For Care Providers
AIDS Education Training Center (AETC):
E-patients.net: Salzburg Statement on Shared Decision Making
New York State Department of Health (NYSDOH):
US Occupational Safety and Health Administration (OSHA):
AIDSinfo: Prevention: Post-Exposure Prophylaxis
Agency for Healthcare Research and Quality (AHRQ): National Guideline Clearinghouse
Centers for Disease Control and Prevention (CDC): NIOSH: Preventing Needlestick Injuries in Health Care Settings
NYC Health: Reporting Diseases and Conditions
New York State (NYS):
New York eHealth Collaborative: NYEC
UCSF Clinician Consultation Center
Phone Consultation: 888-448-4911 (9am – 12am EST, 7 days per week)
AIDSinfo: Drug Database
HIV Clinical Resource:
University of Liverpool: HIV Drug Interactions
UCSF HIV InSite: Database of Antiretroviral Drug Interactions
New York State Department of Health (NYSDOH)
E-patients.net: Salzburg Statement on Shared Decision Making
US Occupational Safety and Health Administration
HIV Clinical Resource
Antiretroviral Agents Recommended for PEP
Updated May 2018
|Dolutegravir (DTG) Safety Statement, updated March 20, 2019|
On December 7, 2018, the DHHS Guidelines Panel issued an update to its prior statement in response to preliminary results from a study that reported increased risk of NTD in babies born to mothers taking DTG-based ART at the time of conception.
Updated data are pending and expected to be released in 2019. Until that time, the Panel’s conservative, interim recommendations remain that DTG-containing regimens should be avoided in the first trimester of pregnancy or in any HIV-exposed individual who may become pregnant. If there are no alternatives to use of DTG for individuals of child-bearing potential, then clinicians should strongly advise the use of effective contraception and should obtain a pregnancy test before initiating treatment.
For pregnant women already taking DTG who present to care in the first trimester of pregnancy, patient-centered counseling should address the risks and benefits of continuing DTG or switching regimens and include the following information:
DTG remains a preferred agent for use in women after the first trimester of pregnancy. Individuals who continue use of DTG after delivery should be counseled regarding possible risk in future pregnancies and should be offered effective, ongoing contraception options.
For more information, see: DHHS Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States
The medications listed below include antiretroviral agents recommended for PEP (tenofovir disoproxil fumarate, emtricitabine, and either raltegravir or dolutegravir) as well as alternative antiretroviral drugs that may be used in the setting of potential HIV resistance, toxicity risks, or constraints on the availability of particular agents. For information on all antiretroviral medications, see Antiretroviral Therapy.
More information about these antiretroviral agents, including dosage and dose adjustment, potential adverse events and drug interactions, and FDA pregnancy categories, can be found through the links included in the table All FDA-Approved HIV Medications. Before using these drugs, package inserts should also be consulted.
Recommended PEP medications:
- Tenofovir disoproxil fumarate (TDF)
- Emtricitabine (FTC)
- Raltegravir (RAL)
- Dolutegravir (DTG)
- Lamivudine (3TC)–equivalent substitute for emtricitabine
Alternative PEP medications:
FDA Pregnancy Categories
A: Adequate and well-controlled studies of pregnant women fail to demonstrate a risk to the fetus during the first trimester of pregnancy (and there is no evidence of risk during later trimesters).
B: Animal reproduction studies fail to demonstrate a risk to the fetus and adequate and well-controlled studies of pregnant women have not been conducted.
C: Safety in human pregnancy has not been determined, animal studies are either positive for fetal risk or have not been conducted, and the drug should not be used unless the potential benefit outweighs the potential risk to the fetus.
D: Positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experiences, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
X: Studies in animals or reports of adverse reactions have indicated that the risk associated with the use of the drug for pregnant women clearly outweighs any possible benefit.
