months and 6 months, respectively, after the first dose for the standard vaccine or 1 month later for the recombinant vaccine see guideline text for more information.

HBIG should be administered as soon as possible post exposure, ideally within 7 days and not later than 14 days, and the HBIG and HBV vaccines should be administered at different sites in the exposed individual. 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. 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.

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. Anti-HBs should be obtained within 1 to 2 months after completion of the last dose of the vaccine. The maximum effective interval for prophylaxis is likely within 14 days for sexual exposure [ Papaevangelou, et al. It should be noted that a brief period of HBsAg positivity, reflecting a false-positive value, can be seen after vaccination [ Rysgaard, et al.

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 ; CDC a ].

Adverse effects of the vaccines, also present at the same rate in placebo, include pain at the injection site and fever [ CDC a ]. 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. In cases of occupational exposure, the risk of HCV infection following a needlestick is 1. 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. 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. 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. 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.

Whether treatment with direct-acting antiviral agents is appropriate will depend upon the individual scenario [ Boerekamps, et al. 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.

The ELISA test is highly sensitive but relatively nonspecific, resulting in a low positive predictive value in low-prevalence populations. Guideline Development and Recommendation Ratings. Turn recording back on. National Center for Biotechnology Information , U. Copyright and Permissions. All Rights Reserved. The use, reproduction, and distribution of original documents and related graphics from this web site is encouraged provided that full credit of source accompanies all uses, in all forms.

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Assessment of exposure, HIV and other baseline testing, and other related activities can proceed after the first dose of PEP is administered. Legal basis and guidance regarding exposure: Public Law federal law. Needle placed in an artery or vein [ Cardo, et al. Presence of blood on needle; however, risk through exposure to dried blood on discarded needles is extremely low [ Zamora, et al.

Receptive anal intercourse: [ Patel, et al. Receptive penile-vaginal intercourse: 8 [ Varghese, et al. Insertive anal intercourse: 11 [ Varghese, et al.

Insertive penile-vaginal intercourse: 4 [ Varghese, et al. Oral sex: Low. Source with high HIV viral load [ Tovanabutra, et al. Sexual Assault Exposure Risk Statistics on sexual assault in the United States show high rates of attempted or completed rape among several populations, including cisgender women, men, children, and transgender individuals: Exposures for which PEP should be considered promptly : Condomless vaginal or anal intercourse during sexual abuse; oral sex with ejaculation or blood exposure during sexual abuse; injuries with exposure to blood from a source known to have HIV; injuries with exposure to blood from a source of unknown HIV status including needlesticks and human bites.

Antiretroviral therapy is recommended for pregnant individuals with HIV and has been used safely during pregnancy [ DHHS ], providing reassurance for its safety profile in pregnant individuals who require PEP. 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. 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.

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. In a 4-country study, 33 cases of occupationally acquired HIV were compared with control subjects.

Case patients were significantly less likely than control subjects to have taken ZDV prophylaxis after exposure, with an odds ratio of 0. 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.

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. Of note, 17 seroconversions occurred among 1, individuals who followed up within the 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.

One systematic review analyzed completion rates among 15 studies 1, initiations of 2-drug PEP regimens and 10 studies 1, 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. When an individual who has been taking pre-exposure prophylaxis PrEP with daily adherence requests PEP following a sexual exposure, clinicians should advise that additional antiretroviral ARV medication for PEP is not warranted in most situations see below for discussion of scenarios in which PEP may be appropriate.

If the source is not available: When the source of a high-risk exposure is not available for HIV testing, clinicians should recommend that the exposed individual complete the day PEP regimen. Box 2 Use of Dolutegravir in Individuals of Childbearing Capacity May Evidence from multiple studies indicates no difference in rates of total birth defects among infants exposed to antiretroviral ARV medications during the first trimester compared with infants exposed later in pregnancy.

Management of the Exposed Site Care of the exposure site should prioritize appropriate cleansing and infection preventive measures and minimize further trauma and irritation to the exposed wound site. When to Consult an Expert Regarding the First Dose of PEP Examples of clinical scenarios that warrant consultation with an experienced HIV care provider include: a source with ARV-resistant HIV, an exposed individual with limited options for PEP medications due to potential drug-drug interactions or comorbidities, or an exposed individual who is pregnant or unconscious.

