Exclusives, Operations

Major Changes in HIV Testing and Post-exposure Follow Up

Scanning electromicrograph of an HIV-infected T cell. (Image/NIAID)

Introduction

So very much has been learned about the human immunodeficiency virus (HIV) since it first appeared in the late 1970s. Long-term studies of infected persons and their response to newer medications has led to several changes in testing and post exposure medical follow up. It is important that all members of the healthcare team be aware of the current science and how it has brought about significant changes in post-exposure testing and medical follow up.

This article is designed to raise awareness of these changes to ensure that an exposed healthcare worker (HCW) receives proper care required by the Occupational safety and Health Administrations (OSHA) requirements under their bloodborne pathogens regulation (1910.1030). This OSHA regulation states that the “employer” must insure that an exposed employee receives proper care and counseling. Proper care is outlined by OSHA’s reference to the Centers for Disease Control and Prevention (CDC) post exposure guidelines and recommendations. Reference to this can be found in the OSHA compliance directive CPL 02-02.069.

A Brief History

The timeline for HIV begins in the 1900s when the spread of this disease transferred from chimpanzees to humans. It appears that the first AIDS case occurred in the mid-west in a 16-year-old boy. Based on this retrospective information, it is believed that HIV/AIDs arrived in the United States before 1966. It was in 1984 that the HIV virus was determined to be the cause of AIDS. By 1995, AIDS became a leading cause of death in the U.S. for persons aged 24 to 44. That demographic has changed significantly.

Changes began with Medications for Those Infected

Significant shifts began with the developed of multi-drug therapies. By 1997, new treatments led to a 47% reduction in AIDS deaths. In 1996, some 38,780 persons died as a result of HIV infection. By 2000, the death rate had declined to 14,499 due to the availability of newer drug treatments. 

Antiviral medications became the foundation for treatment of HIV infected persons. It all started with the drug AZT; this was referred to as monotherapy. Thereafter came a switch to multi-drug therapy which required a very strict schedule for medications. For many, adhering to this schedule was very difficult. Antivirals worked to prevent the HIV virus from reproducing, thereby diminishing the amount of circulating virus.

This knowledge brought about the opportunity to move to combination therapy. Most often used was a triple drug cocktail or Highly Active Antiretroviral Therapy (HAART). Today, this is more commonly referred to as ART (antiretroviral therapy).

Triple drug treatment is readily available to all patients in need of treatment and medications. This wide availability was facilitated by the Ryan White Care Act of 1990 which funded HIV treatment programs across the country. Today, there are a wide variety of funding programs as well as housing programs in place for HIV patients across the country.

Changes in Testing

Rapid HIV test kits entered the market in 2003. These kits made testing for HIV infection widely available; results are ready in twenty minutes and have a 96% accuracy. Post exposure rapid HIV testing is now the standard of care enforced by OSHA. Medical facilities are required to perform rapid HIV testing on source patients. Rapid tests were not only fast and accurate they were low cost between $10 to $20. Another benefit is that several of the rapid tests in the marketplace are “waivered,” which means they can be performed in an emergency department, doctors office or clinic. This means that small rural hospitals, for example, do not need to send blood out for testing. Testing can be done on site.

Although concerns have been expressed about HIV negative sources who might be in the so-called “window period” before seroconversion (ie, the period of time between initial HIV infection and the development of detectable HIV antibodies), no such instances of occupational transmission have been reported in the United States to date. Hence, investigation of whether a source patient might be in the window period is unnecessary for determining whether HIV PEP (Post Exposure Prophylaxis) is indicated. The CDC published in 2005 that there was no window phase because the rapid test actually screens for virus proteins present before seroconversion.

Fourth-generation combination p24 antigen–HIV antibody (Ag/Ab) tests produce both rapid and accurate results, and their p24 antigen detection allows identification of most infections during the window period. The CDC noted in 2005 and again emphasized in 2013 that the is no window phase for HIV testing.  Rapid determination of source patient HIV status provides essential information about the need to initiate and/or continue post exposure prophylactic (PEP) medication. Rapid HIV testing is the medical standard of care and is OSHA enforced based on the CDC post exposure guidelines for HIV. Results from rapid testing on the source patient should take only 20-30 minutes. That being said, there is now a rapid test that gives results in one minute at a cost of only $8.

Viral Load Testing

Viral load testing has been found to be a more reliable marker in monitoring response to treatment. It assists with gauging responses to treatment. Successful treatment can reduce a vial load to levels deemed as “undetectable.” The term undetectable refers to less than 500 down to 40 copies of the virus per milliliter of blood. Remember that dose of an organism is key to the risk for transmission.