AIDSinfo. Statement on Potential Safety Signal in Infants Born to Women Taking Dolutegravir from the HHS Antiretroviral Guideline Panels. 2018 May 18. https://aidsinfo.nih.gov/news/2094/statement-on-potential-safety-signal-in-infants-born-to-women-taking-dolutegravir [accessed 2018 May 23]
U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq). 2018 May 18. https://www.fda.gov/Drugs/DrugSafety/ucm608112.htm [accessed 2018 May 23]
Defendant Testing Guidance
As of November 1, 2007, New York Criminal Procedure Law § 210.16 requires testing of criminal defendants, indicted for certain sex offenses, for human immunodeficiency virus (HIV), upon the request of the victim.
The NYS Department of Health (NYSDOH) is responsible for issuing guidance for the Court on the following:
- Medical and psychological benefit to the victim
- Appropriate HIV test to be ordered for the defendant
- Circumstances when follow-up testing for the defendant is recommended
- Indications for discontinuation of post-exposure prophylaxis (PEP)
The NYSDOH AIDS Institute’s Medical Care Criteria Committee and the Mental Health Guidelines Committee carefully reviewed the issues involved and developed this guidance through a consensus-based process. As requested, the committees specifically addressed HIV risk; however, the victim’s healthcare provider should also consider risk of transmission of hepatitis B, hepatitis C, and other sexually transmitted infections (STIs). The guidelines on the care of sexual assault victims, PEP for Victims of Sexual Assault, developed by the Medical Care Criteria Committee of the NYSDOH AIDS Institute, include recommendations for the post-exposure management of HIV, hepatitis B, and hepatitis C.
Definitions of Significant Risk and Sexual Assault Exposure
The defendant testing law refers to “significant exposure” as defined by 10 NYCRR § 63.10. PEP for Victims of Sexual Assault offers a definition of significant exposure during sexual assault that warrants assessment of the victim. Both definitions are listed below.
- Significant Risk, as defined by 10 NYCRR § 63.10: Three factors are necessary to create a significant risk of contracting or transmitting HIV infection:
- The presence of a significant-risk body substance and
- A circumstance that constitutes significant risk for transmitting or contracting HIV infection and
- The presence of an infectious source and a noninfected person
- Significant risk body substances: Blood, semen, vaginal secretions, breast milk, tissue, and the following body fluids: cerebrospinal, amniotic, peritoneal, synovial, pericardial, and pleural
- Circumstances that constitute “significant risk of transmitting or contracting HIV infection”:
- Sexual intercourse (e.g., vaginal, anal, oral) that exposes a noninfected individual to blood, semen, or vaginal secretions of an HIV-infected individual
- Sharing of needles and other paraphernalia used for preparing and injecting drugs between HIV-infected and noninfected individuals
- Gestation, birthing, or breastfeeding of an infant when the mother is HIV-infected
- Transfusion or transplantation of blood, organs, or other tissues from an HIV-infected individual to a noninfected individual, provided such blood, organs or other tissues have not tested conclusively [negatively] for antibody or antigen and have not been rendered noninfective by heat or chemical treatment
- Other circumstances not identified in paragraphs 1 through 4, above, during which a significant risk body substance (other than breast milk) of an infected individual contacts mucous membranes (e.g., eyes, nose, mouth), nonintact skin (e.g., open wound, skin with a dermatitis condition, abraded areas), or the vascular system of a noninfected person. Such circumstances include, but are not limited to, needlestick or puncture wound injuries and direct saturation or permeation of these body surfaces by the infectious body substance.
- Circumstances that do not involve “significant risk”:
- Exposure to urine, feces, sputum, nasal secretions, saliva, sweat, tears, or vomitus that does not contain blood that is visible to the naked eye
- Human bites where there is no direct blood-to-blood, or blood-to-mucous membrane contact
- Exposure of intact skin to blood or any other body substance
- Occupational settings where individuals use scientifically accepted preventive practices and barrier techniques in circumstances that would otherwise pose a significant risk, provided that such barriers are not breached and remain intact
The NYSDOH AIDS Institute guideline, PEP for Victims of Sexual Assault defines a significant exposure during “sexual assault” as follows: “Direct contact of vagina, penis, anus, or mouth with semen, vaginal fluids, or blood of the alleged assailant, with or without evidence of physical injury, tissue damage, or presence of blood at the site of the assault.”