Use age-appropriate language with children. Clinicians should recommend PEP to individuals reporting sexual assault as follows: A2 — When the exposed individual has experienced direct contact of the vagina, penis, anus, or mouth with the semen, vaginal fluids, or blood of a source, with or without physical injury, tissue damage, or presence of blood. Clinicians should administer the first dose of the human papillomavirus HPV vaccine for individuals aged 18 to 45 years who have not yet been vaccinated.

Clinicians should not routinely perform baseline STI testing of individuals exposed through sexual assault; testing may be offered on a case-by-case basis. Clinicians should provide empiric treatment for gonococcal, chlamydial, and trichomonal infections.

Clinicians should recommend PEP to children reporting sexual assault as follows: A2 — When the exposed child has experienced direct contact of the vagina, penis, anus, or mouth with the semen, vaginal fluids, or blood of an assailant, with or without physical injury, tissue damage, or presence of blood at the site of the assault.

Clinicians should recommend PEP for children who have visible blood from trauma, i. Clinicians should perform baseline STI testing for children who may have been sexually assaulted because they may have experienced long-term, repetitive abuse. Clinicians should provide empiric treatment for gonococcal, chlamydial, and trichomoniasis infections. Clinicians should administer the first dose of the human papillomavirus HPV vaccine for children aged 9 to 17 years who have not yet been vaccinated.

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. Splash of blood, visibly bloody fluid, or other potentially infectious material to the mouth, nose, or eyes. A non-intact skin e. Non-Occupational Exposure Risk Evaluation In many cases of non-occupational exposure, the source is not available for testing.

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. Exposure: Oral-vaginal and oral-anal contact, receptive and insertive; receptive and insertive penile-oral contact, with or without ejaculation. Kissing: Remote risk associated with open-mouthed kissing if blood is exchanged due to sores or bleeding gums [ Kaplan and Heimer ].

Trauma at the site of exposure, especially if there was contact with blood, semen, or vaginal fluids. 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. Counsel sexual assault patients about options for emergency contraception to prevent pregnancy.

Bedsider: Emergency Contraception. 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.

Sexual Assault Victim Bill of Rights. To request a copy of the protocol, call Clinicians should ensure that the evaluation of and treatment for sexual assault of a child is managed by a multidisciplinary team that is experienced in the care of children who have been sexually assaulted. Clinicians should ensure that a Sexual Assault Forensic Examiner who is trained to perform pediatric examinations is included on the team to assist in the medical examination, coordination of care, and discussions about treatment regimen.

If an individual with bleeding in the mouth causes bleeding in someone who they have bitten, the bitten individual is a candidate for PEP. Describe the signs and symptoms of acute retroviral syndrome: Stress the need for immediate medical attention if these symptoms occur, and provide the exposed individual with appropriate access to HIV testing that includes HIV RNA testing if indicated.

Comprehensive evaluation: Identify and assess all specific behaviors that may have resulted in exposure to HIV. High-risk exposure: Provide counseling and educating about risk reduction, including the availability of PrEP. Provide a referral for PrEP care if it is not available on site. See also [ Unger, et al. Clinicians should perform plasma HIV RNA testing in the source if: — The screening test result is nonreactive, but the source reports possible exposure to HIV within the previous 4 weeks e.

A2 — The screening test result is reactive and the confirmatory assay is indeterminate. A3 — If the medical record is not available, clinicians should query the source for this information. Clinicians should perform plasma HIV RNA testing in the source if the screening test result is negative, but the source reports possible exposure to HIV within the previous 4 weeks e.

Box 6 Clinician-to-Clinician Communication Occupational exposure: Communication between clinicians is allowed ; source information may be shared. If the source is deceased, then anonymous testing should be performed. Healthcare proxy and other surrogacy status ends with death. No surrogate is immediately available to consent on behalf of the source: In cases of occupational exposures in which there is significant risk of contracting or transmitting HIV infection, an anonymous HIV test may be ordered without consent of the source if all 4 of the conditions listed below are met.

Expeditious decisions regarding PEP for occupational exposures are essential. The decision to perform anonymous HIV testing of a source may be made immediately if no surrogate is present to provide consent. The source is comatose or is determined by an attending professional to lack the mental capacity to consent.