It has been well established that the use of ART not only improves the overall health of an infected person but is able to reduce the amount of virus in blood and body fluids. Medication and medical follow up to measure viral load is also important. Medical evidence shows that this combination results in on-going undetectable viral load.

Viral load testing on a source patient should take about two- to-three hours when performed in the medical facility. This testing is key to making a determination with regard to offering Post Exposure Prophylatic (PEP) medications. The CDC published, in January of 2018, in conjunction with the PEP resource center, a recommendation that there is up to 72 hours post exposure to offer PEP if the exposure meets established criteria.

The PEP Hotline is open from 11 am.to 8 p.m. EST seven days a week. If you are using the emergency department for your post exposure care, note that emergency department physicians or health care practitioner should call the PEP Hotline for a second opinion before these medications are prescribed. The hotline number is 888-448-4911. The extended time frame for offering PEP, if indicated, allows for healthcare worker referral for proper care and counseling.

Numerous studies have demonstrated that people taking ART and following medical recommendations for three to six months often have undetectable virus in their blood. The Food & Drug Administration (FDA) has approved a new medication that has been shown to lower HIV circulating virus to “undetectable” in eight to 24 weeks. What this means is that just because a patient is HIV positive is not enough information to suggest risk for transmission. Viral load is the key testing method. HIV infected persons are now able to live normal lives. From time of diagnosis to end of life is now reported to be 50 years.

However, should a source patient test positive with viral load, then baseline testing of the exposed healthcare worker should be performed.  The need for PEP would be determined by the type of exposure and the CDC guidelines for post exposure medical follow up. The health care worker would be tested six weeks after the baseline and the last test would be 4 months after the exposure and the rapid test would be used.

Consent for Testing

Each state has a law governing HIV testing. About half of the states require patient informed consent while the other half have what is termed “deemed consent.” Deemed consent means that the state has deemed the patient’s consent if there has been a health-care worker exposure. in 2006, the CDC published new guidelines for HIV testing. In these guidelines they outlined a new approach to testing patients in all healthcare settings.

A key statement in these guidelines was a “separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.” These guidelines also state that prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in healthcare settings. As a result of this publication, many medical facilities have added a statement on general consent to their form for authorization for care. With this in place, previous issues of consent and counseling can be eliminated.  However, there may be conflicts with some state testing laws.

Washington state has updated their state HIV testing law. This should lead the way for other states to follow. The new section of Washington state Senate Bill 6580 states “The legislature finds that great advances have been made in medical technology and treatment of the human immunodeficiency virus (HIV). HIV is treatable and a person living with HIV can lead a relatively healthy life, if they have access to health care and are able to achieve viral suppression. Additionally, if a person’s virus is undetectable, he or she is unable to transmit the virus. It is critical that people are tested for HIV. Therefore, the legislature finds that any and all barriers to HIV testing must be removed.” This law removed the requirement for HIV testing – consent and HIV testing opt out screening.  This is in keeping with the current science and recommend practice.

With all of this new and exciting news , it should be noted that on September 5, 2019 the CDC published that “occupationally acquired HIV would be considered a rare event.” It is important also to note that the number of healthcare workers with occupationally acquired HIV infection has not changed. From 1985 to 2019, there have been no new reported cases of occupational transmission. The last documented case of occupationally acquired HIV infection was reported in 1999.

The CDC is now requesting that HIV testing become a routine part of healthcare. This would assist in identification of persons who are not aware of their infection and get them started on treatment. This would benefit patients as well as care providers.

References

1. The History of HIV and AIDS in the United States, Healthline ,January, 2018.

2. Ryan White Care Act PL 101-381, Enacted by the U.S. Congress, 1990.

3. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis. David T. Kuhar, MD;1 David K. Henderson, MD;2 Kimberly A. Struble, PharmD;3 Walid Heneine, PhD;4 Vasavi Thomas, RPh, MPH; Laura W. Cheever, MD, ScM; Ahmed Gomaa, MD, ScD, MSPH; Adelisa L. Panlilio, MD; for the US Public Health Service Working Group.

4. Michael Shernoff and Raymond A. Smith, HIV Treatments: A History of Scientific Advance, The Body, July, 2001.

5. HIV Treatment and an undetectable viral load to prevent HIV transmission, CATIE, December, 2018.

6. PEP Quick Guide for Occupational Exposures, Clinician Consultation Center, January 1, 2018

7. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, MMWR, September 22, 2006/55(RR14):1-17

8. New Law Removes Barrier to Routine HIV Testing in Washington, Senate Bill 5680, March 21, 2018.