Goals
This guideline on diagnosis and management of acute HIV infection was developed by the Medical Care Criteria Committee of New York State Department of Health AIDS Institute (NYSDOH AI) to guide clinicians in NYS who provide ambulatory, inpatient, and emergency medical care for adults ≥18 years old who present with signs or symptoms of acute HIV infection or report an exposure within the past 4 weeks.
This guideline provides evidence-based clinical recommendations for the diagnosis and treatment of acute HIV infection in adults, with the goals of ensuring that NYS clinicians are able to:
Recognize the risks for and signs and symptoms of acute HIV, include HIV infection in the differential diagnosis, and consider HIV testing in any person who presents with signs and symptoms suggestive of influenza (“flu”), mononucleosis (“mono”), or other viral syndromes, including suspected COVID-19.
Perform appropriate diagnostic and confirmatory testing when HIV infection is suspected and manage the treatment of acute HIV.
Meet the NYS requirements for reporting and partner notification.
Recommend or offer immediate initiation of antiretroviral therapy (ART) to improve the patient’s health and reduce the risk of HIV transmission; refer and confirm that patients can access optimal HIV care.
Initiate or refer the patient for prevention services.
TERMINOLOGY
Acute HIV infection: Describes the period immediately after infection with HIV when an individual is viremic and has detectable p24 antigen or has HIV RNA without diagnostic HIV antibodies. In the medical literature, “primary HIV infection” may describe this same period.
Recent infection: Generally used to describe the
6-month period after infection occurs.
Early infection: May refer to acute or recent
infection, after which infection is defined as chronic.
Early diagnosis for early treatment: Accumulating evidence supports a decision to begin HIV treatment at the time of diagnosis [Lundgren, et al. 2015]. Initiation of ART during acute infection may have several beneficial clinical outcomes, including improved preservation of immunologic function, significantly reduced time to viral suppression, and reduction of the viral reservoir, which could be important for cure strategies [Pires, et al. 2004; Streeck, et al. 2006; Koegl, et al. 2009; Hocqueloux, et al. 2010; Ananworanich, et al. 2012; Buzon, et al. 2012; Lafeuillade, et al. 2012; Margolick, et al. 2012; Phanuphak, et al. 2012; Le, et al. 2013; Saez-Cirion, et al. 2013; Pilcher C, et al. 2015]. The risk of sexual transmission of HIV during acute or recent infection is significantly higher than during chronic infection [Pilcher CD, et al. 2004; Hollingsworth, et al. 2008; Pinkerton 2008; Hollingsworth, et al. 2015]; this difference likely correlates with high levels of viremia and is consistent with other routes of transmission [Bellan, et al. 2015]. The public health benefit of early ART initiation is well documented, with a significant reduction of HIV transmission among virally suppressed individuals. Further, in September 2017, the NYSDOH endorsed the consensus from the Prevention Access Campaign that Undetectable = Untransmittable (“U = U”), which indicates that individuals with a durable (≥6 months) undetectable viral load will not sexually transmit HIV [NYSDOH 2017; Prevention Access Campaign 2018].
Recognizing and diagnosing acute HIV infection is crucial to linking patients to care early and presents an important opportunity to reduce HIV transmission. Factors that may contribute to the increased risk for transmission during acute infection include:
Hyperinfectivity associated with both markedly high viral load levels (often much greater than 10 million viral copies/mm
3) and increased infectiousness of the virus [
Quinn, et al. 2000;
Ma, et al. 2009].
For many reasons, detecting acute HIV infection is an essential link in the chain of prevention. Evidence demonstrates that patients with a recent diagnosis of HIV are more likely to reduce risk behaviors if they are given counseling at the time of testing [Steward, et al. 2009; Fonner, et al. 2012] and are linked to primary HIV care [Metsch, et al. 2008]. In addition, for those who elect to initiate ART, their risk of transmission is significantly diminished [Cohen, et al. 2011; Cohen, et al. 2016].
KEY POINTS
HIV is highly transmissible during acute infection; rapid
initiation of antiretroviral therapy (ART) reduces
transmission, with significant public health benefits, and
early viral suppression preserves immune function, with
significant clinical benefits for the individual with
HIV.
Acute HIV often has nonspecific signs and symptoms and often
goes unsuspected and undetected. This committee urges a high
index of suspicion for acute infection and HIV testing for
any individual who reports recent high-risk behavior or
presents with signs or symptoms of influenza, mononucleosis,
or other viral syndromes.
When HIV infection is diagnosed, immediate linkage to care is
essential; ART dramatically reduces HIV-related morbidity
and mortality, and viral suppression prevents HIV
transmission.
The urgency of ART initiation is even greater if the newly
diagnosed patient is pregnant, has acute HIV infection, is
≥50 years old, or has advanced disease. For these patients,
every effort should be made to initiate ART immediately,
ideally on the same day as diagnosis.