The source is not expected to recover in time for the exposed individual to receive appropriate medical treatment. There is no individual immediately available who has the legal authority to consent in time for the exposed individual to receive appropriate medical treatment.

Anonymous testing of the source: New York State public health law now allows healthcare providers to order anonymous testing in specific types of occupational exposures, and laboratories are no longer required to have a patient name to perform an HIV test in these cases. A clinician may order an anonymous HIV test only when an occupational exposure involves a source who is deceased, comatose, or otherwise unable to consent and there is no surrogate immediately available.

Patient written authorization for release is not required. If a day course of PEP is indicated: If the exposure is assessed to be high-risk and the exposed individual will complete a day course of PEP, arrange for telephone follow-up within 48 hours to ensure the individual has the medications and to assess for adverse effects. A1 — Rapid oral HIV tests are not recommended due to lack of sensitivity to identify recent infections and requirements regarding food, drink, and tobacco use.

Clinicians should continue PEP in any individual who is suspected to be seroconverting A1 or for whom HIV has not been ruled out at week 4 A2 and should refer the patient to an experienced HIV care provider. If the exposed individual declines to complete the day PEP regimen, the clinician should recommend HIV testing at weeks 4 and 12 post exposure.

A negative baseline HIV test only demonstrates that the exposed individual was not previously infected with HIV before the exposure occurred. Exposed Workers In cases of occupational exposure, exposed workers should be counseled that it is in their best interest to receive a baseline HIV test to document their HIV status at the time of the exposure. When results are available, explain them to the patient and ensure understanding.

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.

Emergency contraception: Offer emergency contraception to individuals of childbearing potential who report sexual exposure. If dolutegravir DTG is prescribed to individuals of childbearing capacity, discuss the small risk of teratogenicity in the first trimester and counsel about the need to use birth control while completing the day PEP regimen; there is no elevated risk beyond the first trimester see Box 2: Use of Dolutegravir in Individuals of Childbearing Capacity.

Clinicians should advise individuals who may have been exposed to HIV to avoid breastfeeding for 3 months after the exposure. A2 — Individuals confirmed to be HIV negative may breastfeed.

Impaired renal function: Review baseline laboratory test results to identify the need to adjust ARV medication dosing for renal insufficiency or choose an alternative regimen.

If day PEP is indicated: Ensure the patient understands the need to complete the full 28 days of PEP and explain the adherence requirements. If possible, provide the day supply of medications. If the full course of medications cannot be provided, then supply a starter pack, as noted below, and a prescription for the medications required to complete 28 days of PEP.

Discuss possible adverse effects of PEP medications. Ensure the patient knows what to do if they experience those effects. 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 day PEP regimen. Poor palatability of liquid medication preparations and high pill burden of some pediatric dose formulations can also affect adherence to the PEP regimen. KEY POINT In addition to the risk of seroconversion for the exposed individual, the high viral load levels associated with early or acute HIV infection markedly increase the risk of transmission to the fetus or breastfeeding infant.

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. Process for evaluating the likelihood that the individual was exposed to HIV and the risk of infection. Purpose of the HIV test and interpretation of results. Other baseline laboratory testing requirements and their purpose.

Follow-up visit and testing schedule and purpose. How and when to take the PEP medications, including timing and food requirements. Prescription for the additional 21 days of PEP: Where and when to get it filled and how to pay for the medications; provide information about sources of payment assistance if needed.

Trauma care: Provide information and a referral if the exposed individual would benefit from counseling or trauma care that addresses, among other issues, fear of HIV infection, and candidacy for PEP.

Risk reduction: Individuals who report ongoing high-risk sexual exposure are candidates for PrEP. Referrals: If the clinical setting in which an individual presents for PEP does not support evaluation for and provision of PrEP, then the patient should be given a referral for PrEP care. Families of children exposed to HIV: In addition to the child exposed to HIV, parent s , guardian s , and other family members may also benefit from trauma care.

A3 If a day supply cannot be provided and if the patient does not have immediate access to a day supply, then clinicians should provide a starter pack as indicated below. Occupational exposure: Clinicians should provide at least a 7-day starter pack of PEP medications to a worker assessed as having a high-risk exposure to HIV.

Non-occupational exposure: Clinicians should provide a 7-day starter pack of PEP medications to an individual assessed as having a high-risk exposure to HIV. Other types of high-risk exposures in children: Clinicians should provide a 7-day starter pack of PEP medications to a child assessed as having a high-risk exposure to HIV.