Maximizing Medical and Psychological Benefit to the Victim
The guidelines for initiation of PEP for the sexual assault victim DO NOT change from that which is currently recommended in the NYSDOH AIDS Institute guidelines for PEP following sexual assault. The sexual assault victim should be evaluated in an emergency department (ED) as soon as possible for treatment and discussion of PEP. If a significant exposure, as defined above, did occur and the decision is made to initiate PEP, it should be initiated ideally within 2 hours and generally no later than 36 hours from the time of the exposure. Studies have shown that the sooner PEP is initiated, the more likely it is to be effective. A 28-day course of a 3-drug regimen, as outlined in the guideline PEP for Victims of Sexual Assault, should be used for PEP. The victim should receive HIV testing at baseline (within 72 hours of the exposure) and at 4 weeks and 12 weeks post-exposure, even if PEP is declined.
1. Court-Ordered HIV Testing of Defendants: 7 to 30 Days from the Time of the Exposure
|The Medical Care Criteria Committee recommends that a plasma HIV RNA assay should be used in conjunction with a standard HIV-1 ELISA antibody test when the defendant is tested 7 to 30 days from the time of the victim’s exposure.|
- Rationale for the 7- to 30-day time frame: HIV can be detected as early as 7 days when using both a plasma HIV-1 RNA assay and an HIV antigen/antibody screening test. After 30 days from the time of exposure, the victim will have completed the 28-day PEP regimen; therefore, the testing recommendations change because the use of a plasma HIV-1 RNA assay in addition to the antibody test is not medically beneficial. See Court-Ordered HIV Testing of Defendants: 30 Days to 6 Months from the Time of the Exposure, below, for the psychological benefit that may be gained from defendant testing after 30 days.
- Medical benefit for the victim when testing the defendant between 7 and 30 days: The only clear medical benefit for the victim of testing the defendant for HIV would be the discontinuation of PEP to avoid potential toxicity and side effects; for this benefit to be realized, the defendant’s test results would need to be available within the 28-day period for which the PEP regimen is prescribed.
- The medical decision to discontinue PEP on the part of the victim should be made only in full consultation with the victim’s clinician. The victim’s clinician should consult with a clinician experienced in managing PEP before discontinuing the regimen. The NYSDOH AIDS Institute Clinical Education Initiative (CEI) Line (1-888-637–2342) can be used for phone consultation. When using the CEI Line, providers from New York State should identify themselves as such.
- Psychological benefits of defendant testing for the victim: Defendant testing for HIV may have the following psychological benefits for the victim:
- Providing information that may help the victim understand the degree of risk for acquiring HIV
- The comfort of knowing that exposure to HIV is unlikely in those instances when the defendant tests negative on both the HIV antigen/antibody test and plasma HIV RNA assay
- Allowing the victim to participate more fully in the decision of whether to continue or discontinue the PEP regimen
Because the results of the defendant’s test may be the only criterion used to decide to terminate the victim’s PEP regimen, the Committee concluded that it was necessary to exclude the possibility of the defendant being in the acute stage of HIV-1 infection. The acute stage is the stage in which the virus and viral RNA are present in the blood but the person has not developed enough specific antibodies to be detected by an antibody test. An HIV antigen/antibody immunoassay may detect HIV-1 p24 antigen as early as 14 days and will also detect HIV-1 and HIV-2 antibodies produced once seroconversion has occurred. An HIV-1 RNA assay is capable of detecting HIV-1 as soon as 7 days after infection and would establish a diagnosis; therefore, it is important to use both an HIV antigen/antibody immunoassay and a plasma HIV-1 RNA assay when the completion of the victim’s PEP regimen is contingent on the defendant test results. If the HIV antigen/antibody immunoassay is positive, the laboratory should complete the recommended HIV testing algorithm, which includes supplemental testing using an HIV-1/HIV-2 differentiation test (see NYSDOH AI: HIV Testing Guideline). If the defendant is infected with HIV and is on antiretroviral treatment, the HIV-1 RNA may be suppressed below the test’s detection limit.