All clinical care settings should be prepared, either on-site
or with a confirmed referral, to support patients in
initiating ART as rapidly as possible after diagnosis.
When a diagnosis of acute HIV infection is made, clinicians
should discuss the importance of notifying all recent
contacts and refer patients to partner notification
services, as mandated by
New York
State Law. The NYSDOH can provide assistance
if necessary.
NEW YORK STATE LAW
New York
State Law mandates that physicians must offer
an HIV test to all patients aged 13 years and older (or
younger with risk) if a previous test is not documented,
even in the absence of symptoms consistent with acute
HIV.
Effective November 28, 2016, amendments to the New York State
Public Health Law removed the requirement for written or
oral informed consent prior to ordering an HIV-related test,
including elimination of written consent for HIV testing in
New York State correctional facilities and removing
references to consent forms. The objective of the update is
to eliminate barriers to HIV testing and make HIV testing
comparable to the manner in which other important laboratory
tests are conducted. HIV testing remains voluntary, and
patients have the right to refuse an HIV test, but obtaining
written or oral consent for testing is no longer required in
any setting. At a minimum, patients must be advised orally
that an HIV test is going to be performed.
NYS Public Health Law Article 21 (Chapter 163 of the Laws of
1998) requires the reporting of individuals with HIV as well
as AIDS to the NYSDOH. The law also requires that reports
contain the names of sex or needle-sharing partners known to
the medical provider or whom the infected individual wishes
to have notified. The Medical Provider Report Form (PRF)
(DOH-4189) must be completed within 14 days of diagnosis for
individuals with the following diagnoses or with known sex
or needle-sharing partners:
Initial/new HIV diagnosis: First report of HIV
antibody positive test results.
Previously diagnosed HIV infection (non-AIDS):
Applies to a medical provider who is seeing the
patient for the first time.
Initial/new diagnosis of AIDS: Including <200 CD4
cells/µL or opportunistic infection (AIDS-defining
illness).
Previously diagnosed AIDS: Applies to a medical
provider who is seeing the patient for the first
time.
Known sex or needle-sharing partners of individuals
with diagnosed HIV infection.
Guideline Development
This guideline was developed by the NYSDOH AI Clinical Guidelines Program, which is a collaborative effort between the NYSDOH AI Office of the Medical Director and the Johns Hopkins University School of Medicine, Division of Infectious Diseases.
Established in 1986, the goal of the Clinical Guidelines Program is to develop and disseminate evidence-based, state-of-the-art clinical practice guidelines to improve the quality of care provided to people who have HIV, HCV, or sexually transmitted infections; people with substance use issues; and members of the LGBTQ community. NYSDOH AI guidelines are developed by committees of clinical experts through a consensus-driven process.
The NYSDOH AI charged the Medical Care Criteria Committee (adult HIV and related guidelines) with developing evidence-based clinical recommendations for the diagnosis and management of acute HIV infection. The resulting recommendations are based on an extensive review of the medical literature and reflect a consensus among this panel of experts. Each recommendation is rated for strength and quality of the evidence (see below). If recommendations are based on expert opinion, the rationale for the opinion is included.
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| NYSDOH AI Clinical Guidelines Program
Ratings Scheme, Updated June 26, 2019 [a] |
|---|
| Strength of Recommendation Ratings |
|---|
A
B
C | Strong recommendation
Moderate recommendation
Optional |
| Quality of Supporting Evidence Ratings |
|---|
|
1
|
Indicates that the evidence supporting a
recommendation is derived from published results of
at least one randomized trial with clinical outcomes
or validated laboratory endpoints.
|
|
*
|
Indicates that the evidence supporting a
recommendation is strong because it is based on a
self-evident conclusion(s) or conclusive, published
in vitro data, or because the recommendation
articulates well-established, accepted practice that
cannot be tested because ethics would preclude a
clinical trial.
|
|
2
|
Indicates that the evidence supporting a
recommendation is derived from published results of
at least 1 well-designed, nonrandomized clinical
trial or observational cohort study with long-term
clinical outcomes.
|
|
2†
|
Indicates that the evidence supporting a
recommendation has been extrapolated from published
results of well-designed studies (including
nonrandomized clinical trials) conducted in
populations other than those specifically addressed
by a recommendation. One example would be results of
studies conducted predominantly in a subpopulation
(e.g., one gender) that the committee determines to
be generalizable to the population
under consideration in the guideline. When this
rating is assigned to a recommendation, the
source(s) of the extrapolated evidence and the
rationale for the extrapolation are provided in the
guideline text.
|
|
3
|
Indicates that a recommendation is based on the
expert opinion of the committee members. The
rationale for the recommendation is provided in the
guideline text.
|
a. With the June 2019 update, the ratings for quality of
supporting evidence were expanded to add the * rating and
the 2† rating.