If a child can take only liquid medications, then a day supply should be provided. A3 — Clinicians should include antiemetics in the starter packs for children. If possible, provide 28 days of PEP medications to all patients. If it is not possible to provide the full course of medications, then a 7-day starter pack is recommended for patients all types of exposures. Payment For Occupational PEP Federal law requires covered employers to ensure that all medical evaluations and procedures, vaccines, and post-exposure prophylaxis are made available to the employee within a reasonable time, at a reasonable location, and at no cost to the employee OSHA, Follow-up: Effective November 27, , hospitals providing treatment to victims of sexual assault are required to provide or schedule an appointment for medical follow-up related to PEP and other care as appropriate.

Candidates for pre-exposure prophylaxis PrEP : Clinicians should recommend or refer for PrEP any individual reporting a non-occupational exposure who: A1 — Reported an exposure for which post-exposure prophylaxis PEP was not indicated following assessment of risk.

Initial and Ongoing Follow-Up Initial follow-up within 48 hours: Clinicians should follow up with the exposed individual within 48 hours, either by telephone call or in person, to assess PEP tolerability and adherence and to confirm access to the medications required to complete the full day PEP regimen. Follow-Up of Sexual Assault Patients If a sexual assault patient is too distraught to engage in discussion and decision-making about PEP, then the care provider should encourage the individual to take a single dose of PEP and revisit the discussion the following day.

KEY POINT Sexual assault patients may need focused encouragement and support from clinicians and other care providers to initiate PEP and to adhere to the medication regimen for 28 days when it is indicated.

Follow up in person or by telephone within 48 hours to accomplish the following: — Assess for signs or symptoms of acute HIV. Make referrals or arrangements for follow-up care as needed, including referral to an experienced HIV care provider if needed. If ongoing exposure risk is high: Counsel and educate the patient about risk reduction, including the availability of PrEP.

Plan for follow-up care: Review the plan for follow-up care with the patient and with a rape crisis counselor or outreach worker who will follow the patient after discharge from the emergency department or other healthcare setting. Empiric STI treatment: Confirm that empiric treatment for gonorrhea, chlamydia, and trichomonas was given at the initial presentation. After obtaining a baseline HIV test within 72 hours of exposure, clinicians should obtain sequential confidential HIV testing of the exposed individual at 4 and 12 weeks post exposure, using a U.

Clinicians should initiate the HBV vaccine series in non—HBV-immune individuals who are exposed to HBV in blood or bodily fluid, with the first dose administered during the initial evaluation. Clinicians should not delay the decision to vaccinate while testing for hepatitis B surface antibody anti-HBs for patients who are known to be non-immune or whose serostatus is unknown. Clinicians should administer prophylactic hepatitis B immune globulin HBIG and initiate the HBV vaccine series in an individual exposed to blood or bodily fluid from a source with known acute or chronic HBV infection if the immune status of the exposed individual is unknown or non-immune.

Ideally, clinicians should administer the first dose of the HBV vaccine [ a , b ] within 24 hours of exposure, and HBIG should be administered [ b ] as soon as possible, ideally within 7 days. If the source is at high risk of HBV infection [ c ], then clinicians should proceed as if the source is HBsAg-positive A3 ; if the source is negative, then no further action is necessary. HBV: 1. The 3-dose vaccine e. Enter the email address you signed up with and we'll email you a reset link.

Need an account? Click here to sign up. Download Free PDF. PEP trial The Lancet, Ander Cohen. A short summary of this paper. PEP trial. Moreover, the risk of Department of Medicine for the Elderly, Finchley immediately after orthopaedic surgery? Prevention of aspirin in the long-term prophylaxis of patients on both heparin and aspirin pulmonary embolism and deep vein VTE after orthopaedic surgery. However, thrombosis with low dose aspirin: Pulmonary there is no need.

Lancet ; — Trial Collaborative Group. Prevention of thromboembolism up to 35 days after Despite the PEP trial, aspirin is not pulmonary embolism and deep vein hip surgery or arthroplasty. Median follow-up was 2. Overall, patients assigned to placebo and assigned to perindopril reached the primary endpoint HR 0. By 1 year, reductions in the primary outcome HR 0.



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