Negative test results from both the HIV antigen/antibody test and the HIV-1 RNA assay would indicate that the defendant is not infected with HIV and would permit discontinuation of the victim’s PEP regimen. Positive test results for either the HIV antibodies or HIV-1 RNA assay, or both, would indicate that the defendant is infected with HIV and that the victim’s PEP regimen should be completed. When making decisions regarding the management of the victim, the defendant should be considered to be HIV-infected until proven negative. Table 1 outlines the different possibilities of test results, how each result would affect the victim’s PEP regimen, and the necessary follow-up.
|Table 1. Defendant Testing Recommendations: 7 to 30 Days from Time of Sexual Assault|
Tests to obtain: HIV antigen/antibody test (4th generation screening test) and HIV RNA test, either qualitative or quantitative plasma HIV-1 RNA assay. If antibodies are not confirmed, but the HIV-1 RNA assay is positive, the defendant is considered infected and is likely to be in the acute stage of infection.
|Defendant Test Results||Victim PEP||Defendant Retesting and Follow-Up|
|PEP may be discontinued after consultation with physician||
|PEP should be continued||
|PEP should be continued||
||PEP should be continued||
|Inconclusive or invalid results from either the antigen/antibody or RNA test||PEP should be continued||
2. Court-Ordered HIV Testing of Defendants: 30 Days to 6 Months from Time of Exposure
- Medical benefit for the victim when testing the defendant between 30 days and 6 months: There is no medical benefit for the victim when testing the defendant for HIV during the 30-day to 6-month period. If the victim chose to receive PEP, the 4-week PEP regimen will have been completed at this point. If the victim tests negative at 3 months, then HIV transmission by exposure from the assault can be excluded.
- Psychological benefits for the victim when testing the defendant between 30 days and 6 months: Defendant testing for HIV may be mandated by the court for up to 6 months after the assault have the following psychological benefits for the victim:
- Providing information that may help the victim understand the degree of risk for acquiring HIV
- The comfort of knowing that exposure to HIV is unlikely in those instances when the defendant tests HIV negative
|Table 2. Defendant Testing Recommendations: 30 Days to 6 Months from Time of Sexual Assault|
Test to obtain: HIV screening test
|Defendant Test Results||Defendant Retesting and Follow-Up|
|*According to the manufacturer package inserts, the window period for some rapid tests is up to 42 days; therefore, a laboratory-based HIV antigen/antibody test should be used for defendant testing between 30 and 42 days from the time of the assault.|
Responsibilities of the Public Health Officer, County, or State
- Responsibilities to the defendant:
- Provide pretest information
- Obtain appropriate HIV test(s), depending on the timing of testing in relation to when the exposure occurred
- Provide post test counseling
- Responsibilities to the victim:
- Notify the victim of the defendant’s test results
- Instruct the victim to inform his/her healthcare provider of the results and discuss how to proceed with PEP
- Responsibility to the court: Notify the court in writing that the test(s) was performed and the results were shared with victim
- Reminder: Disclosure of confidential HIV-related information shall be made to the defendant upon his or her request. Disclosure to a person other than the defendant will be limited to the person making the application (i.e., the victim). The victim may then disclose the defendant’s HIV test results to the victim’s medical care provider, legal representative, and close family members or legal guardian. The victim may also share the HIV-related information with his or her sex or needle-sharing partners if it is believed that these individuals were exposed to HIV. Victims cannot disclose the defendant’s name during these discussions.
Disclosure shall not be permitted to any other person or the court.